Clinical trial NCT02757768
Conditions: Benign Prostatic Hyperplasia Overactive Bladder
Keywords: Myrbetriq Lower Urinary Tract Symptoms Benign Prostatic Hyperplasia Overactive Bladder Betmiga Mirabegron Tamsulosin Hydrochloride
Sponsor: Astellas Pharma Global Development, Inc.
Start date: 2016-06-13; Completion date: 2018-09-11
Enrollment: 715 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study was to assess the efficacy, safety, and tolerability of mirabegron versus placebo in men with overactive bladder (OAB) symptoms while taking tamsulosin hydrochloride for lower urinary tract symptoms (LUTS) due to Benign Prostatic Hyperplasia (BPH).

Detailed description:
At Screening (Visit 1), participants entered into a 4-week open label tamsulosin hydrochloride 0.4 mg QD run-in period prior to being randomized into the 12-week double-blind treatment period (Visit 2). At conclusion of the 4-week tamsulosin hydrochloride run-in period, participants completed a 3-day diary just prior to Baseline (Visit 2). Approximately 7 days prior to Visit 2 participants received a phone call reminding them about the diary and to answer any questions.

If participants met all entry criteria at the end of the tamsulosin hydrochloride run-in period, participants were randomized to 1 of 2 treatment groups (mirabegron or placebo) for 12 weeks of treatment in addition to the continuation of tamsulosin hydrochloride 0.4 mg QD. Those participants randomized to Mirabegron started at 25 mg and increased to 50 mg after 4 weeks. Those participants randomized to placebo started blinded product matched to the mirabegron 25 mg tablet and increased to blinded product matched to 50 mirabegron after 4 weeks. Once a participant increased dose, the participant remained on that dose for the remainder of the study unless for safety reasons was required to discontinue study drug.

A training diary was completed in the first 2 weeks of the tamsulosin hydrochloride run-in period. During this evaluation period at least one telephone contact took place with the participant. Diaries were completed at home, using the electronic patient-reported outcome (ePRO) device, for 3 consecutive days prior to each visit: Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4), and Week 12/End of Treatment (Visit 5). Site staff contacted the participant approximately 7 days prior to the scheduled visit to remind the participant to complete the electronic diary, review completion instruction and review changes to concomitant medications and adverse events (if applicable).

Three days before Visits 2 (Baseline), 3 (Week 4), 4 (Week 8), and 5 (Week 12), participants completed a 3-day diary, using the ePRO device in which the participant recorded micturition frequency, urgency (PPIUS), incontinence and volume voided. In addition, the diary captured morning and evening blood pressure and pulse rate measurements via Home Blood Pressure Monitoring (HBPM). At Visit 1, International Prostate Symptom Score (IPSS) was completed. At Visits 2, 3, 4, and 5, participants completed the IPSS, EQ-5D-5L, OAB-q, PPBC, and TS-VAS. Maximum urinary flow (Qmax) was measured at Visit 1 (Screening/tamsulosin hydrochloride run-in) and Visit 5 (Week 12/End of Treatment). Post-void residual volume (PVR) was assessed at Screening/tamsulosin hydrochloride run-in (Visit 1), Baseline (Visit 2) and at Week 4 (Visit 3), Week 8 (Visit 4), and Week 12/End of Treatment (Visit 5). A follow-up phone call (Visit 6) was conducted 4-weeks after End of Treatment (Visit 5). Total study participation was approximately 20 weeks.

Arms: arm 1: Participants received initial dose of 25 mg of mirabegron which was increased to 50 mg after 4 weeks. In addition to mirabegron participants received 0.4 mg of oral tamsulosin hydrochloride daily throughout the study. arm 2: Participants received matching placebo in addition to oral tamsulosin hydrochloride daily throughout the study.
Interventions: intervention 1: Mirabegron intervention 2: Placebo intervention 3: Tamsulosin Hydrochloride
Intervention descriptions: intervention 1: Participants received initial dose of 25 mg of mirabegron (oral tablet) which was increased to 50 mg after 4 weeks. intervention 2: Participants received initial dose of 25 mg of matching placebo (oral tablet) which was increased to 50 mg after 4 weeks. intervention 3: Participants received once daily treatment with tamsulosin hydrochloride 0.4 mg (oral tablet) throughout the study.

Protocol documents:
Prot_000.pdf: 
A Phase 4, Double-Blind, Randomized, Placebo-controlled, Multi-
Center Study to Evaluate the Efficacy, Safety, and Tolerability of 
Mirabegron in Men with Overactive Bladder (OAB) Symptoms
While Taking the Alpha Blocker Tamsulosin Hydrochloride for 
Lower Urinary Tract Symptoms (LUTS) due to Benign Prostatic 
Hyperplasia (BPH)
PLUS
ISN/Protocol 178-MA-1008
ClinicalTrials.gov Identifier: NCT02757768
Date of Protocol Version 5.2: 22 Jan 2018
Sponsor: Astellas Pharma Global Development, Inc.
Medical Affairs, Americas
1 Astellas Way
Northbrook, IL 60062, USA


Sponsor: APGD, Medical Affairs, Americas
ISN/Protocol 178-MA-1008
EudraCT 2015-004036-36
- CONFIDENTIAL -
22 Jan 2018
Astellas
Page 1 of 87
A Phase 4, Double-Blind, Randomized, Placebo-controlled, Multi-
Center Study to Evaluate the Efficacy, Safety, and Tolerability 
of Mirabegron in Men with Overactive Bladder (OAB) Symptoms 
While Taking the Alpha Blocker Tamsulosin Hydrochloride
for Lower Urinary Tract Symptoms (LUTS) due to 
Benign Prostatic Hyperplasia (BPH)
PLUS
ISN/Protocol 178-MA-1008
Version 5.2
Incorporating Substantial Amendment 4 [See Attachment 1]
22 January 2018
IND 69,416
EudraCT 2015-004036-36
Sponsor:
Astellas Pharma Global Development, Inc.
Medical Affairs, Americas
1 Astellas Way
Northbrook, IL 60062
Investigator information is on file at Astellas.  
--------------------------------------------------------------------------------------------------------------------------------------
This confidential document is the property of the Sponsor.  No unpublished information contained in this 
document may be disclosed without prior written approval of the Sponsor.


Sponsor: APGD, Medical Affairs, Americas
ISN/Protocol 178-MA-1008
EudraCT 2015-004036-36
- CONFIDENTIAL -
22 Jan 2018
Astellas
Page 2 of 87
Table of Contents
I.
SIGNATURES ······················································································ 8
II.
CONTACT DETAILS OF KEY SPONSOR’S PERSONNEL····························10
III.
LIST OF ABBREVIATIONS AND DEFINITION OF KEY TERMS ··················12
IV.
SYNOPSIS··························································································17
V.
FLOW CHART AND SCHEDULE OF ASSESSMENTS·································24
1
INTRODUCTION·················································································28
1.1
Background ····················································································28
1.2
Summary of Non-clinical and Clinical Data···············································29
1.2.1
Mirabegron (YM178) ···································································29
1.2.1.1
Summary of Non-clinical Studies of Mirabegron······························29
1.2.1.2
Summary of the Pharmacokinetics of Mirabegron ····························30
1.2.1.3
Summary of Clinical Data with Mirabegron ···································30
1.2.2
Tamsulosin Hydrochloride ·····························································32
1.2.2.1
Summary of Non-clinical Studies of Tamsulosin Hydrochloride············32
1.2.2.2
Summary of the Pharmacokinetics of Tamsulosin Hydrochloride···········33
1.2.2.3
Summary of Clinical Data with Tamsulosin Hydrochloride··················33
1.3
Summary of Key Safety Information for Study Drugs ···································34
1.3.1
Summary of Key Safety Information for Mirabegron ······························34
1.3.2
Summary of Key Safety Information for Tamsulosin Hydrochloride·············35
1.3.3
Summary of Key Safety Information for Combination of Mirabegron and 
Tamsulosin Hydrochloride ·····························································35
1.4
Risk-Benefit Assessment·····································································36
2
STUDY OBJECTIVE(S), DESIGN, AND ENDPOINTS ··································36
2.1
Study Objectives ··············································································36
2.2
Study Design and Dose Rationale···························································37
2.2.1
Study Design·············································································37
2.2.2
Dose Rationale···········································································38
2.3
Endpoints·······················································································38
2.3.1
Primary Endpoints·······································································38
2.3.2
Secondary Endpoints····································································38
2.3.3
Exploratory Endpoint ···································································39
2.3.4
Safety Variables ·········································································39


Sponsor: APGD, Medical Affairs, Americas
ISN/Protocol 178-MA-1008
EudraCT 2015-004036-36
- CONFIDENTIAL -
22 Jan 2018
Astellas
Page 3 of 87
3
STUDY POPULATION··········································································39
3.1
Selection of Study Population ·······························································39
3.2
Inclusion Criteria··············································································39
3.3
Exclusion Criteria ·············································································40
4
TREATMENT(S)··················································································42
4.1
Identification of Investigational Product(s) ················································42
4.1.1
Test Drug(s)··············································································42
4.1.2
Concomitant Medication ·······························································43
4.1.3
Placebo····················································································43
4.2
Packaging and Labeling ······································································43
4.3
Study Drug Handling ·········································································43
4.4
Blinding ························································································44
4.4.1
Blinding Method·········································································44
4.4.2
Confirmation of the Indistinguishability of the Study Drugs ······················44
4.4.3
Retention of the Assignment Schedule and Procedures for Treatment Code 
Breaking ··················································································45
4.4.4
Breaking the Treatment Code for Emergency ·······································45
4.4.5
Breaking the Treatment Code by the Sponsor ·······································45
4.5
Assignment and Allocation ··································································45
5
TREATMENTS AND EVALUATION························································46
5.1
Dosing and Administration of Study Drug(s) and Other Medication(s)················46
5.1.1
Dose/Dose Regimen and Administration Period ····································46
5.1.2
Increase or Reduction in Dose of the Study Drug(s)································46
5.1.3
Previous and Concomitant Treatment (Medication and Non-Medication 
Therapy) ··················································································46
5.1.3.1
Previous Medication (Drugs and Therapies) ···································46
5.1.3.2
Concomitant Medication (Drugs and Therapies) ······························47
5.1.4
Treatment Compliance··································································47
5.2
Demographics and Baseline Characteristics ···············································48
5.2.1
Demographics············································································48
5.2.2
Medical History··········································································48
5.2.3
Diagnosis of the Target Disease, Severity, and Duration of Disease··············48
5.3
Efficacy Assessment··········································································48
5.3.1
Patient Diary – Micturition and Incontinence········································48


Sponsor: APGD, Medical Affairs, Americas
ISN/Protocol 178-MA-1008
EudraCT 2015-004036-36
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22 Jan 2018
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5.3.2
Patient Perception of Intensity of Urgency Scale (PPIUS)·························49
5.3.3
Total Urgency and Frequency Score (TUFS) ········································50
5.3.4
International Prostate Symptom Score (IPSS) ·······································50
5.3.5
OAB Symptoms, Quality of Life, Bladder Health and Treatment Benefit ·······50
5.3.5.1
Overactive Bladder-questionnaire (OAB-q)····································50
5.3.5.2
Patient Perception of Bladder Condition (PPBC)······························51
5.3.5.3
EQ-5D-5L ··········································································51
5.3.5.4
Treatment Satisfaction – Visual Analog Scale (TS-VAS) ····················51
5.4
Safety Assessment ············································································51
5.4.1
Vital Signs················································································51
5.4.2
Patient Diary – Subject Measurement Vital Signs···································52
5.4.3
Adverse Events ··········································································53
5.4.3.1
Adverse Events of Possible Hepatic Origin ····································53
1.1.1.1
Adverse Events of Special Interest ··············································53
5.4.4
Laboratory Assessments································································53
5.4.5
Physical Examination···································································55
5.4.6
Electrocardiogram (ECG) ······························································55
5.4.7
Post-Void Residual Volume (PVR) ···················································56
5.4.8
Uroflowmetry············································································56
5.4.9
Follow-up Phone Call to Patients······················································56
5.5
Adverse Events and Other Safety Aspects ·················································56
5.5.1
Definition of Adverse Events (AEs) ··················································56
5.5.2
Definition of Serious Adverse Events (SAEs) ·······································57
5.5.3
Criteria for Causal Relationship to the Study Drug ·································58
5.5.4
Criteria for Defining the Severity of an Adverse Event ····························58
5.5.5
Reporting of Serious Adverse Events (SAEs) ·······································58
5.5.6
Follow-up of Adverse Events··························································60
5.5.7
Monitoring of Common Serious Adverse Events ···································60
5.5.8
Procedure in Case of Pregnancy·······················································60
5.5.9
Emergency Procedures and Management of Overdose ·····························60
5.5.10
Supply of New Information Affecting the Conduct of the Study··················60
5.6
Test Drug Concentration ·····································································60
5.7
Other Measurements, Assessments or Methods ···········································60
5.8
Total Amount of Blood·······································································61
6
DISCONTINUATION············································································61


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ISN/Protocol 178-MA-1008
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22 Jan 2018
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6.1
Discontinuation of Individual Subject(s)···················································61
6.2
Discontinuation of the Site···································································61
6.3
Discontinuation of the Study·································································62
7
STATISTICAL METHODOLOGY ···························································62
7.1
Sample Size····················································································63
7.2
Analysis Set····················································································63
7.2.1
Full Analysis Set ········································································63
7.2.2
Full Analysis Set - Incontinence (FAS-I)·············································63
7.2.3
Safety Analysis Set (SAF)······························································63
7.3
Demographics and Other Baseline Characteristics········································64
7.4
Analysis of Efficacy ··········································································64
7.4.1
Analysis of Primary Endpoint ·························································64
7.4.1.1
Primary Analysis···································································64
7.4.1.2
Secondary Analysis································································64
7.4.1.3
Subgroup Analysis·································································65
7.4.2
Analysis of Secondary Endpoints ·····················································65
7.4.3
Analysis of Exploratory Endpoints····················································65
7.5
Analysis of Safety·············································································66
7.5.1
Adverse Events ··········································································66
7.5.2
Laboratory Assessments································································66
7.5.3
Vital Signs················································································66
7.5.4
Physical Examination ···································································67
7.5.5
ECGs······················································································67
7.5.6
PVR ·······················································································67
7.5.7
Qmax ·······················································································67
7.6
Analysis of Pharmacokinetics ·······························································67
7.7
Analysis of Pharmacodynamics ·····························································67
7.8
Protocol Deviations and Other Analyses···················································68
7.9
Interim Analysis (and Early Discontinuation of the Clinical Study)····················68
7.10
Handling of Missing Data, Outliers, Visit Windows, and Other Information ·········68
8
OPERATIONAL AND ADMINISTRATIVE CONSIDERATIONS ····················68
8.1
Procedure for Clinical Study Quality Control ·············································68
8.1.1
Data Collection ··········································································68


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8.1.2
Specification of Source Documents···················································69
8.1.3
Clinical Study Monitoring······························································69
8.1.4
Direct Access to Source Data/Documents············································70
8.1.5
Data Management ·······································································70
8.1.6
Protocol Deviations ·····································································70
8.1.7
End of Trial in All Participating Countries···········································71
8.2
Ethics and Protection of Subject Confidentiality··········································71
8.2.1
Institutional Review Board (IRB) / Independent Ethics Committee (IEC) / 
Competent Authorities (CA) ···························································71
8.2.2
Ethical Conduct of the Study···························································71
8.2.3
Informed Consent of Subjects ·························································72
8.2.3.1
Subject Information and Consent················································72
8.2.3.2
Supply of New and Important Information Influencing the Subject’s 
Consent and Revision of the Written Information ·····························72
8.2.4
Subject Confidentiality ·································································72
8.3
Administrative Matters ·······································································73
8.3.1
Arrangement for Use of Information and Publication of the Clinical Study ·····73
8.3.2
Documents and Records Related to the Clinical Study ·····························73
8.3.3
Protocol Amendment and/or Revision················································73
8.3.4
Signatory Investigator for Clinical Study Report····································74
9
QUALITY ASSURANCE········································································74
10
STUDY ORGANIZATION······································································74
10.1
Independent Data-Monitoring Committee (IDMC) | Data and Safety Monitoring 
Board (DSMB) | Monitoring Committee | Other Evaluation Committee(s) ···········74
10.2
Other Study Organization ····································································74
10.2.1
Cardiovascular Adjudication Committee·············································74
10.2.2
Neoplasm Adjudication Committee···················································75
11
REFERENCES ····················································································76
12
APPENDICES ·····················································································79
12.1
Appendix 1: List of Prohibited and Restricted Concomitant Medications ·············79
12.2
Appendix 2: Liver Safety Monitoring and Assessment···································81
12.3
Appendix 3: Common Serious Adverse Events ···········································83
12.4
Appendix 4: Investigator Criteria for Hypertension ······································84
12.5
Appendix 5: Investigator Criteria for Tachycardia········································85


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EudraCT 2015-004036-36
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Page 7 of 87
13
ATTACHMENT 1: SUBSTANTIAL AMENDMENT 4 ···································86
14
SPONSOR’S SIGNATURES····································································87


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I.
SIGNATURES
1.  SPONSOR’S SIGNATURE
A Phase 4, Double-Blind, Randomized, Placebo-Controlled, Multi-Center Study to 
Evaluate the Efficacy, Safety, and Tolerability of Mirabegron in Men with Overactive 
Bladder (OAB) Symptoms While Taking the Alpha Blocker Tamsulosin Hydrochloride
for Lower Urinary Tract Symptoms (LUTS) due to Benign Prostatic Hyperplasia (BPH)
ISN/Protocol 178-MA-1008 / Version 5.2 / 22 January 2018
Required signatures (e.g. Protocol authors, Sponsor’s reviewers and contributors, etc.) are 
located in Section 14, Signatures; e-signatures (when applicable) are located at the end of 
this document.


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2.  INVESTIGATOR’S SIGNATURE
A Phase 4, Double-Blind, Randomized, Placebo-Controlled, Multi-Center Study to 
Evaluate the Efficacy, Safety, and Tolerability of Mirabegron in Men with Overactive 
Bladder (OAB) Symptoms While Taking the Alpha Blocker Tamsulosin Hydrochloride
for Lower Urinary Tract Symptoms (LUTS) due to Benign Prostatic Hyperplasia (BPH)
ISN/Protocol 178-MA-1008 / Version 5.2 / 22 January 2018
I have read all pages of this clinical study protocol for which Astellas is the Sponsor. I agree 
to conduct the study as outlined in the protocol and to comply with all the terms and 
conditions set out therein. I confirm that I will conduct the study in accordance with ICH 
GCP guidelines and applicable local regulations. I will also ensure that sub-Investigator(s) 
and other relevant members of my staff have access to copies of this protocol and the ICH 
GCP guidelines to enable them to work in accordance with the provisions of these 
documents.
Principal Investigator:
Signature:
Printed Name:
Date (DD Mmm YYYY)
Address:






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III.
LIST OF ABBREVIATIONS AND DEFINITION OF KEY TERMS
List of Abbreviations
Abbreviations
Description of abbreviations
ADR
Adverse Drug Reaction
AE
Adverse Event
ALP
Alkaline Phosphatase
ALT
Alanine Aminotransferase (GPT)
ANCOVA
Analysis of Covariance
APGD
Astellas Pharma Global Development
AST
Aspartate Aminotransferase (GOT)
AUC
Area under the concentration-time curve
AUCinf
Area under the plasma concentration – from time zero to infinity
AUCtau
Area under the plasma concentration – from time zero to tau
AUST
Astellas U.S. Technologies, Inc.
BOO
Bladder Outlet Obstruction
BP
Blood Pressure
BPH
Benign Prostatic Hyperplasia
Bpm
Beats per minute
BPO
Benign Prostatic Obstruction
BUN
Blood Urea Nitrogen
CA
Competent Authority
CBC
Complete Blood Count
Cfu
Colony Forming Unit
CI
Confidence Intervals
CRCL
Creatinine Clearance
Cmax
Maximum concentration
CRF
Case Report Form
CRO
Contract Research Organization
CTD
Clinical Trial Directive
CYP2D6
Cytochrome P450 2D6
CYP3A4
Cytochrome P450 3A4
CYP
Cytochrome P450
DBP
Diastolic Blood Pressure
DILI
Drug-induced Liver Injury
DMC
Data Monitoring Committee
DSMB
Data Safety Monitoring Board
ECG
Electrocardiogram
eCRF
Electronic Case Report Form
EDC
Electronic Data Capture
eGFR
Estimated Glomerular Filtration Rate
ESRD
End Stage Renal Disease
EOT
End of Treatment
ePRO
Electronic Patient Reported Outcome


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Abbreviations
Description of abbreviations
EQ-5D-5L
Measure of health status questionnaire developed by the EuroQol Group
EU
Europe
FAS
Full analysis set
FAS-I
Full analysis set – Incontinence
FDA
Food and Drug Administration
GCP
Good Clinical Practice
GGT/γ-GT
γ-Glutamyl Transpeptidase (GGT)
HBPM
Home Blood Pressure Monitoring
HCO3
Bicarbonate
HIPAA
Health Insurance Portability and Accountability Act
IB
Investigator’s Brochure
ICF
Informed Consent Form
ICH 
International Conference on Harmonization of Technical Requirements for 
Registration of Pharmaceuticals for Human Use
IEC
Independent Ethics Committee
INR
International Normalized Ratio
IPSS
International Prostate Symptom Score
IRB
Institutional Review Board
IRT
Interactive Response Technology
ISN
International Study Number
Kg
Kilogram
LA-CRF
Liver Abnormality  - Case Report Form
LCE
Leukocyte Esterase
LFT
Liver Function Tests
LOCF
Last Observation Carried Forward
LS
Least Square
LSO
Last Subject Out
LUTS
Lower Urinary Tract Symptoms
MedDRA
Medical Dictionary for Regulatory Activities
Mg
Milligram
Min
Minutes
mL
Milliliter
mmHg
Millimeter of Mercury
msec
Millisecond
N/n
Number
NASH
Non-Alcoholic Steatohepatitis
NA
North America
NDA
New Drug Application
OAB
Overactive Bladder
OAB-q
Overactive Bladder – questionnaire
OCAS
Oral Controlled Absorption System
PBO
Placebo


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Abbreviations
Description of abbreviations
PCS
Potentially Clinically Significant
PHI
Personal Health Information
PPBC
Patient Perception of Bladder Condition
PPIUS
Patient Perception of Intensity of Urgency Scale
PR
Pulse Rate
PRO
Patient Reported Outcomes
PTM
Placebo to Match
PTNS
Percutaneous Tibial Nerve Stimulation
PVR
Post-Void Residual Volume
QD
Once Daily
Qmax
Maximum urinary flow rate
QoL
Quality of Life
QT
Time interval between QRS complex to end of T wave
QTcF
Fridericia’s Correction Formula
SAE
Serious adverse event
SAF
Safety Analysis Set
SAP
Statistical Analysis Plan
SBP
Systolic Blood Pressure
SD
Standard Deviation
SE
Standard Error
SFL
Screen failure log
SOP
Standard Operating Procedure
SPC
Summary of Product Characteristics
SUSAR
Suspected unexpected serious adverse reactions
t ½
Terminal Elimination Half-Life
TBL
Total bilirubin
TEAE
Treatment Emergent Adverse Event
TMF
Trial Master File
TLF
Tables, Listings and Figures
TS-VAS
Treatment Satisfaction Visual Analog Scale
TUFS
Total Urgency and Frequency Score
ULN
Upper Limit of Normal
US
United States
UTI
Urinary Tract Infection
YM178
Mirabegron/Myrbetriq/Betmiga


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Definition of Key Study Terms
Terms
Definition of terms
Adverse Event
An adverse event is any untoward medical occurrence in a subject 
administered a study drug and which does not necessarily have a causal 
relationship with this treatment.
Baseline 
The baseline value is defined as the last measurement before the first dose of 
double-blind study drug. For variables based on the electronic diary, the 3 days 
of the diary recorded prior to the randomization visit will be used to derive 
these variables at baseline.
Discontinuation
The act of concluding participation, prior to completion of all protocol-
required elements, in a trial by an enrolled subject.
End of Study
The time of the last subject’s last protocol-defined assessment.
Enrolled
A screened subject who has received the study medication.
Frequency
The complaint of voiding too often during the day.
Incontinence
Any involuntary leakage of urine. For purposes of data analysis specifically for 
this study, both full void incontinence with or without any urgency as well as 
partial void incontinence with passed urine in the toilet will be considered as 
incontinence.
Micturition
Any voluntary micturition (episodes of incontinence only are not included).
Mixed urinary 
incontinence
The complaint of involuntary leakage associated with urgency and also with 
exertion, effort, sneezing or coughing.
Nocturia
Waking at night one or more times to void (i.e. any voiding associated with 
sleep disturbance between the time the subject goes to bed with the intention to 
sleep until the time the subject gets up in the morning with the intention to stay 
awake).
Overactive Bladder
Urgency, with or without urgency incontinence, usually with frequency and 
nocturia, which can be described as the OAB syndrome, urge syndrome or 
urgency-frequency syndrome.
Randomization
The process of assigning trial subjects to treatment or control groups using an 
element of chance to determine assignments in order to reduce bias.
Run-In Failure
Screened subject who did not fulfill protocol inclusion and/or exclusion 
criteria at Visit 2. Subjects who are considered a run-in failure cannot be re-
screened into the study at a later date.
Screened
A subject who has signed informed consent and has performed the screening 
visit.
Screening Failure
Screened subject who did not fulfill protocol inclusion and/or exclusion 
criteria, or decided not to participate anymore (withdrew consent) prior to Visit 
2. Subjects who are considered a screen failure at Visit 1 due to an acute 
condition that resolved (e.g., a treated UTI, an ECG that a cardiologist cleared, 
discontinuation of a prohibited or restricted medication) may be re-screened 
into the study at a later date.


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Terms
Definition of terms
Serious Adverse 
Event
An adverse event is considered “serious” if, in the view of either the 
Investigator or Sponsor, it results in any of the following outcomes: results in 
death, is life threatening, results in persistent or significant 
disability/incapacity or substantial disruption of the ability to conduct normal 
life functions, results in congenital anomaly, or birth defect, requires inpatient 
hospitalization or leads to prolongation of hospitalization, or a medically 
important event.
Stress urinary 
incontinence
The complaint of involuntary leakage on effort or exertion, or on sneezing or 
coughing.
Subject Number
Number assigned to each subject by the Interactive Response System after 
signature of informed consent and prior to any specific procedures.
Treatment-
Emergent Adverse 
Event
An adverse event starting or worsening in the period from first double-blind 
medication intake until 30 days after last double-blind medication intake.
Urgency
A sudden and compelling desire to pass urine that is difficult to defer.
Urgency Urinary 
Incontinence
The complaint of involuntary leakage accompanied by or immediately 
proceeded by urgency.


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IV.
SYNOPSIS
Date and Version # of Protocol Synopsis:
22 January 2018/Version 5.2
Sponsor:  Astellas Pharma Global Development Inc.
(APGD), Medical Affairs, Americas
Protocol Number:  178-MA-1008
Name of Study Drug: Mirabegron
Phase of Development:  4
Title of Study:  
A Phase 4, Double-Blind, Randomized, Placebo-Controlled, Multi-Center Study to Evaluate the 
Efficacy, Safety, and Tolerability of Mirabegron in Men with Overactive Bladder (OAB) Symptoms 
While Taking the Alpha-Blocker Tamsulosin Hydrochloride for Lower Urinary Tract Symptoms 
(LUTS) due to Benign Prostatic Hyperplasia (BPH)
Planned Study Period: 
From 2Q2016 to 2Q2018
Study Objective(s): 
Primary Objective:
To study the efficacy of mirabegron versus placebo in men with OAB symptoms while taking 
tamsulosin hydrochloride for LUTS due to BPH.
Secondary Objective:
To assess safety and tolerability of mirabegron versus placebo in men with OAB symptoms while 
taking tamsulosin hydrochloride for LUTS due to BPH.
Other Objectives:
To assess patient reported outcomes (PROs) as measured by Symptom Bother and Total Health 
Related Quality of Life scores as assessed by the Overactive Bladder-questionnaire (OAB-q), 
EQ-5D-5L, Patient Perception of Bladder Condition (PPBC), Patient Perception of Intensity of 
Urgency Scale (PPIUS), International Prostate Symptom Score (IPSS), and Treatment Satisfaction-
Visual Analog Scale (TS-VAS).
Planned Total Number of Study Centers and Location(s):  
Approximately 100 centers
North America and Europe
Study Population:  
Men ≥40 years of age with OAB symptoms who take tamsulosin hydrochloride for LUTS due to 
BPH.
Number of Subjects to be Enrolled / Randomized:  
Approximately 985 subjects will be screened to achieve 640 randomized and approximately 544
completed.
Subjects will be randomized 1:1.
320 randomized to mirabegron; 320 randomized to placebo


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Study Design Overview:  
This is a randomized, double-blind, placebo-controlled, parallel-group, multi-center study.
At Screening (Visit 1), subjects will enter into a 4-week open label tamsulosin hydrochloride 0.4 mg 
QD run-in period prior to being randomized into the 12-week double-blind treatment period (Visit 2).  
At the conclusion of the 4-week tamsulosin hydrochloride run-in period, subjects will complete a 
3-day diary just prior to Baseline (Visit 2). Approximately 7 days prior to Visit 2 subjects will receive 
a phone call reminding them about the diary and to answer any questions.
A training diary will be completed in the first 2 weeks of the tamsulosin hydrochloride run-in period. 
During this evaluation period at least one telephone contact will take place with the subject. Diaries 
will be completed at home, using the electronic patient-reported outcome (ePRO) device, for 
3 consecutive days prior to each visit: Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4), and 
Week 12/End of Treatment (Visit 5). Site staff will contact the subject approximately 7 days prior to 
the scheduled visit to remind the subject that they need to complete the electronic diary, review 
completion instructions and review changes to concomitant medications and adverse events (if 
applicable). 
If subjects meet all entry criteria at the end of the tamsulosin hydrochloride run-in period, subjects 
will be randomized to 1 of 2 treatment groups (mirabegron or placebo) for 12 weeks of treatment in 
addition to the continuation of tamsulosin hydrochloride 0.4 mg QD. Those subjects randomized to 
mirabegron will start at 25 mg and will increase to 50 mg after 4 weeks.  Those subjects randomized 
to placebo will start blinded product matched to the mirabegron 25 mg tablet and will increase to 
blinded product matched to 50 mg mirabegron after 4 weeks. Once a subject has increased dose, he 
will remain on that dose for the remainder of the study unless for safety reasons he is required to 
discontinue study drug.
Three days before Visits 2 (Baseline), 3 (Week 4), 4 (Week 8), and 5 (Week 12), subjects will 
complete a 3-day diary, using the electronic patient-reported outcome (ePRO) device in which they 
will record micturition frequency, urgency (PPIUS), incontinence and volume voided.  In addition the 
diary will capture morning and evening blood pressure and pulse rate measurements via Home Blood 
Pressure Monitoring (HBPM). At Visit 1, International Prostate Symptom Score (IPSS) will be 
completed. At Visits 2, 3, 4, and 5, subjects will complete the IPSS, EQ-5D-5L, OAB-q, PPBC, and 
TS-VAS.  Maximum urinary flow (Qmax) will be measured at Visit 1 (Screening/tamsulosin
hydrochloride run-in) and Visit 5 (Week 12/End of Treatment).  Post-void residual volume (PVR) 
will be assessed at Screening/tamsulosin hydrochloride run-in (Visit 1), Baseline (Visit 2) and at 
Week 4 (Visit 3), Week 8 (Visit 4) and Week 12/End of Treatment (Visit 5). A follow-up phone call 
(Visit 6) will be conducted 4-weeks after End of Treatment (Visit 5). Total study participation is 
approximately 20 weeks.
Inclusion:  
Inclusion Criteria assessed at Visit 1 (Screening):
1.
Institutional Review Board (IRB)/Independent Ethics Committee (IEC) – approved written 
Informed Consent and privacy language as per national regulations (e.g., HIPAA Authorization 
for US sites) must be obtained from the subject or legally authorized representative prior to any 
study-related procedures (including withdrawal of prohibited medication, if applicable).
2.
Men ≥40 years of age with history of OAB symptoms (urinary frequency and urgency with or 
without incontinence) while taking tamsulosin hydrochloride 0.4 mg daily for at least 2 months to 
treat LUTS due to BPH.
3.
Subject has symptoms of OAB (frequency of ≥8 micturitions per day and urgency episodes of 
≥2 per day) for ≥3 months prior to Screening.
4.
Subject has an IPSS score ≥8.


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5.
Subject has Prostate-Specific Antigen (PSA) <4 ng/mL OR PSA ≥4 but <10 ng/mL with a 
prostate biopsy that is negative for cancer in the past two years.
6.
Subject is willing and able to complete the 3-day diary (including urine volumes, vital sign 
measurements), and Quality of Life questionnaires.
7.
Subject and their spouses/partners who are of childbearing potential must be using a highly 
effective method of birth control, which includes established use of oral, injected or implanted 
hormonal methods of contraception, placement of an IUD or IUS. Birth control must be practiced 
from Screening and continue throughout the study and for 30 days after the final study drug 
administration. In addition, sperm donation will not be allowed throughout the study and for 
30 days after the final study drug administration.
8.
Subject agrees not to participate in another interventional study while on treatment.
Inclusion Criteria assessed at Visit 2 (Baseline) based on the 3-day diary:
9.
Subject continues to meet all inclusion criteria of Visit 1 (Screening).
10. Subject must experience an average of 8 or more micturitions per day over the 3-day diary period.
11. Subject must experience an average of 2 or more episodes of urgency per day (grade 3 or 4) over 
the 3-day diary period.
Waivers to the inclusion criteria will NOT be allowed.
Exclusion:  
Exclusion Criteria assessed at Visit 1 (Screening):
1.
Subject has PVR >200 mL.
2.
Subject has Qmax <5.0 mL/second with a minimum voided volume of 125 mL.
3.
Subject has hematuria >3 rbc/hpf that has not been fully evaluated.
4.
Subject has evidence of Urinary Tract Infection (UTI). Urine culture and sensitivity will be 
performed for positive leukocytes, nitrites, or turbidity, or at the Investigator’s discretion, and will 
be confirmed with a culture greater than 100,000 cfu/mL. If a subject has a UTI, at Screening 
(Visit 1) the subject may be rescreened after successful treatment of the UTI (confirmed by a 
laboratory result of negative urine culture).
5.
Subject has neurogenic bladder (spinal cord injury, multiple sclerosis, Parkinson’s etc.).
6.
Subject has diabetic neuropathy.
7.
Previous open, robotic or minimally invasive prostate surgery (including transurethral 
procedures). Planned (scheduled) pelvic or prostate surgery during the study period.
8.
Planned (scheduled) cataract or glaucoma surgery during the study period.
9.
Subject with significant stress incontinence as determined by the Investigator.
10. Subject with clinically significant bladder outlet obstruction as determined by the Investigator.
11. Subject has an indwelling catheter or practices intermittent self-catheterization.
12. Subject has experienced 3 or more episodes of recurrent urinary tract infection within the last 
12 months.
13. Subject has a symptomatic urinary tract infection, prostatitis, chronic inflammation such as 
interstitial cystitis, bladder stones, previous pelvic radiation therapy, or previous or current 
malignant disease of the pelvic organs (i.e., within the confines of the pelvis including the 
bladder, prostate and rectum; organs of the lower gastrointestinal tract are not necessarily 
considered pelvic organs such as the distal ascending colon, the full transverse colon and 
proximal portion of the descending colon are in the abdomen).
14. Subject has received intravesical injection in the past 12 months with botulinum toxin, 
resiniferatoxin, or capsaicin.
15. Subject has ever received electro-stimulation therapy for OAB (e.g. sacral nerve stimulation or 


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Percutaneous Tibial Nerve Stimulation [PTNS]).
16. Subject began or has changed a bladder training program or pelvic floor exercises less than 
30 days prior to Screening.
17. Subject has postural hypotension or syncope or postural orthostatic tachycardia.
18. Subject has moderate or severe hepatic impairment defined as Child-Pugh Class B or C.
19. Subject has severe renal impairment defined as estimated creatinine clearance less than 
29 mL/min/1.73 m2 as determined by central laboratory calculation of eGFR. A subject with End 
Stage Renal Disease (ESRD) or undergoing dialysis is also not a candidate for the study.
20. Subject has severe uncontrolled hypertension, which is defined as a sitting systolic blood pressure 
≥180 mmHg and/or diastolic blood pressure ≥110 mmHg.
21. Subject has baseline resting pulse rate <60 BPM or >90 BPM.
22. Subject has evidence of QT prolongation on Screening (Visit 1) or Baseline (Visit 2)
electrocardiogram (ECG) defined as QTcF >450 msec.
23. Subject has any clinically significant ECG abnormality, as determined by the Investigator.
24. Subject has AST or ALT >2x upper limit of normal (ULN), or γ-GT >3x ULN and considered 
clinically significant by the Investigator.
25. Subject has a hypersensitivity to any components of mirabegron, tamsulosin hydrochloride, or 
any of the inactive ingredients.
26. Subject has a history of angioedema.
27. Subject has any clinically significant condition, which in the opinion of the Investigator makes the 
subject unsuitable for study participation.
28. Subject has been treated with an experimental device within 28 days or received an 
investigational agent within 28 days or 5 half-lives, whichever is longer, prior to Screening.
29. Subject has a concurrent malignancy or history of any malignancy (within the past 5 years), 
except non-metastatic basal or squamous cell carcinoma of the skin that has been treated 
successfully.
30. Subject has ongoing alcohol and/or drug abuse.
31. Subject is using prohibited medications defined in Appendix 1, Part A within 30 days prior to 
Screening (Visit 1) through Follow-Up Phone Call (Visit 6).
32. Subject has stopped, started or changed the dose of a restricted medication (defined in
Appendix 1, Part B) within 30 days prior to Screening (Visit 1) through Follow-Up Phone Call 
(Visit 6).
33. Subject has participated in an interventional trial within 30 days prior to Screening (Visit 1).
34. Subject is involved in the conduct of the study as an employee of the Astellas group, third party 
associated with the study, or the study site team.
35. Subject has previously received mirabegron in the 6 months prior to Screening (Visit 1).
Exclusion Criteria assessed at Visit 2 (Baseline):
36. Subject was non-compliant during the 4-week tamsulosin hydrochloride run-in period, defined as 
taking less than 80% or greater than 120% of study medication.
37. Subject had an average total daily urine volume >3000 mL as recorded in the 3-day diary.
Waivers to the exclusion criteria will NOT be allowed.


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Test Drug Dose:
Mirabegron 25 mg QD for 4 weeks along with tamsulosin hydrochloride 0.4 mg capsule (US) / tablet 
(EU/CA). Mirabegron 25 mg dose will be titrated to mirabegron 50 mg QD at 4 weeks. Mirabegron 
50 mg dose will be maintained for the remaining 8 weeks of the study along with tamsulosin 
hydrochloride 0.4 mg capsule (US) / tablet (EU/CA).
Mode of Administration:
Oral same time each day (with or without food).
Study protocol recommends taking at the same time daily as the tamsulosin hydrochloride capsule
(US) / tablet (EU/CA). Tamsulosin hydrochloride should be taken 30 minutes following the same 
meal each day.
Reference Therapy Dose:
Placebo matched to mirabegron 25 mg QD for 4 weeks along with tamsulosin hydrochloride 0.4 mg
capsule (US) / tablet (EU/CA).
Dose will be titrated to placebo matched to mirabegron 50 mg at 4 weeks.
Placebo matched to mirabegron 50 mg will be maintained for the remaining 8 weeks of the study 
along with tamsulosin hydrochloride 0.4 mg capsule (US) / tablet (EU/CA).
Mode of Administration:
Oral same time each day (with or without food).
Study protocol recommends taking at the same time daily as the tamsulosin hydrochloride capsule
(US) / tablet (EU/CA). Tamsulosin hydrochloride should be taken 30 minutes following the same 
meal each day.
Drug(s) for Run-In Period: 
Tamsulosin hydrochloride capsule (US) / tablet (EU/CA).
Dose:
0.4 mg QD.
Mode of Administration: 
Oral taken each day approximately 30 minutes following the same meal.
Concomitant Medication Restrictions or Requirements:   
Prohibited Medications (Appendix 1, Part A)
Medications prohibited between Screening/tamsulosin hydrochloride run-in (Visit 1) and 
Week 16/Follow-up phone call (Visit 6) include other alpha-adrenergic blockers , anticholinergics, 
antispasmodics, strong and moderate inhibitors of CYP2D6 with narrow therapeutic index, 
specifically thioridazine, flecainide, propafenone, amitriptyline, paroxetine, and terbinafine, and 
moderate and strong inhibitors of CYP3A4 (see Appendix 1, Part A).  These medications must have 
been discontinued at least 30 days prior to Screening/tamsulosin hydrochloride run-in (Visit 1).
Current or previous use of mirabegron within 6 months prior to Screening (Visit 1) is also prohibited.
Restricted medications (Appendix 1, Part B)
Medications restricted between Screening/tamsulosin hydrochloride run-in (Visit 1) and Follow-up 
Phone Call (Visit 6) include loop diuretics, 5-Alpha reductase inhibitors and PDE5 inhibitors (see
Appendix 1, Part B). These medications are permitted provided the subject has been taking the 
medication on a long-term basis, i.e. has not stopped, or started, or changed dose within the 30 days 
prior to Screening/tamsulosin hydrochloride run-in (Visit 1), no new drug of the same class has been 
added to the regimen within the 30 days prior to Screening/tamsulosin hydrochloride run-in (Visit 1), 
and the subject remains on the medication at the same dose during the course of the study.  


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For 5-alpha reductase inhibitors the subject must have been taking the medication for at least 6 
months. No alpha-blockers other than tamsulosin hydrochloride are allowed. Intermittent use of PDE5 
inhibitors (e.g. tadalafil) for treating erectile dysfunction (ED) is allowed.  PDE5 inhibitors that are 
taken on a daily basis for the management of LUTS are not allowed. 
Restricted Non-Drug Therapy
Subjects participating in any behavioral modification therapy (i.e. pelvic floor exercises, Kegel 
exercises, biofeedback, timed voiding, etc.) or other nondrug therapy must have started the therapy 
within 30 days prior to Screening/tamsulosin hydrochloride run-in (Visit 1) and must continue the 
same schedule through Follow-Up Phone Call (Visit 6). Neurostimulation for OAB is a strict 
exclusion criterion.
Duration of Treatment:  
Subjects will be randomized to 1 of 2 treatment groups in a 1:1 randomization (mirabegron or 
placebo) for a maximum of 12 weeks after a 4 week run-in period on tamsulosin hydrochloride. A 
Follow-up phone call (Visit 6) will be completed 4 weeks after Week 12/End of Treatment (Visit 5). 
Subject participation will last approximately 20 weeks.
Endpoints for Evaluation:  
Primary:

Change from Baseline (Visit 2) to Week 12/End of Treatment (Visit 5) in mean number of 
micturitions per day based on a 3-day diary.
Secondary:

Change from Baseline (Visit 2) to Week 4, Week 8, and Week 12/End of Treatment (Visit 5) 
in mean volume voided per micturition.

Change from Baseline (Visit 2) to Week 4, Week 8, and Week 12/End of Treatment (Visit 5) 
in mean number of incontinence episodes per day (FAS-I).

Change from Baseline (Visit 2) to Week 4, Week 8, and Week 12/End of Treatment (Visit 5) 
in mean number of urgency episodes (grade 3 and 4) per day.

Change from Baseline (Visit 2) to Week 4, Week 8, and Week 12/End of Treatment (Visit 5) 
in IPSS total score and subscales (Voiding, Storage, and Quality of Life).

Change from Baseline (Visit 2) to Week 4, Week 8, and Week 12/End of Treatment (Visit 5) 
in mean number of urgency incontinence episodes per day (FAS-I).

Change from Baseline (Visit 2) to End of Treatment (Visit 5) in Symptom Bother Total 
Health related quality of life and subscale (coping, concern, sleep, social interaction, and 
symptom bother) scores as assessed by OAB-q questionnaire.

Change from Baseline (Visit 2) to Week 4, Week 8, and Week 12/End of Treatment (Visit 5) 
as assessed by EQ-5D-5L questionnaire.

Change from Baseline (Visit 2) to Week 4, Week 8, and Week 12/End of Treatment (Visit 5) 
in PPBC.

Change from Baseline (Visit 2) to Week 4, Week 8, and Week 12/End of Treatment (Visit 5) 
in Total Urgency and Frequency Score (TUFS) using PPIUS (Grade 3 or 4).

Change from Baseline (Visit 2) to Week 4, Week 8, and Week 12/End of Treatment (Visit 5) 
in mean number of nocturia episodes per day.

Change from Baseline (Visit 2) to Week 4, Week 8, and Week 12/End of Treatment (Visit 5) 
in TS-VAS scores. 

Change from Baseline (Visit 2) to Week 4, Week 8, and Week 12/End of Treatment (Visit 5) 
in the number of protective garments (e.g. absorbent pads, incontinence briefs, disposable 
underwear).


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Exploratory:

Performance of subgroup analyses by PSA cutoff scores for < 2, 2-4. 
Safety Variables:

Incidence and severity of treatment emergent adverse events (TEAEs) including AEs of 
special interest.

Vital signs: sitting systolic and diastolic blood pressure and pulse rate (home blood pressure
monitoring [HBPM] and office measurements).

ECG parameters (heart rate, PR, RR, QRS, QT, QTcF intervals).

Laboratory parameters (hematology, serum chemistry, including liver function tests, and 
urinalysis).

PVR and Qmax.
Statistical Methods: See Section 7 STATISTICAL METHODOLOGY
Sample size justification: 
The primary endpoint for this study is change from Baseline to End of Treatment in mean number of 
micturitions per day based on a 3-day diary. 
A number of 272 evaluable subjects per treatment group provides 80% power to detect a reduction of 
0.65 in the mean number of micturitions per day over placebo in the mirabegron group at an alpha 
level of 0.05.  A standard deviation of 2.7 for change from Baseline in micturitions was assumed. 
If 85% of the randomized subjects are evaluable, 640 subjects should be randomized.  With an 
expected drop-out rate of 35% by the end of the tamsulosin hydrochloride run-in phase (V2), 985
subjects need to be screened.
Safety:  
Safety analyses will be done on the Safety Analysis Set (SAF), which consists of subjects who 
received at least one dose of double-blind medication.  Treatment emergent adverse events will be 
coded using the MedDRA dictionary and will be summarized by treatment group. The number and 
percentage of treatment-emergent AEs, SAEs, AEs leading to discontinuation, and AEs related to 
study drug will be summarized by system organ class, preferred term and treatment group. Laboratory 
variables (biochemistry, hematology, and urinalysis) will be descriptively summarized for Baseline 
(Visit 2), Week 4, Week 8, and Week 12/End of Treatment and change from Screening to End of 
Treatment will be summarized by treatment group. Vital sign changes will be summarized by 
treatment group.  Categorical changes in vital signs will also be examined. In addition, post-void 
residual volumes as measured by bladder sonography and Qmax will be summarized by change from 
baseline.  Centrally assessed ECGs will also be summarized by treatment group.
Interim analyses: 
Not applicable.


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V.
FLOW CHART AND SCHEDULE OF ASSESSMENTS
Flow Chart
mirabegron 25 mg QD 
plus tamsulosin
hydrochloride 0.4 mg QD
mirabegron 50 mg QD
plus tamsulosin hydrochloride 0.4 mg QD
placebo matched to 
mirabegron 25 mg QD 
plus tamsulosin 
hydrochloride 0.4 mg QD
placebo matched to mirabegron 50 mg
plus tamsulosin hydrochloride 0.4 mg QD
Treatment 
Period
Open-label
V
V
V
V
V
Screening/tams
ulosin 
hydrochloride
Follow-up 
Phone Call 
V
Double-blind
(4
(8
Randomiz


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Table 1
Schedule of Assessments
Screening/
Tamsulosin 
Hydrochloride  Run-
In
Treatment Period
Follow-up 
Phone Call
Visit
1
2
3
4
5
6
Day
-28
1
28
56
84
114
Week
-4
0
4
8
12
16
Visit Windows
+/- 3 d
—
+/- 7 d
+/- 7 d
+/- 7 d
+/- 3 d
Visit Windows (Study Days) a
-31 to -25
—
21 to 35
49 to 63
77 to 91
111-117
Informed Consent
X
Inclusion/Exclusion Criteria
X
X
Medical History and OAB History
X
Demographics
X
Enter 4-week tamsulosin hydrochloride run-in b
X
Reminder Phone Call c
X
X
X
X
Randomization d
X
Physical Exam 
X
X
Weight and Height
X
Office Visit Vital Signs (pulse and blood pressure)
X
X
X
X
X
Serum PSA
X
Serum chemistry, hematology & urinalysis e, f
X
X
X
X
X
12-Lead ECG g
X
X
X
X
X
PVR (Ultrasonography or Bladder Scan)
X
X
X
X
X
Uroflowmetry (Qmax) h
X
X
IPSS
X
X
X
X
X
Medication History and OAB Medication History i
X
Concomitant Medications Assessment
X
X
X
X
X
X
Adverse Event Assessment j
X
X
X
X
X
X
Dispense Study Drug 
X
X
X
X
Drug Accountability
X
X
X
X
Dose Titration k
X
Instruct Subject on 3-day Diary l
X
X
X
X
Subject Completes 3-day Diary including HBPM
Xm
Xm
Xm
Xm
EQ-5D-5L
X
X
X
X
Table continued on next page


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Screening/
Tamsulosin 
Hydrochloride  Run-
In
Treatment Period
Follow-up 
Phone Call
Visit
1
2
3
4
5
6
Day
-28
1
28
56
84
114
Week
-4
0
4
8
12
16
Visit Windows
+/- 3 d
—
+/- 7 d
+/- 7 d
+/- 7 d
+/- 3 d
Visit Windows (Study Days) a
-31 to -25
—
21 to 35
49 to 63
77 to 91
111-117
OAB-q
X
X
X
X
PPBC 
X
X
X
X
PPIUS
X
X
X
X
TS-VAS
X
X
X
X
Review Subject Diary n
X
X
X
X
a. After Visit 1 (Screening/tamsulosin hydrochloride run-in), visit windows/study days will be calculated based on the Visit 2 (Baseline) visit date. Study procedures (e.g., bladder 
scan) for a particular visit do not need to be completed on the visit date if this is not feasible for the subject, as long as study procedures are performed per protocol within the 
applicable visit window. Any procedure not done or performed outside the applicable visit window will be noted as a protocol excursion.
b. Subjects must take at least 22 days, but no more than 34 days of tamsulosin hydrochloride run-in medication.
c. Reminder Phone Call to complete the diary and to answer any questions is to occur approximately 7 days prior to the visit.
d. Randomization is to occur after confirming all eligibility criteria and after performing all other visit procedures at Visit 2.
e. Blood samples need not be fasting. A central laboratory will be used for all laboratory hematology and biochemistry/PSA assessments. Local laboratories will be used for all 
urinalysis and urine culture and sensitivity. 
f. Urine culture and sensitivity must be performed for positive leukocyte esterase (LCE), nitrites, or turbidity, or at the discretion of the PI. It is not required to send isolated trace 
positive leukocyte esterase samples for culture. If a subject has a UTI (defined as > 100,000 CFU), the subject may be rescreened after successful treatment of the UTI 
(confirmed by a laboratory result of negative urine culture).
g. ECGs will be submitted to a central laboratory. Initial inclusion will be based on PI interpretation of ECG eligibility at Screening (Visit 1) and Baseline (Visit 2); however, if 
the QTcF interval is >450 ms on the printed ECG at Baseline (Visit 2), an expedited central ECG reading (within 24 hours) should be requested and reviewed before the subject 
is allowed to be randomized. Final central readings must be reviewed by the Investigator for the duration of the study for immediate safety assessment and subject care.
h. Qmax can be completed within two weeks of Screening (Visit 1). The subject must void a minimum of 125 mL for the uroflow measurement to be considered adequate.
i.
All medications taken within 30 days prior to Screening (Visit 1) must be recorded in the eCRF.
j.
Adverse Event collection will begin from the time of informed consent and continue through the Follow-up Phone Call (Visit 6).
k. All subjects will be titrated to the 50 mg dose of mirabegron or placebo to match (PTM) after 4 weeks of treatment. Patients will remain on 0.4 mg of tamsulosin hydrochloride 
for the duration of the study.
Footnotes continued on next page


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l.
At the Screening/tamsulosin hydrochloride run-in (Visit 1), all subjects will be provided with an ePRO device (electronic diary) that will be used to record the date and time of 
each  micturition, incontinence, urgency episode, measure of urine volume voided, sleep interruption, and protective garments. Home measurements of am and pm pulse rate 
and systolic and diastolic blood pressure will be electronically captured in the diary. Additionally, the diary will be used to record medication intake every day during the study, 
as well as to complete questionnaires. Training on device use must be done at Visit 1 and as necessary throughout the study.  Approximately 7 days prior to Visit 2 subjects will 
receive a phone call reminding them about the diary and to answer any questions. Subjects will be instructed to begin completing the electronic diary 3 days prior to each in 
office study visit including Visit 2 (Baseline), Visits 3 - 5 (Treatment Period) and to complete the diary for the full 3 days.  
m. For Visits 2, 3, 4 and 5, subjects will complete the electronic diary (including am and pm HBPM) for the 3 days prior to the study visit.
n. Investigator, or designee, must review the subject’s diary with the subject to ensure completion compliance and discuss data captured.


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1
INTRODUCTION
1.1
Background
Overactive bladder (OAB) syndrome is a highly prevalent medical condition. The prevalence 
of OAB is estimated to be 34 million in the US and 22 million in Europe [Irwin et al, 2009; 
Kim et al, 2006; Stewart et al, 2003; Milsom et al, 2001]. International Continence Society 
(ICS) defines OAB as urgency, with or without urge incontinence, usually with frequency 
and nocturia [Abrams et al, 2003; Lee and Lee, 2014]. Prevalence of OAB symptoms 
increases with age, and the prevalence of OAB wet (with incontinence) is greater in women 
than in men [Jaffe and Te, 2005]. In clinical practice, it is recognized that men may 
experience OAB symptoms concurrent with those of benign prostatic hyperplasia (BPH).
BPH is a condition affecting over 50% of men by age 60 [Bechis et al, 2014]. It is also a 
common cause of lower urinary tract symptoms (LUTS) such as frequent urination, urgency, 
nocturia, and the sensation of incomplete bladder emptying [Miller and Tarter, 2009]. In 
2008, an estimated 917 million men worldwide were affected by LUTS from BPH [Irwin et 
al, 2011]. LUTS can be divided into storage and voiding symptoms, with BPH predominantly 
associated with voiding LUTS symptoms. Patients with voiding symptoms may also have 
concomitant storage symptoms. Analysis of the general population identified that the 
combination of storage and voiding LUTS was the most common type of LUTS, affecting 
8.9% of the general population sample in a multinational, population-based study (EPIC) 
[Irwin et al, 2009; Irwin et al, 2006].
Alpha-blockers, such as tamsulosin hydrochloride, are commonly prescribed to manage BPH 
symptoms but may fail to alleviate storage (OAB) symptoms [Lee and Lee, 2014]. Thus, the 
American Urological Association (AUA) has identified combination therapy with an 
α-blocker and anticholinergic as a potential treatment option for patients with BPH and 
coexisting OAB symptoms [AUA Guidelines, 2010].
The use of antimuscarinics (e.g., tolterodine and solifenancin) as add-on therapy to alpha-
blockers such as tamsulosin hydrochloride has been evaluated in a number of clinical studies 
in men with OAB and BPH [ADAM study by Chapple et al, 2009; VICTOR study by Kaplan 
et al, 2009; TIME study by Kaplan et al, 2006]. Evaluated add-on therapies were generally 
found to be well-tolerated and showed an added benefit over alpha-blocker monotherapy in 
improving OAB-related symptoms.
Mirabegron (Myrbetriq®/Betmiga®) is a potent and selective human beta-3 adrenergic 
receptor agonist approved for the treatment of OAB with symptoms of urge, urinary 
incontinence, urgency and urinary frequency [Mirabegron US Package Insert, 2015 and 
Myrbetriq Canadian Monograph, March 2015, EU SmPC, 2015]. For the mirabegron 
monotherapy clinical development program, 32 phase 1 studies and 13 phase 2 and 3 studies 
(10 in patients with OAB, 1 in patients with LUTS/bladder outlet obstruction (BOO) and 2 in 
patients with type 2 diabetes mellitus) were conducted. Several global phase 3 studies have 
demonstrated the efficacy, safety and tolerability of once daily mirabegron in patients with 
OAB. In these clinical trials, the incidence of urinary retention did not increase with 


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mirabegron, and it was lower than that of placebo and the active control antimuscarinic [Nitti 
et al, 2013]. In a phase 2 study of 200 men with LUTS and BOO, mirabegron was also found 
to be safe and generally well-tolerated, with no adverse effects on either the detrusor pressure 
at maximum flow rate or on the maximum flow rate [Study 178-CL-060].
The use of the beta-3 adrenergic agonist mirabegron to treat OAB symptoms as add-on 
therapy to tamsulosin hydrochloride will be evaluated for efficacy, safety, and tolerability of 
the combination therapy. It is anticipated from previous studies of add-on therapies, the 
combination of mirabegron and tamsulosin hydrochloride will show an added benefit over α-
blocker monotherapy in improving OAB-related symptoms.
1.2
Summary of Non-clinical and Clinical Data
Detailed information on the non-clinical studies conducted with mirabegron and tamsulosin
hydrochloride can be found in the approved product labeling, Summary of Product 
Characteristics (SmPC) and US Package Insert for mirabegron and tamsulosin hydrochloride, 
copies of which will be made available to the Investigator, Institutional Review Boards 
[IRB], Independent Ethics Committees [IEC] and other bodies as appropriate. Summaries of 
findings from non-clinical and clinical studies with mirabegron and tamsulosin hydrochloride
which may have relevance for the current study are listed below.
1.2.1
Mirabegron (YM178)
Mirabegron was approved for the treatment of OAB in adults in Japan in 2011 and in the US, 
Canada and Europe in 2012. Mirabegron is a selective human beta-3 adrenergic agonist and 
the first of a new class of compounds with a different mode of action from the current 
standard of care, muscarinic receptor antagonists, in the treatment of patients with OAB. 
Antimuscarinics and mirabegron both reduce micturition frequency and incontinence. Data 
from the phase 2 study 178-CL-100 showed that mirabegron has a similar effect size to 
antimuscarinics. Consistent with the Phase 2 data, one phase 3b comparative trial 
(178-EC-001) between mirabegron and solifenacin in patients dissatisfied with their previous 
antimuscarinic showed that the two drugs had similar effect sizes for micturition frequency 
and incontinence.
1.2.1.1 Summary of Non-clinical Studies of Mirabegron
Mirabegron is a potent and selective agonist of the human beta-3 adrenergic receptor. 
Mirabegron has low intrinsic activity for human beta-1 and beta-2 adrenergic receptors. 
Mirabegron has no significant affinity for other pharmacological targets in a comprehensive 
test battery of receptors, ion channels and enzymes. Mirabegron directly relaxes human 
bladder in vitro through activation of beta-3 adrenergic receptors. Studies in conscious and 
anesthetized rat models of bladder function demonstrate modulation consistent with a 
beneficial profile in OAB patients.
Increases in heart rate have been observed following mirabegron administration to rats, dogs, 
and monkeys. Decreases in blood pressure were observed in dogs but not in rats or monkeys. 
Assessment of the potential for mirabegron to delay cardiac repolarization demonstrated that 
mirabegron and its most abundant human metabolites were free from effects on cardiac 


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repolarization in isolated dog Purkinje fibers and guinea pig papillary muscles. Furthermore, 
in isolated perfused dog ventricular tissue neither mirabegron nor its metabolites induced 
electrophysiological changes. Mirabegron and its five most abundant human metabolites did 
not significantly alter the IKr (hERG), IKs (hKvLOT1/mink), Ito (hKv4.3/KChip2.2), Ina 
(hNAV1.5), or Ica (hCav 1.2) conductance in in vitro studies at relevant concentrations 
(>100-fold human Cmax) at a 100 mg dose.
Single and repeat dose toxicology studies in dogs, monkeys, and rats demonstrate 
cardiovascular changes at high doses. In a 13-week rat toxicology study, significant increases 
in plasma alanine aminotransferase (ALT) were observed at doses of 30 mg/kg and higher 
(22-fold higher than maximum recommended human dose). Modest (less than 2-fold) 
increases in alkaline phosphatase (ALP) and aspartate aminotransferase (AST) were observed 
at high doses (72-fold higher than the maximum recommended human dose), together with 
reversible changes in hepatocytes. Modest elevation of ALT was also observed in monkeys 
but the changes observed were deemed to be below the level of toxicological significance and 
there were no changes in liver histopathology. There were no significant changes in liver 
enzymes or liver histopathology in dogs. Mirabegron was not genotoxic, carcinogenic, or 
teratogenic in the battery of conventional in vitro and in vivo studies.
1.2.1.2 Summary of the Pharmacokinetics of Mirabegron
After oral administration of mirabegron in healthy volunteers, peak mirabegron plasma 
concentrations were attained between 3 to 5 hours. The absolute bioavailability increases 
from 29% at a dose of 25 mg to 45% at a dose of 150 mg under fasted conditions in healthy 
volunteers. Mean Cmax and AUCinf increased more than dose proportionality over the 
recommended dose range. Steady state concentrations were achieved within 7 days of once 
daily dosing with mirabegron. The Cmax and AUCtau of mirabegron and its metabolites 
following multiple oral doses in older adult subjects (≥65 years) were similar in those in 
younger subjects (18 to 45 years). The Cmax and AUCtau of mirabegron were approximately 
40-60% higher in females than in males. The mean terminal t½ is comparable in both sexes. 
Evaluation of special populations in the phase 1 studies demonstrated that volunteers with 
severe renal impairment (CrCL 15 to 29 mL/min or eGFR 15 to 29 mL/min per 1.73 m2) or 
moderate hepatic impairment (Child-Pugh Class B) had an approximately 2-fold increase in 
exposure to mirabegron relative to normal healthy volunteers.
The in vitro oxidative metabolism of mirabegron in human liver microsomes is primarily 
mediated by cytochrome P450 (CYP) 3A4, but a possible role for CYP2D6 could not be 
excluded. In vitro CYP inhibition studies suggest that mirabegron is a moderate and time-
dependent inhibitor of CYP2D6 and a weak inhibitor of CYP3A4.
1.2.1.3 Summary of Clinical Data with Mirabegron
The clinical development program consists of 48 completed clinical studies to date over 
approximately 10 years and is comprised of 13,640 subjects (1,909 volunteers and 
11,731 patients) including patients with OAB, type 2 diabetes mellitus, and lower urinary 
tract symptoms (LUTS)/bladder outlet obstruction (BOO). A total of 34 phase 1 studies and 


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14 phase 2 and 3 studies (11 in patients with OAB, 1 in patients with LUTS/BOO and 2 in 
patients with type 2 diabetes mellitus) have been conducted globally.
Mirabegron has been studied across the dose range of 25 mg to 200 mg once daily in OAB 
patients. Mirabegron 25 mg, 50 mg, and 100 mg demonstrated statistical superiority 
compared to placebo for the co-primary endpoints of incontinence episodes and micturition 
frequency. Both the 50 mg and 100 mg doses also demonstrated superiority compared to 
placebo for almost all key secondary endpoints defined in the phase 3 program.
Evaluation of the combined safety data from the mirabegron clinical program to date shows
mirabegron to be safe and well tolerated. The incidence of Treatment Emergent Adverse 
Events (TEAEs) in the active treatment group is comparable with the incidence in the 
placebo group. The most frequently reported TEAE was hypertension which includes reports 
of blood pressure above the normal range, and BP increased from baseline, occurring 
predominantly in subjects with baseline hypertension. Most commonly reported adverse 
reactions (>2% and >placebo) were hypertension, nasopharyngitis, urinary tract infection and 
headache. Most of the events were mild or moderate in intensity. Other adverse reactions 
occurring at greater than 1% and greater than placebo include constipation, upper respiratory 
infection, arthralgia, diarrhea, tachycardia, abdominal pain and fatigue (Table 2). The number 
of serious TEAEs is low and comparable across mirabegron and placebo treatment groups.
Table 2
Percentage of Patients with Adverse Reactions, Derived from All Adverse 
Events, Exceeding Placebo Rate and Reported by 1% or More Patients 
Treated With MYRBETRIQ® 25 mg or 50 mg Once Daily
Placebo
(%)
MYRBETRIQ®
25 mg
(%)
MYRBETRIQ®
50 mg
(%)
Number of Patients
1380
432
1375
Hypertension*
7.6
11.3
7.5
Nasopharyngitis
2.5
3.5
3.9
Urinary Tract Infection
1.8
4.2
2.9
Headache
3
2.1
3.2
Constipation
1.4
1.6
1.6
Upper Respiratory Tract Infection
1.7
2.1
1.5
Arthralgia
1.1
1.6
1.3
Diarrhea
1.3
1.2
1.5
Tachycardia
0.6
1.6
1.2
Abdominal Pain
0.7
1.4
0.6
Fatigue
1
1.4
1.2
* Includes reports of blood pressure above the normal range, and BP increased from baseline, occurring 
predominantly in subjects with baseline hypertension.


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In the US Package Insert, mirabegron is contraindicated in patients with hypersensitivity 
reactions. It has warnings and precautions for increases in blood pressure, angioedema, 
urinary retention in patients with bladder outlet obstruction, and in patients taking drugs 
metabolized by CYP2D6.
In the Canadian Monograph, mirabegron is contraindicated in patients with severe 
uncontrolled hypertension, patients who are pregnant, and patients who are hypersensitive to 
mirabegron or to any ingredient in the formulation or component of the container. 
Mirabegron has warnings and precautions for neoplasm, Stevens-Johnson syndrome, 
increases in serum ALT/AST and bilirubin, QTc prolongation, increases in blood pressure 
and heart rate, urinary retention, and in patients taking drugs metabolized by CYP2D6. The
monograph does not recommend use of mirabegron in patients with severe hepatic 
impairment, end stage renal disease, pregnant and nursing women, and pediatric patients 
(<18 years of age).
In the EU Summary of Product Characteristics (EU SmPC), mirabegron is contraindicated in 
patients with hypersensitivity reactions and for those with uncontrolled hypertension 
(SBP > 180, or DBP > 110). It has warnings and precautions for increases in blood pressure, 
QTc prolongation, and urinary retention in patients with bladder outlet obstruction. It 
recommends not to use in patients with moderate or severe hepatic impairment (Child-Pugh 
Class B or C) or end stage renal disease.
For further information, please refer to the full prescribing information for mirabegron 
[Mirabegron US Package Insert, 2015 and Myrbetriq Canadian Monograph, March 2015, EU 
SmPC, 2015].
1.2.2
Tamsulosin Hydrochloride
Tamsulosin hydrochloride was registered in Japan in 1993, in the European Community in 
1995 and in the USA in 1997. In the US, tamsulosin hydrochloride is indicated for treatment 
of the signs and symptoms of BPH and in the EU, for lower urinary tract symptoms (LUTS) 
associated with BPH. Since the launch of tamsulosin hydrochloride, a worldwide exposure of 
more than 24 million patient years has demonstrated that tamsulosin hydrochloride is 
effective and safe in the treatment of LUTS associated with BPH. The most common adverse 
event is dizziness and weakness.  Intra-operative Floppy Iris syndrome during cataract and 
glaucoma surgery has been associated with tamsulosin hydrochloride use.  The initiation of 
tamsulosin hydrochloride in patients with scheduled cataract or glaucoma surgery is not 
recommended (see US Package Insert, 2014 and EU SmPC, 2013).
1.2.2.1 Summary of Non-clinical Studies of Tamsulosin Hydrochloride
Tamsulosin hydrochloride is an antagonist of alpha1A adrenoceptors in the prostate. The 
symptoms associated with benign prostatic hyperplasia (BPH) are related to bladder outlet 
obstruction, which is comprised of two underlying components: static and dynamic. The 
static component is related to an increase in prostate size caused, in part, by a proliferation of 
smooth muscle cells in the prostatic stroma. However, the severity of BPH symptoms and the 
degree of urethral obstruction do not correlate well with the size of the prostate. The dynamic 


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component is a function of an increase in smooth muscle tone in the prostate and bladder 
neck leading to constriction of the bladder outlet. Smooth muscle tone is mediated by the 
sympathetic nervous stimulation of alpha1 adrenoceptors. Antagonism of these adrenoceptors 
can cause smooth muscles in the bladder neck and prostate to relax, resulting in an 
improvement in urine flow rate and a reduction in symptoms of BPH.
Tamsulosin hydrochloride, an alpha1 adrenoceptor blocking agent, exhibits selectivity for 
alpha1 receptors in the human prostate. At least three discrete alpha1 adrenoceptor subtypes 
have been identified: alpha1A, alpha1B, and alpha1D; their distribution differs between human 
organs and tissue. Approximately 70% of the alpha1 receptors in the human prostate are of 
the alpha1A subtype.
1.2.2.2 Summary of the Pharmacokinetics of Tamsulosin Hydrochloride
The pharmacokinetics of tamsulosin hydrochloride have been evaluated in adult healthy 
volunteers and patients with BPH after single and/or multiple administration with doses 
ranging from 0.1 mg to 1 mg. Absorption of tamsulosin hydrochloride from capsules of 
0.4 mg is essentially complete (90%) following oral administration under fasting conditions. 
Tamsulosin hydrochloride exhibits linear kinetics following single and multiple dosing, with 
achievement of steady-state concentrations by the fifth day of a once-a-day dosing. The time 
to maximum concentration (Tmax) is reached by 4 to 5 hours under fasting conditions and by 
6 to 7 hours when administered with food. Taking capsules under fasted conditions results in 
a 30% increase in bioavailability (AUC) and 40% to 70% increase in peak concentrations 
(Cmax) compared to fed conditions.
Tamsulosin hydrochloride is extensively metabolized by cytochrome P450 enzymes in the 
liver and less than 10% of the dose is excreted in urine unchanged. However, the 
pharmacokinetic profile of the metabolites in humans has not been established. In vitro 
results indicate the CYP3A4 and CYP2D6 are involved in the metabolism of tamsulosin
hydrochloride as well as some minor participation of other CYP isoenzymes. Inhibition of 
hepatic drug-metabolizing enzymes may lead to increased exposure to tamsulosin
hydrochloride. 
1.2.2.3 Summary of Clinical Data with Tamsulosin Hydrochloride
Four placebo-controlled clinical studies and one active-controlled clinical study enrolled a 
total of 2296 patients (1003 received 0.4 mg capsules tamsulosin hydrochloride once daily, 
491 received 0.8 mg capsules tamsulosin hydrochloride once daily, and 802 were control 
patients) in the US and Europe.
In the two US placebo-controlled, double-blind, 13-week, multi-center studies [Study 1 
(US92-03A) and Study 2 (US93-01)], 1486 men with the signs and symptoms of BPH were 
enrolled. In both studies, patients were randomized to either placebo, tamsulosin 
hydrochloride capsules 0.4 mg once daily, or tamsulosin hydrochloride capsules 0.8 mg once 
daily. Patients in tamsulosin hydrochloride capsules 0.8 mg once daily treatment groups 
received a dose of 0.4 mg once daily for one week before increasing to the 0.8 mg once daily 
dose. The primary efficacy assessments included: 1) total American Urological Association 


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(AUA) Symptom Score questionnaire, which evaluated irritative (frequency, urgency, and 
nocturia), and obstructive (hesitancy, incomplete emptying, intermittency, and weak stream) 
symptoms, where a decrease in score is consistent with improvement in symptoms; and 2) 
peak urine flow rate, where an increased peak urine flow rate value over baseline is 
consistent with decrease urinary obstruction.
Mean total AUA Symptom Scores for both tamsulosin hydrochloride capsules 0.4 mg and 
0.8 mg once daily groups showed a rapid decrease starting at one week after dosing and 
remained decreased through 13 weeks in both studies.
For further information, please refer to the full prescribing information for tamsulosin 
hydrochloride [Flomax® (tamsulosin hydrochloride) Capsules, 0.4 mg US Package Insert, 
2014, Flomax Relief® MR, 2014, and Tamsulosin hydrochloride, EU SmPC, 2013].
1.3
Summary of Key Safety Information for Study Drugs
1.3.1
Summary of Key Safety Information for Mirabegron
Mirabegron was first approved in Japan on 1 July 2011, and was launched to market on 
16 September 2011 under the trade name Betanis®. On 28 June 2012, mirabegron received 
approval in the United States (trade name: Myrbetriq®). The approved indication is the 
treatment of OAB with symptoms of urinary incontinence, urgency, and urinary frequency. 
On 20 December 2012, mirabegron received marketing approval in the EU under the trade 
name Betmiga®. On 6 March 2013, mirabegron received approval in Canada (trade name: 
Myrbetriq®). As of September 3, 2015, mirabegron has regulatory approval in 58 countries.
The safety of mirabegron treatment has been well characterized in 5,863 subjects in the 
phase 2/3 studies, including 5,648 subjects with OAB, treated with mirabegron at doses 
ranging from 25 to 200 mg once daily. Of the 5,648 subjects with OAB who received 
mirabegron, 1,572 subjects received mirabegron continuously for at least 6 months, 
1,482 subjects for at least 9 months, and 622 for at least 1 year.
Important potential risks include QT prolongation with supratherapeutic doses or in high-risk 
populations, increased heart rate, increased blood pressure, non-immediate cutaneous 
hypersensitivity reactions and exposure in utero. The potential risks of QT prolongation, 
increased heart rate, or increased blood pressure are greater with increasing exposure. The 
expected adverse drug reactions for mirabegron are presented in Table 2  The approved 
therapeutic dose of mirabegron in the United States and Canada is 25 mg once daily which 
may be increased to 50 mg once daily based on individual patient efficacy and tolerability 
[Mirabegron US Package Insert, 2015 and Myrbetriq Canadian Monograph, March 2015]. In 
the EU the approved starting dose of mirabegron is 50 mg once daily [EU SmPC, 2015].  The 
favorable benefit risk profile of mirabegron is not expected to change over time.
A mean increase of approximately 1 bpm for pulse rate was observed in OAB patients who 
received mirabegron 50 mg. This magnitude of change was similar for both 12-week and 
long-term studies, for men and women, and in both the mirabegron and tolterodine (active 
control) treatment groups. In patients with OAB, categorical increases in pulse rate were 
noted more frequently with mirabegron and tolterodine than with placebo, with similar 


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changes observed for mirabegron 50 mg and tolterodine. Pulse increases were more 
pronounced in young subjects in comparison to older adults (age 55 years and greater) 
subjects. Changes in pulse were reversible upon discontinuation of treatment.
An approximate mean increase in 1 mmHg from baseline for SBP/DBP was observed in 
OAB patients who received mirabegron 50 mg compared with placebo. This magnitude of 
change was similar for both 12-week and long-term studies, for men and women, and in both 
the mirabegron and tolterodine treatment groups. TEAE and SAE related to hypertension 
were similar for mirabegron 50 mg, placebo, and tolterodine in the 12-week studies, and were 
similar for mirabegron and tolterodine in the long-term study. Blood pressure increases were 
more pronounced in young subjects in comparison to older adult (age 55 years and greater) 
subjects. Changes in blood pressure were reversible upon discontinuation of treatment. Please 
refer to the product insert for expected adverse drug reactions (ADR).
Detailed information on the clinical safety profile for mirabegron can be found in the full 
prescribing information [Mirabegron US Package Insert, 2015, Myrbetriq Canadian 
Monograph, March 2015, and EU SmPC, 2015].
According to current package inserts, no dose adjustment is necessary for older adult patients. 
The pharmacokinetics of mirabegron is not significantly influenced by age. The Cmax and 
AUC of mirabegron following multiple oral doses in older adult volunteers (≥ 65 years) were 
similar to those in younger volunteers (18 to 45 years). Of 5,648 patients who received 
mirabegron in the phase 2 and 3 studies, 2,029 (35.9%) were 65 years of age or older, and 
557 (9.9%) were 75 years of age or older. No overall differences in safety or effectiveness 
were observed between patients younger than 65 years of age and those 65 years of age or 
older in the studies [Mirabegron US Package Insert, 2015 and Myrbetriq Canadian 
Monograph, March 2015, EU SmPC, 2015].
1.3.2
Summary of Key Safety Information for Tamsulosin Hydrochloride
In the phase 3 trials (178-CL-046, 178-CL-047, 178-CL-074), 308 men were on tamsulosin
hydrochloride across treatment groups. There were no differences in rates of hypertension or 
elevated heart rate between men on and off tamsulosin hydrochloride.
1.3.3
Summary of Key Safety Information for Combination of Mirabegron and 
Tamsulosin Hydrochloride
Study 178-CL-080 was an open-label, 2-treatment arm, 2-sequence study to investigate the 
cardiovascular (CV) interactions between mirabegron (100 mg) and tamsulosin hydrochloride
(0.4 mg as a single dose) in healthy male volunteers. Under the conditions of the study, the 
CV results suggest there is no clinically relevant pharmacodynamic interaction between 
tamsulosin hydrochloride and mirabegron. Combination treatment of mirabegron and 
tamsulosin hydrochloride did not appear to affect the safety profiles of either drug. In this 
interaction study, there were no serious adverse events and no events of syncope in either 
treatment arm.


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In Japanese men with OAB induced by benign prostatic obstruction, addition of mirabegron 
to tamsulosin hydrochloride was shown to be more effective for ameliorating storage 
symptoms compared to tamsulosin hydrochloride monotherapy [Ichihara et al, 2014].
1.4
Risk-Benefit Assessment
Subjects randomized to placebo treatment are unlikely to benefit from the study beyond the 
benefits they receive from tamsulosin hydrochloride alone. However, OAB is not a life-
threatening disease and it is not expected that a 12-week exposure to placebo treatment will 
have a negative impact on disease progress, given that subjects will have been on tamsulosin
hydrochloride prior to study entry and it will be continued. Subjects receiving mirabegron are 
likely to benefit from at least a partial relief of symptoms during the study.
There is extensive clinical experience with tamsulosin hydrochloride monotherapy in the 
treatment of BPH.  Clinical equipoise is maintained in the study because an alpha blocker is 
considered standard treatment of men with BPH and because the subjects are continuing on 
their usual prescribed dose as opposed to being placed on a tamsulosin hydrochloride placebo.
Mirabegron has a distinct mechanism of action (beta-3 adrenergic agonist) compared with the 
current standard of care, primarily antimuscarinics, for the treatment of symptoms of OAB. 
Antimuscarinics have been studied concomitantly with alpha blockers and appear to be 
efficacious without added risk.  Muscarinic antagonists and beta-3 adrenergic agonists 
modulate bladder function through distinct molecular pathways. Thus concomitant use of 
tamsulosin hydrochloride and mirabegron offers the possibility of enhancing efficacy in the 
treatment of men with BPH who have co-existing OAB.
2
STUDY OBJECTIVE(S), DESIGN, AND ENDPOINTS
2.1
Study Objectives
The primary objective is to study the efficacy of mirabegron versus placebo in men with 
OAB symptoms while taking tamsulosin hydrochloride for LUTS due to BPH.
The secondary objective is to assess safety and tolerability of mirabegron versus placebo in 
men with OAB symptoms while taking tamsulosin hydrochloride for LUTS due to BPH.
Other objectives are to assess patient reported outcomes (PROs) as measured by Symptom 
Bother and Total Health Related Quality of Life scores as assessed by the Overactive Bladder 
questionnaire (OAB-q), EQ-5D-5L, Patient Perception of Bladder Condition (PPBC), Patient 
Perception of Intensity of Urgency Scale (PPIUS), International Prostate Symptom Score 
(IPSS), and Treatment Satisfaction-Visual Analog Scale (TS-VAS).


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2.2
Study Design and Dose Rationale
2.2.1
Study Design
This is a randomized, double-blind, placebo-controlled, parallel-group, multi-center study.
Approximately 985 subjects will be enrolled at up to 100 study centers in North America and 
Europe.
At Screening (Visit 1), subjects will enter into a 4-week open label tamsulosin hydrochloride 
0.4 mg QD run-in period prior to being randomized into the 12-week double-blind treatment 
period (Visit 2).  At the conclusion of the 4-week tamsulosin hydrochloride run-in period, 
subjects will complete a 3-day diary just prior to Baseline (Visit 2). Approximately 7 days 
prior to Visit 2 subjects will receive a phone call reminding them about the diary and to 
answer any questions.
A training diary will be completed in the first 2 weeks of the tamsulosin hydrochloride run-in 
period. During this evaluation period at least one telephone contact will take place with the 
subject. Diaries will be completed at home, using the electronic patient-reported outcome 
(ePRO) device, for 3 consecutive days prior to each visit: Baseline (Visit 2), Week 4 
(Visit 3), Week 8 (Visit 4), and Week 12/End of Treatment (Visit 5). Site staff will contact 
the subject approximately 7 days prior to the scheduled visit to remind the subject that they 
need to complete the electronic diary, review completion instructions and review changes to 
concomitant medications and adverse events (if applicable). 
If subjects meet all entry criteria at the end of the tamsulosin hydrochloride run-in period, 
subjects will be randomized to 1 of 2 treatment groups (mirabegron or placebo) for 12 weeks 
of treatment in addition to the continuation of tamsulosin hydrochloride 0.4 mg QD. Those 
subjects randomized to mirabegron will start at 25 mg and will increase to 50 mg after 
4 weeks.  Those subjects randomized to placebo will start blinded product matched to the 
mirabegron 25 mg tablet and will increase to blinded product matched to 50 mg mirabegron 
after 4 weeks. Once a subject has increased dose, he will remain on that dose for the 
remainder of the study unless for safety reasons he is required to discontinue study drug.
Three days before Visits 2 (Baseline), 3 (Week 4), 4 (Week 8), and 5 (Week 12), subjects 
will complete a 3-day diary, using the electronic patient-reported outcome (ePRO) device in 
which they will record micturition frequency, urgency (PPIUS), incontinence and volume
voided.  In addition the diary will capture morning and evening blood pressure and pulse rate 
measurements via HBPM. At Visit 1, International Prostate Symptom Score (IPSS) will be 
completed. At Visits 2, 3, 4, and 5, subjects will complete the IPSS, EQ-5D-5L, OAB-q, 
PPBC, and TS-VAS.  Maximum urinary flow (Qmax) will be measured at Visit 1 
(Screening/tamsulosin hydrochloride run-in) and Visit 5 (Week 12/End of Treatment).  
Post-void residual volume (PVR) will be assessed at Screening/tamsulosin hydrochloride
run-in (Visit 1), Baseline (Visit 2) and at Week 4 (Visit 3), Week 8 (Visit 4) and Week 
12/End of Treatment (Visit 5). A follow-up phone call (Visit 6) will be conducted 4-weeks 
after End of Treatment (Visit 5). Total study participation is approximately 20 weeks.


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2.2.2
Dose Rationale
The approved dose in the treatment of overactive bladder in the United States and Canada is 
mirabegron 25 mg daily, which may be increased to 50 mg daily based on individual efficacy 
and tolerability [Mirabegron US Package Insert, 2015 and Myrbetriq Canadian Monograph, 
March 2013]. The recommended dose of mirabegron in the European SmPC is 50 mg [EU 
SmPC, 2015]. The dosing regimen for the study is starting with mirabegron 25 mg with an 
obligatory increase to mirabegron 50 mg after 4 weeks of treatment which is intended to 
reflect a pragmatic and clinically plausible regimen. The treatment effect size at Week 4 in 
the phase 3a program approaches the maximum treatment response for incontinence and 
micturition.
2.3
Endpoints
2.3.1
Primary Endpoints
The primary endpoint is:
●
Change from Baseline (Visit 2) to Week 12/ End of Treatment (Visit 5) in mean 
number of micturitions per day based on a 3-day diary.
2.3.2
Secondary Endpoints
The secondary endpoints are:
●
Change from Baseline (Visit 2) to Week 4, Week 8, and Week 12/End of Treatment 
(Visit 5) in mean volume voided per micturition.
●
Change from Baseline (Visit 2) to Week 4, Week 8, and Week 12/End of Treatment 
(Visit 5) in mean number of incontinence episodes per day (FAS-I).
●
Change from Baseline (Visit 2) to Week 4, Week 8, and Week 12/End of Treatment 
(Visit 5) in mean number of urgency episodes (grade 3 and 4) per day.
●
Change from Baseline (Visit 2) to Week 4, Week 8, and Week 12/End of Treatment 
(Visit 5) in IPSS total score and subscales (Voiding, Storage, and Quality of Life).
●
Change from Baseline (Visit 2) to Week 4, Week 8, and Week 12/End of Treatment 
(Visit 5) in mean number of urgency incontinence episodes per day (FAS-I).
●
Change from Baseline (Visit 2) to Week 4, Week 8, and Week 12/End of Treatment 
(Visit 5) in Symptom Bother Total Health Related Quality of Life and subscale 
(coping, concern, sleep, social interaction, and symptom bother) scores as assessed by 
OAB-q questionnaire.
●
Change from Baseline (Visit 2) to Week 4, Week 8, and Week 12/End of Treatment 
(Visit 5) as assessed by EQ-5D-5L questionnaire.
●
Change from Baseline (Visit 2) to Week 4, Week 8, and Week 12/End of Treatment 
(Visit 5) in PPBC. 
●
Change from Baseline (Visit 2) to Week 4, Week 8, and Week 12/End of Treatment 
(Visit 5) in Total Urgency and Frequency Score (TUFS) using PPIUS (Grade 3 or 4).
●
Change from Baseline (Visit 2) to Week 4, Week 8, and Week 12/End of Treatment 
(Visit 5) in mean number of nocturia episodes per day.


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●
Change from Baseline (Visit 2) to Week 4, Week 8, and Week 12/End of Treatment 
(Visit 5) in TS-VAS scores. 
●
Change from Baseline (Visit 2) to Week 4, Week 8, and Week 12/End of Treatment 
(Visit 5) in the number of protective garments (e.g. absorbent pads, incontinence 
briefs, disposable underwear).
2.3.3
Exploratory Endpoint
The exploratory endpoint is:
●
Performance of subgroup analyses by PSA cutoff scores for < 2, 2-4. 
2.3.4
Safety Variables
The safety variables are:
●
Incidence and severity of treatment emergent adverse events (TEAEs) including AEs 
of special interest (see Section 5.4.3.2).
●
Vital signs: sitting systolic and diastolic blood pressure and pulse rate (home blood 
pressure monitoring [HBPM] and office measurements).
●
ECG parameters (heart rate, PR, RR, QRS, QT, QTcF intervals).
●
Laboratory parameters (hematology, serum chemistry, including liver function tests, 
and urinalysis).
●
Change in PVR and Qmax.
3
STUDY POPULATION
3.1
Selection of Study Population
The study will enroll men at least 40 years of age who have symptoms of overactive bladder 
while taking the α-blocker tamsulosin hydrochloride for Lower Urinary Tract Symptoms 
(LUTS) due to Benign Prostatic Hyperplasia (BPH). Six hundred forty (640) subjects will be 
randomized to 1 of 2 treatment groups in a 1:1 randomization (mirabegron or placebo); 320
randomized to mirabegron; 320 randomized to placebo.
3.2
Inclusion Criteria
Inclusion Criteria assessed at Visit 1 (Screening).
Subject is eligible for the study if all of the following apply:
1.
Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved written 
Informed Consent and privacy language as per national regulations (e.g., HIPAA 
Authorization for US sites) must be obtained from the subject or legally authorized 
representative prior to any study-related procedures (including withdrawal of prohibited 
medication, if applicable).
2.
Men ≥40 years of age with history of OAB symptoms (urinary frequency and urgency 
with or without incontinence) while taking tamsulosin hydrochloride 0.4 mg daily for at 
least 2 months to treat LUTS due to BPH.


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3.
Subject has symptoms of OAB (frequency of ≥8 micturitions per day and urgency 
episodes of ≥2 per day) for ≥3 months prior to Screening.
4.
Subject has an IPSS score ≥8.
5.
Subject has Prostate-Specific Antigen (PSA) < 4 ng/mL OR PSA ≥4 but <10 ng/mL with 
a prostate biopsy that is negative for cancer in the past two years.
6.
Subject is willing and able to complete the 3-day diary (including urine volumes, vital 
sign measurements), and Quality of Life questionnaires.
7.
Subject and their spouses/partners who are of childbearing potential must be using a 
highly effective method of birth control, which includes established use of oral, injected 
or implanted hormonal methods of contraception, placement of an IUD or IUS. Birth 
control must be practiced from Screening and continue throughout the study and for 
30 days after the final study drug administration. In addition, sperm donation will not be 
allowed throughout the study and for 30 days after the final study drug administration.
8.
Subject agrees not to participate in another interventional study while on treatment.
Inclusion Criteria assessed at Visit 2 (Baseline) based on the 3-day diary:
9.
Subject continues to meet all inclusion criteria of Visit 1 (Screening).
10. Subject must experience an average of 8 or more micturitions per day over the 3-day 
diary period. 
11. Subject must experience an average of 2 or more episodes of urgency per day (grade 3 or 
4) over the 3-day diary period.
Waivers to the inclusion criteria will NOT be allowed.
3.3
Exclusion Criteria
Exclusion Criteria assessed at Visit 1 (Screening).
Subject will be excluded from participation if any of the following apply:
1.
Subject has PVR >200 mL.
2.
Subject has Qmax <5.0 mL/second with a minimum voided volume of 125 mL.
3.
Subject has hematuria >3 rbc/hpf that has not been fully evaluated.
4.
Subject has evidence of Urinary Tract Infection (UTI). Urine culture and sensitivity will 
be performed for positive leukocytes, nitrites, or turbidity, or at the Investigator’s 
discretion, and will be confirmed with a culture greater than 100,000 cfu/mL. If a subject 
has a UTI, at Screening (Visit 1) the subject may be rescreened after successful treatment 
of the UTI (confirmed by a laboratory result of negative urine culture).
5.
Subject has neurogenic bladder (spinal cord injury, multiple sclerosis, Parkinson’s etc.).
6.
Subject has diabetic neuropathy.


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7.
Previous open, robotic or minimally invasive prostate surgery (including transurethral 
procedures). Planned (scheduled) pelvic or prostate surgery planned during the study 
period.
8.
Planned (scheduled) cataract or glaucoma surgery during the study period. 
9.
Subject with significant stress incontinence as determined by the Investigator.
10. Subject with clinically significant bladder outlet obstruction as determined by the 
Investigator. 
11. Subject has an indwelling catheter or practices intermittent self-catheterization.
12. Subject has experienced 3 or more episodes of recurrent urinary tract infection within the 
last 12 months.
13. Subject has a symptomatic urinary tract infection, prostatitis, chronic inflammation such 
as interstitial cystitis, bladder stones, previous pelvic radiation therapy, or previous or 
current malignant disease of the pelvic organs (i.e., within the confines of the pelvis 
including the bladder, prostate and rectum; organs of the lower gastrointestinal tract are 
not necessarily considered pelvic organs as the distal ascending colon, the full transverse 
colon and proximal portion of the descending colon are in the abdomen).
14. Subject has received intravesical injection in the past 12 months with botulinum toxin, 
resiniferatoxin, or capsaicin.
15. Subject has ever received electro-stimulation therapy for OAB (e.g., sacral nerve 
stimulation or Percutaneous Tibial Nerve Stimulation [PTNS]).
16. Subject began or has changed a bladder training program or pelvic floor exercises less 
than 30 days prior to Screening.
17. Subject has postural hypotension or syncope or postural orthostatic tachycardia.
18. Subject has moderate or severe hepatic impairment defined as Child-Pugh Class B or C.
19. Subject has severe renal impairment defined as estimated creatinine clearance less than 
29 mL/min/1.73 m2 as determined by central laboratory calculation of eGFR. A subject 
with End Stage Renal Disease (ESRD) or undergoing dialysis is also not a candidate for 
the study.
20. Subject has severe uncontrolled hypertension, which is defined as a sitting systolic blood 
pressure ≥180 mmHg and/or diastolic blood pressure ≥110 mmHg.
21. Subject has baseline resting pulse rate <60 BPM or >90 BPM.
22. Subject has evidence of QT prolongation on Screening (Visit 1) or Baseline (Visit 2) 
electrocardiogram (ECG) defined as QTcF >450 msec.
23. Subject has a clinically significant ECG abnormality, as determined by the Investigator.
24. Subject has AST or ALT >2x upper limit of normal (ULN), or γ-GT >3x ULN and 
considered clinically significant by the Investigator.


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25. Subject has a hypersensitivity to any components of mirabegron, tamsulosin 
hydrochloride, or any of the inactive ingredients. 
26. Subject has a history of angioedema.
27. Subject has any clinically significant condition, which in the opinion of the Investigator 
makes the subject unsuitable for study participation.
28. Subject has been treated with an experimental device within 28 days or received an 
investigational agent within 28 days or 5 half-lives, whichever is longer, prior to 
Screening.
29. Subject has a concurrent malignancy or history of any malignancy (within the past 
5 years), except non-metastatic basal or squamous cell carcinoma of the skin that has 
been treated successfully.
30. Subject has ongoing alcohol and/or drug abuse.
31. Subject is using prohibited medications defined in Appendix 1, Part A within 30 days 
prior to Screening (Visit 1) through Follow-Up Phone Call (Visit 6).
32. Subject has stopped, started or changed the dose of a restricted medication (defined in
Appendix 1, Part B) within the 30 days prior to Screening (Visit 1) through Follow-Up 
Phone Call (Visit 6).
33. Subject has participated in an interventional trial within 30 days prior to Screening 
(Visit 1).
34. Subject is involved in the conduct of the study as an employee of the Astellas group, 
third party associated with the study, or the study site team.
35. Subject has previously received mirabegron in the 6 months prior to Screening (Visit 1).
Exclusion Criteria assessed at Visit 2 (Baseline):
36. Subject was non-compliant during the 4-week tamsulosin hydrochloride run-in period, 
defined as taking less than 80% or greater than 120% of study medication.
37. Subject had an average total daily urine volume >3000 mL as recorded in the 3-day 
diary.
Waivers to the exclusion criteria will NOT be allowed. 
4
TREATMENT(S)
4.1
Identification of Investigational Product(s)
4.1.1
Test Drug(s)
Mirabegron will be supplied as 25 mg and 50 mg OCAS (Oral Controlled Absorption 
System) modified release tablets. Mirabegron OCAS tablets contain the following excipient: 
Polyethylene Oxide 2000000 NF, Polyethylene Glycol 8000 NF, Hydroxypropyl Cellulose 
NF, Butylated Hydroxytoluene NF, and Magnesium Stearate NF. The tablets are film coated 


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using Opadry® 03F43159 (25 mg) and 03F42192 (50 mg). The opadry formulation contains: 
Hypromellose USP, Polythylene Glycol 8000, Yellow Ferric Oxide NF and Red Ferric Oxide 
NF.
The mirabegron tablets are packaged in blisters and must be stored at room temperature, 
25°C (77°F); excursion permitted to 15°-30°C (59°-86°F).
The clinical trial material of mirabegron OCAS tablets have been manufactured for Astellas 
by Astellas Pharma Technologies, Inc.
All investigational materials must be kept in a secure area inaccessible to unauthorized 
individuals.
4.1.2
Concomitant Medication
Tamsulosin hydrochloride will be supplied as 0.4 mg capsules (US) / tablets (EU/CA) in 
either commercial blister packs or commercial bottles. All storage and handling information 
can be found in the product package insert or the Summary of Product Characteristics (SPC).
4.1.3
Placebo
The placebo to match (PTM) mirabegron OCAS tablets contain Polyethylene Oxide 2000000 
NF, Polyethylene Glycol 8000 NF, Hydroxypropyl Cellulose NF, Butylated Hydroxytoluene 
NF, and Magnesium Stearate NF. The tablets are film coated using Opadry® 03F42192 
which contains: Hypromellose USP, Polyethylene Glycol 8000, Yellow Ferric Oxide and 
Red Ferric Oxide NF.
The PTM mirabegron OCAS tablets have been manufactured for Astellas by Astellas Pharma 
Technologies, Inc.
The mirabegron PTM tablets are packaged in blisters. The blisters must be stored at room 
temperature, 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F).
4.2
Packaging and Labeling
All medication used in this study will be prepared, packaged, and labeled in accordance with 
AUST Standard Operating Procedures (SOPs), Good Manufacturing Practice (GMP) 
guidelines, ICH GCP guidelines, and applicable local laws/regulations.
All Investigational Medicinal Products will bear a label conforming to regulatory guidelines, 
Good Manufacturing Practice and local laws and regulations which identifies the contents as 
investigational drug.
4.3
Study Drug Handling
Current ICH GCP Guidelines require the Investigator to ensure that study drug deliveries 
from the Sponsor are received by the Investigator/or designee and
●
that such deliveries are recorded,
●
that study drug is handled and stored according to labeled storage conditions,
●
that study drug is only dispensed to study subjects in accordance with the protocol, and


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●
that any unused study drug is returned to the Sponsor or standard procedures for the 
alternative disposition of unused study drug are followed.
The supplied study drug should not be stored at a temperature outside the temperature range 
specified on the study drug label. Any temperature excursion outside the temperature range 
should be evaluated by the Sponsor.
Drug inventory and accountability records for the study drugs will be kept by the 
Investigator/or designee. Study drug accountability throughout the study must be documented 
and reconciled. The following guidelines are therefore pertinent:
●
The Investigator agrees not to supply study drugs to any persons except the eligible 
subjects in this study in accordance with the protocol.
●
The Investigator or designee will keep the study drugs in a pharmacy or other locked and 
secure storage facility under controlled storage conditions, accessible only to those 
authorized by the Investigator to dispense these test drugs.
●
A study drug inventory will be maintained by the Investigator or designee. The inventory 
will include details of material received and a clear record of when they were dispensed 
and to which subject.
●
At the conclusion or termination of this study, the Investigator or designee agrees to 
conduct a final drug supply inventory and to record the results of this inventory on the 
Drug Accountability Record. It must be possible to reconcile delivery records with those 
of used and/or returned medication. Any discrepancies must be accounted for and 
documented. Appropriate forms of deliveries and returns must be signed by the site staff 
delegated this responsibility.
●
The site must return study drug to the Sponsor or designee at the end of the study or 
upon expiration.
4.4
Blinding
4.4.1
Blinding Method
This is a randomized, double-blind, placebo-controlled, parallel group study. Randomization 
will be stratified by geographic region (NA, EU). Subjects will be assigned to a treatment 
group in the order which they meet the criteria for randomization. After the completion of the 
4-week open label tamsulosin hydrochloride run-in period, subjects will be randomized to 
either 25 mg mirabegron or PTM for 4 weeks of treatment and then an obligatory increase to 
mirabegron 50 mg or 50 mg PTM for the remainder of the study. Subjects will receive their 
allocated treatment according to a computer-generated randomization schedule prepared by 
the Sponsor or designee prior to the start of the study. The subject, Investigator and Sponsor 
will not be aware of the treatment regimen.
4.4.2
Confirmation of the Indistinguishability of the Study Drugs
Mirabegron and mirabegron PTM tablets will be used in this study. The mirabegron PTM 
will be identical in size, color and appearance to the mirabegron 25 mg and mirabegron 
50 mg tablets.


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4.4.3
Retention of the Assignment Schedule and Procedures for Treatment Code 
Breaking
Study drug treatment may be revealed only for reasons relating to the subject’s safety and 
when critical therapeutic decisions are contingent on knowing the assigned study drug.
Withdrawal of a subject from the study (refer to Section 6.1) is not a sufficient reason to 
break the study blind. Any decision to break the blind should be discussed with the Astellas 
Study Physician (refer to Section II for contact information).
If the blind is broken for a subject, the reason is to be documented as a written entry in the 
source document. Key information will be recorded at the time when the blind is broken. This 
includes the date the blind was broken, the reason, the person who requested the breaking of 
the blind, the name of the person who broke the blind, and the name of the Astellas 
representative contacted.
4.4.4
Breaking the Treatment Code for Emergency
In order to break the treatment code (unblinding) for a subject, the assigned study medication 
information is accessible through the IWRS. The Sponsor must be notified immediately if the 
blind is broken. The date, time, and reason the blind was broken must be recorded in the 
source documents and on the appropriate Electronic Case Report Form (eCRF) if applicable.
Breaking the treatment code, or unblinding of an individual subject’s treatment assignment, 
may be done only for reasons relating to subject safety or when critical therapeutic decisions 
are contingent upon knowing the blinded study drug assignment.
4.4.5
Breaking the Treatment Code by the Sponsor
The Sponsor may break the treatment code for subjects who experience a Suspected 
Unexpected Serious Adverse Reaction (SUSAR), in order to determine if the individual case 
or a group of cases requires expedited regulatory reporting. Individual Emergency Codes will 
be provided to the limited staff, who are responsible to break the codes for all SUSAR cases
for reporting purposes.
4.5
Assignment and Allocation
After a subject signs informed consent, a subject number will be assigned. To obtain a subject 
number, the Investigator or designee will utilize a web or phone-based Interactive Response 
Technology (IRT), available seven days a week and 24 hours a day.
Subjects who meet all the inclusion and none of the exclusion criteria will enter a 4-week 
tamsulosin hydrochloride 0.4 mg capsule (US) / tablet (EU/CA) run-in period (Visit 1). At 
Visit 2 (Baseline), subjects will be randomly assigned to receive mirabegron or placebo using 
a 1:1 randomization schedule. Randomization will be stratified by geographic region (NA, 
EU).
To obtain the randomization treatment, the Investigator or designee will utilize a web or 
phone-based IRT, available seven days a week and 24 hours a day. After submitting certain 
information about the eligible subject, the randomized drug assignment will be provided by 


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the IRT. Study drug assignment will remain blinded to all staff. Each study drug will be 
preprinted with a Medication ID number. The Medication ID number assigned to the subject 
will be noted in the electronic case report form (eCRF) for study drug.
Once a subject number is assigned, if the corresponding subject does not receive study drug, 
the subject number will not be used again. 
5
TREATMENTS AND EVALUATION
5.1
Dosing and Administration of Study Drug(s) and Other 
Medication(s)
5.1.1
Dose/Dose Regimen and Administration Period
Subjects will be randomized to one of two treatment groups in a 1:1 ratio to either 
mirabegron or placebo (PTM). Those subjects randomized to mirabegron will start at 25 mg 
tablet QD for 4 weeks along with tamsulosin hydrochloride 0.4 mg capsule (US) / tablet 
(EU/CA). Mirabegron dose will be titrated to mirabegron 50 mg QD at 4 weeks. Mirabegron 
50 mg dose will be maintained for the remaining 8 weeks of the study along with tamsulosin 
hydrochloride capsule 0.4 mg (US) / tablet (EU/CA). Oral mirabegron can be taken with or 
without food, but during the course of the study will be taken the same time each day as the 
concomitant tamsulosin hydrochloride medication.
Those subjects randomized to placebo will start placebo to match (PTM) mirabegron 25 mg 
tablet QD for 4 weeks along with tamsulosin hydrochloride 0.4 mg capsule (US) / tablet 
(EU/CA). PTM mirabegron 25 mg will be increased to PTM mirabegron 50 mg and will be
maintained for the remaining 8 weeks of the study along with tamsulosin hydrochloride 
0.4 mg capsule (US) / tablet (EU/CA). Subjects will be instructed to take PTM at the same 
time each day as the concomitant tamsulosin hydrochloride medication.
Subjects will be instructed to take oral tamsulosin hydrochloride 0.4 mg approximately one-
half hour following the same meal each day.
5.1.2
Increase or Reduction in Dose of the Study Drug(s)
The study design employs a dose increase from 25 mg mirabegron to 50 mg mirabegron at 
Week 4 (Visit 3). Once a patient has increased dose, he will remain on that dose for the 
remainder of the study unless for safety reasons that require discontinuation of study drug.
5.1.3
Previous and Concomitant Treatment (Medication and Non-Medication 
Therapy)
5.1.3.1 Previous Medication (Drugs and Therapies)
The Investigator must record the use of previous (all medication taken within 30 days prior to 
Screening [Visit 1]) and current concomitant treatment, both drug and non-drug therapies, 
prescribed and over-the-counter and all alternative medicines, in the eCRFs. This also 
includes drugs used on a chronic and as-needed basis.


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Subjects must be instructed not to start any new medication, both prescribed and over-the-
counter, without consulting the Investigator, unless the new medication is required for 
emergency use. Subjects must be instructed to notify the Investigator immediately if 
medications were required for emergency use.
5.1.3.2 Concomitant Medication (Drugs and Therapies)
Concomitant medications will be captured from Screening/tamsulosin hydrochloride run-in 
(Visit 1) through the Follow-Up Phone Call (Visit 6).
Prohibited Medications (Appendix 1, part A)
Medications prohibited between Screening/tamsulosin hydrochloride run-in (Visit 1) and 
Week 16/Follow-up phone call (Visit 6) include other alpha-adrenergic blockers, 
anticholinergics, antispasmodics, strong and moderate inhibitors of CYP2D6 with narrow 
therapeutic index, specifically thioridazine, flecainide, propafenone, amitriptyline, 
paroxetine, and terbinafine, and moderate and strong inhibitors of CYP3A4 (see Appendix 1,
Part A).  These medications must have been discontinued at least 30 days prior to 
Screening/tamsulosin hydrochloride run-in (Visit 1). Current or previous use of mirabegron 
within 6 months prior to Screening (Visit 1) is also prohibited.
Restricted Medications (Appendix 1, part B)
Medications restricted between Screening/tamsulosin hydrochloride run-in (Visit 1) and 
Week 16/Follow-up Phone Call (Visit 6) include loop diuretics, 5-Alpha reductase inhibitors 
and PDE5 inhibitors (see Appendix 1, Part B). These medications are permitted provided the 
subject has been taking the medication on a long-term basis, i.e. has not stopped, or started, 
or changed dose within the 30 days prior to Screening/tamsulosin hydrochloride run-in 
(Visit 1), no new drug of the same class has been added to the regimen within the 30 days 
prior to Screening/tamsulosin hydrochloride run-in (Visit 1), and the subject remains on the 
medication at the same dose during the course of the study.  For 5-alpha reductase inhibitors
the subject must have been taking the medication for at least 6 months. No alpha-blockers 
other than tamsulosin hydrochloride are allowed. Intermittent use of PDE5 inhibitors 
(e.g. tadalafil) for treating erectile dysfunction (ED) is allowed.  PDE5 inhibitors that are 
taken on a daily basis for the management of LUTS are not allowed. 
Restricted Non-Drug Therapy
Subjects participating in any behavioral modification therapy (i.e., pelvic floor exercises, 
Kegel exercises, biofeedback, timed voiding, etc.) or other nondrug therapy must have started 
the therapy within 30 days prior to Screening/tamsulosin hydrochloride run-in (Visit 1) and 
must continue the same schedule through Follow-Up Phone Call (Visit 6). Neurostimulation
for OAB is a strict exclusion criterion.
5.1.4
Treatment Compliance
Study subjects should be counseled on the need to meet 100% compliance with study drug.  
Investigator or designee should ensure that study subjects meet this goal throughout the study 


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period.  Compliance will be verified by the accounting of each study drug at each monthly 
visit starting with the Baseline (Visit 2). 
If compliance during the tamsulosin hydrochloride run-in period is less than 80% or greater 
than 120% of study medication the subject is considered non-compliant and will be excluded 
from the study.
If compliance for blinded treatment is less than 80%, the Investigator or designee is to 
counsel the subject and ensure steps are taken to improve compliance. Subjects who are less 
than 80% compliant with the dosage regimen for any two consecutive visit periods during the 
study should be withdrawn from the study.
5.2
Demographics and Baseline Characteristics
5.2.1
Demographics
The subject’s date of birth (or age, if local regulations do not allow recording of subject’s 
date of birth), gender, race, ethnicity, height, and weight will be recorded at 
Screening/tamsulosin hydrochloride run-in (Visit 1).
5.2.2
Medical History
Medical history (other than for overactive bladder), including smoking history will be 
obtained at Screening/tamsulosin hydrochloride run-in (Visit 1) from each subject. All 
relevant past and present conditions, as well as prior surgical procedures will be recorded for 
the main body systems.
5.2.3
Diagnosis of the Target Disease, Severity, and Duration of Disease
A detailed history of OAB and lower urinary tract symptoms (LUTS) due to Benign Prostatic 
Hyperplasia (BPH) for each subject will be obtained at Screening/tamsulosin hydrochloride 
run-in (Visit 1). This includes date of onset of OAB symptoms, OAB symptoms at time of 
diagnosis and at Screening, OAB non-drug therapy and medication history for OAB and 
reason for treatment termination. In addition information regarding the history of BPH and 
LUTS will be collected.
5.3
Efficacy Assessment
5.3.1
Patient Diary – Micturition and Incontinence
During the study, subjects will be requested to complete a “3-day diary” which will be 
implemented on an electronic handheld device. This diary will collect data on micturition and 
incontinence, sleep interruption, protective garments, vital sign measurements and the Patient 
Perception of Intensity of Urgency Scale (PPIUS) prior to Visits 2, 3, 4, and 5. The 
information from the diaries will be used to evaluate the efficacy of treatment. Therefore, 
subjects will receive full instructions and training on how to complete the diary at 
Screening/tamsulosin hydrochloride run-in (Visit 1) and will be counseled on the importance 
of completing the diaries prior to the next visit. The diaries and questionnaires will be 
reviewed during each visit after Screening/tamsulosin hydrochloride run-in (Visit 1) by the 
Investigator or designee to ensure accuracy of completion.


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A training diary will be completed in the first 2 weeks of the tamsulosin hydrochloride run-in 
period. The purpose of this training diary is to familiarize the subject with using the 
electronic handheld device and for the Investigator to assess the ability and willingness of the 
subject to complete the diary. During these 2 weeks the Investigator will remotely evaluate 
diary completion and will provide additional instructions if necessary. During this evaluation 
period at least one telephone contact will take place with the subject. The diary that is 
completed during the last 3 days before randomization will be used to establish Baseline data. 
Therefore, it is very important to ensure that any compliance or completion issues are 
discussed during the 2-week training diary.
Diaries will be completed at home for 3 consecutive days prior to each visit: Baseline 
(Visit 2), Week 4 (Visit 3), Week 8 (Visit 4), and Week 12/End of Treatment (Visit 5).  Site 
staff will contact the subject approximately 7 days prior to the scheduled visit to remind the 
subject they need to complete the electronic diary, review completion instructions and review 
changes to concomitant medications and adverse events (if applicable).
A diary day starts at midnight and ends at midnight the following day. Time to bed with 
intention to sleep, time to wake with intention of staying awake, type of episode 
(urination/incontinence), time of episode, urgency severity (see Section 5.3.2), measure of 
urine volume voided, and sleep interruption will be recorded by the subject in the micturition 
diary.
At Baseline (Visit 2), diary data, including frequency of micturition (urination episodes) and 
urgency episodes (grade 3 and 4) with or without incontinence will be reviewed to confirm 
inclusion criteria.
Voiding episodes will be recorded in one of three ways: “urination”, “incontinence”, or “both”
in the electronic diary. Micturitions will be counted for “urination” episodes in which the 
subject fully voids in the toilet.  “Incontinence” will be counted for episodes in which the full 
void was incontinent and the subject did not make it to the toilet to finish urinating. If a 
subject experienced incontinence and then passed urine into the toilet this should be recorded 
as “both”. During analysis, “both” will be counted towards micturition and incontinence. In 
addition to micturition information, the electronic diary will also collect time of medication 
intake and vital signs along with sleep interruption and protective garment use (see Table 1, 
Schedule of Assessments).
5.3.2
Patient Perception of Intensity of Urgency Scale (PPIUS)
The Patient Perception of Intensity of Urgency Scale (PPIUS) will be completed as part of 
the micturition diary.
For each micturition and/or incontinence episode, subjects will be asked to rate the degree of 
associated urgency according to the following validated 5-point scale. The categories are 
recommended by the Committee for Proprietary Medicinal Products [CPMP/EWP/18/01, 
Final].


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0 – No, urgency, I felt no need to empty my bladder, but did so for other reasons.
1 – Mild urgency, I could postpone voiding as long as necessary, without fear of wetting 
myself.
2 – Moderate urgency, I could postpone voiding for a short while, without fear of wetting 
myself.
3 – Severe urgency, I could not postpone voiding, but had to rush to the toilet in order not to 
wet myself.
4 – Urge incontinence, I leaked before arriving at the toilet.
The PPIUS will be completed at Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4), and 
Week 12/End of Treatment (Visit 5).
5.3.3
Total Urgency and Frequency Score (TUFS)
The Total Urgency and Frequency Score (TUFS) is calculated by adding the PPIUS scores of 
every void in a patient’s 3-day diary, and dividing this by the number of days recorded in the 
diary [Chapple et al, 2014]. 
5.3.4
International Prostate Symptom Score (IPSS)
The International Prostate Symptom Score (IPSS) consists of seven questions concerning 
urinary symptoms and one question concerning quality of life.
The IPSS will be completed at Screening (Visit 1), Baseline (Visit 2), Week 4 (Visit 3), 
Week 8 (Visit 4), and Week 12/End of Treatment (Visit 5).
5.3.5
OAB Symptoms, Quality of Life, Bladder Health and Treatment Benefit
OAB has significant effects on health-related quality of life (QoL) of afflicted subjects. This 
has been quantified in various empirical studies [Wall et al, 1993]. QoL is determined by 
socio-demographic, clinical, psychological and social factors. This underlies the importance 
of assessing the perceptions of subjects when evaluating the effects of medical or 
pharmacological treatment [Palmtag 2004]. In this study, the Overactive Bladder-
questionnaire (OAB-q), EQ-5D-5L, the Patient Perception of Bladder Condition (PPBC), and 
Treatment Satisfaction – Visual Analog Scale (TS-VAS) will be utilized.
5.3.5.1 Overactive Bladder-questionnaire (OAB-q)
OAB symptoms and QoL in relation to OAB will be assessed by the Overactive Bladder-
questionnaire (OAB-q) [Coyne et al, 2002]. This questionnaire has validated psychometric 
properties, has been used extensively in QoL-research in respondents with OAB, and has 
been shown to be responsive in treatment studies [Coyne et al, 2002]. The OAB-q is a self-
reported questionnaire with 33 items, which contain the dimensions Coping, Concern, Sleep, 
Social Interaction, and a Symptom Bother scale with eight symptoms [Garely et al, 2007].
The OAB-q will be assessed at Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4), and 
End of Treatment (Visit 5).


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5.3.5.2 Patient Perception of Bladder Condition (PPBC)
The Patient Perception of Bladder Condition (PPBC) is a validated, global assessment tool 
using a 6-point Likert scale that asks subjects to rate their subjective impression of their 
current bladder condition [Coyne et al, 2006]. The PPBC questionnaire will be assessed at 
Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4), and End of Treatment (Visit 5).
5.3.5.3 EQ-5D-5L
The EQ-5D-5L is an international standardized non-disease specific (i.e., generic) instrument 
for describing and valuing health status. It has a multidimensional measure of health-related 
QoL, capable of being expressed as a single index value and specifically designed to 
complement other health status measures [Euroqol, 1990; Herdman et al, 2011].
The EQ-5D-5L has five dimensions: Mobility, Self-Care, Usual Activities, Pain/Discomfort, 
and Anxiety/Depression. Each dimension has 5 response levels (e.g., no problems, slight 
problems, moderate problems, severe problems, and extreme problems/unable to perform the 
activity). In addition, it has a visual analog scale that elicits a self-rating by the respondent of 
his health status.
EQ-5D-5L will be assessed at Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4), and End 
of Treatment (Visit 5).
5.3.5.4 Treatment Satisfaction – Visual Analog Scale (TS-VAS)
The Treatment Satisfaction – Visual Analog Scale (TS-VAS) is a visual analog scale that 
asks subjects to rate their satisfaction with the treatment by placing a vertical mark on a line 
that runs from 0 (No, not at all) to 10 (Yes, completely). The TS-VAS will be assessed at 
Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4), and End of Treatment (Visit 5).
5.4
Safety Assessment
The safety evaluation including vital signs, adverse event recording, clinical laboratory 
assessments and physical examination will be performed according to Table 1, Schedule of 
Assessments.
Requirements related to the evaluation, reporting and analysis of Drug-Induced Liver Injury 
(DILI) information are found in Appendix 2 (Liver Safety Monitoring and Assessment). In 
the event of a confirmed, marked hepatic abnormality as defined in Appendix 2, it is the 
Investigator’s responsibility to ensure contact with the Sponsor/delegated CRO by telephone 
or fax immediately (i.e., within 24 hours of awareness).
5.4.1
Vital Signs
Vital signs, including pulse rate and blood pressure, will be measured in the diary for 3 days 
prior to each visit and at all in-office visits according to Table 1, Schedule of Assessments.
The Investigator responsibility for reporting the Treatment Emergent Adverse Event (TEAE)
of hypertension will be based on office visit measurements and not on diary review.
For office based vital signs the patient should be seated comfortably for at least 5 minutes 
with the back supported, feet on the floor, arm supported in a horizontal position, and the 


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blood pressure cuff at heart level for each blood pressure measurement. The Investigator will 
use the same device and cuff size throughout the study. The same arm should be used 
throughout the study.
An AE of hypertension will be recorded, independent of Investigator assessment of clinical 
significance or relatedness, if one of the following criteria is met on 2 or more consecutive 
visits:
1. If the average systolic blood pressure is >140 mmHg AND/OR the average diastolic 
blood pressure is >90 mmHg at two consecutive visits after Baseline (Visit 2) in subjects 
who were normotensive (average systolic blood pressure <140 mmHg AND average 
diastolic blood pressure <90 mmHg) [WHO-ISH, 2013] at Baseline (Visit 2).
2. If the average systolic blood pressure is increased ≥20 mmHg AND/OR the average 
diastolic blood pressure is increased ≥10 mmHg at two consecutive visits as compared to 
Baseline (Visit 2) in subjects with hypertension at Baseline (Visit 2).
3. If treatment with antihypertensive drugs is INITIATED for treatment of hypertension OR 
if the dose of prior antihypertensive drugs is INCREASED due to an increase in blood 
pressure.
An AE of “increased Blood Pressure” should be considered if the above conditions are not 
met, but a high blood pressure is recorded (see Appendix 4).
An AE of tachycardia should be considered if resting heart rate (pulse rate) is > 100 bpm (see
Appendix 5). The Investigator responsibility for reporting the TEAE will be based on office 
visit measurements and not on diary review. 
5.4.2
Patient Diary – Subject Measurement Vital Signs
During Visit 1, the Investigator should instruct the subject on how to perform and document 
in the electronic diary the self-measurement of BP and PR. The subject will have an 
opportunity to familiarize himself with the self-measurement of BP and PR and recording of 
the data.
The electronic diary will capture HBPM vital signs. It will be completed in both the morning 
and evening for 3 consecutive days prior to each visit: Baseline (Visit 2), Week 4 (Visit 3), 
Week 8 (Visit 4), Week 12/End of Treatment (Visit 5). 
Validated devices for measuring BP and PR will be provided to subjects along with detailed 
operating instructions. At home, according to the “The ABCD’s of Blood Pressure 
Measurement” [American Heart Association, April 2012], the subject should rest for at least 
5 minutes before taking the measurements. The subject should be quiet and relaxed, sitting in 
a chair with their feet on the floor, legs should not be crossed, and arms should be bare and 
supported at heart level. The cuff should be put on according to the instructions of the 
Investigator. The subject should not move and should remain silent during the reading as 
moving and talking can affect the reading. The subject should measure his BP and PR in 
triplicate during the 3 consecutive days prior to the next visit, on the arm chosen from the 
Screening measurements.


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Measurement should be taken after waking up in the morning and again in the evening. The 
subject should ensure that the morning measurements of vital signs are taken BEFORE 
breakfast and BEFORE study medication intake. The evening BP measurement is not 
specified in relation to either a meal or the time study drug was taken. It is recommended to 
be taken after 4 pm and before going to bed. 
Three readings at each occasion should be taken, each about 2 minutes apart. Date, time, 
systolic and diastolic BP, and PR will be documented in the electronic diary. The subject 
should take care to have a 30 minute rest after exercise or smoking or intake of caffeine or 
alcohol, prior to taking a measurement.
5.4.3
Adverse Events
Adverse Event collection will begin from the time of informed consent and continue through 
the Follow-up Phone Call (Visit 6). See Section 5.5 Adverse Events and Other Safety 
Aspects for information regarding adverse event collection and data handling.
5.4.3.1 Adverse Events of Possible Hepatic Origin 
See Appendix 2 Liver Safety Monitoring and Assessment for detailed information on liver 
abnormalities, monitoring and assessment, if the AE for a subject enrolled in the study and 
receiving study drug is accompanied by increases in liver function testing (LFT, e.g.: AST, 
ALT, bilirubin, etc.) or is suspected to be due to hepatic dysfunction. 
Subjects with AEs of hepatic origin accompanied by Liver Function Test (LFT) 
abnormalities should be carefully monitored.  
5.4.3.2 Adverse Events of Special Interest
Adverse Events of Special Interest include:
●
Blood pressure and pulse rate (defined in Section 5.4.1, analysis in Section 7.5.3)
●
Acute urinary retention (urinary retention requiring catheterization)
●
Benign prostatic obstruction (BPO) requiring surgery.
5.4.4
Laboratory Assessments
Below is a table of the laboratory tests that will be performed during the conduct of the study. 
See Table 1  Schedule of Assessments for study visit collection dates. For this study, a 
central laboratory will be used for all laboratory hematology and biochemistry/PSA 
assessments. Local laboratories will be used for all urinalysis and urine culture and 
sensitivity. 


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Table 3
Laboratory Assessments
Screening/tamsulosin hydrochloride run-in 
(Visit 1)
Baseline (Visit 2)
Week 4 (Visit 3)
Week 8 (Visit 4)
Week 12/End of Treatment (Visit 5)
Hematology
CBC
Hemoglobin
Hematocrit
Screening/tamsulosin hydrochloride run-in 
(Visit 1)
Baseline (Visit 2)
Week 4 (Visit 3)
Week 8 (Visit 4)
Week 12/End of Treatment (Visit 5)
Biochemistry/PSA
Serum PSA (Visit 1 only)
Sodium
Potassium
Calcium
Chloride
Glucose
Creatinine
Alkaline phosphatase
HCO3
BUN
AST
ALT
GGT
Total bilirubin
Total protein
Albumin
INR
Screening/tamsulosin hydrochloride run-in 
(Visit 1)
Baseline (Visit 2)
Week 4 (Visit 3)
Week 8 (Visit 4)
Week 12/End of Treatment (Visit 5)
Urinalysis 
(Microscopic)
Protein
Glucose
pH
Blood
WBC
RBC
Epithelial cells
LCE
Nitrites
Bacteria
Urine Culture*
*Urine culture and sensitivity must be performed for positive leukocyte esterase (LCE), nitrites, or turbidity, or at the 
discretion of the Investigator. Urine culture and sensitivity at the discretion of the Investigator will be performed at a local 
laboratory. It is not required to send isolated trace positive leukocyte esterase samples for culture.
Clinical significance of out-of-range laboratory findings is to be determined and documented 
by the Investigator/sub-Investigator who is a qualified physician.
Before the start of the study, sampling and shipment procedures will be provided in a 
laboratory manual. The Investigator may decide to repeat the tests, should the results be 
outside normal ranges and considered clinically relevant, or if the original sample could not 
be analyzed.
If the blood sample at Visit 1 cannot be analyzed, the test results are considered a lab error or 
the test results are increased related to a temporary condition unrelated to OAB and likely to 
resolve at short notice, it is acceptable to repeat the laboratory tests to check eligibility 
criteria. The subject should be requested to come for an unscheduled visit between Visit 1 


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and Visit 2. If the repeat test results are still exclusionary, the subject should not be 
randomized. Repeat test to check eligibility criteria can only be repeated once before Visit 2.
Any changes in laboratory values are to be evaluated by the Investigator. Clinically relevant 
changes must be recorded as AEs in the eCRF (see Section 5.5.1).
5.4.5
Physical Examination
The subject will have a physical examination performed at Screening/tamsulosin 
hydrochloride run-in (Visit 1) and at Week 12 (Visit 5). This includes examination of main 
body systems. Date of physical examination and any clinically relevant adverse findings not 
documented in the medical history will be recorded as an AE in the eCRF (see Section 5.5.1).
5.4.6
Electrocardiogram (ECG)
A single 12-lead ECG will be recorded at Screening/tamsulosin hydrochloride run-in 
(Visit 1), Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4), and End of Treatment 
(Visit 5). ECG will be taken with the subject in the supine position (subject is allowed to be 
sitting if unable to be supine).
ECGs will be submitted to a central laboratory to allow for central reading (ECG recordings 
will be performed according to ICH guidelines E14 to make them readable and interpretable 
for potential later assessment by an independent cardiologist). Recordings will be made at a 
speed of 25 mm/s and all leads have to include at least four complexes. This is according to 
the standard setting on the machines.
The ECGs should be transmitted from the machine to the central laboratory (following the 
steps indicated in the user manual). In addition, one print copy of the original ECG traces 
should be maintained in the study file. These should be clearly marked with the subject 
identification number (in such a way that they are anonymized), visit date, and visit number, 
and should be kept with the source documents.
The ECG machine will produce automatically calculated interval duration measurements and 
an evaluation on the printed ECG. The manually read analysis reports of the central ECG 
readings will be made available to the Investigators (within 72 hours). The final ECG reports 
sent by the central laboratory must be reviewed by the Investigator and should be used for 
immediate safety assessment and subject care since there might be slight changes from the 
initial analysis produced by the ECG machines.
If the QTcF interval is >450 ms on the printed ECG at Visit 2, an expedited central ECG 
reading (within 24 hours) should be requested. In this case the final ECG report should be 
received/reviewed before the subject is allowed to be randomized.
The ECG report itself should not be captured on the eCRF, but will be captured in the central 
ECG laboratory database. Only the visit, ECG date, automated QTc, overall ECG 
interpretation and relevant comments will be captured in the eCRF.


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If specific concerns regarding the cardiac safety of a subject exist, a dual approach is 
recommended:
●
On-site evaluation of the ECGs should be conducted by a local cardiologist,
●
In addition, the central ECG laboratory can be contacted (24 hours a day) to provide 
the final centrally read ECG analysis results within a shorter timeframe than the usual 
72 hours (for contact details see the ECG Study Manual provided by the central ECG 
laboratory).
Any abnormalities (based on the Central Reading Interpretation) must be evaluated in clinical 
context (based on subject’s medical history and concomitant medication) and the Investigator 
should determine if it is clinically significant and record with Potentially Clinically 
Significant (PCS). Any clinically significant abnormality should be reported as an AE.
5.4.7
Post-Void Residual Volume (PVR)
Post-Void Residual (PVR) volume will be assessed by ultrasonography or bladder scan at 
Screening/tamsulosin hydrochloride run-in (Visit 1), Baseline (Visit 2), Week 4 (Visit 3), 
Week 8 (Visit 4), and Week 12/End of Treatment (Visit 5).
5.4.8
Uroflowmetry
Maximum flow rate (Qmax) will be assessed at Screening/tamsulosin hydrochloride run-in 
(Visit 1) and Week 12/End of Treatment (Visit 5). The subject must void a minimum of 
125 mL for the uroflow measurement to be considered adequate. 
5.4.9
Follow-up Phone Call to Patients
Subjects will be contacted 4 weeks after Week 12/End of Treatment (Visit 5) by telephone 
for a Follow-up Phone Call (Visit 6) to assess concomitant medications and any adverse 
events that may have occurred following the end of treatment.
5.5
Adverse Events and Other Safety Aspects
5.5.1
Definition of Adverse Events (AEs)
An AE is defined as any untoward medical occurrence in a subject administered a study drug 
or has undergone study procedures and which does not necessarily have a causal relationship 
with this treatment.  An AE can therefore be any unintended sign (including an abnormal 
laboratory finding), symptom, or disease temporally associated with the use of a medicinal 
(investigational) product, whether or not related to the medicinal (investigational) product. 
Some countries may have additional local requirements for events that are required to be 
reported as AEs or in an expedited manner similar to an SAE.  In these cases, it is the 
Investigator’s responsibility to ensure these AEs or other reporting requirements are followed 
and the information is appropriately recorded in the (e)CRF accordingly.  


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An abnormality identified during a medical test (e.g., laboratory parameter, vital sign, ECG 
data, physical exam) should be defined as an AE only if the abnormality meets one of the 
following criteria:
●
Induces clinical signs or symptoms
●
Requires active intervention
●
Requires interruption or discontinuation of study medication
●
The abnormality or investigational value is clinically significant in the opinion of the 
Investigator.
5.5.2
Definition of Serious Adverse Events (SAEs)
An adverse event is considered “serious” if, in the view of either the Investigator or Sponsor, 
it results in any of the following outcomes:
●
Results in death
●
Is life threatening (an adverse event is considered “life-threatening” if, in the view of 
either the Investigator or Sponsor, its occurrence places the subject at immediate risk of 
death. It does not include an adverse event that, had it occurred in a more severe form, 
might have caused death)
●
Results in persistent or significant disability/incapacity or substantial disruption of the 
ability to conduct normal life functions 
●
Results in congenital anomaly, or birth defect
●
Requires inpatient hospitalization or leads to prolongation of hospitalization 
(hospitalization for treatment/observation/examination caused by AE is to be considered 
as serious) 
●
Other medically important events.
Medical and scientific judgment should be exercised in deciding whether expedited reporting 
is appropriate in other situations, such as important medical events that may not be 
immediately life-threatening or result in death or hospitalization but may jeopardize the 
subject or may require intervention to prevent one of the other outcomes listed in the 
definition above. These events, including those that may result in disability/incapacity, 
should also usually be considered serious. Examples of such events are intensive treatment in 
an emergency room or at home for allergic bronchospasm; blood dyscrasias or convulsions 
that do not result in hospitalization; or development of drug dependency or drug abuse.
Stroke, myocardial infarction, dysrhythmias, and uncontrolled hypertension will also be 
examined.
In addition to AEs special situations (SS) (with or without an associated AE) occurring on the 
medicinal products administered to the subject as part of the study (e.g., study drug, 
comparator, background therapy) that may require expedited reporting and/or safety 
evaluation include, but are not limited to:
●
Overdose of the medicinal product(s)
●
Suspected abuse/misuse of the medicinal product(s)
●
Inadvertent or accidental exposure to the medicinal product(s)


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●
Medication error involving the medicinal product(s) (with or without subject/patient 
exposure to the Sponsor medicinal product, e.g., name confusion)
All of the events of interest noted above should be recorded on the eCRF. Any SS that also 
meets the criteria for an SAE should be recorded on the AE page of the eCRF and marked 
‘serious’ and the SAE worksheet and submitted to Astellas. 
The Sponsor has a list of events that they classify as “always serious” events.  If an adverse 
event is reported that is considered to be an event per this classification as “always serious”, 
additional information on the event may be requested.  
5.5.3
Criteria for Causal Relationship to the Study Drug
Adverse events that fall under either "Possible" or "Probable" should be defined as "adverse 
events whose relationship to the study drugs could not be ruled out".
Causal relationship to 
the study drug
Criteria for causal relationship
Not Related
A clinical event, including laboratory test abnormality, with a temporal  
relationship to drug administration which makes a causal relationship 
improbable, and/or in  which other drugs, chemicals or underlying disease 
provide plausible explanations.
Possible
A clinical event, including laboratory test abnormality, with a reasonable 
time sequence to administration of the drug, but which could also be 
explained by concurrent disease or other drugs or chemicals. Information 
on drug withdrawal may be lacking or unclear.
Probable
A clinical event, including laboratory test abnormality, with a reasonable 
time sequence to administration of the drug, unlikely to be attributed to 
concurrent disease or  other drugs or chemicals, and which follows a 
clinically reasonable response on re- administration (rechallenge) or 
withdrawal (dechallenge).
5.5.4
Criteria for Defining the Severity of an Adverse Event
The following standard with 3 grades is to be used to measure the severity of adverse events, 
including abnormal clinical laboratory values.
●
Mild: 
No disruption of normal daily activities
●
Moderate:
Affect normal daily activities
●
Severe: 
Inability to perform daily activities
5.5.5
Reporting of Serious Adverse Events (SAEs)
The reference safety information for mirabegron to be used for this study is the Company 
Core Data Sheet (CCDS) for mirabegron, Section 4.8- Undesirable Effects.
Please refer to the reference safety information for details of prescribing information 
(contraindications, special warnings and precautions).
In the case of a serious adverse event (SAE), the Investigator must contact the Sponsor by 
telephone or fax immediately (within 24 hours of awareness).


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The Investigator should complete and submit an SAE Worksheet containing all information 
that is required by the Regulatory Authorities to the Sponsor by fax immediately (within 
24 hours of awareness). If the faxing, scanning or emailing of an SAE Worksheet is not 
possible within 24 hours, the local drug safety contact should be informed by phone. Please 
fax the SAE Worksheet to:
Astellas Pharma Global Development, Inc. – United States
Product Safety & Pharmacovigilance
North America telefax numbers: 
International telefax number: 
Email: 
If there are any questions, or if clarification is needed regarding the SAE, please contact the 
Sponsor's Medical Monitor/Expert or his/her designee (see Section II Contact Details of Key 
Sponsor’s Personnel). 
Follow-up information for the event should be sent promptly (within 7 days of the initial 
notification).
Full details of the SAE should be recorded on the medical records and on the eCRF.
The following minimum information is required:
●
ISN/Study number, 
●
Subject number, sex and age,
●
The date of report,
●
A description of the SAE (event, seriousness of the event)
●
Causal relationship to the study drug.
The Sponsor or Sponsor's designee will submit expedited safety reports (i.e., IND Safety 
Reports) to the regulatory agencies (i.e., FDA) as necessary, and will inform the Investigators 
of such regulatory reports. Investigators must submit safety reports as required by their 
Institutional Review Board (IRB)/Independent Ethics Committee (IEC) within timelines set 
by regional regulations (i.e., EU, (e)CTD, FDA). Documentation of the submission to and 
receipt by the IRB/IEC of expedited safety reports should be retained by the site.
The Sponsor or Sponsor’s designee will notify all Investigators responsible for ongoing 
clinical studies with the study drug of all SAEs which require submission per local 
requirements to the IRB/IEC/head of the study site.
The heads of the study sites/Investigators should provide written documentation of IRB/IEC   
notification for each report to the Sponsor.
For Suspected Unexpected Serious Adverse Reactions (SUSAR) from a blinded trial, 
unblinded CIOMS-I report will be submitted to the authorities and IRB/IEC where required.


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5.5.6
Follow-up of Adverse Events
All AEs occurring during or after the subject has discontinued the study are to be followed up 
until resolved or judged to be no longer clinically significant, or until they become chronic to 
the extent that they can be fully characterized. 
If during AE follow-up, the adverse event progresses to an "SAE", or if a subject experiences 
a new SAE, the Investigator must immediately report the information to the Sponsor. 
5.5.7
Monitoring of Common Serious Adverse Events
Common serious adverse events are SAEs commonly anticipated to occur in the study 
population independent of drug exposure. SAEs classified as “common” are provided in
Appendix 3 Most Common Serious Adverse Events for reference. The list does NOT 
change your reporting obligations or prevent the need to report an AE meeting the definition 
of an SAE as detailed above. The purpose of this list is to alert you that some events reported 
as SAEs may not require expedited reporting to the regulatory authorities based on the 
classification of “common serious adverse events” as specified in Appendix 3 Common 
Serious Adverse Events. The Sponsor will monitor these events throughout the course of 
the study for any change in frequency. Any changes to this list will be communicated to the 
participating investigational sites. Investigators must report individual occurrences of these 
events as stated in Section 5.5.5 Reporting of Serious Adverse Events. 
5.5.8
Procedure in Case of Pregnancy
If during the conduct of a clinical trial, a male subject impregnates his partner, the subject 
should report the pregnancy to the Investigator. The Investigator will report the pregnancy to 
the Sponsor or delegated CRO as an SAE.
5.5.9
Emergency Procedures and Management of Overdose
In the event of suspected overdose, refer to the approved Package Insert, SPC, or local 
product information supplied by the manufacturer for each agent. 
5.5.10
Supply of New Information Affecting the Conduct of the Study
When new information becomes available necessary for conducting the clinical study 
properly, the Sponsor will inform all Investigators involved in the clinical study as well as the 
regulatory authorities. Investigators should inform the IRB/IEC of such information when 
needed.
5.6
Test Drug Concentration
Not applicable.
5.7
Other Measurements, Assessments or Methods
Not applicable.


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5.8
Total Amount of Blood
Blood samples will be taken for the purposes of hematology, biochemistry and PSA analysis 
at Screening/tamsulosin hydrochloride run-in (Visit 1), Baseline (Visit 2), Week 4 (Visit 3), 
Week 8 (Visit 4), and Week 12/End of Treatment (Visit 5). It is anticipated the total amount 
of blood taken will not exceed 50 mL throughout the duration of the study.
6
DISCONTINUATION
6.1
Discontinuation of Individual Subject(s)
A discontinuation is a subject who enrolled in the study and for whom study treatment is 
permanently discontinued prematurely for any reason.  
The subject is free to withdraw from the study treatment and/or study for any reason and at 
any time without giving reason for doing so and without penalty or prejudice. The 
Investigator is also free to terminate a subject's involvement in the study at any time if the 
subject's clinical condition warrants it.
If a subject is discontinued from the study with an ongoing adverse event or an unresolved 
laboratory result that is significantly outside of the reference range, the Investigator will 
attempt to provide follow-up until the condition stabilizes or no longer is clinically 
significant. 
Subjects will be discontinued if they meet any of the following criteria:
●
ALT or AST >3x ULN and total bilirubin >2x ULN
●
ALT or AST >8x ULN on one occasion
●
ALT or AST >5x ULN for more than 2 consecutive weeks
●
ALT or AST >3x ULN with the appearance of fatigue, nausea, vomiting, right upper 
quadrant pain or tenderness, fever, rash and/or eosinophilia (>5%)
Subjects may also be discontinued for:
●
Medically important adverse event(s)
●
Protocol deviation(s) (e.g., subject took prohibited medication that in the Investigator’s 
opinion, after discussion with the Medical Monitor, may negatively impact the subject’s 
safety or demonstrated lack of cooperation in following protocol-specified 
procedures/instructions)
●
Withdrawal of consent
●
Investigator and/or Sponsor feel it is in the subject’s best interest
6.2
Discontinuation of the Site
If an Investigator intends to discontinue participation in the study, the Investigator must 
immediately inform the Sponsor.


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6.3
Discontinuation of the Study
The Sponsor may terminate this study prematurely, either in its entirety or at any study site, 
for reasonable cause provided that written notice is submitted in advance of the intended 
termination. Advance notice is not required if the study is stopped due to safety concerns. If 
the Sponsor terminates the study for safety reasons, the Sponsor will immediately notify the 
Investigator and subsequently provide written instructions for study termination.
7
STATISTICAL METHODOLOGY
The statistical analysis will be coordinated by the responsible biostatistician of Astellas. A 
Statistical Analysis Plan (SAP) will be written to provide details of the analysis, along with 
specifications for tables, listings and figures to be produced. The SAP will be finalized before 
database softlock at the latest. Any deviations from the analysis planned in SAP will be 
justified in the Clinical Study Report (CSR).
Prior to Database Lock, a Final Review of Data and TLFs Meeting will be held to allow a 
review of the clinical trial data and to verify the data that will be used for analysis set 
classification. If required, consequences for the statistical analysis will be discussed and 
documented.  A meeting to determine analysis set classifications may also be held prior to 
database hard lock.
In general, baseline is defined as the last measurement before the first dose of double-blind 
study drug. For variables based on the electronic diary, the 3 days of the diary recorded prior 
to Visit 2/Baseline (Week 0) will be used to derive these variables at baseline just as the 
3 diary days before each post-baseline visit will be used to derive these variables at these 
visits.
The End of Treatment (EOT) visit is defined as the last post-baseline visit during the double-
blind study period for which data is available. The EOT visit value for diary variables is the
average or number of the diary measurements for Week 12, as applicable. If no Week 12 
diary data measurements are available, then the last available earlier post-baseline average or 
number of the diary measurements within a designated visit window will be used (LOCF). 
Data from the EOT visit will be analyzed to account for subjects prematurely terminating the 
study and is regarded as the primary visit. The EOT visit will be Week 12/EOT (Visit 5) for 
subjects who complete the study.
All statistical comparisons will be made using a two-sided test at α = 0.05 significance level 
and confidence intervals (CIs) will be reported with a coverage consistent with this 
significance level unless specified otherwise. 
All efficacy and safety variables will be summarized using descriptive statistics. Continuous 
variables will be summarized using the descriptive statistics number of non-missing 
observations (N), mean, standard deviation (SD) or standard error (SE), minimum, median, 
and maximum unless specified otherwise. Categorical variables will be described using N 
and percent.


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7.1
Sample Size
The primary endpoint for this study is change from baseline to end of treatment in mean 
number of micturitions per day based on a 3-day diary.
Based on subgroup analysis of prior OAB studies, 544 subjects (272 evaluable subjects per 
treatment group) provides 80% power to detect a reduction of 0.65 in the mean number of 
micturitions per day over placebo in the mirabegron group at an alpha level of 0.05.  A 
standard deviation for change from baseline in micturitions of 2.7 was assumed. 
If 85% of the randomized subjects are evaluable, 640 subjects should be randomized.  With 
an expected drop-out rate of 35% by the end of the tamsulosin hydrochloride run-in phase
(V2), 985 subjects need to be screened.
7.2
Analysis Set
Three main analysis populations will be defined: Full Analysis Set (FAS), Full Analysis Set -
Incontinence (FAS-I), and Safety Analysis Set (SAF).
Detailed criteria for analysis sets will be laid out in Classification Specifications and the 
allocation of subjects to analysis sets will be determined prior to database hard-lock. 
7.2.1
Full Analysis Set
The FAS will include all subjects who meet all of the following criteria:
●
Subjects who took at least 1 dose of double-blinded study drug after Randomization,
●
Reported at least 1 micturition in the baseline diary and at least 1 micturition 
post-baseline,
The FAS will be used for the summary of all baseline characteristics, including demographic, 
disease state data, prior medications, prior medical history and a statistical analysis of 
efficacy endpoints and QoL instruments.
7.2.2
Full Analysis Set - Incontinence (FAS-I)
The FAS-I will include all subjects who meet all of the following criteria:
●
Subjects who took at least 1 dose of double-blinded study drug after Randomization,
●
Reported at least 1 micturition in the baseline diary and at least 1 micturition post-
baseline,
●
Reported at least 1 incontinence episode in the baseline diary.
The FAS-I will be used for the analysis of incontinence episodes.
7.2.3
Safety Analysis Set (SAF)
The SAF will consist of all randomized subjects who received at least one dose of 
double-blind study medication. The SAF will be used for summarizing demographic and 
baseline OAB characteristics and safety data. 


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7.3
Demographics and Other Baseline Characteristics
Demographic and OAB baseline characteristics will be summarized using descriptive 
statistics by treatment group, mirabegron and placebo.
7.4
Analysis of Efficacy 
Efficacy analysis will be conducted on the FAS and PPS. Incontinence episodes will be 
analyzed with the FAS-I. The interpretation of results from statistical tests will be based on 
the FAS.
7.4.1
Analysis of Primary Endpoint
7.4.1.1 Primary Analysis
The primary efficacy variable is change from baseline to end of treatment in mean number of 
micturitions per day based on a 3-day electronic diary. The primary analysis will be 
performed for the FAS at the EOT visit, i.e. Week 12 for subjects who complete the study or 
last post-baseline visit during the double-blind study period for subjects who discontinue 
early.
The hypothesis for comparison is as follows:
H0: Difference between mirabegron and placebo in change from baseline to end of treatment 
in mean number of micturitions per day based on a 3-day electronic diary is 0.
H1: Difference between mirabegron and placebo in change from baseline to end of treatment 
in mean number of micturitions per day based on a 3-day electronic diary is not equal to 0.
Change from baseline to end of treatment in mean number of micturitions per day will be 
analyzed using Analysis of Covariance (ANCOVA). The response variable will be the mean 
change in number of micturition episodes per day from baseline to end of the study with 
treatment group, geographic region, and age group as fixed factors and baseline as a covariate. 
Within the framework of this ANCOVA model, LS means and two-sided 95% CIs for the 
mean change from baseline within each treatment group will be provided. Differences in LS 
means between mirabegron and placebo will be derived together with 95% CIs and p-values. 
Further details may be found in the SAP.
7.4.1.2 Secondary Analysis
The primary analysis will be repeated for completers only, i.e. without utilizing LOCF 
imputation for subjects with missing Week 12 values. Additionally, Week 4 and Week 8 
values will be analyzed similarly to End of Treatment.
An analysis of change from baseline in mean number of micturitions per day using a Mixed 
Model Repeated Measures (MMRM) with age group, geographic region, time (visit), and a 
time-by-treatment interaction as factors and the number of micturition episodes at baseline as 
covariate will serve as another sensitivity analysis. The repeated measures model will present 
LS means and two-sided 95% CIs for changes from baseline within each treatment group. 


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7.4.1.3 Subgroup Analysis
Subgroup analyses will include analyses by geographic region, age group, by previous OAB 
medication, and reason for treatment termination if previously treated.  If sample sizes are 
sufficient, subgroup analyses by race will be performed.  More details on subgroup analyses 
will be provided in the SAP.
7.4.2
Analysis of Secondary Endpoints 
Secondary variables are change to end of treatment in mean incontinence episodes per day, 
mean volume voided per micturition, mean number of urgency episodes (grade 3 and 4) per 
day, IPSS total score and subscales (Voiding, Storage, and Quality of Life), Symptom Bother 
and Total Health related quality of life scores as assessed by OAB-q questionnaire (and 
subscales), TUFS, PPBC, EQ-5D-5L, and TS-VAS.
An analysis of change from baseline in PRO values using a Mixed Model Repeated Measures 
(MMRM) with geographic region, age group, time (visit), and a time-by-treatment interaction 
as factors and PRO value at baseline as a covariate will serve as a sensitivity analysis. The 
repeated measures model will present LS means and two-sided 95% CIs for changes from 
baseline within each treatment group.
Analysis of mean change in number of incontinence episodes per day from Baseline to End 
of Treatment will be performed on the FAS-I using ANCOVA model, p-values will be 
calculated by stratified ranking ANCOVA. The response variable is standardized ranks on 
change from Baseline to End of Treatment, with Baseline standardized ranks as covariates 
and geographic region as a stratum. Standardized ranks are used to adjust for differences in 
the number of subjects at each geographic region. Further details may be found in the 
Statistical Analysis Plan.
The number of incontinence episodes and protective garment use during the 3-day diary 
period will be analyzed using a mixed effects Poisson regression model with treatment group, 
age group, and geographic region as factors and number of incontinence episodes at baseline 
as a covariate. Differences in LS means between mirabegron and placebo will be calculated 
together with 95% CI.
Other secondary efficacy variables will be analyzed using the same ANCOVA model as 
described for micturitions (refer to Section 7.4.1.1). Descriptive analyses of the EQ-5D-5L 
will be in the Clinical Study Report.  Other planned utility indices and analyses will be 
calculated in a separate report from the Statistical Analysis Plan and Clinical Study Report.
Responder analyses will be performed for 50% reduction in micturition frequency and for 
number of subjects with less than 8 micturitions per day at End of Treatment.
7.4.3
Analysis of Exploratory Endpoints
Subgroup analyses by PSA cutoff scores for < 2, 2-4 will be performed. 


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7.5
Analysis of Safety
7.5.1
Adverse Events
Adverse events will be coded using the Medical Dictionary for Regulatory Activities 
(MedDRA).  The number and percentage of treatment-emergent AEs, SAEs, AEs leading to 
discontinuation, and AEs related to study drug will be summarized by system organ class, 
preferred term and treatment group. The number and percentage of TEAEs by severity and 
relationship to study drug will also be summarized. All AEs will be listed.
7.5.2
Laboratory Assessments
Laboratory variables (biochemistry, hematology, and urinalysis) will be descriptively 
summarized for Baseline (Visit 2), Week 4, Week 8, and Week 12/EOT and change from 
Screening to EOT will be summarized by treatment group.
For each hematology and biochemistry laboratory parameter, laboratory test results will be 
classified as low (L), normal (N), or high (H) according to the laboratory-supplied reference 
ranges. Shift tables of reference range changes from Screening to Week 12/EOT and most 
extreme value during the double-blind treatment period by treatment group will be 
summarized.
7.5.3
Vital Signs
Pulse rate, systolic blood pressure, and diastolic blood pressure will be summarized by 
treatment group using descriptive statistics (mean, standard deviation, minimum, maximum 
and median) for baseline value, post-baseline time point values (Week 4, Week 8, and 
Week 12/EOT), and change from baseline to each post-baseline time points. The average 
change from baseline to end of treatment for each vital sign variable will be analyzed using 
the ANCOVA model with treatment group and geographic region as fixed factors and 
baseline vital sign value as covariate.  Results will be summarized separately for office based 
measurements and HBPM. No p-values will be calculated.
An analysis of change from baseline of vital signs using a Mixed Model Repeated Measures 
(MMRM) model with geographic region, age group, time (visit), and a time-by-treatment 
interaction as factors and the baseline values as covariate will serve as another sensitivity 
analysis. The repeated measures model will present LS means and two-sided 95% CIs for 
changes from baseline within each treatment group. 
Number and percentage of subjects with more than 2/5/10/15/20 mmHg increase from 
baseline in SBP, more than 2/5/10/15 mmHg increase in DBP or more than 5/10/15 bpm 
increase from baseline in pulse rate, on 2 consecutive post-baseline visits will be summarized 
by treatment group. Number and percentage of subjects with vital sign values shifting 
between JNC-7 defined risk categories will be summarized by treatment group. These 
categories are listed below:


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Category
Systolic BP (mm Hg)
Diastolic BP (mm Hg)
Normal 
< 120
<80
Prehypertension
120-139
80-89
Hypertension Stage 1
140-159
90-99
Hypertension Stage 2
>=160
>=100
Number and percentage of subjects with a PR > 100 bpm at any office visit or by HBPM will 
be summarized by treatment group separately.
7.5.4
Physical Examination
Physical examination will be listed by treatment group.
7.5.5
ECGs
ECG variables (heart rate, PR interval, RR interval, QRS interval, QT interval, and QTc 
interval) will be summarized using frequency tables and percentages for each treatment group 
at Baseline, Week 4, Week 8, and Week 12/EOT, including changes from Baseline to EOT.
The overall ECG interpretation from the local Investigator (normal, abnormal – not clinically 
significant, abnormal – clinically significant) will be summarized by treatment group and 
visit. Also a shift table will be produced for showing the shift from baseline by treatment 
group and visit. Parameters from central ECG readings (QT, QTcB, QTcF, HR, PR, QRS, 
RR, coded abnormalities and overall conclusion) and their change from baseline will be 
summarized using descriptive statistics by treatment group and visit. Numbers and 
percentages of subjects with QTcF values >450 ms, >480 ms or >500 ms or with changes 
from baseline in QTcF ≥30 msec or ≥60 msec will be summarized by treatment group.
7.5.6
PVR
PVR volume and its change from baseline will be summarized by treatment and visit. Shifts 
in PVR from baseline to each visit and from baseline to worst post-baseline value will be 
produced.  Number and percentages of subjects with a PVR > 200 ml will be tabulated.  
7.5.7
Qmax
Qmax will be analyzed from change from baseline (collected at the beginning of the run-in 
period) and summarized by treatment and visit.  Numbers and percentages of subjects with 
Qmax < 5.0 mL/s will be tabulated.
7.6
Analysis of Pharmacokinetics
Not applicable.
7.7
Analysis of Pharmacodynamics
Not applicable.


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7.8
Protocol Deviations and Other Analyses
Protocol deviations as defined in Section 8.1.6 Protocol Deviations will be summarized for 
all randomized subjects by treatment group and total as well as by site. A data listing will be 
provided by site and subject.
The protocol deviation criteria will be uniquely identified in the summary table and listing. 
The unique identifiers will be as follows:
PD1 - Entered into the study even though they did not satisfy entry criteria, 
PD2 - Developed withdrawal criteria during the study and was not withdrawn,
PD3 - Received wrong treatment or incorrect dose,
PD4 - Received excluded concomitant treatment. 
Any other analyses will be specified in the Statistical Analysis Plan (SAP).
7.9
Interim Analysis (and Early Discontinuation of the Clinical Study)
No formal interim analysis is planned.
7.10
Handling of Missing Data, Outliers, Visit Windows, and Other 
Information
For efficacy variables and vital sign data, analysis at End of Treatment will take into account 
subjects who withdraw before Week 12 and therefore do not have efficacy measurements 
available for that visit. The End of Treatment analysis is a Last Observation Carried Forward 
(LOCF) approach. As a secondary analysis, a mixed model repeated measures analysis will 
be performed for selected variables as described in Sections 7.4.1 and 7.4.2
Other imputation rules to account for missing data will be described in the SAP.
Subjects do not always adhere strictly to the visit timing the protocol. Visit windows around 
the target days for each visit will be defined in the SAP.
8
OPERATIONAL AND ADMINISTRATIVE CONSIDERATIONS
8.1
Procedure for Clinical Study Quality Control
8.1.1
Data Collection
The Investigator or site designee is responsible to ensure that all data in the eCRFs and 
queries are accurate and complete and that all entries are verifiable with source documents. 
These documents should be appropriately maintained by the site.
The Investigator or designee will enter data collected using an Electronic Data Capture 
(EDC) system.
Laboratory tests are performed and sent to a Central Lab for testing. The Central Lab will 
compile the results and send to data file to Astellas or designee for inclusion in the clinical 
database.


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The monitor should verify the data in the eCRFs with source documents and confirm that 
there are no inconsistencies between them.
For screening failures, the minimum demographic data (sex, birth date or age, race and 
informed consent date) and reason for screening failure will be collected in the screen failure 
log (SFL), if applicable. This information can be entered into the study database.
Subject diaries will be completed by the subjects on an electronic device. The information 
completed by the subjects on the electronic device will be automatically uploaded into a 
central website. The Investigator or site designee should review the diary data on the website 
for correct completion while the subject is at the site. The diary data will be transferred 
electronically to Sponsor or designee at predefined intervals during the study. The vendor 
will provide Sponsor or designee with a complete and clean copy of the data.
8.1.2
Specification of Source Documents
Source data must be available at the site to document the existence of the study subjects and 
to substantiate the integrity of study data collected. Source data must include the original 
documents relating to the study, as well as the medical treatment and medical history of the 
subject.
The following information should be included in the source medical records:
●
Demographic data (age, sex, race, ethnicity, height and body weight)
●
Inclusion and exclusion criteria details
●
Participation in study and original signed and dated informed consent forms 
●
Visit dates
●
Medical history and physical examination details
●
Key efficacy and safety data, if applicable (as specified in the protocol)
●
Adverse events and concomitant medication 
●
Results of relevant examinations (e.g., ECG charts, X-ray films etc.)
●
Laboratory printouts (if applicable)
●
Dispensing and return of study drug details
●
Reason for premature discontinuation (if applicable)
●
Randomization number (if applicable)
8.1.3
Clinical Study Monitoring
The Sponsor or delegated CRO is responsible for monitoring the clinical study to ensure that 
subject's human rights, safety, and well-being are protected, that the study is properly 
conducted in adherence to the current protocol and GCP, and study data reported by the 
Investigator/sub-Investigator are accurate and complete and that they are verifiable with 
study-related records such as source documents. The Sponsor is responsible for assigning 
study monitor(s) to this study for proper monitoring. They will monitor the study in 
accordance with planned monitoring procedures.


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8.1.4
Direct Access to Source Data/Documents
The Investigator and the study site must accept monitoring and auditing by the Sponsor or 
delegated CRO as well as inspections from the IRB/IEC and relevant regulatory authorities. 
In these instances, they must provide all study-related records, such as source documents 
(refer to Section 8.1.2 "Specification of Source Documents") when they are requested by the 
Sponsor monitors and auditors, the IRB/IEC, or regulatory authorities. The confidentiality of 
the subject's identities shall be well protected consistent with local and national regulations 
when the source documents are subject to direct access.
8.1.5
Data Management
Data Management will be coordinated by the CRO appointed by the Sponsor in accordance 
with the CRO’s standard operating procedures (SOPs) for data management. All study 
specific processes and definitions will be documented by Data Management. Coding of 
medical terms and medications will be performed using MedDRA and World Health 
Organization (WHO) Drug Dictionary respectively. Data analysis will be performed 
according to Astellas data standards.
8.1.6
Protocol Deviations
A protocol deviation is generally an unplanned excursion from the protocol that is not 
implemented or intended as a systematic change. The Investigator is responsible for ensuring 
the study is conducted in accordance with the procedures and evaluations described in this 
protocol and must protect the rights, safety, and welfare of subjects. The Investigator should 
not implement any deviation from, or changes of, the protocol, unless it is necessary to 
eliminate an immediate hazard to trial subjects.  
A protocol waiver is a documented prospective approval of a request from an Investigator to 
deviate from the protocol. Protocol waivers are strictly prohibited.
For the purposes of this protocol, deviations requiring notification to Sponsor are defined as 
any subject who: 
●
Entered into the study even though they did not satisfy entry criteria
●
Developed withdrawal criteria during the study and not withdrawn
●
Received wrong treatment or incorrect dose
●
Received excluded concomitant treatment. 
When a deviation from the protocol is identified for an individual subject, the Investigator or 
designee must ensure the Sponsor is notified. The Sponsor will follow-up with the 
Investigator, as applicable, to assess the deviation and the possible impact to the safety and / 
or efficacy of the subject to determine subject continuation in the study. 
If a deviation impacts the safety of a subject, the Investigator must contact the Sponsor 
immediately.
The Investigator will also assure that deviations meeting IRB/IEC and applicable regulatory 
authorities’ criteria are documented and communicated appropriately. All documentation and 


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communications to the IRB/IEC and applicable regulatory authorities will be provided to the 
Sponsor and maintained within the Trial Master File (TMF).
NOTE:  Other deviations outside of the categories defined above that are required to be 
reported by the IRB/IEC in accordance with local requirements will be reported, as 
applicable.
8.1.7
End of Trial in All Participating Countries
The end of trial in all participating countries is defined as the Last Subject’s Last Visit.
8.2
Ethics and Protection of Subject Confidentiality
8.2.1
Institutional Review Board (IRB) / Independent Ethics Committee (IEC) / 
Competent Authorities (CA)
Good Clinical Practice (GCP) requires that the clinical protocol, any protocol amendments, 
the Investigator’s Brochure (IB), the informed consent and all other forms of subject 
information related to the study (e.g., advertisements used to recruit subjects) and any other 
necessary documents be reviewed by an IEC/IRB.  The IEC/IRB will review the ethical, 
scientific and medical appropriateness of the study before it is conducted.  IEC/IRB approval 
of the protocol, informed consent and subject information and/or advertising, as relevant, will 
be obtained prior to the authorization of drug shipment to a study site.
Any substantial amendments to the protocol will require IEC/IRB approval prior to 
implementation of the changes made to the study design at the site.  The Investigator will be 
required to submit, maintain and archive study essential documents according to ICH GCP.
Any serious adverse events that meet reporting criteria, as dictated by local regulations, will 
be reported to both responsible Ethics Committees and Regulatory Agencies, as required. 
During the conduct of the study, the Investigator should promptly provide written reports 
(e.g., ICH Expedited Reports, and any additional reports required by local regulations) to the 
IEC/IRB of any changes that affect the conduct of the study and/or increase the risk to 
subjects. Written documentation of the submission to the IEC/IRB should also be provided to 
Sponsor.
If required by local regulations, the Investigator shall make accurate and adequate written 
progress reports to the IEC/IRB at appropriate intervals, not exceeding one year. The 
Investigator shall make an accurate and adequate final report to the IRB/IEC within 90 days 
after the close-out visit for APGD-Sponsored studies, or for APEB/APEL-Sponsored studies 
within one year after last subject out (LSO) or termination of the study.
8.2.2
Ethical Conduct of the Study
The study will be conducted in accordance with the protocol, ICH guidelines, applicable 
regulations and guidelines governing clinical study conduct and the ethical principles that 
have their origin in the Declaration of Helsinki. 


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8.2.3
Informed Consent of Subjects
8.2.3.1 Subject Information and Consent
The Investigator or his/her representative will explain the nature of the study to the subject or 
his guardian or legal representative, and answer all questions regarding this study.  Prior to 
any study related screening procedures being performed on the subject, the informed consent 
statement will be reviewed and signed and dated by the subject or his guardian or legal 
representative, the person who administered the informed consent and any other signatories 
according to local requirements. A copy of the signed informed consent form will be given to 
the subject and the original will be placed in the subject’s medical record. An entry must also 
be made in the subject’s dated source documents to confirm that informed consent was 
obtained prior to any study-related procedures and that the subject received a signed copy.
The signed consent forms will be retained by the Investigator and made available (for review 
only) to the study monitor and auditor regulatory authorities and other applicable individuals 
upon request.
8.2.3.2 Supply of New and Important Information Influencing the Subject’s Consent 
and Revision of the Written Information
1.
The Investigator or his/her representative will immediately inform the subject orally 
whenever new information becomes available that may be relevant to the subject’s 
consent or may influence the subject’s willingness to continue to participate in the study 
(e.g., report of serious drug adverse drug reaction). The communication must be 
documented in the subject’s medical records and must document whether the subject is 
willing to remain in the study or not.
2.
The Investigator must update their ICF and submit it for approval to the IRB/IEC. The 
Investigator or his/her representative must obtain written informed consent from the 
subject on all updated ICFs throughout their participation in the study. The Investigator 
or his/her designee must re-consent subjects with the updated ICF even if relevant 
information was provided orally. The Investigator or his/her representative who obtained 
the written informed consent and the subject should sign and date the informed consent 
form. A copy of the signed informed consent form will be given to the subject and the 
original will be placed in the subject’s medical record. An entry must be made in the 
subject’s records documenting the re-consent process.
8.2.4
Subject Confidentiality
The Sponsor affirms the subject's right to protection against invasion of privacy. Only a 
subject identification number and/or initials will identify subject data retrieved by the 
Sponsor. However, the Sponsor requires the Investigator to permit the Sponsor, Sponsor's 
representative(s), the IRB/IEC and when necessary, representatives of the regulatory health 
authorities to review and/or to copy any medical records relevant to the study.


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The Sponsor will ensure that the use and disclosure of protected health information (PHI) 
obtained during a research study complies with the federal and/or regional legislation related 
to the privacy and protection of personal information (i.e., HIPAA). 
8.3
Administrative Matters
8.3.1
Arrangement for Use of Information and Publication of the Clinical Study
Information concerning the study drug, patent applications, processes, unpublished scientific 
data, the Investigator's Brochure (IB) and other pertinent information is confidential and 
remains the property of the Sponsor. Details should be disclosed only to the persons involved 
in the approval or conduct of the study. The Investigator may use this information for the 
purpose of the study only. It is understood by the Investigator that the Sponsor will use the 
information obtained during the clinical study in connection with the development of the drug 
and therefore may disclose it as required to other clinical Investigators or to regulatory 
agencies. In order to allow for the use of the information derived from this clinical study, the 
Investigator understands that he/she has an obligation to provide the Sponsor with all data 
obtained during the study.
Publication of the study results is discussed in the Clinical Study Agreement.
8.3.2
Documents and Records Related to the Clinical Study
The Investigator will archive all study data (e.g., Subject Identification Code List, source 
data, and Investigator's File) and relevant correspondence. These documents are to be kept on 
file for the appropriate term determined by local regulation (for US sites, two years after 
approval of the NDA or discontinuation of the IND). It is recommended, however, that 
records be retained for at least five years in the event follow-up is necessary to help 
determine any potential hazards to subjects who took part in the study. The Sponsor will 
notify the site/Investigator if the NDA is approved or if the IND is discontinued. The 
Investigator agrees to obtain the Sponsor's agreement prior to disposal, moving, or 
transferring of any study-related records. The Sponsor will archive and retain all documents 
pertaining to the study according to local regulations.
Data generated by the methods described in the protocol will be recorded in the subjects' 
medical records and/or study progress notes. All data will be entered into the EDC system for 
each subject.
8.3.3
Protocol Amendment and/or Revision
Any changes to the study that arise after approval of the protocol must be documented as 
protocol amendments: substantial amendments and/or non-substantial amendments. 
Depending on the nature of the amendment, either IRB/IEC/CA approval or notification may 
be required. The changes will become effective only after the approval of the Sponsor, the 
Investigator, the regulatory authority, and the IRB/IEC (if applicable).
Amendments to this protocol must be signed by the Sponsor and the Investigator. Written 
verification of IRB/IEC approval will be obtained before any amendment is implemented 
which affects subject safety or the evaluation of safety, and/or efficacy. Modifications to the 


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protocol that are administrative in nature do not require IRB/IEC approval, but will be 
submitted to the IRB/IEC for their information, if required by local regulations.
If there are changes to the Informed Consent, written verification of IRB/IEC approval must 
be forwarded to the Sponsor.  An approved copy of the new Informed Consent must also be 
forwarded to the Sponsor.
8.3.4
Signatory Investigator for Clinical Study Report
ICH E3 guidelines recommend and EU Directive 2001/83/EC requires that a final study 
report be signed by the representative for the Coordinating Investigator(s) or the Principal 
Investigator(s). The representative for the Coordinating Investigator (s) or the Principal 
Investigator(s) will have the responsibility to review the final study results to confirm to the 
best of his/her knowledge it accurately describes the conduct and results of the study. The 
representative for Coordinating Investigator(s) or the Principal Investigator(s) will be 
selected from the participating Investigators by the Sponsor prior to database lock.
9
QUALITY ASSURANCE
The Sponsor is implementing and maintaining quality assurance and quality control systems 
with written SOPs to ensure that trials are conducted and data are generated, documented, 
recorded, and reported in compliance with the protocol, GCP, and applicable regulatory 
requirement(s).
The Sponsor or Sponsor's designee may arrange to audit the clinical study at any or all 
investigational sites and facilities. The audit may include on-site review of regulatory 
documents, case report forms, and source documents. Direct access to these documents will 
be required by the auditors.
10
STUDY ORGANIZATION
10.1
Independent Data-Monitoring Committee (IDMC) | Data and Safety 
Monitoring Board (DSMB) | Monitoring Committee | Other 
Evaluation Committee(s)
Not applicable.
10.2
Other Study Organization
10.2.1
Cardiovascular Adjudication Committee
A cardiovascular adjudication committee is in place to assess all serious adverse events of 
potential cardiovascular nature occurring in the study. The committee will consist of three 
independent members of appropriate expertise who are not directly involved in the clinical 
study and who are blinded to the treatment allocation. Event related information of the cases 
will be sent to the committee for blinded assessment. The assessments will be captured on 
paper CRFs, and entered into a clinical database. A separate charter describes the 
classification of those events to be adjudicated (including but not limited to cardiac 


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arrhythmia and thromboembolic events) and the specification of the event-related documents, 
listing, data flow, method(s) for data collection and data transfer.
10.2.2
Neoplasm Adjudication Committee
A neoplasm adjudication committee is in place to assess all potential neoplasm events 
occurring in the study. The committee will consist of three independent reviewers of 
appropriate expertise who are not directly involved in the clinical study and who are blinded 
to the treatment allocation. Event related information of the cases will be sent to the 
committee for blinded assessment. The assessments will be captured on paper CRFs, and 
entered into a clinical database. A separate charter describes the classification of those events 
to be adjudicated and the specification of the event-related documents, listings, data flow, 
method(s) for data collection and data transfer.


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11
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symptomatic enlarged prostate. Clinical Interventions in Aging. 2009;4:251-8.
Milsom I, Abrams P, Cardozo L, Roberts RG, Thuroff J, Wein AJ. How widespread are the 
symptoms of an overactive bladder and how are they managed? A population-based prevalence 
study. BJU Int 2001;87:760-6.
Nitti VW, Rosenberg S, Mitcheson DH, He W, Fakhoury A and Martin NE. Urodynamics and safety 
of the β3-adrenoceptor agonist mirabegron in males with lower urinary tract symptoms and 
bladder outlet obstruction. J Urol. 2013;190:1320-7.
Palmtag H. The patient’s perspective: redefining end points. Urology. 2004;64(Suppl 6A):17-20.
Stewart WF, Van Rooyen JB, Cundiff GW, Abrams P, Herzog AR, Corey AR et al. Prevalence and 
burden of overactive bladder in the United States. World J Urol. 2003;20:327-36.
The ABCD’s of Blood Pressure Measurement. American Heart Association, April 2012.
Wall LL, Norton PA, DeLancey JOL. Practical Urogynecology, Baltimore, Williams & Wilkins,1993.
WHO-ISH. World Health Organization/International Summary of Safety (ISS) Final. Data on File, 
2013.
Company Reports:
Adapted from Astellas. Myrbetriq®. Integrated Summary of Safety (ISS) Final. Data on File.
Betmiga® Summary of Product Characteristics, 2015.
Astellas. Data on file. 2012.


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Company Core Data Sheet for mirabegron.
Flomax® CR, Canadian Monograph, 2014.
Flomax® Package Insert – Astellas Global Development, Inc., 2014.
Mirabegron (YM178) Package Insert – Astellas Global Development, Inc., 2015.
Myrbetriq Canadian Product Monograph. March 2015.
Tamsulosin hydrochloride, EU SmPC, 2013.


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12
APPENDICES
12.1
Appendix 1: List of Prohibited and Restricted Concomitant 
Medications
Part A – Prohibited Medications
Use of these medications in any formulation is not permitted between Screening (Visit 1) and
Week 16/Follow-Up Phone Call (Visit 6) and must have been discontinued at least 30 days 
prior to Screening.  Current or previous use of mirabegron within 6 months prior to Screening 
(Visit 1) is also prohibited. This list is not exhaustive.  In case of doubt, the Investigator must 
contact the local study monitor.
Alpha1 and Nonselective Adrenergic Blockers
Alfuzosin
Prazosin
Doxazosin
Terazosin
Silodosin
Trazodone
Phenoxybenzamine
Phentolamine
Tolazoline
Typical/atypical antipsychotics
Anticholinergics/Antispasmodics
Atropine
Baclofen
Biperiden
Clomipramine
Cyclobenzaprine
Darifenacin
Dicyclomine/Dicycloverine
Emepronium
Glycopyrronium/Glycopyrrolate
Fesoterodine
Flavoxate
Hyoscine
Hyoscyamine
Ipratropium
Isopropamide
Orphenadrine
Oxybutynin
Oxyphencyclimine
Propantheline
Propiverine
Scopolamine/(Butyl)hyoscine
Tolterodine
Trospium
Otilonium
Tiotropium
Solifenacin
Potent and Moderate CYP3A4 Inhibitors
Indinavir
Nelfinavir
Ritonavir
Clarithromycin
Itraconazole
Ketoconazole
Nefazadone
Saquinavir
Telithromycin
Cimetidine
Clotrimazole
Cyclosporine
Erythromycin
Fluconazole
Itraconazole
Ketoconazole
Macrolide antibiotics
Strong and Moderate Inhibitors of CYP2D6 Substrates and those with Narrow Therapeutic Index 
Aripiprazole (neuroleptic)
Amitriptyline/ Nortriptyline
(TCA)
Donepezil (Acetylcholinesterase 
inhibitor)
Thioridazine (anti-psychotic)
Flecainide (anti-arrhythmic)
Propafenone (anti-arrhythmic)
Imipramine/Desipramine
(TCA)
Tramadol (analgesic)
Venlafaxine/Desvenlaxafine (SNRI)
Paroxetine
Terbinafine


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Part B - Medications Permitted With Restrictions
Medications restricted between Screening (Visit 1) and Follow-Up Phone Call (Visit 6)
include loop diuretics, PDE5 inhibitors, and 5-Alpha reductase inhibitors.  All medications in 
Part B of Appendix 1Appendix 1: List of Prohibited and Restricted Concomitant Medications
are permitted provided the subject has been taking this medication on a long-term basis, i.e. 
has not stopped, or started or changed dose within 30 days prior to Screening (Visit 1), no 
new drug of the same class has been added to the regimen within the 30 days prior to 
Screening (Visit 1), and the subject remains on the medication at the same dose during the 
course of the study.  
Loop Diuretics
Furosemide
Bumetanide
Piretanide
5-alpha Reductase Inhibitors (minimum 6 months duration)
Dutasteride
Finasteride
PDE5 Inhibitors (only intermittent use for ED is allowed, daily use for BPH/LUTS is prohibited)
Sildenafil
Tadalafil
Vardenafil


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12.2
Appendix 2: Liver Safety Monitoring and Assessment
If laboratory testing for a subject enrolled in study and receiving study drug reveals an 
increase in serum aminotransferases (AT) to >3X ULN, bilirubin > 2 × ULN, at least all four 
of the usual serum hepatic measures (ALT, AST, ALP, and TBL) must be repeated. Testing 
should be repeated within 48-72 hours of notification of the test results. Alerts will be 
generated by the central lab regarding moderate and severe liver abnormality to inform the 
Investigator, study monitor and study team. Subjects should be asked if they have any 
symptoms suggestive of hepatobiliary dysfunction.
Definition of Liver Abnormalities
Confirmed abnormalities will be characterized as moderate and severe where ULN:
ALT or AST
Total Bilirubin
Moderate
> 3× ULN 
or
> 2× ULN
Severe*
> 3× ULN
and
> 2× ULN
In addition, the subject should be considered to have severe hepatic abnormalities for any of 
the following:
●
ALT or AST > 8× ULN
●
ALT or AST > 5× ULN for more than 2 weeks  
●
ALT or AST > 3× ULN and INR > 1.5 (If INR testing is applicable/evaluated).
●
ALT or AST > 3× ULN with the appearance of fatigue, nausea, vomiting, right upper 
quadrant pain or tenderness, fever, rash and/or eosinophilia (> 5%). 
The Investigator may determine that abnormal liver function results, other than as described 
above, may qualify as moderate or severe abnormalities and require additional monitoring 
and follow-up.
Follow-up Procedures
Confirmed moderate and severe abnormalities in hepatic functions should be thoroughly 
characterized by obtaining appropriate expert consultations, detailed pertinent history, 
physical examination and laboratory tests. The site should complete the Liver Abnormality 
Case Report Form (LA-CRF) or an appropriate document. Subjects with confirmed abnormal 
liver function testing should be followed as described below.
Confirmed moderately abnormal LFTs should be repeated 2-3 times weekly then weekly or 
less if abnormalities stabilize or the study drug has been discontinued and the subject is 
asymptomatic.
Severe hepatic liver function abnormalities as defined above, in the absence of another 
etiology, may be considered an important medical event and may be reported as a Serious 
Adverse Event (SAE).  The Sponsor should be contacted and informed of all subjects for 


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whom severe hepatic liver function abnormalities possibly attributable to study drug are 
observed.
To further assess abnormal hepatic laboratory findings, the Investigator is expected to:
●
Obtain a more detailed history of symptoms and prior or concurrent diseases.  Symptoms 
and new onset-diseases should be recorded as ‘adverse events’ on the AE page of the 
(e)CRF. Illnesses and conditions such as hypotensive events, and decompensated cardiac 
disease that may lead to secondary liver abnormalities should be noted. Non-alcoholic 
steatohepatitis (NASH) is seen in obese hyperlipoproteinemic, and/or diabetic patients 
and may be associated with fluctuating aminotransferase levels.   The Investigator should 
ensure that the medical history form captures any illness that pre-dates study enrollment 
that may be relevant in assessing hepatic function. 
●
Obtain a history of concomitant drug use (including non-prescription medication, 
complementary and alternative medications), alcohol use, recreational drug use, and 
special diets.  Medications, including dose, should be entered on the concomitant 
medication page of the (e)CRF.  Information on alcohol, other substance use, and diet 
should be entered on the LA-CRF or an appropriate document.
●
Obtain a history of exposure to environmental chemical agents.
●
Based on the subject’s history,  other testing may be appropriate including: 
o
acute viral hepatitis (A, B, C, D, E or other infectious agents) 
o
ultrasound or other imaging to assess biliary tract disease
o
other laboratory tests including INR, direct bilirubin
●
Consider gastroenterology or hepatology consultations.
●
Submit results for any additional testing and possible etiology on the LA-CRF or an 
appropriate document.
Study Discontinuation
In the absence of an explanation for increased LFT’s, such as viral hepatitis, pre-existing or 
acute liver disease or exposure to other agents associated with liver injury, the subject may be 
discontinued from the study. The Investigator may determine that it is not in the subject’s 
best interest to continue study enrollment. Discontinuation of treatment should be considered 
if:
●
ALT or AST > 8 × ULN
●
ALT or AST > 5 × ULN for more than 2 weeks 
●
ALT or AST > 3 × ULN and TBL > 2 × ULN or INR > 1.5) (If INR testing is 
applicable/evaluated)
●
ALT or AST > 3 × ULN with the appearance of fatigue, nausea, vomiting, right upper 
quadrant pain or tenderness, fever, rash and/or eosinophilia (> 5%). 
Reference
Guidance for Industry titled “Drug-Induced Liver Injury: Premarketing Clinical Evaluation” issued by 
FDA on July 2009.  


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12.3
Appendix 3: Common Serious Adverse Events
For this protocol, there is no list of common serious adverse events that the Sponsor 
considers to be associated with the disease state being studied for which a single occurrence 
will be excluded from IND safety reporting. All SAEs should be reported. 


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12.4
Appendix 4: Investigator Criteria for Hypertension
Investigator Criteria for Determining TEAE of Hypertension
During each office visit a systolic and diastolic blood pressure will be measured. The 
Investigator responsibility for reporting the TEAE of hypertension will be based on office 
visit measurements and not on diary review. 
For post-baseline assessments, the Investigator will use the following criteria, as defined in 
the protocol, to determine if a subject is considered hypertensive:
An AE of hypertension will be recorded if one of the following criteria is met on 
2 consecutive visits:
1.
If the average systolic blood pressure is ≥ 140 mmHg AND/OR the average diastolic 
blood pressure is ≥ 90 mmHg at two consecutive visits after Baseline (Visit 2) in subjects 
who were normotensive (average systolic blood pressure < 140 mmHg and average 
diastolic blood pressure < 90 mmHg [WHO-ISH, 2013]) at Baseline (Visit 2).
2.
If the average systolic blood pressure is increased >20 mmHg AND/OR the average 
diastolic blood pressure is increased > 10 mmHg at two consecutive visits as compared 
to Baseline (Visit 2) in subjects with hypertension at Baseline (Visit 2).
3.
If treatment with antihypertensive drugs is initiated for treatment of hypertension or if 
the dose of prior antihypertensive drugs is increased due to an increase in blood pressure.
In addition, the Investigator can record an AE based on clinical assessment.


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12.5
Appendix 5: Investigator Criteria for Tachycardia
Investigator Criteria for Determining TEAE of Tachycardia
During each office visit pulse rate will be measured.  The Investigator responsibility for 
reporting the TEAE of tachycardia will be based on office visit measurements and not on 
diary review.  Tachycardia is defined as a resting heart frequency > 100 beats per minute 
(bpm) measured as pulse rate. If pulse rate is > 100 bpm at the office visit, the Investigator is 
to record an AE of tachycardia. However, if the Investigator’s clinical assessment was that 
this did not constitute an AE of tachycardia, then an AE will as not be recorded.


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13
ATTACHMENT 1: SUBSTANTIAL AMENDMENT 4
I.  The purpose of this amendment is:
Substantial Changes
1.  Updated Reference Safety Information (RSI)
DESCRIPTION OF CHANGE:
Revised RSI from the US Package Insert, Canadian Monograph, and SmPC to the Company 
Core Data Sheet for mirabegron. 
RATIONALE:
Astellas Pharmacovigilance (PV) refers to the Company Core Data Sheet for mirabegron as the 
physical reference for RSI. There is no change in the risk to patients or what safety information is 
reported with this update to the protocol. This update provides consistency of RSI with PV and the 
protocol.
II.  Amendment Summary of Changes:
Substantial Changes:
1. Updated Reference Safety Information (RSI)
Page 58, 5.5.5 Reporting of Serious Adverse Events (SAEs)
WAS:
The reference safety information for mirabegron to be used for this study is the US Package 
Insert for the US, EU SmPC for EU countries and the Canadian Monograph for Canada. The 
reference safety information is equal in each document.
IS AMENDED TO:
The reference safety information for mirabegron to be used for this study is the Company 
Core Data Sheet (CCDS) for mirabegron, Section 4.8 Undesirable effects.US Package 
Insert for the US, EU SmPC for EU countries and the Canadian Monograph for Canada. The 
reference safety information is equal in each document.
1. Updated Reference Safety Information (RSI)
Page 77, 11 References
ADDED:
Company Core Data Sheet for mirabegron.



SAP_001.pdf: 
A Phase 4, Double-Blind, Randomized, Placebo-controlled, Multi-
Center Study to Evaluate the Efficacy, Safety, and Tolerability of 
Mirabegron in Men with Overactive Bladder (OAB) Symptoms
While Taking the Alpha Blocker Tamsulosin Hydrochloride for 
Lower Urinary Tract Symptoms (LUTS) due to Benign Prostatic 
Hyperplasia (BPH)
PLUS
ISN/Protocol 178-MA-1008
ClinicalTrials.gov Identifier: NCT02757768
Date of Statistical Analysis Plan Version 1.2: 27 Sep 2018
Sponsor: Astellas Pharma Global Development, Inc.
Medical Affairs, Americas
1 Astellas Way
Northbrook, IL 60062, USA


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sĂƌŝĐĞƐ ŽĞƐŽƉŚĂŐĞĂů
sĂƌŝĐŽƐĞ ǀĞŝŶƐ ŽĨ ĂďĚŽŵŝŶĂů ǁĂůů
ŶŽƌĞĐƚĂů ǀĂƌŝĐĞƐ
ŶŽƌĞĐƚĂů ǀĂƌŝĐĞƐ ŚĂĞŵŽƌƌŚĂŐĞ
/ŶƚƌĂŚĞƉĂƚŝĐ ƉŽƌƚĂů ŚĞƉĂƚŝĐ ǀĞŶŽƵƐ ĨŝƐƚƵůĂ
WĞƌŝƚŽŶĞŽǀĞŶŽƵƐ ƐŚƵŶƚ
WŽƌƚĂů ƐŚƵŶƚ
^ŵĂůůͲĨŽƌͲƐŝǌĞ ůŝǀĞƌ ƐǇŶĚƌŽŵĞ
^ƉŝĚĞƌ ŶĂĞǀƵƐ
,ĞƉĂƚŝƚŝƐ͕ ŶŽŶͲŝŶĨĞĐƚŝŽƵƐ ;^DYͿ
ĐƵƚĞ ŐƌĂĨƚ ǀĞƌƐƵƐ ŚŽƐƚ ĚŝƐĞĂƐĞ ŝŶ ůŝǀĞƌ
ůůĞƌŐŝĐ ŚĞƉĂƚŝƚŝƐ
ƵƚŽŝŵŵƵŶĞ ŚĞƉĂƚŝƚŝƐ
ŚƌŽŶŝĐ ŐƌĂĨƚ ǀĞƌƐƵƐ ŚŽƐƚ ĚŝƐĞĂƐĞ ŝŶ ůŝǀĞƌ
ŚƌŽŶŝĐ ŚĞƉĂƚŝƚŝƐ
DocUUID : f1c70a60-c521-4b7f-ac81-17461fb8bee9


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6$3 )LQDO  6HSWHPEHU 
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3DJH  RI 
'ƌĂĨƚ ǀĞƌƐƵƐ ŚŽƐƚ ĚŝƐĞĂƐĞ ŝŶ ůŝǀĞƌ
,ĞƉĂƚŝƚŝƐ
,ĞƉĂƚŝƚŝƐ ĂĐƵƚĞ
,ĞƉĂƚŝƚŝƐ ĐŚŽůĞƐƚĂƚŝĐ
,ĞƉĂƚŝƚŝƐ ĐŚƌŽŶŝĐ ĂĐƚŝǀĞ
,ĞƉĂƚŝƚŝƐ ĐŚƌŽŶŝĐ ƉĞƌƐŝƐƚĞŶƚ
,ĞƉĂƚŝƚŝƐ ĨƵůŵŝŶĂŶƚ
,ĞƉĂƚŝƚŝƐ ƚŽǆŝĐ
/ƐĐŚĂĞŵŝĐ ŚĞƉĂƚŝƚŝƐ
>ƵƉƵƐ ŚĞƉĂƚŝƚŝƐ
EŽŶͲĂůĐŽŚŽůŝĐ ƐƚĞĂƚŽŚĞƉĂƚŝƚŝƐ
ZĂĚŝĂƚŝŽŶ ŚĞƉĂƚŝƚŝƐ
'ƌĂŶƵůŽŵĂƚŽƵƐ ůŝǀĞƌ ĚŝƐĞĂƐĞ
>ŝǀĞƌ ƐĂƌĐŽŝĚŽƐŝƐ
>ŝǀĞƌ ŶĞŽƉůĂƐŵƐ͕ ďĞŶŝŐŶ ;ŝŶĐů ĐǇƐƚƐ ĂŶĚ ƉŽůǇƉƐͿ ;^DYͿ
ĞŶŝŐŶ ŚĞƉĂƚŝĐ ŶĞŽƉůĂƐŵ
&ŽĐĂů ŶŽĚƵůĂƌ ŚǇƉĞƌƉůĂƐŝĂ
,ĂĞŵĂŶŐŝŽŵĂ ŽĨ ůŝǀĞƌ
,ĂĞŵŽƌƌŚĂŐŝĐ ŚĞƉĂƚŝĐ ĐǇƐƚ
,ĞƉĂƚŝĐ ĂĚĞŶŽŵĂ
,ĞƉĂƚŝĐ ĐǇƐƚ
,ĞƉĂƚŝĐ ĐǇƐƚ ƌƵƉƚƵƌĞĚ
,ĞƉĂƚŝĐ ŚĂĞŵĂŶŐŝŽŵĂ ƌƵƉƚƵƌĞ
>ŝǀĞƌ ŶĞŽƉůĂƐŵƐ͕ ŵĂůŝŐŶĂŶƚ ĂŶĚ ƵŶƐƉĞĐŝĨŝĞĚ ;^DYͿ
>ŝǀĞƌ ŵĂůŝŐŶĂŶƚ ƚƵŵŽƵƌƐ ;^DYͿ
,ĞƉĂƚŝĐ ĂŶŐŝŽƐĂƌĐŽŵĂ
,ĞƉĂƚŝĐ ĐĂŶĐĞƌ ŵĞƚĂƐƚĂƚŝĐ
,ĞƉĂƚŝĐ ĐĂŶĐĞƌ ƐƚĂŐĞ /
,ĞƉĂƚŝĐ ĐĂŶĐĞƌ ƐƚĂŐĞ //
,ĞƉĂƚŝĐ ĐĂŶĐĞƌ ƐƚĂŐĞ ///
,ĞƉĂƚŝĐ ĐĂŶĐĞƌ ƐƚĂŐĞ /s
,ĞƉĂƚŽďůĂƐƚŽŵĂ
,ĞƉĂƚŽďůĂƐƚŽŵĂ ƌĞĐƵƌƌĞŶƚ
,ĞƉĂƚŽĐĞůůƵůĂƌ ĐĂƌĐŝŶŽŵĂ
DŝǆĞĚ ŚĞƉĂƚŽĐĞůůƵůĂƌ ĐŚŽůĂŶŐŝŽĐĂƌĐŝŶŽŵĂ
>ŝǀĞƌ ƚƵŵŽƵƌƐ ŽĨ ƵŶƐƉĞĐŝĨŝĞĚ ŵĂůŝŐŶĂŶĐǇ ;^DYͿ
,ĞƉĂƚŝĐ ŶĞŽƉůĂƐŵ
,ĞƉĂƚŽďŝůŝĂƌǇ ŶĞŽƉůĂƐŵ
>ŝǀĞƌ ƌĞůĂƚĞĚ ŝŶǀĞƐƚŝŐĂƚŝŽŶƐ͕ ƐŝŐŶƐ ĂŶĚ ƐǇŵƉƚŽŵƐ ;^DYͿ
ůĂŶŝŶĞ ĂŵŝŶŽƚƌĂŶƐĨĞƌĂƐĞ ĂďŶŽƌŵĂů
ůĂŶŝŶĞ ĂŵŝŶŽƚƌĂŶƐĨĞƌĂƐĞ ŝŶĐƌĞĂƐĞĚ
ŵŵŽŶŝĂ ĂďŶŽƌŵĂů
ŵŵŽŶŝĂ ŝŶĐƌĞĂƐĞĚ
DocUUID : f1c70a60-c521-4b7f-ac81-17461fb8bee9


6SRQVRU $VWHOODV 3KDUPD *OREDO 'HYHORSPHQW ,QF
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ƐĐŝƚĞƐ
ƐƉĂƌƚĂƚĞ ĂŵŝŶŽƚƌĂŶƐĨĞƌĂƐĞ ĂďŶŽƌŵĂů
ƐƉĂƌƚĂƚĞ ĂŵŝŶŽƚƌĂŶƐĨĞƌĂƐĞ ŝŶĐƌĞĂƐĞĚ
ĂĐƚĞƌĂƐĐŝƚĞƐ
ŝůĞ ŽƵƚƉƵƚ ĂďŶŽƌŵĂů
ŝůĞ ŽƵƚƉƵƚ ĚĞĐƌĞĂƐĞĚ
ŝůŝƌƵďŝŶ ĐŽŶũƵŐĂƚĞĚ ĂďŶŽƌŵĂů
ŝůŝƌƵďŝŶ ĐŽŶũƵŐĂƚĞĚ ŝŶĐƌĞĂƐĞĚ
ŝŽƉƐǇ ůŝǀĞƌ ĂďŶŽƌŵĂů
ůŽŽĚ ďŝůŝƌƵďŝŶ ĂďŶŽƌŵĂů
ůŽŽĚ ďŝůŝƌƵďŝŶ ŝŶĐƌĞĂƐĞĚ
ůŽŽĚ ďŝůŝƌƵďŝŶ ƵŶĐŽŶũƵŐĂƚĞĚ ŝŶĐƌĞĂƐĞĚ
ƌŽŵŽƐƵůƉŚƚŚĂůĞŝŶ ƚĞƐƚ ĂďŶŽƌŵĂů
ŚŝůĚͲWƵŐŚͲdƵƌĐŽƚƚĞ ƐĐŽƌĞ ŝŶĐƌĞĂƐĞĚ
&ŽĞƚŽƌ ŚĞƉĂƚŝĐƵƐ
'ĂůĂĐƚŽƐĞ ĞůŝŵŝŶĂƚŝŽŶ ĐĂƉĂĐŝƚǇ ƚĞƐƚ ĂďŶŽƌŵĂů
'ĂůĂĐƚŽƐĞ ĞůŝŵŝŶĂƚŝŽŶ ĐĂƉĂĐŝƚǇ ƚĞƐƚ ĚĞĐƌĞĂƐĞĚ
'ĂŵŵĂͲŐůƵƚĂŵǇůƚƌĂŶƐĨĞƌĂƐĞ ĂďŶŽƌŵĂů
'ĂŵŵĂͲŐůƵƚĂŵǇůƚƌĂŶƐĨĞƌĂƐĞ ŝŶĐƌĞĂƐĞĚ
'ƵĂŶĂƐĞ ŝŶĐƌĞĂƐĞĚ
,ĞƉĂƉůĂƐƚŝŶ ĂďŶŽƌŵĂů
,ĞƉĂƉůĂƐƚŝŶ ĚĞĐƌĞĂƐĞĚ
,ĞƉĂƚŝĐ ĂƌƚĞƌǇ ĨůŽǁ ĚĞĐƌĞĂƐĞĚ
,ĞƉĂƚŝĐ ĐŽŶŐĞƐƚŝŽŶ
,ĞƉĂƚŝĐ ĞŶǌǇŵĞ ĂďŶŽƌŵĂů
,ĞƉĂƚŝĐ ĞŶǌǇŵĞ ĚĞĐƌĞĂƐĞĚ
,ĞƉĂƚŝĐ ĞŶǌǇŵĞ ŝŶĐƌĞĂƐĞĚ
,ĞƉĂƚŝĐ ĨƵŶĐƚŝŽŶ ĂďŶŽƌŵĂů
,ĞƉĂƚŝĐ ŚǇĚƌŽƚŚŽƌĂǆ
,ĞƉĂƚŝĐ ŵĂƐƐ
,ĞƉĂƚŝĐ ƉĂŝŶ
,ĞƉĂƚŝĐ ƐĞƋƵĞƐƚƌĂƚŝŽŶ
,ĞƉĂƚŝĐ ǀĂƐĐƵůĂƌ ƌĞƐŝƐƚĂŶĐĞ ŝŶĐƌĞĂƐĞĚ
,ĞƉĂƚŽďŝůŝĂƌǇ ƐĐĂŶ ĂďŶŽƌŵĂů
,ĞƉĂƚŽŵĞŐĂůǇ
,ĞƉĂƚŽƐƉůĞŶŽŵĞŐĂůǇ
,ǇƉĞƌĂŵŵŽŶĂĞŵŝĂ
,ǇƉĞƌďŝůŝƌƵďŝŶĂĞŵŝĂ
,ǇƉĞƌĐŚŽůŝĂ
,ǇƉĞƌƚƌĂŶƐĂŵŝŶĂƐĂĞŵŝĂ
<ĂǇƐĞƌͲ&ůĞŝƐĐŚĞƌ ƌŝŶŐ
>ŝǀĞƌ ĨƵŶĐƚŝŽŶ ƚĞƐƚ ĂďŶŽƌŵĂů
>ŝǀĞƌ ŝŶĚƵƌĂƚŝŽŶ
DocUUID : f1c70a60-c521-4b7f-ac81-17461fb8bee9


6SRQVRU $VWHOODV 3KDUPD *OREDO 'HYHORSPHQW ,QF
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,613URWRFRO 0$
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>ŝǀĞƌ ƉĂůƉĂďůĞ ƐƵďĐŽƐƚĂů
>ŝǀĞƌ ƐĐĂŶ ĂďŶŽƌŵĂů
>ŝǀĞƌ ƚĞŶĚĞƌŶĞƐƐ
DŝƚŽĐŚŽŶĚƌŝĂů ĂƐƉĂƌƚĂƚĞ ĂŵŝŶŽƚƌĂŶƐĨĞƌĂƐĞ ŝŶĐƌĞĂƐĞĚ
DŽůĂƌ ƌĂƚŝŽ ŽĨ ƚŽƚĂů ďƌĂŶĐŚĞĚͲĐŚĂŝŶ ĂŵŝŶŽ ĂĐŝĚ ƚŽ ƚǇƌŽƐŝŶĞ
KĞĚĞŵĂ ĚƵĞ ƚŽ ŚĞƉĂƚŝĐ ĚŝƐĞĂƐĞ
WĞƌŝŚĞƉĂƚŝĐ ĚŝƐĐŽŵĨŽƌƚ
ZĞƚƌŽŐƌĂĚĞ ƉŽƌƚĂů ǀĞŝŶ ĨůŽǁ
dŽƚĂů ďŝůĞ ĂĐŝĚƐ ŝŶĐƌĞĂƐĞĚ
dƌĂŶƐĂŵŝŶĂƐĞƐ ĂďŶŽƌŵĂů
dƌĂŶƐĂŵŝŶĂƐĞƐ ŝŶĐƌĞĂƐĞĚ
hůƚƌĂƐŽƵŶĚ ůŝǀĞƌ ĂďŶŽƌŵĂů
hƌŝŶĞ ďŝůŝƌƵďŝŶ ŝŶĐƌĞĂƐĞĚ
yͲƌĂǇ ŚĞƉĂƚŽďŝůŝĂƌǇ ĂďŶŽƌŵĂů
ϱΖŶƵĐůĞŽƚŝĚĂƐĞ ŝŶĐƌĞĂƐĞĚ
ůŽŽĚ ĂůŬĂůŝŶĞ ƉŚŽƐƉŚĂƚĂƐĞ ĂďŶŽƌŵĂů
ůŽŽĚ ĂůŬĂůŝŶĞ ƉŚŽƐƉŚĂƚĂƐĞ ŝŶĐƌĞĂƐĞĚ
ůŽŽĚ ĐŚŽůŝŶĞƐƚĞƌĂƐĞ ĂďŶŽƌŵĂů
ůŽŽĚ ĐŚŽůŝŶĞƐƚĞƌĂƐĞ ĚĞĐƌĞĂƐĞĚ
ĞĨŝĐŝĞŶĐǇ ŽĨ ďŝůĞ ƐĞĐƌĞƚŝŽŶ
'ůƵƚĂŵĂƚĞ ĚĞŚǇĚƌŽŐĞŶĂƐĞ ŝŶĐƌĞĂƐĞĚ
,ĂĞŵŽƌƌŚĂŐŝĐ ĂƐĐŝƚĞƐ
,ǇƉŽĂůďƵŵŝŶĂĞŵŝĂ
>ĞƵĐŝŶĞ ĂŵŝŶŽƉĞƉƚŝĚĂƐĞ ŝŶĐƌĞĂƐĞĚ
WĞƌŝƉŽƌƚĂů ŽĞĚĞŵĂ
WĞƌŝƚŽŶĞĂů ĨůƵŝĚ ƉƌŽƚĞŝŶ ĂďŶŽƌŵĂů
WĞƌŝƚŽŶĞĂů ĨůƵŝĚ ƉƌŽƚĞŝŶ ĚĞĐƌĞĂƐĞĚ
WĞƌŝƚŽŶĞĂů ĨůƵŝĚ ƉƌŽƚĞŝŶ ŝŶĐƌĞĂƐĞĚ
WŶĞƵŵŽďŝůŝĂ
WŽƌƚĂů ǀĞŝŶ ĨůŽǁ ĚĞĐƌĞĂƐĞĚ
WŽƌƚĂů ǀĞŝŶ ƉƌĞƐƐƵƌĞ ŝŶĐƌĞĂƐĞĚ
ZĞƚŝŶŽů ďŝŶĚŝŶŐ ƉƌŽƚĞŝŶ ĚĞĐƌĞĂƐĞĚ
hƌŽďŝůŝŶŽŐĞŶ ƵƌŝŶĞ ĚĞĐƌĞĂƐĞĚ
hƌŽďŝůŝŶŽŐĞŶ ƵƌŝŶĞ ŝŶĐƌĞĂƐĞĚ
>ŝǀĞƌͲƌĞůĂƚĞĚ ĐŽĂŐƵůĂƚŝŽŶ ĂŶĚ ďůĞĞĚŝŶŐ ĚŝƐƚƵƌďĂŶĐĞƐ ;^DYͿ
ŶƚŝƚŚƌŽŵďŝŶ /// ĚĞĐƌĞĂƐĞĚ
ůŽŽĚ ĨŝďƌŝŶŽŐĞŶ ĂďŶŽƌŵĂů
ůŽŽĚ ĨŝďƌŝŶŽŐĞŶ ĚĞĐƌĞĂƐĞĚ
ůŽŽĚ ƚŚƌŽŵďŝŶ ĂďŶŽƌŵĂů
ůŽŽĚ ƚŚƌŽŵďŝŶ ĚĞĐƌĞĂƐĞĚ
ůŽŽĚ ƚŚƌŽŵďŽƉůĂƐƚŝŶ ĂďŶŽƌŵĂů
ůŽŽĚ ƚŚƌŽŵďŽƉůĂƐƚŝŶ ĚĞĐƌĞĂƐĞĚ
ŽĂŐƵůĂƚŝŽŶ ĨĂĐƚŽƌ ĚĞĐƌĞĂƐĞĚ
DocUUID : f1c70a60-c521-4b7f-ac81-17461fb8bee9


6SRQVRU $VWHOODV 3KDUPD *OREDO 'HYHORSPHQW ,QF
6$3 )LQDO  6HSWHPEHU 
,613URWRFRO 0$
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3DJH  RI 
ŽĂŐƵůĂƚŝŽŶ ĨĂĐƚŽƌ /y ůĞǀĞů ĂďŶŽƌŵĂů
ŽĂŐƵůĂƚŝŽŶ ĨĂĐƚŽƌ /y ůĞǀĞů ĚĞĐƌĞĂƐĞĚ
ŽĂŐƵůĂƚŝŽŶ ĨĂĐƚŽƌ s ůĞǀĞů ĂďŶŽƌŵĂů
ŽĂŐƵůĂƚŝŽŶ ĨĂĐƚŽƌ s ůĞǀĞů ĚĞĐƌĞĂƐĞĚ
ŽĂŐƵůĂƚŝŽŶ ĨĂĐƚŽƌ s// ůĞǀĞů ĂďŶŽƌŵĂů
ŽĂŐƵůĂƚŝŽŶ ĨĂĐƚŽƌ s// ůĞǀĞů ĚĞĐƌĞĂƐĞĚ
ŽĂŐƵůĂƚŝŽŶ ĨĂĐƚŽƌ y ůĞǀĞů ĂďŶŽƌŵĂů
ŽĂŐƵůĂƚŝŽŶ ĨĂĐƚŽƌ y ůĞǀĞů ĚĞĐƌĞĂƐĞĚ
,ǇƉŽĐŽĂŐƵůĂďůĞ ƐƚĂƚĞ
,ǇƉŽĨŝďƌŝŶŽŐĞŶĂĞŵŝĂ
,ǇƉŽƉƌŽƚŚƌŽŵďŝŶĂĞŵŝĂ
,ǇƉŽƚŚƌŽŵďŝŶĂĞŵŝĂ
,ǇƉŽƚŚƌŽŵďŽƉůĂƐƚŝŶĂĞŵŝĂ
/ŶƚĞƌŶĂƚŝŽŶĂů ŶŽƌŵĂůŝƐĞĚ ƌĂƚŝŽ ĂďŶŽƌŵĂů
/ŶƚĞƌŶĂƚŝŽŶĂů ŶŽƌŵĂůŝƐĞĚ ƌĂƚŝŽ ŝŶĐƌĞĂƐĞĚ
WƌŽƚĞŝŶ  ĚĞĐƌĞĂƐĞĚ
WƌŽƚĞŝŶ ^ ĂďŶŽƌŵĂů
WƌŽƚĞŝŶ ^ ĚĞĐƌĞĂƐĞĚ
WƌŽƚŚƌŽŵďŝŶ ůĞǀĞů ĂďŶŽƌŵĂů
WƌŽƚŚƌŽŵďŝŶ ůĞǀĞů ĚĞĐƌĞĂƐĞĚ
WƌŽƚŚƌŽŵďŝŶ ƚŝŵĞ ĂďŶŽƌŵĂů
WƌŽƚŚƌŽŵďŝŶ ƚŝŵĞ ƉƌŽůŽŶŐĞĚ
WƌŽƚŚƌŽŵďŝŶ ƚŝŵĞ ƌĂƚŝŽ ĂďŶŽƌŵĂů
WƌŽƚŚƌŽŵďŝŶ ƚŝŵĞ ƌĂƚŝŽ ŝŶĐƌĞĂƐĞĚ
dŚƌŽŵďŝŶ ƚŝŵĞ ĂďŶŽƌŵĂů
dŚƌŽŵďŝŶ ƚŝŵĞ ƉƌŽůŽŶŐĞĚ
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