Clinical trial NCT02235909
Conditions: Hypertension
Keywords: Pediatric Hypertension High Blood Pressure Hypertension Pediatric Primary Hypertension Secondary Hypertension
Sponsor: Arbor Pharmaceuticals, Inc.
Start date: 2015-03-30; Completion date: 2019-11-11
Enrollment: 377 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to evaluate the efficacy and safety of the study drug relative to an active comparator losartan which is in the same class of drug and is approved for use in the pediatric population aged 6 years and older. Approximately 260 subjects will participate in a 6-week, double-blind, randomized, treatment phase, followed by a 2-week, double-blind, randomized, placebo-controlled withdrawal phase. A 44-week, open-label extension in which all subjects will receive azilsartan and other antihypertensive medications (if needed). Blood pressure will be assessed throughout the study.

Detailed description:
The purpose of the study is to evaluate the efficacy and safety of the study drug relative to an active comparator losartan which the same class of drug and is approved for use in the pediatric population aged 6 years and older. Approximately 260 subjects will participate in a 6-week, double-blind, randomized, treatment phase, followed by a 2-week, double-blind, randomized, placebo-controlled withdrawal phase. This study also includes a 44-week, open-label extension Phase in which all subjects will receive azilsartan and other antihypertensive medications (if needed) in order to reach an optimal blood pressure. Blood pressure will be assessed in the clinic throughout the study, and subjects may also participate in a 24-hour ambulatory blood pressure monitoring procedure at baseline, at the end of the double-blind Phase and at the end of the open-label Phase.

Arms: arm 1: 6-week, double-blind (DB), randomized, treatment phase (DB Phase): Azilsartan medoxomil low-dose (AZM-L), 10 mg once daily. arm 2: 6-week, double-blind (DB), randomized, treatment phase (DB Phase): Starting at Losartan 25/50 and force titrated to 50/100 mg daily at Week 2. arm 3: Experimental Arm in the Withdrawal Phase, subjects will be randomized (1:1) to continue taking their previously assigned active treatment (AZM-L) that was taken in Double blind OR to be switched to placebo. arm 4: Placebo Arm in the Withdrawal Phase for subjects who were on AZM-L in double blind then randomized (1:1) to placebo for withdrawal phase arm 5: Azilsartan Medoxomil 10 mg which can be titrated to higher dose(s) (up to 40 mg for subjects \<50 kg or up to 80 mg for subjects ≥50 kg) arm 6: Withdrawal Phase, subjects will be randomized (1:1) to continue taking their previously assigned active treatment or to be switched to placebo. arm 7: Placebo Arm In the Withdrawal Phase, subjects will be randomized (1:1) to continue taking their previously assigned active treatment or to be switched to placebo. arm 8: 6-week, double-blind (DB), randomized, treatment phase (DB Phase), Azilsartan medoxomil Medium-dose (AZM-M), 20 mg once daily at Week 2. arm 9: 6-week, double-blind (DB), randomized, treatment phase (DB Phase): Azilsartan medoxomil High-dose (AZM-H), 40 mg AZM-M arm 10: Experimental Arm in the Withdrawal Phase, subjects will be randomized (1:1) to continue taking their previously assigned active treatment (AZM-M) that was taken in Double blind OR to be switched to placebo. arm 11: Experimental Arm in the Withdrawal Phase, subjects will be randomized (1:1) to continue taking their previously assigned active treatment (AZM-H) that was taken in double blind OR to be switched to placebo. arm 12: Placebo arm in the Withdrawal Phase for subjects who were on AZM-M in double blind then randomized (1:1) to matching placebo for withdrawal phase arm 13: Placebo arm in the Withdrawal Phase for subjects who were on AZM-H in Double blind then randomized (1:1) to matching placebo for withdrawal phase
Interventions: intervention 1: Azilsartan Medoxomil Low-dose intervention 2: Losartan intervention 3: Placebo for Azilsartan Medoxomil intervention 4: Placebo for Losartan intervention 5: Azilsartan Medoxomil Medium-dose (20 mg) intervention 6: Azilsartan Medoxomil High-dose (40 mg)
Intervention descriptions: intervention 1: Azilsartan medoxomil low-dose (AZM-L) 10 mg intervention 2: None intervention 3: None intervention 4: None intervention 5: Azilsartan medoxomil medium-dose (AZM-M) 20 mg intervention 6: Azilsartan medoxomil high-dose (AZM-L) 40 mg

Protocol documents:
Prot_000.pdf: 
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SAP_001.pdf: 
 
 
 
Arbor 
Ar14.001 
Statistical Analysis Plan 
Page 1 of 56 
 
Document: 
2014-000674-18 Statistical Analysis Plan Version 7.0 
Version Number: 
7.0 
Author: 
Sonelca Southey, Angelo Castelnovo 
Version Date: 
13JAN2020 
Template No.:  CS_TP_BS016 Revision 5 
Reference:  CS_WI_BS005 
Effective Date: 01Apr2018 
 
Copyright © 2009, 2010, 2012, 2016, 2018 IQVIA. All rights reserved. The contents of this document are confidential and proprietary 
to IQVIA Holdings Inc. and its subsidiaries. Unauthorized use, disclosure or reproduction is strictly prohibited. 
 
 
 
STATISTICAL ANALYSIS PLAN 
 
AR14.001 
 
A RANDOMIZED, DOUBLE-BLIND, EFFICACY AND SAFETY STUDY OF 
AR 14 (AZILSARTAN MEDOXOMIL) TREATMENT AND 
WITHDRAWAL, FOLLOWED BY AN OPEN-LABEL EXTENSION, IN 
CHILDREN 6 TO LESS THAN 18 YEARS OF AGE WITH HYPERTENSION. 
 
 
AUTHOR: SONELCA SOUTHEY, ANGELO CASTELNOVO 
VERSION NUMBER AND DATE: V7.0, 13JAN2020 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


 
 
 
Arbor 
Ar14.001 
Statistical Analysis Plan 
Page 2 of 56 
 
Document: 
2014-000674-18 Statistical Analysis Plan Version 7.0 
Version Number: 
7.0 
Author: 
Sonelca Southey, Angelo Castelnovo 
Version Date: 
13JAN2020 
Template No.:  CS_TP_BS016 Revision 5 
Reference:  CS_WI_BS005 
Effective Date: 01Apr2018 
 
Copyright © 2009, 2010, 2012, 2016, 2018 IQVIA. All rights reserved. The contents of this document are confidential and proprietary 
to IQVIA Holdings Inc. and its subsidiaries. Unauthorized use, disclosure or reproduction is strictly prohibited. 
 
STATISTICAL ANALYSIS PLAN SIGNATURE PAGE 
Statistical Analysis Plan V7.0 (Dated 13Jan2020) for Protocol AR14.001. 
 
 
Name 
Signature 
Date 
Author: 
Sonelca Southey 
 
 
 
Position: 
Associate Biostatistician  
 
Company: 
IQVIA 
 
Author: 
Angelo Castelnovo 
 
 
 
Position: 
Biostatistician II  
 
Company: 
IQVIA 
 
Upon review of this document, the undersigned approves this version of the Statistical Analysis Plan, 
authorizing that the content is acceptable for the reporting of this study. 
 
Name 
Signature 
Date 
Approved By: 
Stacy Woodard 
 
 
 
Position: 
Senior Biostatistics Director 
 
Company: 
IQVIA 
 
Approved By: 
Steven Caras, MD, 
PhD 
 
 
 
Position: 
Vice President, Clinical Development 
 
Company: 
Arbor Pharmaceuticals, LLC 


 
 
 
Arbor 
Ar14.001 
Statistical Analysis Plan 
Page 3 of 56 
 
Document: 
2014-000674-18 Statistical Analysis Plan Version 7.0 
Version Number: 
7.0 
Author: 
Sonelca Southey, Angelo Castelnovo 
Version Date: 
13JAN2020 
Template No.:  CS_TP_BS016 Revision 5 
Reference:  CS_WI_BS005 
Effective Date: 01Apr2018 
 
Copyright © 2009, 2010, 2012, 2016, 2018 IQVIA. All rights reserved. The contents of this document are confidential and proprietary 
to IQVIA Holdings Inc. and its subsidiaries. Unauthorized use, disclosure or reproduction is strictly prohibited. 
 
MODIFICATION HISTORY 
 
 
Unique 
Identifier 
for this 
Version 
Date of the 
Document 
Version 
Author 
Significant Changes from  
Previous Authorized Version 
1.0 
10Nov2017 
Yang Wang 
Not Applicable – First Version. 
2.0 
16Jul2018 
Aditi Acharya 
Added appropriate figures.  
Added statistical analysis details for 
baseline characteristics and subgroup 
analysis. 
3.0 
20Sep2018 
Aditi Acharya 
Updated as per Client’s comments. 
4.0 
04Dec2018 
Aditi Acharya 
Updated PROC MI code in Appendix. 
5.0 
14Jan2019 
Aditi Acharya 
Updated Appendix 3 with the derived 
Low and High Lab criteria to be used for 
the outputs. 
Updated Appendix 5 Proc MI code. 
Updated section 4.4 PK analysis. 
Updated Appendix 1 with treatment 
and procedure details for each phase. 
Added appropriate baseline seDBP, 
SESBP or MAP in section 15.4.3.2. 
6.0 
19Mar2019 
Aditi Acharya 
Updated section 3.2 and 3.5. 
7.0 
13Jan2020 
Sonelca 
Southey, Angelo 
Castelnovo 
Updated layout of entire SAP. Changed 
company name to IQVIA. Included 
references throughout relating to the 
open-label phase. 
 
 
 


 
 
 
Arbor 
Ar14.001 
Statistical Analysis Plan 
Page 4 of 56 
 
Document: 
2014-000674-18 Statistical Analysis Plan Version 7.0 
Version Number: 
7.0 
Author: 
Sonelca Southey, Angelo Castelnovo 
Version Date: 
13JAN2020 
Template No.:  CS_TP_BS016 Revision 5 
Reference:  CS_WI_BS005 
Effective Date: 01Apr2018 
 
Copyright © 2009, 2010, 2012, 2016, 2018 IQVIA. All rights reserved. The contents of this document are confidential and proprietary 
to IQVIA Holdings Inc. and its subsidiaries. Unauthorized use, disclosure or reproduction is strictly prohibited. 
 
LIST OF ABBREVIATIONS 
 
ABPM 
ambulatory blood pressure monitoring 
ACE 
angiotensin-converting enzyme 
ACS 
abnormal, clinically significant 
AE 
adverse event 
ANCOVA 
analysis of covariance 
ANCS 
abnormal, not clinically significant 
AZM 
AZM-H 
AZM-L 
AZM-M 
azilsartan medoxomil 
high dose azilsartan medoxomil 
low dose azilsartan medoxomil 
intermediate dose azilsartan medoxomil 
BMI 
body mass index 
BP 
blood pressure 
CI 
confidence interval 
CKD 
CSR 
chronic kidney disease 
clinical study report 
DB 
double-blind 
DBL 
database lock 
DBP 
diastolic blood pressure 
DMC 
Data Monitoring Committee 
ECG 
electrocardiogram 
eCRF 
electronic case report form 
EU 
European Union 
FAS 
full analysis set 
IVRS 
interactive voice response system 
IWRS 
interactive web response system 
LOCF 
last observation carried forward 
LS 
least-squares 
MAP 
mean arterial pressure 
MedDRA 
Medical Dictionary for Regulatory Activities 
MMRM 
mixed models for repeated measures 
OL 
open-label 
PPS 
per-protocol set 
PT 
preferred term 


 
 
 
Arbor 
Ar14.001 
Statistical Analysis Plan 
Page 5 of 56 
 
Document: 
2014-000674-18 Statistical Analysis Plan Version 7.0 
Version Number: 
7.0 
Author: 
Sonelca Southey, Angelo Castelnovo 
Version Date: 
13JAN2020 
Template No.:  CS_TP_BS016 Revision 5 
Reference:  CS_WI_BS005 
Effective Date: 01Apr2018 
 
Copyright © 2009, 2010, 2012, 2016, 2018 IQVIA. All rights reserved. The contents of this document are confidential and proprietary 
to IQVIA Holdings Inc. and its subsidiaries. Unauthorized use, disclosure or reproduction is strictly prohibited. 
 
SAE 
serious adverse event 
SAP 
statistical analysis plan 
SD 
standard deviation 
SBP 
systolic blood pressure 
seDBP 
seated diastolic blood pressure 
seSBP 
seated systolic blood pressure 
SOC 
system organ class 
TEAE 
treatment- emergent adverse event 
ULN 
upper limit of normal 
US 
United States 
WHO-DD 
World Health Organization Drug Dictionary  
 
 
 


 
 
 
Arbor 
Ar14.001 
Statistical Analysis Plan 
Page 6 of 56 
 
Document: 
2014-000674-18 Statistical Analysis Plan Version 7.0 
Version Number: 
7.0 
Author: 
Sonelca Southey, Angelo Castelnovo 
Version Date: 
13JAN2020 
Template No.:  CS_TP_BS016 Revision 5 
Reference:  CS_WI_BS005 
Effective Date: 01Apr2018 
 
Copyright © 2009, 2010, 2012, 2016, 2018 IQVIA. All rights reserved. The contents of this document are confidential and proprietary 
to IQVIA Holdings Inc. and its subsidiaries. Unauthorized use, disclosure or reproduction is strictly prohibited. 
 
TABLE OF CONTENTS 
 
1. 
INTRODUCTION ................................................................................................................. 11 
2. 
STUDY OBJECTIVES .......................................................................................................... 11 
2.1. 
Primary Objective ...................................................................................................................................... 11 
2.2. 
Secondary Objectives ................................................................................................................................ 11 
2.3. 
Additional Objectives ................................................................................................................................ 11 
3. 
STUDY DESIGN ................................................................................................................... 12 
3.1. 
General Description ................................................................................................................................... 12 
3.2. 
Randomization .......................................................................................................................................... 13 
3.3. 
Treatments and Dosing .............................................................................................................................. 14 
3.4. 
Schedule of Events ..................................................................................................................................... 15 
3.5. 
Sample Size................................................................................................................................................ 16 
3.6. 
Changes to Analysis from Protocol ............................................................................................................ 16 
4. 
PLANNED ANALYSES ........................................................................................................ 16 
4.1. 
Data Monitoring Committee ...................................................................................................................... 16 
4.2. 
Interim Analysis ......................................................................................................................................... 16 
4.3. 
Final Analysis ............................................................................................................................................. 17 
4.4. 
Pharmacokinetic Analysis .......................................................................................................................... 17 
5. 
ANALYSIS SETS .................................................................................................................. 17 
5.1. 
All Subjects Enrolled Set [ENR] .................................................................................................................. 17 


 
 
 
Arbor 
Ar14.001 
Statistical Analysis Plan 
Page 7 of 56 
 
Document: 
2014-000674-18 Statistical Analysis Plan Version 7.0 
Version Number: 
7.0 
Author: 
Sonelca Southey, Angelo Castelnovo 
Version Date: 
13JAN2020 
Template No.:  CS_TP_BS016 Revision 5 
Reference:  CS_WI_BS005 
Effective Date: 01Apr2018 
 
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5.2. 
All Subjects Randomized Set [RND] ........................................................................................................... 18 
5.3. 
Full Analysis Set [FAS] ................................................................................................................................ 18 
5.4. 
Safety Analysis Set [SAF]............................................................................................................................ 18 
5.5. 
Per Protocol Set [PPS] ................................................................................................................................ 18 
5.6 
Pharmacokinetic Set [PK]........................................................................................................................... 19 
6. 
GENERAL CONSIDERATIONS .......................................................................................... 19 
6.1. 
Reference Start Date and Study Day .......................................................................................................... 19 
6.2. 
Baseline ..................................................................................................................................................... 19 
6.3. 
Endpoints .................................................................................................................................................. 21 
6.4. 
Retests, Unscheduled Visits and Early Termination Data ........................................................................... 22 
6.5. 
Windowing Conventions ............................................................................................................................ 22 
6.6. 
Summary Statistics .................................................................................................................................... 22 
6.7. 
Statistical Tests .......................................................................................................................................... 23 
6.8. 
Precision .................................................................................................................................................... 23 
6.9. 
Common Calculations ................................................................................................................................ 23 
6.10. 
Software Version ................................................................................................................................... 23 
7. 
STATISTICAL CONSIDERATIONS ................................................................................... 24 
7.1. 
Adjustments for Covariates and Factors to be Included in Analyses .......................................................... 24 
7.2. 
Multicenter Studies ................................................................................................................................... 24 
7.3. 
Missing data .............................................................................................................................................. 24 
7.4. 
Multiple Comparisons/ Multiplicity ........................................................................................................... 24 
7.5. 
Examination of Subgroups ......................................................................................................................... 25 


 
 
 
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8. 
OUTPUT PRESENTATIONS .............................................................................................. 26 
9. 
DISPOSITION AND WITHDRAWALS ............................................................................. 26 
10. 
DEMOGRAPHIC AND OTHER BASELINE CHARACTERISTICS .............................. 27 
11. 
MEDICAL HISTORY ........................................................................................................ 27 
12. 
MEDICATIONS ................................................................................................................. 28 
13. 
STUDY MEDICATION EXPOSURE ............................................................................... 29 
13.1. 
Derivations ............................................................................................................................................ 29 
14. 
STUDY MEDICATION COMPLIANCE .......................................................................... 29 
14.1. 
Derivations ............................................................................................................................................ 29 
15. 
EFFICACY OUTCOMES ................................................................................................... 30 
15.1. 
Primary Efficacy ..................................................................................................................................... 30 
15.1.1. 
Primary Efficacy Variable(s) & Derivation(s)......................................................................................... 30 
15.1.2. 
Missing Data Methods for Primary Efficacy Variable(s) ........................................................................ 31 
15.1.3. 
Primary Analysis of Primary Efficacy Variable(s)................................................................................... 31 
15.1.4. 
Sensitivity Analysis of Primary Efficacy Variable(s) ............................................................................... 31 
15.2. 
Secondary Efficacy ................................................................................................................................. 32 
15.2.1. 
Secondary Efficacy Variables & Derivations ......................................................................................... 32 
15.2.1.1.......................................................................................................................................................... 32 
15.2.1.2.......................................................................................................................................................... 32 
15.2.1.3.......................................................................................................................................................... 32 
15.2.2. 
Missing Data Methods for Secondary Efficacy Variable(s) .................................................................... 32 
15.2.2.1.......................................................................................................................................................... 32 
15.2.2.2.......................................................................................................................................................... 32 
15.2.2.3.......................................................................................................................................................... 32 
15.2.3. 
Analysis of Secondary Efficacy Variables .............................................................................................. 33 
15.2.3.1.......................................................................................................................................................... 33 
15.2.3.2.......................................................................................................................................................... 33 
15.2.3.3.......................................................................................................................................................... 33 


 
 
 
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15.3. 
Additional Efficacy ................................................................................................................................. 34 
15.3.1. 
Additional Efficacy Variables & Derivations ......................................................................................... 34 
15.3.1.1.......................................................................................................................................................... 34 
15.3.1.2.......................................................................................................................................................... 34 
15.3.1.3.......................................................................................................................................................... 34 
15.3.1.4.......................................................................................................................................................... 34 
15.3.2. 
Missing Data Methods for Additional Efficacy Variable(s) .................................................................... 34 
15.3.2.1.......................................................................................................................................................... 34 
15.3.2.2.......................................................................................................................................................... 34 
15.3.2.3.......................................................................................................................................................... 35 
15.3.3. 
Analysis of Additional Efficacy Variables .............................................................................................. 35 
15.3.3.1.......................................................................................................................................................... 35 
15.3.3.2.......................................................................................................................................................... 35 
15.3.3.3.......................................................................................................................................................... 35 
15.4. 
Exploratory Efficacy ............................................................................................................................... 36 
15.4.1. 
Exploratory Efficacy Variables & Derivations ....................................................................................... 36 
15.4.1.1.......................................................................................................................................................... 36 
15.4.1.2.......................................................................................................................................................... 36 
15.4.1.3.......................................................................................................................................................... 36 
15.4.2. 
Missing Data Methods for Exploratory Efficacy Variable(s) .................................................................. 36 
15.4.2.1.......................................................................................................................................................... 36 
15.4.2.2.......................................................................................................................................................... 36 
15.4.2.3.......................................................................................................................................................... 36 
15.4.3. 
Analysis of Exploratory Efficacy Variables ............................................................................................ 36 
15.4.3.1.......................................................................................................................................................... 36 
15.4.3.2.......................................................................................................................................................... 37 
16. 
SAFETY OUTCOMES ....................................................................................................... 37 
16.1. 
Adverse Events ...................................................................................................................................... 37 
16.1.1. 
All TEAEs ............................................................................................................................................. 38 
16.1.1.1. 
Severity ....................................................................................................................................... 38 
16.1.1.2. 
Relationship to Study Medication ................................................................................................ 38 
16.1.2. 
Serious Treatment Emergent Adverse Events ...................................................................................... 38 
16.1.3. 
Treatment Emergent Adverse Events Leading to Death ....................................................................... 39 
16.1.4. 
All Adverse Events Leading to Death ................................................................................................... 39 
16.2. 
Laboratory Evaluations .......................................................................................................................... 39 
16.2.1. 
Laboratory Reference Ranges and Markedly Abnormal Criteria ........................................................... 39 
16.3. 
ECG Evaluations ..................................................................................................................................... 40 


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16.4.
Vital Signs..............................................................................................................................................40
16.5.
Physical Examination .............................................................................................................................41
16.6.
Other Safety Assessments......................................................................................................................41
17.
REFERENCES ...................................................................................................................42
PROGRAMMING CONVENTIONS FOR OUTPUTS.......................................42
IQVIA Output Conventions....................................................................................................................................42
Dates & Times.......................................................................................................................................................43
Spelling Format.....................................................................................................................................................43
Presentation of Treatment Groups........................................................................................................................43
Presentation of Visits............................................................................................................................................44
Definition of Phases and Treatment Assignment: .................................................................................................44
Listings..................................................................................................................................................................45
General Display.....................................................................................................................................................45
PARTIAL DATE CONVENTIONS.....................................................................46
Algorithm for Treatment Emergence of Adverse Events:.......................................................................................46
MARKEDLY ABNORMAL CRITERIA .............................................................48
Z-SCORE CALCULATION USING CDC GROWTH CURVE...........................51
MONTE CARLO MARKOV CHAIN (MCMC) ..................................................55
ECG HIGH LOW CRITERIA..............................................................................57


 
 
 
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1. 
INTRODUCTION 
This document describes the rules and conventions to be used in the presentation and analysis of efficacy 
and safety data for Protocol AR14.001. It describes the data to be summarized and analyzed and the 
procedures for creating the statistical outputs.  It includes specifics of the statistical analyses to be 
performed and presented in the final clinical study report (CSR). 
 
This statistical analysis plan (SAP) is based on Protocol version 1.0, dated 20 February 2014. 
 
A separate data monitoring committee (DMC) document was prepared for the DMC specific analyses. 
2. 
STUDY OBJECTIVES 
2.1. PRIMARY OBJECTIVE 
The primary objective is  
• 
To evaluate the antihypertensive effect of azilsartan medoxomil (AZM) compared with placebo after 
a randomized, double-blind, withdrawal (Withdrawal Phase). 
2.2. SECONDARY OBJECTIVES 
The secondary objectives are  
• 
To evaluate the antihypertensive effect of AZM compared with losartan during double-blind 
treatment (Double-Blind Phase). 
• 
To evaluate the safety and tolerability of AZM relative to placebo and losartan during double-blind 
treatment, and of AZM during a long-term, open-label extension (OL Phase). 
2.3.  ADDITIONAL OBJECTIVES 
The additional objective is: 
• 
To assess the population pharmacokinetics of azilsartan derived from AZM (To be covered by a 
separate analysis plan). 


 
 
 
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3. 
STUDY DESIGN 
3.1. GENERAL DESCRIPTION 
AR14.001 is a global phase 3, efficacy and safety study of AZM in children aged 6 to <18 years with primary or 
secondary hypertension. Approximately 260 subjects will participate in a 6- week, double-blind (DB), randomized, 
treatment phase (DB Phase), followed by a 2 week, double-blind, randomized placebo-controlled withdrawal 
(Withdrawal Phase). In the DB Phase, subjects will be randomized (1:1:1:1) to 1 of 4 treatment arms AZM (low 
[AZM-L], intermediate [AZM-M] or high [AZM-H]) using 4 doses (10, 20, 40, and 80 mg) or losartan. The dose of 
AZM or losartan used will be dependent on the subject’s weight. In the Withdrawal Phase, subjects will be 
randomized (1:1) to continue taking their previously assigned active treatment or to be switched to placebo.  In the 
Withdrawal Phase, subjects will be randomized (1:1) to continue taking their previously assigned active treatment 
or to be switched to placebo.  
 
This study also includes a 44-week, Open-label extension (OL Phase) in which all subjects will receive AZM and 
other antihypertensive medications (if needed) according to a titrate-to-target blood pressure (BP) algorithm. The 
study will be conducted at approximately 120 sites. BP will be assessed in the clinic throughout the study, and 
subjects may also participate in a 24-hour ambulatory blood pressure monitoring (ABPM) procedure at Baseline, at 
the end the DB Phase and at the end of the OL Phase. 
 
Due to lower than expected standard deviation, the sample size was reduced to approximately 213 by Protocol 
Amendment 01  (Section 13.3). 
 
Refer to Table A: Schematic of Study Design for an overview of the study design. 


 
 
 
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Table A: 
Schematic of Study Design 
 
AZM-L=low-dose AZM, AZM-M=intermediate-dose AZM, AZM-H=high-dose AZM, RZ=Randomization, D=Day, 
W=Week. 
(a) β-blocker use should be tapered off gradually during the first week of the washout. If the seated diastolic blood 
pressure (seDBP) remains below inclusion criterion #4 (Section 7.1 of the Protocol) after the washout, it can be 
extended in 1-week increments up to 2 times, for a maximum washout of 4 weeks (for currently treated subjects 
only). Placebo should continue during the extension(s). 
(b) All subjects randomized to AZM-M, AZM-H or losartan will be force-titrated at Week 2. 
(c) If possible, the procedures planned for Week 8 or 52 should be completed at the time of discontinuation for 
subjects who prematurely withdraw from DB or OL treatment, respectively. 
3.2. RANDOMIZATION 
The investigator or investigator’s designee will access the interactive (voice/web) response system 
(IVRS/IWRS) at Screening to obtain the subject’s study number. The investigator or the investigator’s 
designee will utilize the IVRS/IWRS to enter the subject into the Placebo Run-in Phase. The IVRS/IWRS will 
also be used to randomize the subject into the DB Phase and later the Withdrawal Phase. The DB Phase 


 
 
 
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randomization will be stratified by age (Tanner stage <3, ≥3), weight (≥25 to <50 kg, ≥50 kg), and race (non-
Black, Black).  
 
Enrolment caps will also be applied to randomization to ensure a percentage of subjects with secondary 
hypertension of approximately 40%-60% and to ensure that no more than ≈25% of subjects are post-renal 
transplant subjects and no more than ≈60% of subjects weigh greater than or equal to 50 kg at Baseline. 
Randomization for the Withdrawal Phase will be stratified by the treatment received in the DB Phase (i.e., 
AZM-L, AZM-M, or AZM-H or losartan). 
 
Protocol Amendment 01, dated 12 Dec 2018, revised the number of secondary hypertensive subjects and < 
50 kg subjects due to difficulty in recruiting these subpopulations.  The expected number of secondary 
hypertensive subjects and subjects weighing less than 50 kg was not achieved. The revised expected 
percentage of subjects with secondary hypertension and subjects weighing less than 50 kg will be at least 
20% of the total subject population. 
3.3. TREATMENTS AND DOSING 
Eligible subjects in the DB phase will be randomized into 1 of 4 DB treatment arms using an IVRS/IWRS. The 
4 treatment groups include (1) AZM-L, (2) AZM-M, or (3) AZM-H or (4) losartan. 
 
The dose (or tablet strengths) taken by each subject will be dependent on treatment assignment. All subjects 
randomized to AZM will initiate treatment at 10 mg. Subjects assigned to the AZM-M group will be force-
titrated at Week 2 to the final randomized dose of 20 mg which will be maintained for the final 4 weeks of 
the DB Phase. Subjects assigned to the AZM-H group will be force-titrated at Week 2 to the final randomized 
dose of 40 mg or 80 mg, with the lower of the 2 possible doses being received by subjects who weigh <50 kg 
and the higher dose being received by subjects who are ≥50 kg. Similarly, subjects who are randomized to 
losartan will initiate treatment at a low dose (25/50 mg) and force titrated at Week 2 to the final losartan 
dose (50/100 mg).  
 
Similarly, subjects who are randomized to losartan and weighing < 50 kg will initiate treatment at the 25 mg 
dose and force titrated at Week 2 to the 50 mg losartan dose. Subjects who weigh ≥ 50 kg will initiate 
treatment at 50 mg and forced titrated at Week 2 to the 100 mg losartan dose. 
 
In the Withdrawal Phase, subjects will be re-randomized using IVRS/IWRS to continue receiving their 
previously assigned active treatment or placebo. 
 
At the beginning of the OL Phase, all subjects will be dispensed AZM 10 mg, which can be titrated to higher 
dose(s) (up to 40 mg for subjects <50 kg or up to 80 mg for subjects ≥50 kg) and additional medication(s) 
may be added if needed to achieve BP targets during the OL extension. Because body weight is likely to 
change, dose adjustments may occur during the OL Phase if growth assessments (height and weight) made 
at Week 8/Visit 9 or at any visit scheduled during the extension necessitate a dose by weight adjustment. 
Refer to Table B: Treatment Arms for a summary of the 4 treatment arms. 
 
 


 
 
 
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Table B:  
Treatment Arms 
 
L=low, M=intermediate, H=high. 
 
(a) The body weight category assigned at Baseline for each subject will remain unchanged throughout the DB Phase 
and Withdrawal Phase. During the OL Phase, weight category will be determined at each scheduled visit and the 
dose of medication should be adjusted accordingly. 
(b) In the OL Phase, AZM can be titrated and/or other antihypertensive medications can be added to achieve and 
maintain target BP. 
 
Subjects <50 kg will be required to swallow 2 tablets with a maximum diameter of 7.5 mm and thickness of 4.2 mm 
and 1 capsule with a maximum length of 15.64 mm and thickness of 7.42 mm as their daily dose. Subjects ≥50 kg 
will be required to swallow 2 tablets with a maximum diameter of 9.5 mm and thickness of 5.3 mm and 1 capsule 
with a maximum length of 16.19 mm and thickness of 8.30 mm as their daily dose. 
3.4. SCHEDULE OF EVENTS 
Schedule of events can be found in Section 9.3 of the Protocol. 


 
 
 
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3.5. SAMPLE SIZE 
Original Protocol text: 
Assuming a standard deviation (SD) of 10.5 mm Hg and an overall 10% dropout rate (i.e., the DB and 
Withdrawal Phases), 195 subjects randomized to AZM into the DB Phase (65/arm) will provide 80% power to 
detect a difference of 4.5 mmHg between AZM (pooled) and placebo by a 2-sample t-test of the mean seDBP 
change from Week 6/Final Visit of the DB Phase to Week 8/Final Visit of the Withdrawal Phase at the 0.05 
significance level (2-sided).  
 
Revised Sample Size Justification (From Protocol Amendment 01, dated 12 December 2018): 
Upon review of pooled blinded data of the primary endpoint, the SD was 7.82 which was much less than 
what was previously specified. Taking into consideration variability in the SD, an SD estimate of 8.3 is used in 
the revised sample size (all other assumptions being the same) below. Assuming an SD of 8.3 mm Hg and an 
overall 10% dropout rate (i.e., the DB and Withdrawal Phases), approximately 208 subjects randomized to 
AZM or losartan during the DB Phase (52/arm) will provide >80% power to detect a difference of 4.5 mmHg 
between AZM (pooled) and placebo by a 2-sample t-test of the mean seDBP change from Week 6/Final Visit 
of the DB Phase to Week 8/Final Visit of the Withdrawal Phase at the 0.05 significance level (2-sided). 
3.6. CHANGES TO ANALYSIS FROM PROTOCOL 
Refer to Section 3.5. 
4. 
PLANNED ANALYSES 
The following analyses will be performed for this study: 
• 
Analyses DMC meetings. 
• 
Interim Analysis. 
• 
Final Analysis. 
4.1. DATA MONITORING COMMITTEE  
A DMC Charter, describing the methodology and presentation of results and access to results will be 
provided by IQVIA as a separate document. 
4.2. INTERIM ANALYSIS  
A formal interim analysis will take place for this study after all subjects have completed the Withdrawal 


 
 
 
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Phase and after complete and final data (i.e., all relevant data issues have been resolved) for the Withdrawal 
and DB phases have been entered and locked into the clinical database. Subject treatment assignments will 
be unblinded for this interim analysis. The interim analysis will include the primary and secondary endpoints 
along with all additional efficacy and safety endpoints related to the DB and Withdrawal Phases. Since this 
interim analysis will be performed on final data for the Withdrawal and DB Phases, no alpha spending 
correction will be needed.  
 
Derivations and definitions for the interim analysis will be based on those required for the final analysis 
contained in this analysis plan, unless deviations are stated within the text. Only safety and efficacy outputs 
for the DB and Withdrawal phase, will be provided for the interim analysis.  
 
This formal interim planned analysis identified in this SAP will be performed by IQVIA Biostatistics following 
Sponsor Authorization of this SAP, Database Lock of DB and Withdrawal phases, Sponsor Authorization of 
Analysis Sets and Unblinding of Treatment.  
4.3. FINAL ANALYSIS  
The planned analyses for the open-label phase, identified in this SAP, will be performed by IQVIA 
Biostatistics following Sponsor Authorization of this Statistical Analysis Plan and Final Database Lock.  
4.4. PHARMACOKINETIC ANALYSIS  
No Pharmacokinetic (PK) Analysis will not be performed by IQVIA. A third party (Takeda) will be responsible 
for the PK analysis.  
5. 
ANALYSIS SETS 
Agreement and authorization of subjects included/excluded from each analysis set will be conducted prior 
to the unblinding of the study.  
5.1. ALL SUBJECTS ENROLLED SET [ENR] 
The all subjects enrolled (ENR) set will contain all subjects whose parent/legal guardian provide informed 
consent on behalf of their child for this study. 
 
A subject will be programmatically included in the ENR analysis set if the participant has a date of informed 
consent in the database as recorded on the Demography (DEMOG) and Screen Failure Form (SFL_IVRS) 
electronic case report form (eCRF).  
 


 
 
 
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5.2. ALL SUBJECTS RANDOMIZED SET [RND] 
The all subjects randomized (RND) set will contain all subjects in the ENR set who were randomized to study 
medication. 
 
A participant will be programmatically included in the RND analysis set if the participant has a randomization 
number derived from an external randomization sheet, created by the IVRS/IWRS, and used in the 
randomization module of the eCRF. The randomization schedule will be sent to the IQVIA biostatistician as a 
password protected EXCEL sheet via email.  
 
For analysis and presentations based on the RND analysis set, participants will be analyzed according to the 
assigned treatment, regardless of the treatment received. 
5.3. FULL ANALYSIS SET [FAS] 
The definition for FAS, as follows, will be applied independently for both the DB Phase and Withdrawal 
Phase of the study. The FAS will include all randomized subjects who receive at least 1 dose of the double-
blind study medication for the respective study phase. Subjects will be analyzed according to the treatment 
group to which they are randomized.  
5.4. SAFETY ANALYSIS SET [SAF] 
The safety analysis set (SAF) will contain all subjects who receive at least one dose of study medication. 
Subjects will be analyzed according to the study medication they received for the study phase being 
summarized. 
 
If there is any uncertainty concerning a subject’s treatment status, then they will be assumed treated for the 
purposes of analysis.  
5.5. PER PROTOCOL SET [PPS]  
The per protocol analysis set (PPS) will contain all subjects in the FAS excluding those identified as major 
protocol violators. Major deviations from the protocol leading to exclusion from the PPS will be identified 
prior to database lock, but may likely include relevant entry criteria, receiving incorrect treatment 
assignment, taking prohibited medication, non-compliance to dosing schedule and deviation from study 
procedures. For the PPS major protocol violation, focus will be placed on violations that may confound the 
interpretation of the primary endpoint. Therefore, protocol deviations during the follow-up phase, for 
example, wouldn’t be considered major violation for exclusion from the PPS.  
 


 
 
 
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Primary and Secondary efficacy analyses using the PPS will be performed. 
5.6 PHARMACOKINETIC SET [PK] 
The pharmacokinetic set analysis set (PK) will contain all subjects who receive at least one dose of study 
medication. A subject will be included in the analysis only when there is at least 1 measurable concentration 
of plasma. PK analysis will not be performed by IQVIA. A third party (Takeda) will perform the PK analysis. 
6. 
GENERAL CONSIDERATIONS 
The FAS will be the primary data set used for efficacy analyses of the DB Phase and the Withdrawal Phase, 
unless otherwise specified. Efficacy analysis (FAS, PPS) will use planned treatment and Safety Analysis will 
use actual treatment. All routine safety analysis will be based on the SAF. All analysis of data (i.e., efficacy 
and safety) from the OL Phase will use the SAF and subjects will be summarized overall (i.e., all subjects 
together) and by status of additional antihypertensive use (i.e., AZM alone versus AZM plus additional 
antihypertensives). 
6.1. REFERENCE START DATE AND STUDY DAY 
Reference start date is defined as the day of the first dose of study medication, (Day 1 is the day of the first 
dose of study medication) and will appear in every listing where an assessment date or event date appears.  
 
Study Day will be calculated from the reference start date and will be used to show start/ stop day of 
assessments and events. 
 
 Study day will be calculated as follows:  
• 
If the date of the event is on or after the reference date, then:  
o 
Study Day = (date of event – reference date) + 1. 
• 
If the date of the event is prior to the reference date, then:  
o 
Study Day = (date of event – reference date). 
 
In the situation where the event date is partial or missing, Study Day, and any corresponding durations will 
appear partial or missing in the listings. 
6.2. BASELINE  
Unless otherwise specified, baseline is defined as the last non-missing measurement taken prior to reference 
start date (including unscheduled assessments). In case where the last non-missing measurement and the 
reference start date coincide, that measurement will be considered pre-treatment. 


 
 
 
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For subjects randomized but not treated, baseline is defined as the last non-missing measurement taken on 
or before randomization. 
 
 


 
 
 
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6.3. ENDPOINTS 
The primary endpoint for this study is  
• 
Change from Week 6/Final Visit of the DB Phase to Week 8/Final Visit of the Withdrawal Phase in 
trough clinic seDBP between AZM and placebo. 
Secondary endpoints for this study are: 
• 
Change from Week 6/Final Visit of the DB Phase to Week 8/ Final Visit of the Withdrawal Phase in 
trough clinic seDBP and mean arterial pressure (MAP) between AZM and placebo. 
• 
Change from baseline in trough clinic seDBP, seated systolic blood pressure (seSBP), and MAP to Week 
6/Final Visit of the DB Phase for AZM and losartan. 
• 
Percentage of subjects who achieve target BP (seDBP, seSBP, both) at Week 8/Final Visit of the 
Withdrawal Phase, with the target defined as <90th percentile for age, gender, and height. 
Safety Endpoints for this study are: 
• 
Adverse events (AEs). 
• 
Physical examination. 
• 
Laboratory tests. 
• 
12-lead electrocardiogram (ECG) finding. 
• 
Vital signs. 
• 
Anthropometric (height, weight, and body mass index z-scores) measurements. 
Additional Endpoints for this study are: 
• 
Change from baseline in trough clinic seDBP, seSBP and MAP at all visits of the DB Phase, excluding 
the Week 6/Final Visit for AZM and losartan. 
• 
Change from baseline in trough clinic seDBP, seSBP and MAP at all visits of the OL Phase, including 
Week 52/Final Visit. 
• 
Percentage of subjects who achieve the following additional BP targets (for seSBP, seDBP and both): 
• 
All Subjects: 
• 
<90th percentile at Week 6/Final Visit of the DB Phase and Week 52/Final Visit of the OL Phase 
• 
in subjects with chronic kidney disease (CKD). 
• 
<90th percentile at Weeks 6, 8, and 52/Final Visits of the DB Phase, Withdrawal Phase, and OL 
Phase, respectively. 
• 
<50th percentile at Weeks 6, 8, and 52/Final Visits of the DB Phase, Withdrawal Phase, and OL 
Phase, respectively. 
• 
Estimation of the exposure using population pharmacokinetics of azilsartan. 
Exploratory Endpoints are: 
• 
Change from baseline to Week 6/Final Visit of the DB Phase and to Week 52/Final Visit of the OL Phase in 
24-hour, 12-hour, daytime, night time, and trough DBP and SBP by ABPM. 
• 
AZM dose response for change from baseline to Week 6/Final Visit of the DB Phase in clinic seDBP and 
seSBP.  


 
 
 
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6.4. RETESTS, UNSCHEDULED VISITS AND EARLY TERMINATION DATA 
In general, for by-visit summaries, data recorded at the nominal visit will be presented. Measurements from 
unscheduled visits will not be included in by-visit summaries but may contribute to the final visit or last 
observation carried forward (LOCF) value, or best/ worst case value where required.  
 
In the case of a retest (same visit number assigned), the latest available measurement for that visit will be 
used for by-visit summaries.  
 
Data collected at early termination visits will be mapped to the next planned visit number for that subject. 
For by-visit summaries, only visits in which a measure was scheduled to be collected will be summarized. 
Listings will include scheduled, unscheduled, retest and early discontinuation data. 
6.5. WINDOWING CONVENTIONS  
No visit windowing will be performed for this study. 
6.6. SUMMARY STATISTICS 
 Unless otherwise specified for presentations: 
• 
The default summary statistics for numeric variables are as follows: 
• 
Number of observations (n). 
• 
Arithmetic mean. 
• 
Standard deviation (SD). 
• 
Minimum (Min). 
• 
Median. 
• 
Maximum (Max). 
 
• 
The default summary statistics for categorical variables are as follows: 
• 
Number of observations (n). 
• 
Percentage of subjects with non-missing data per category. 
Percentages will be rounded to one decimal place. However, for counts frequencies that are greater than 0, 
if the calculated percent would round to 0%, then <0.1% will be displayed instead. Likewise, for counts 
frequencies that are less than the total possible, if the calculated percentage would round to 100%, then 
>99.9% will be displayed instead. The denominator for each percentage will be the total number of subjects 
with non-missing data in the treatment group and population (analysis population) being presented, unless 
otherwise specified.  


 
 
 
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6.7. STATISTICAL TESTS 
Unless otherwise noted, all tests of treatment effects will be conducted at a 2-sided alpha level of 0.05 
and/or 2-sided 95% confidence interval (CI). 
6.8. PRECISION 
All values will be rounded using the SAS® function ROUND, as the last step prior to presentation. All 
computed percentages (%) will be presented using one decimal place. Categories with a ‘0’ count will not 
display the percentage (%) value. If the original data has N decimal places (as derived from the raw data), 
then the summary statistics for quantitative data will contain the following number of decimal places (to a 
maximum of 3 places): 
• 
Minimum and maximum: N 
• 
Mean and median: N + 1 
• 
SD: N+ 2 
P-values greater than or equal to 0.001 and less than or equal to 0.999 will be rounded to 3 significant digits 
and presented with three decimal places. Any p-value less than 0.001 will be presented as ‘<0.001’, while p-
values greater than 0.999 will be presented as ‘>0.999’. CIs will be presented to one more decimal place than 
the raw data. 
6.9. COMMON CALCULATIONS 
For quantitative measurements, change from baseline will be calculated as: 
 
• 
Test Value at Visit X (Post-baseline visit) – Baseline Value 
• 
If baseline is missing, change from baseline will be presented as missing in the listing. That is, 
no imputation for change from baseline will be performed.  
Calculation of BP Percentile: 
 “The fourth report on diagnosis, evaluation, and Treatment of High Blood Pressure in Children and 
Adolescents” (https://www.nhlbi.nih.gov/files/docs/resources/heart/hbp_ped.pdf ) will be used to calculate 
BP Percentile.  
6.10. SOFTWARE VERSION 
All analyses will be conducted using SAS® version 9.4, or higher, on the WINDOWS 32 bit operating system.  


 
 
 
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7. 
STATISTICAL CONSIDERATIONS 
7.1. ADJUSTMENTS FOR COVARIATES AND FACTORS TO BE INCLUDED IN ANALYSES 
The following covariates and factors are used in the analyses. For details of their inclusion in the models, see 
the specific analysis section. 
• 
Week 6/Final Visit of the DB Phase seDBP. 
• 
Baseline seDBP. 
• 
Baseline seSBP. 
• 
Baseline MAP. 
• 
Treatment during DB Phase (AZM low, med, high dose and losartan). 
• 
Treatment during Withdrawal Phase, (AZM low, med, high and placebo).  
• 
Treatment for study drug (AZM low, med, high). 
• 
Age (Tanner stage <3, ≥3). 
• 
Weight (<50 kg, ≥50 kg). 
• 
Race Group (Black or African American, Non- Black or African American). 
7.2. MULTICENTER STUDIES 
This study will be conducted by multiple investigators at multiple centers internationally.  Randomization to 
treatment arms is not stratified by country/ center. 
Center pooling will not be carried out for use in analyses for this study. 
7.3. MISSING DATA 
Missing safety data (not considering dates) will not be imputed.  
For efficacy data, two different methods will be used.  
• 
Multiple Imputation:  using the Markov Chain Monte Carlo method.  
• 
Last-observation-carried-forward (LOCF):  the last post baseline double-blind observed value will be 
carried forward where data are missing (e.g., the subject has missing data or has dropped out of the 
study).  
Details for how to handle missing efficacy data are in section 15.1 - 15.2 of this analysis plan.  
7.4. MULTIPLE COMPARISONS/ MULTIPLICITY 
To control for multiplicity of the type 1 error, the following sequential testing procedure will be employed in 


 
 
 
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the analysis of the primary endpoint using an analysis of covariance (ANCOVA) model and estimate 
statements: Step 1, the mean AZM effect versus placebo will be tested, if statistically significant then testing 
will continue to the next step; Step 2, AZM high dose effect versus placebo will be tested, if statistically 
significant then testing will continue to the next step; Step 3, AZM med dose effect versus placebo will be 
tested, if statistically significant then testing will continue to the next step; Step 4, AZM low dose effect 
versus placebo will be tested. 
7.5. EXAMINATION OF SUBGROUPS 
Subgroup analyses will be conducted on the primary endpoint and secondary endpoints. Statistical analysis 
will be conducted (comparing Pooled AZM vs Placebo) within each subgroup and the p-value will be 
reported.  
The following subgroups will be assessed and described within the exploratory analysis sections: 
• 
Gender:  
• 
Female 
• 
Male 
• 
Age (Tanner stage): 
• 
Tanner stage <3  
• 
Tanner stage ≥3  
• 
Race in 2 categories: 
• 
Black or African American.  
• 
Non- Black or African American (American Indian or Alaska Native, Asian, Native 
Hawaiian/Other Pacific Islanders, White). 
• 
Weight Group: 
• 
<50 kg 
• 
≥50 kg  
• 
Chronic Kidney Disease 
• 
Yes 
• 
No  
• 
Region:  
• 
US 
• 
Non-US  
• 
Diagnosis:  
• 
Primary Hypertension 
• 
Secondary Hypertension 
• 
Renal Transplant 
• 
Yes 
• 
No 


 
 
 
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8. 
OUTPUT PRESENTATIONS 
Appendix 1 shows conventions for presentation of data in outputs. 
 
The templates provided with this SAP describe the presentations for this study and therefore the format and 
content of the summary tables, listings, and figures (TLFs) to be provided by IQVIA Biostatistics. 
 
Note that verbatim terms, specifications (for example the reason a specific assessment was not done) and all 
variables in the TLF shells that contain the suffix (eCRF) contain verbatim text that may include spelling 
mistakes. Verbatim text will be presented in the listings “as is” and no manual “hard-coding” corrections of 
such data will be made.  
9. 
DISPOSITION AND WITHDRAWALS 
All subjects who provide informed consent will be accounted for in this study.  
 
The number and percentage of subjects in each disposition category will be presented; there will be no 
inferential analysis of subject disposition data. 
 
Disposition of all enrolled but not randomized subjects will be tabulated according to screen failure/run-in 
failure, including primary reason for screen/run-in failure (pretreatment event, major protocol deviation, 
lost to follow-up, voluntary withdrawal, study termination, did not meet entrance criteria, other) as entered 
on the electronic case report form (eCRF). 
 
Disposition of all randomized subjects will be tabulated by study phase, treatment group, pooled AZM (for 
DB and Withdrawal phases only) and overall. Treatments for DB phase are Losartan, AZM low dose, AZM 
intermediate dose, AZM high dose. Treatments for Withdrawal phase are Placebo, Losartan, AZM low dose, 
AZM intermediate dose, AZM high dose. Treatments for OL phase are AZM alone, AZM plus additional 
antihypertensive. 
 
Primary reasons for discontinuation of study drug/visits, as entered on the eCRF, will be tabulated by phase 
and treatment group; the reasons include adverse event, major protocol deviation, lost to follow-up, 
voluntary withdrawal, study termination, pregnancy, lack of efficacy, PI discretion and other. 
 
Major protocol deviations will be summarized for RND by phase, treatment group, pooled AZM (for DB and 
Withdrawal phases only) and overall. Protocol deviations will be presented in a data listing. Also, violation of 
Inclusion/Exclusion criteria will be listed for RND. 
 
The number of subjects included in each analysis population will be summarized by phase, treatment group, 
pooled AZM (for DB and Withdrawal phases only) and overall. 
Subject disposition, study discontinuation and study visit dates and times will be listed based on RND. 


 
 
 
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10. DEMOGRAPHIC AND OTHER BASELINE CHARACTERISTICS 
Demographic data and other baseline characteristics will be presented based on RND. 
 
Statistical testing will be carried out and the p-value will be reported for demographic or other baseline 
characteristics. T-test will be done for continuous variables and Chi-square test will be done for categorical 
variables. 
 
The following demographic and baseline characteristics will be summarized using descriptive statistics and p-
value for each study phase (DB, Withdrawal, OL) by treatment group, pooled AZM (for DB and Withdrawal 
phases only) and overall: 
• 
Age (years)  
• 
Tanner Stage (<3, ≥3) 
• 
Race 
• 
Race Group (Black or African American, Non- Black or African American) 
• 
Ethnicity 
• 
Gender  
• 
Height (cm) 
• 
Weight (kg) 
• 
Weight Group (<50 kg, ≥50 kg) 
• 
Body Mass Index (BMI) 
• 
Diagnosis of Chronic Kidney Disease 
• 
Renal Transplant 
• 
Hypertension Diagnosis (Primary or Secondary Hypertension) 
• 
Baseline Sitting DBP 
• 
Baseline Sitting SBP 
• 
Baseline Standing DBP 
• 
Baseline Standing SBP 
• 
Baseline ABPM DBP 
• 
Baseline ABPM SBP 
• 
Female Reproductive Status 
• 
Current Hypertensive Medication 
• 
Glomerular Filtration Rate 
 
All individual demographic and baseline characteristics will be listed by site and subject number. 
11. MEDICAL HISTORY 
Hypertension and other relevant Medical History information are collected on eCRF Medical History – 
Hypertension and Medical History pages and will be presented for the SAF.  
 


 
 
 
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• 
Other relevant Medical History will be coded using Medical Dictionary for Regulatory Activities 
(MedDRA) Version 20.0 or higher. 
o 
Medical History conditions are defined as those conditions which stop prior to or at Screening.  
o 
Other relevant Medical History will be presented by system organ class (SOC) and preferred 
term (PT).  
 
Hypertension and other relevant medical history will be summarized for subjects in each study phase (DB, 
Withdrawal, OL) by treatment group, pooled AZM (for DB and Withdrawal phases only) and overall.  A list of 
medical history per subject will be presented. 
12. MEDICATIONS 
Medication History includes medications that stopped at or within 30 days prior to signing of informed 
consent (Informed consent date > medication end date ≥ Informed consent date -30). 
 
See Appendix 2 for handling of partial dates for medications. 
 
• 
For Double Blind Phase: 
Concomitant medications include medications started at or within 30 days prior to signing of informed 
consent through end of the double blind phase (informed consent date -30 ≤ medication start date ≤ end of 
double blind study date) or ended before the first dose of the study medication in the withdrawal phase as 
well as medications started before 30 days prior to signing of informed consent but stopped on at or after 
signing of informed consent (medication start date< informed consent date -30 and medication end date≥ 
informed consent date).   
• 
For Withdrawal phase: 
Concomitant medications include medications started prior to, on or after the first dose of study medication 
in the withdrawal phase and ended on or after the date of first dose of study medication in the withdrawal 
phase or were ongoing till the end of the withdrawal phase. 
• 
For Open Label: 
Concomitant medications include medications started prior to, on or after the first dose of study medication 
in the Open Label phase and ended on or after the date of first dose of study medication in the Open Label 
phase or were ongoing till the end of the Open Label phase. 
 
Medication History and Concomitant Medication information for Single or Double-Blind phase are collected 
on the concomitant medication page in the eCRF and concomitant medication information for Open Label 
phase is collected on concomitant medication – open label page in the eCRF. They will be presented for the 
SAF and coded using World Health Organization Drug Dictionary (WHO-DD). 
 
Medication History and Concomitant Medications will be presented by treatment group for different phases 


 
 
 
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based on Safety population. The summary of Medication History and Concomitant Medication will be 
provided by Therapeutic Classification (2nd level of ATC) and preferred medication name. Therapeutic 
Classification will be sorted alphabetically. Preferred Medication Names are sorted by decreasing total 
number of subjects. Preferred Medication Names are sorted by decreasing total number of subjects. 
 
In the summaries, subjects experiencing more than one medication within the same therapeutic class and 
preferred name will be counted only once. 
 
Concomitant medications will be listed for the RND. 
13. STUDY MEDICATION EXPOSURE 
Exposure to study medication in days will be presented by phase based on SAF. 
 
The date of first study medication administration during DB phase will be taken from the eCRF “In-clinic 
dosing” form at Day 1. The date of last study medication during DB phase will be taken from the eCRF “In-
clinic dosing” form at Week 6 (if subject complete the DB phase) or “End of Study Drug” form. The date of 
first study medication during withdrawal phase will be taken from the eCRF “Prior dose” form at Week 6. 
The date of last study medication during Withdrawal phase will be taken from eCRF “In-clinic dosing” form at 
Week 8 (if subject complete the Withdrawal phase) or “End of Study Drug” form. The date of first study 
medication administration during OL phase will be taken from the eCRF “In-clinic dosing” form at Week 8. 
The date of last study medication during Open Label phase will be taken from the eCRF “Prior dose” form at 
Week 54 (if subject complete the Open Label phase) or “End of Study Drug” form. 
13.1. DERIVATIONS 
For each phase, the derivation of study medication exposure is calculated as following: 
 
Duration of exposure (days) = date of last study medication administration in the phase – date of first study 
medication administration + 1.  
14. STUDY MEDICATION COMPLIANCE  
Compliance to study medication will be presented for the SAF. 
14.1. DERIVATIONS 
Compliance with study medication—based on the drug accountability data—will be calculated as the 
number of tablets taken (total dispensed – total returned) divided by the prescribed number of tablets 


 
 
 
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expressed as a percentage, see calculations below. For the OL extension phase of the study, dosing is 1 
tablet orally per day for study drug AZM. 
 
For the run-in, double-blind and withdrawal phases of the study, dosing is 2 tablets and 1 capsule orally per 
day for the study drug and it is assumed that the subject should take medication from the visit day at which 
their medication is initially dispensed to their last medication return date.  For example, for double-blind 
phase, the initial dispense date is Day 1 and the last return date is Week 6, then the subject should have 
taken 2 tablets and 1 capsule on Days 1 to the day before Week 6. Assuming that the day before Week 6 for 
the subject is Day 42, the total number of prescribed tablets would be 42×3 = 126 
 
Ѳ = Number of capsules required to be taken per day. 
 
• 
”Per Visit” Compliance to study medication will be calculated as follows: 
 
{ ([N of Capsules dispensed at Visit X(n−1)] − [N of Capsules returned at Visit X(n)])} ÷ Ѳ
[Date of Visit Xn] − [Date of Dispensing at Visit Xn−1] 
 x 100 
 
• 
Compliance to study medication per phase (Visit X(n) is the last visit in the phase) will be calculated as 
follows: 
{([N of Capsules dispensed at Visit 1] – [N of Capsules returned at Visit 2])
+ ⋯+
([N of Capsules dispensed at Visit X(n−1)] – [N of Capsules returned at Visit X(n)])} ÷ Ѳ
[Date of Visit X(n)] − [Date of Dispensing at Visit 1] 
 
x 100 
 
For subjects who permanently stop the study medication, the “Date of Visit X(n)” will be replaced by the 
date of study withdrawal. 
15. EFFICACY OUTCOMES  
At each visit, three serial sitting BP measurements will be obtained and the average (arithmetic mean) of the 
3 serial measurements will be used for the efficacy analysis. 
15.1. PRIMARY EFFICACY 
15.1.1. PRIMARY EFFICACY VARIABLE(S) & DERIVATION(S) 
Change from Week 6/Final Visit of the DB Phase to Week 8/Final Visit of the Withdrawal Phase in trough 
clinic seated diastolic blood pressure (seDBP) between AZM and placebo which is collected in the eCRF.  


 
 
 
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15.1.2. MISSING DATA METHODS FOR PRIMARY EFFICACY VARIABLE(S) 
The primary analysis will use multiple imputations for missing data, supported by sensitivity analysis using 
observed data. Multiple imputation is a stochastic parameter estimation method for partially observed data. 
Missing data will be assumed to follow an arbitrary missing data pattern, and a multivariate response model 
will be fitted separately for each treatment group using the Markov Chain Monte Carlo (MCMC) method. 
This method of imputation draws each missing value from its conditional distribution, given the observed 
data (baseline and post baseline values of the parameter) expected to be predictive of the missing pattern. 
Details on MCMC method is found in Appendix 5. 
15.1.3. PRIMARY ANALYSIS OF PRIMARY EFFICACY VARIABLE(S) 
The primary objective of this study is to evaluate the antihypertensive effect of AZM compared with placebo 
after a randomized, double-blind, withdrawal (Withdrawal Phase).  
 
The primary efficacy analysis will be performed for the FAS. The primary analysis will exclude subjects that 
were treated with losartan during the DB Phase.   
 
The primary efficacy variable analysis will be an ANCOVA model with treatment (AZM low, med, high and 
placebo), age (Tanner stage <3, ≥3), race (Black or African American, Non- Black or African American) and 
weight (<50 kg, ≥50 kg) as fixed effects, and Week 6/Final Visit of the DB Phase seDBP as a covariate. The 
primary comparison, mean (i.e. pooled) AZM effect versus placebo, will be made using an ANCOVA contrast 
statement. Comparisons between each AZM dose to placebo will also be done from the framework of the 
above ANCOVA using contrast statements.  
 
To control for multiplicity of the type 1 error, the sequential testing procedure mentioned in Section 7.4 will 
be employed in the analysis of the primary endpoint. 
 
Summary of observed seDBP at Week 6 and Week 8 will be presented. Change in seDBP from Week 6 to 
Week 8 and the results from the analysis (Least square (LS) means, Standard Error, LS Mean Difference (SE), 
P-value and 95% Confidence Interval for Difference in LS means) will also be presented.  
 
Profile plots (line with symbol at each visit with +/- 1 SE error bars) will be displayed for observed seDBP and 
boxplot will be displayed for the change in seDBP from Week 6 to Week 8. 
15.1.4. SENSITIVITY ANALYSIS OF PRIMARY EFFICACY VARIABLE(S) 
Sensitivity analysis of primary efficacy variable will be based on observed data and the analysis will be 
conducted by using the same ANCOVA model mentioned above with observed seDBP only.  


 
 
 
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to IQVIA Holdings Inc. and its subsidiaries. Unauthorized use, disclosure or reproduction is strictly prohibited. 
 
15.2. SECONDARY EFFICACY 
The secondary efficacy analyses will be performed for the FAS. 
15.2.1. SECONDARY EFFICACY VARIABLES & DERIVATIONS 
15.2.1.1. 
Change from Week 6/Final Visit of the DB Phase to Week 8/Final Visit of the Withdrawal Phase in trough 
clinic seSBP and MAP between AZM and placebo.  
Clinic seSBP and seDBP are collected from eCRF and MAP is calculated as following. 
• 
MAP = seSBP + 2 (seDBP) 
                         3 
15.2.1.2. 
Change from baseline in trough clinic seDBP, seSBP, and MAP at Week 6/Final Visit for AZM and losartan. 
Clinic seDBP and seSBP are collected from eCRF and MAP is calculated using formula mentioned above.  
15.2.1.3. 
Percentage of subjects who achieve target BP (seDBP, seSBP, both) at Week 8/Final Visit of the Withdrawal 
Phase, with the target defined as <90th percentile for age, gender, and height. 
15.2.2. MISSING DATA METHODS FOR SECONDARY EFFICACY VARIABLE(S) 
15.2.2.1. 
The same multiple imputations for missing data as primary endpoint (Section 15.1.2) will be used for Change 
from Week 6/Final Visit of the DB Phase to Week 8/Final Visit of the Withdrawal Phase in trough clinic seSBP 
and MAP.  
15.2.2.2. 
For change from baseline in trough clinic seDBP, seSBP, and MAP to Week 6/Final Visit, last observation 
carried forward (LOCF) method for missing data will be used for the sensitivity analysis. In the LOCF analysis 
data set, the last post baseline double-blind observed value will be carried forward and used for all 
subsequent scheduled time points in the DB Phase where data are missing (e.g., the subject has missing data 
or has dropped out of the study). 
15.2.2.3. 
For analysis of percentage of subjects who achieve target BP at Week 8/Final Visit of the Withdrawal Phase 
will be based on LOCF. Sensitivity analysis will be done using multiple imputation 


 
 
 
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to IQVIA Holdings Inc. and its subsidiaries. Unauthorized use, disclosure or reproduction is strictly prohibited. 
 
15.2.3. ANALYSIS OF SECONDARY EFFICACY VARIABLES 
15.2.3.1. 
Change from Week 6/Final Visit of the DB Phase to Week 8/Final Visit of the Withdrawal Phase in trough 
clinic seSBP and MAP will be analyzed using an ANCOVA model with treatment (AZM low, med, high and 
placebo), age (Tanner stage <3, ≥3), race (Black or African American, Non- Black or African American) and 
weight (<50 kg, ≥50 kg) as fixed effects, and baseline value (seDBP or MAP) as a covariate. The comparison, 
mean (i.e., pooled) AZM effect versus placebo, will be made using an ANCOVA contrast statement. 
Comparisons between each AZM dose to placebo will also be done from the framework of the above 
ANCOVA using contrast statements.  
This analysis will exclude subjects that were treated with losartan during the DB Phase. There will be no 
sequential testing procedure for this analysis. 
Profile plots (line with symbol at each visit with +/- 1 SE error bars) will be displayed for observed seSBP and 
MAP and boxplot will be displayed for the change in seSBP and MAP from Week 6 to Week 8. 
15.2.3.2. 
Change from baseline in trough clinic seDBP, seSBP, and MAP at Week 6/Final Visit, will be analyzed with a 
mixed models for repeated measure (MMRM) with treatment (AZM low, med, high dose and losartan), time 
point (Week 2, Week 4, Week 6), treatment by time interaction, age (Tanner stage <3, ≥3), race (Black or 
African American, Non- Black or African American) and weight (<50 kg, ≥50 kg) as fixed effects, and 
corresponding baseline value (seDBP, seSBP, MAP) as a covariate. An unstructured covariance matrix will be 
used to model the within-subject variation-covariance errors.  The comparison, mean (i.e., pooled) AZM 
effect versus losartan, will be made using contrast statement. Comparisons between each AZM dose to 
losartan will be done from the framework of the above MMRM. Observed data will be used to perform 
MMRM. Sensitivity analyses will be performed including ANCOVA at each time point using last observation 
carried forward (LOCF). 
In case of non-convergence, the following tests in sequence will be used:  heterogeneous Toeplitz covariance 
structure, heterogeneous autoregressive covariance structure, heterogeneous compound symmetry 
covariance structure, and compound symmetry covariance structure. 
Profile plots (line with symbol at each visit with +/- 1 SE error bars) will be displayed for the change in seDBP, 
seSBP and seMAP from baseline to Week 6. 
15.2.3.3. 
The analysis of subject who achieves target BP (seDBP, seSBP, both) at Week 8/Final Visit of the Withdrawal 
Phase, with the target defined as <90th percentile for age, gender, and height, will be conducted using 
logistic models with treatment (AZM low, med, high and placebo), age (Tanner stage <3, ≥3), race (Black or 
African American, Non- Black or African American)and weight (<50 kg, ≥50 kg) as fixed effects and baseline 
clinic seated BP as a covariate. The analysis will be based on LOCF data.  Sensitivity analysis will be done 
using multiple imputation. The number and percentage of subjects who achieved target BP at Week 8/Final 
Visit of the Withdrawal Phase will be presented, along with the odds ratios and associated 95% CIs. 
Percentage will be calculated as: 
Number of subjects with target blood pressure / Number of subjects with BP at week 8Profile plots (line with 


 
 
 
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to IQVIA Holdings Inc. and its subsidiaries. Unauthorized use, disclosure or reproduction is strictly prohibited. 
 
symbol at each visit with +/- 1 SE error bars) will be displayed for the change in seDBP, seSBP and seMAP 
from baseline to Week 8. 
15.3. ADDITIONAL EFFICACY  
15.3.1. ADDITIONAL EFFICACY VARIABLES & DERIVATIONS 
15.3.1.1. 
Change from baseline in trough clinic seDBP, seSBP, and MAP at all visits of the DB Phase, excluding the 
Week 6/Final Visit (Week 2 and Week 4) for AZM and losartan. 
15.3.1.2. 
Change from baseline in trough clinic seDBP, seSBP, and MAP at all visits of the OL Phase, including Week 
52/Final Visit. 
15.3.1.3. 
Percentage of subjects who achieve the following additional BP targets (for seSBP, seDBP, both): 
 
All Subjects: 
– 
<90th percentile at Week 6 and Week 52/Final Visit of the DB Phase and OL Phase. 
 
Subjects with chronic kidney disease (CKD): 
– 
<90th percentile at Weeks 6, 8, and 52/Final Visits of the DB Phase, Withdrawal Phase, and OL Phase. 
– 
<50th percentile at Weeks 6, 8, and 52/Final Visits of the DB Phase, Withdrawal Phase, and OL Phase. 
15.3.1.4. 
Estimation of the exposure using population pharmacokinetics of azilsartan. (This will not be covered by this 
SAP or performed by IQVIA. A third party (Takeda) will be responsible for the PK analysis). 
15.3.2. MISSING DATA METHODS FOR ADDITIONAL EFFICACY VARIABLE(S) 
15.3.2.1. 
For Change from baseline in trough clinic seDBP, seSBP, and MAP at Week 2 and Week 4 of the DB Phase, 
last observation carried forward (LOCF) method for missing data will be used for the sensitivity analysis. 
15.3.2.2. 
Observed change from baseline in trough clinic seDBP, seSBP, and MAP at all visits of the OL Phase will be 


 
 
 
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used, including Week 52/Final Visit, no method will be used for missing data.  
15.3.2.3. 
For the analysis of subjects who achieve the BP targets at Week 6/Final Visit of DB phase and Week 8/Final 
Visit of Withdrawal phase (for seSBP, seDBP, both), LOCF will be used. Sensitivity analyses on trough seDBP, 
seSBP, and MAP will be performed on observed values and using multiple imputation for missing trough BP 
data. No missing data will be used for percentage of subjects who achieve the BP targets at Week 52. 
15.3.3. ANALYSIS OF ADDITIONAL EFFICACY VARIABLES 
15.3.3.1. 
Change from baseline in trough clinic seDBP, seSBP, and MAP at visits Week 2 and Week 4 of DB Phase will 
be will be analyzed using the same MMRM model that is described in section 15.2.3.2 and the result will 
come from the same model as well.  
15.3.3.2. 
No statistical model will be used for Change from Baseline in trough clinic seDBP, seSBP, and MAP at all visits 
of the OL Phase, including Week 52/Final Visit. Only descriptive statistics will be provided 
15.3.3.3. 
The analysis for whether a subject who achieves the BP targets at Week 6/Final Visit in the DB Phase (for 
seSBP, seDBP, both), will be logistic models on observed data with treatment (AZM low, med, high dose and 
losartan), age (Tanner stage <3, ≥3), race (Black or African American, Non- Black or African American) and 
weight (<50 kg, ≥50 kg) as fixed effects and baseline clinic seated BP as a covariate. The number and 
percentage of subjects who achieved target BP will be presented, along with the odds ratios and associated 
95% CIs. Sensitivity analyses on trough seDBP, seSBP, and both will be performed for DB analysis on 
observed values and using multiple imputation for missing trough BP data to assess the impact of LOCF 
methodology and drop-outs. For Week 52/Final Visit of the OL Phase, the number and percentage of 
subjects who achieve the BP targets will be provided. 
 
For subjects with CKD, the analysis for weather a subject who achieves the BP targets at week 6/Final Visit in 
the DB phase and week 8/Final visit in the WD phase (for seSBP, seDBP, both), will be logistic models on 
observed data with treatment (AZM low, med, high dose and losartan), age (Tanner stage <3, ≥3), race (Black 
or African American, Non- Black or African American) and weight (<50 kg, ≥50 kg) as fixed effects and 
baseline clinic seated BP as a covariate. The number and percentage of subjects who achieved target BP will 
be presented, along with the odds ratios and associated 95% CIs. . Sensitivity analyses on trough seDBP, 
seSBP, and both will be performed for DB analysis on observed values and using multiple imputation for 
missing trough BP data to assess the impact of LOCF methodology and drop-outs. For Week 52/Final Visit of 
the OL Phase, the number and percentage of subjects with CKD who achieve the BP targets will be provided. 
 


 
 
 
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15.4. EXPLORATORY EFFICACY  
15.4.1. EXPLORATORY EFFICACY VARIABLES & DERIVATIONS 
15.4.1.1. 
Change from baseline to Week 6/Final Visit of the DB Phase and to Week 52/Final Visit of the OL Phase in 24-
hour, 12-hour, daytime, night time, and trough DBP and SBP by ABPM.  
15.4.1.2. 
AZM dose response for change from Baseline to Week 6/Final Visit of the DB Phase, Week 2 and Week 4 of 
the DB Phase in clinic seDBP, seSBP and MAP. 
15.4.1.3. 
Primary endpoint and secondary endpoints for subgroup analysis.  
15.4.2. MISSING DATA METHODS FOR EXPLORATORY EFFICACY VARIABLE(S) 
15.4.2.1. 
For ABPM results, no missing data method will be used. 
15.4.2.2. 
For analysis of AZM dose response of the DB phase, LOCF will be used for missing data. 
15.4.2.3. 
Same method for missing data will be used for subgroup analysis of primary and secondary endpoints as that 
in Section 15.1.2 and 15.2.2.  
15.4.3. ANALYSIS OF EXPLORATORY EFFICACY VARIABLES 
15.4.3.1. 
For Change from Baseline to Week 6/Final Visit of the DB Phase in 24-hour, 12-hour, daytime, night time, 
and trough DBP and SBP by ABPM, descriptive statistics will be provided for the change from Baseline as well 
as the difference between each AZM treatment and losartan for 24-hour, 12-hour, daytime, night time, and 
trough ABPM SBP/DBP. For Change from Baseline to Week 52/Final Visit of the OL Phase in 24-hour, 12-
hour, daytime, night time, and trough DBP and SBP by ABPM, descriptive statistics will be provided for the 
change from Baseline for 24-hour, 12-hour, daytime, night time, and trough ABPM SBP/DBP.  


 
 
 
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to IQVIA Holdings Inc. and its subsidiaries. Unauthorized use, disclosure or reproduction is strictly prohibited. 
 
Daytime is defined as 6 am – 9:59 pm 
Nighttime is defined as 10 pm - 5:59 am 
Profile plots (line with symbol at each visit with +/- 1 SE error bars) will be displayed for the observed seDBP 
and seSBP and the change in seDBP and seSBP from baseline to Week 6 and to Week 52 in 24-hour, 12-hour, 
daytime, night time by ABPM. 
 
15.4.3.2. 
Exploratory dose response analysis using only AZM low, med and high dose groups, for change from Baseline 
to Week 6/ Final Visit, Week 2, Week 4 of the DB Phase in clinic seDBP, seSBP and MAP will be performed 
using linear regression model with weight adjusted dose (mg/kg) as the continuous covariate. LOCF will be 
used for missing data. The intercept with Standard Error and estimate of the coefficient with Standard Error 
will be displayed with the summaries. Additionally, an ANCOVA with treatment, age and weight as fixed 
effects, and baseline seDBP, seSBP or MAP as covariate will be performed to assess between-group 
comparisons.  
16. SAFETY OUTCOMES 
All outputs for safety outcomes will be based on the Safety Analysis Set.  
 
There will be no statistical comparisons between the treatment groups for safety data, unless otherwise 
specified with the relevant section.  
 
Safety analyses will be presented separately for the different study phases (i.e., DB, Withdrawal, and OL 
Phases). Summaries for the DB and Withdrawal Phases will be by Overall (i.e., all subjects), AZM treated 
subjects (pooled), and by the individual treatments; summaries for the OL Phase will by Overall and by status 
of additional antihypertensive use (i.e., AZM alone and AZM plus additional antihypertensive). 
 
For safety analysis, baseline value for the DB Phase analyses will be the last available value prior to the first 
dose of DB Phase study drug. Baseline value for the Withdrawal Phase will be the last available value from 
the DB Phase. Baseline value for the OL Phase will be the last available value prior to the first dose of DB 
Phase study drug. 
16.1. ADVERSE EVENTS 
Adverse Events (AEs) will be coded using Medical Dictionary for Regulatory Activities (MedDRA) central 
coding dictionary, Version 20.0 or higher.  
 
Treatment emergent adverse events (TEAEs) are defined as AEs that started or worsened in severity on or 
after the first dose of study medication and no more than 14 days (30 days for SAEs) after the last dose of 
study drug.  TEAEs will be defined within each study phase.   
 


 
 
 
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For the DB Phase, TEAEs will include events whose date of onset occurred after the first dose of double-blind 
study drug and before the first dose of withdrawal study drug, or within 14 days (30 days for serious AEs) 
after the last dose of the double-blind study drug for subjects who did not enter the withdrawal study phase. 
  
For the Withdrawal Phase, TEAEs will include events whose date of onset occurred after the first dose of 
withdrawal study drug and before the first dose of open-label study drug, or within 14 days (30 days for 
serious AEs) after the last dose of the withdrawal study drug for subjects who did not enter the open-label 
study phase.  For those subjects who switched from AZM to Placebo in WD phase, all AEs occurred on the 
first 3 days of WD period will be attributed to AZM. 
 
For the OL Phase, TEAEs, will include events whose date of onset occurred after the first dose of open-label 
study drug and within 14 days (30 days for serious AEs) after the last dose of the open-label study drug. See 
Appendix 2 for handling of partial dates for AEs.  In the case where it is not possible to define an AE as 
treatment emergent or not, the AE will be classified by the worst case; i.e. treatment emergent.  
 
An overall summary of number of subjects within each of the categories described in the sub-section below, 
will be provided as specified in the templates.  
 
Listings will include all AEs (TEAEs and Non-TEAEs). 
16.1.1. ALL TEAES  
Incidence of TEAEs will be presented by System Organ Class (SOC) and Preferred Term (PT) and broken down 
further by maximum severity and relationship to study medication. 
16.1.1.1. Severity 
Severity is classed as mild/ moderate/ severe (increasing severity). TEAEs starting after the first dose of study 
medication with a missing severity will be classified as severe. If a subject reports a TEAE more than once 
within that SOC/ PT, the AE with the worst case severity will be used in the corresponding severity 
summaries. 
16.1.1.2. Relationship to Study Medication 
Relationship, as indicated by the Investigator, is classed as ”Unrelated”, “Unlikely”, “Possibly”, “Probably” 
and “Definitely” (increasing severity of relationship). Missing relationship will be classified as related. If a 
subject reports the same AE more than once within that SOC/ PT, the AE with the worst case relationship to 
study medication will be used in the corresponding relationship summaries.  
A list of TEAEs will be presented. 
16.1.2. SERIOUS TREATMENT EMERGENT ADVERSE EVENTS 
Serious Treatment Emergent Adverse Events (SAEs) are those events recorded as ”Serious” on the Adverse 


 
 
 
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Events page of the (e)CRF. A summary of serious TEAEs by SOC and PT will be prepared. 
A list of Serious TEAEs will be presented. 
16.1.3. TREATMENT EMERGENT ADVERSE EVENTS LEADING TO DEATH 
TEAEs leading to Death are those events which are recorded as ”Fatal” on the Adverse Events page of the 
(e)CRF. A summary of TEAEs leading to death by SOC and PT will be prepared. 
A list of TEAEs leading to death will be presented. 
16.1.4. ALL ADVERSE EVENTS LEADING TO DEATH 
AEs leading to Death are those events which are recorded as ”Fatal” on the Adverse Events page of the 
(e)CRF. A summary of AEs leading to death and discontinuation by SOC and PT will be presented. 
A list of All AEs leading to death will be presented. 
16.2. LABORATORY EVALUATIONS 
Results from the central laboratory will be included in the reporting of this study by laboratory parameter.  
Presentations will use SI Units.  
 
The following summaries will be provided for laboratory data: 
• 
Actual and change from baseline by visit (for quantitative measurements) 
• 
Incidence of markedly abnormal values according to central laboratory reference ranges 
• 
Shift from baseline according to normal range criteria (for quantitative measurements and categorical 
measurements) 
• 
Listing of values meeting markedly abnormal criteria 
 
Sample collection information will be listed. Lab results will be listed for Hematology, Chemistry and 
Urinalysis respectively. Lab results which are out of normal range, or meet the markedly abnormal, will also 
be listed respectively for Hematology, Chemistry and Urinalysis.  
 
Number and percentage of subjects with elevated creatinine will be summarized by visit. 
16.2.1. LABORATORY REFERENCE RANGES AND MARKEDLY ABNORMAL CRITERIA 
Quantitative laboratory measurements will be compared with the relevant laboratory reference ranges in SI 
units and categorized as: 
• 
Low: Below the lower limit of the laboratory reference range.  
• 
Normal: Within the laboratory reference range (upper and lower limit included). 
• 
High: Above the upper limit of the laboratory reference range. 


 
 
 
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In addition to the high and low quantitative laboratory assignments (as identified by means of the laboratory 
reference ranges), markedly abnormal quantitative safety (and other) laboratory assessments will also be 
identified in accordance with the predefined markedly abnormal criteria as presented in provided in 
Appendix 3. 
16.3. ECG EVALUATIONS 
Results from the central ECG (Electrocardiogram) Reading Centre will be included in the reporting of this 
study.  
 
The following ECG parameters will be reported for this study: 
• 
PR Interval (msec) 
• 
QRS Interval (msec) 
• 
QT Interval (msec) 
• 
QTc Interval (msec) 
• 
HR (bpm) 
• 
Overall assessment of ECG (Investigator’s judgment): 
o 
Normal 
o 
Abnormal, Not Clinically Significant (ANCS) 
o 
Abnormal, Clinically Significant (ACS) 
 
Corrected QT interval will be calculated by Arbor or designee and will not be recorded on the CRF. 
High Low criteria in listing will be derived using table in Appendix 6. 
 
A list of ECG evaluations will be provided as well. 
16.4. VITAL SIGNS 
The following Vital Signs measurements will be reported for this study: 
• 
Sitting/Standing Systolic Blood Pressure (mmHg) 
• 
Sitting/Standing Diastolic Blood Pressure (mmHg) 
• 
Sitting/Standing Pulse Rate (bpm) 
 
At each visit, three serial sitting BP measurements will be obtained and the average (arithmetic mean) of the 
3 serial measurements will be used for the summary. 
 
Descriptive summaries by visit and change from baseline will be provided for vital sign data.  


 
 
 
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to IQVIA Holdings Inc. and its subsidiaries. Unauthorized use, disclosure or reproduction is strictly prohibited. 
 
16.5. PHYSICAL EXAMINATION  
Physical examination data will be listed.   
16.6. OTHER SAFETY ASSESSMENTS 
The following summaries will be provided for anthropometric data: 
• 
Height z-score 
• 
Weight z-score 
• 
BMI z-score 
 
Height, weight and BMI are collected on the Weight and Height page of eCRF.  
 
Z-score will be calculated using CDC growth charts.  The detail is explained in Appendix 4. 
 
Descriptive summaries by visit and change from baseline will be provided for anthropometric data. 


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to IQVIA Holdings Inc. and its subsidiaries. Unauthorized use, disclosure or reproduction is strictly prohibited.
17.
REFERENCES 
PROGRAMMING CONVENTIONS FOR OUTPUTS
IQVIA OUTPUT CONVENTIONS
Outputs will be presented according to the following: 
•
Output File Naming Conventions:
•
File names should only consist of uppercase letters, lowercase letters, digits (0 to 9) and underscores. 
A period should only be used to indicate a separator between the file name and the extension. No 
spaces, other special characters or punctuation marks are permitted.
•
As far as possible, output files should be in RTF format, although .DOC files are also permitted.
•
The program, program log and output file name should reflect the type and number of the statistical 
output. If this is not possible, then the output name should be at least as descriptive as possible. A 
prefix can be used to distinguish between a Table, Listing and Figure document (‘T’ for table, ‘L’ for 
listing and ‘F’ for figure). If there is only 1 digit in the number of the table, listing or figure in the place 
where 2 digits are possible, a leading zero should be added in the file name to make sorting consistent 
with the sequence (e.g. T14_3_01_1.RTF).
•
Paper Size, Orientation and Margins
Landscape
Portrait
Paper Size
U.S. Letter (8.5 x 11 inch)
U.S. Letter (8.5 x 11 inch)
Margins (Inches):
Top 
Bottom
Left
Right
1.25
1 
1 
1
1 
1 
1.25
1
Header (Inches)
0.5
0.5
Footer (Inches)
0.5
0.5
SAS® Specifications:
PAGESIZE
LINESIZE
46 (8-point size, Courier)
41 (9-point size, Courier)
134 (8-point size, Courier)
119 (9-point size, Courier)
67 (8-point size, Courier)
60 (9-point size, Courier)
93 (8-point size, Courier)
82 (9-point size, Courier)
•
Fonts


 
 
 
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Document: 
2014-000674-18 Statistical Analysis Plan Version 7.0 
Version Number: 
7.0 
Author: 
Sonelca Southey, Angelo Castelnovo 
Version Date: 
13JAN2020 
Template No.:  CS_TP_BS016 Revision 5 
Reference:  CS_WI_BS005 
Effective Date: 01Apr2018 
 
Copyright © 2009, 2010, 2012, 2016, 2018 IQVIA. All rights reserved. The contents of this document are confidential and proprietary 
to IQVIA Holdings Inc. and its subsidiaries. Unauthorized use, disclosure or reproduction is strictly prohibited. 
 
• 
The font type ‘Courier New’ should be used as a default for tables and listings, with a font size of 8. 
Single spacing should be used for all text. 
• 
Figures should have a default font of  “Courier New”. 
• 
This can be achieved by using the following options in SAS®: 
• 
goptions 
• 
gunit = pct 
• 
cback = white 
• 
colors = (black) 
• 
hby = 2.4 
• 
ftext = "TimesRoman" 
• 
htext = 2.5 
• 
device = cgmof97l 
• 
gaccess = gsasfile; 
• 
filename gsasfile "….cgm"; 
• 
Spacing: 
• 
There must be a minimum of 1 blank space between columns (preferably 2). 
• 
Missing values: 
• 
A “0” should be used to indicate a zero frequency. 
• 
A blank will be used to indicate missing data in an end-of-text table or patient listing. 
• 
Figure output conventions: 
• 
Figures should be provided in RTF files using the SAS® Output Delivery System (ODS), as Computer 
Graphics Metafile (CGM) formatted graphical output generated by SAS®. 
• 
The CGM file itself should contain the title or footer. 
• 
The image should be clear and of high quality when viewed in the Word document, and when printed. 
• 
In general, boxes around the figures should be used. 
DATES & TIMES 
Dates will be shown in ddmmmyyyy format, time of day in hh:mm format and datetime values as 
"ddmmmyyyy; hh:mm". In case of partial dates or time of day, missing information will be replaced by 
dashes. 
SPELLING FORMAT 
English US.  
PRESENTATION OF TREATMENT GROUPS 
For outputs, treatment groups will be represented as follows and in that order: 


 
 
 
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Version Date: 
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to IQVIA Holdings Inc. and its subsidiaries. Unauthorized use, disclosure or reproduction is strictly prohibited. 
 
Phase 
Treatment Group 
For Tables and Graphs 
Double Blind Phase 
Losartan 
Losartan 
 
AZM low 
AZM-L 
 
AZM Intermediate 
AZM-M 
 
AZM High 
AZM-H 
Withdrawal Phase 
Placebo 
Placebo 
 
Losartan 
Losartan 
 
AZM low 
AZM-L 
 
AZM Intermediate 
AZM-M 
 
AZM High 
AZM-H 
Open Label Phase 
AZM Only 
AZM Only 
 
AZM plus additional 
antihypertensives 
AZM Plus 
PRESENTATION OF VISITS 
For outputs, visits will be represented as follows and in that order: 
Long Name (default) 
Short Name  
Screening /Visit 1 
Scr /V1 
Washout/Placebo Run-In /Visit 2 
PRI /V2 
D-1/ Visit 3 
D-1 /V3 
D1/ Visit 4 
D1 /V4 
Week 2 / Visit 5 
W2 / V5 
Week 4 / Visit 6 
W4 / V6 
Week6 – 1D / Visit 7 
W6-1D / V7 
Week 6 / Visit 8 
W6 / V8 
Week 8 / Visit 9 
W8 / V9  
Week 12 / Visit 10 
W12 / V10 
Week 20 / Visit 11 
W20 / V11 
Week 28 / Visit 12 
W28 / V12 
Week 36 / Visit 13 
W36 / V13 
Week 44 / Visit 14 
W44 / V14 
Week 52 – 1D /Visit 15 
W 52 –1D / V15 
Week 52 /Visit 16 
W52 / V16 
Week 54 /Visit 17 
W54 / V17 
DEFINITION OF PHASES AND TREATMENT ASSIGNMENT: 
Visit4/D1 - Visit 8/W6 = Double Blind Phase 
Visit 8/W6 - Visit9/W8 = Withdrawal Phase 


 
 
 
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Document: 
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Version Number: 
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Author: 
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Version Date: 
13JAN2020 
Template No.:  CS_TP_BS016 Revision 5 
Reference:  CS_WI_BS005 
Effective Date: 01Apr2018 
 
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to IQVIA Holdings Inc. and its subsidiaries. Unauthorized use, disclosure or reproduction is strictly prohibited. 
 
Visit9/W8 - Visit16/W52 = Open Label Phase 
 
All the data collected for procedures (Con Meds, Vital Signs, AE assessments, Laboratory tests, Pregnancy tests) at 
Visit 8/ W6 will be used as visit 8/W6/last visit of DB phase in DB analysis and as WD phase baseline in WD phase 
analysis because all the measurements are taken before WD phase drug is given to the subjects at Visit 8/W6. 
 
All the data collected for procedure (Con Meds, Vital Signs, Physical Examination, AE assessments, Laboratory tests, 
Pregnancy tests, ECG) at Visit9/ W8 will be used as visit 9/W8/last visit of WD Phase in WD phase analysis and OL 
baseline in OL analysis because all the measurements are taken before OL drug is given to the subjects at Visit 9/ 
W8. 
 
Visit 4/Day 1 - First day of Double-Blind Dose 
Visit 8/Week 6 - First day of Withdrawal Phase Dose 
Visit 9/Week 8 – First day of Open Label Dose 
LISTINGS 
All listings will be ordered by the following (unless otherwise indicated in the template): 
• 
Site-subject ID, 
• 
Randomized treatment group (or treatment received if it’s a safety output), first by active dose [by 
ascending dose group] and then control/ placebo 
• 
Phase 
• 
Visit 
• 
Date (where applicable), 
• 
For listings where non-randomized subjects are included, these will appear in a category after the 
randomized treatment groups labelled ‘Not Randomized’. 
GENERAL DISPLAY 
When a table/listing is split in multiple pages, the footnotes added to explain the table/listing should be 
displayed on each page of the table/listing and not only on the last one. 
 
 


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Document:
2014-000674-18 Statistical Analysis Plan Version 7.0
Version Number:
7.0
Author:
Sonelca Southey, Angelo Castelnovo
Version Date:
13JAN2020
Template No.:  CS_TP_BS016 Revision 5
Reference:  CS_WI_BS005
Effective Date: 01Apr2018
Copyright © 2009, 2010, 2012, 2016, 2018 IQVIA. All rights reserved. The contents of this document are confidential and proprietary 
to IQVIA Holdings Inc. and its subsidiaries. Unauthorized use, disclosure or reproduction is strictly prohibited.
PARTIAL DATE CONVENTIONS
Imputed dates will NOT be presented in the listings.
ALGORITHM FOR TREATMENT EMERGENCE OF ADVERSE EVENTS: 
START DATE
STOP 
DATE
ACTION
Known
Known
If start date < study med start date, then not TEAE
If start date >= study med start date, then TEAE
Partial
If start date < study med start date, then not TEAE
If start date >= study med start date, then TEAE
Missing
If start date < study med start date, then not TEAE
If start date >= study med start date, then TEAE
Partial, but known 
components show that 
it cannot be on or after 
study med start date
Known
Not TEAE
Partial
Not TEAE
Missing
Not TEAE
Partial, could be on or 
after study med start 
date
Known
If stop date < study med start date, then not TEAE
If stop date >= study med start date, then TEAE
Partial
If Informed consent year and AE start year is same and 
study med start year is later, impute start date to 
informed consent date.
If study med start year and AE start year is same, 
impute start date to study med start date
If study med start year is earlier then 2016, impute the 
start date to first day of the year
Impute stop date as latest possible date (i.e. last day of 
month if day unknown or 31st December if day and 
month are unknown), then:
If stop date < study med start date, then not TEAE
If stop date >= study med start date, then TEAE
Missing
Assumed TEAE
Missing
Known
If stop date < study med start date, then not TEAE
If stop date >= study med start date, then TEAE


 
 
 
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Statistical Analysis Plan 
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Document: 
2014-000674-18 Statistical Analysis Plan Version 7.0 
Version Number: 
7.0 
Author: 
Sonelca Southey, Angelo Castelnovo 
Version Date: 
13JAN2020 
Template No.:  CS_TP_BS016 Revision 5 
Reference:  CS_WI_BS005 
Effective Date: 01Apr2018 
 
Copyright © 2009, 2010, 2012, 2016, 2018 IQVIA. All rights reserved. The contents of this document are confidential and proprietary 
to IQVIA Holdings Inc. and its subsidiaries. Unauthorized use, disclosure or reproduction is strictly prohibited. 
 
START DATE 
STOP 
DATE 
ACTION 
 
Partial 
Impute stop date as latest possible date (i.e. last day of 
month if day unknown or 31st December if day and 
month are unknown), then: 
If stop date < study med start date, then not TEAE 
If stop date >= study med start date, then TEAE 
 
Missing 
Assumed TEAE 
ALGORITHM FOR MEDICATION HISTORY / CONCOMITANT MEDICATIONS:  
START 
DATE 
STOP 
DATE 
ACTION 
Known 
Known 
If Informed consent date > medication end date ≥ Informed consent date -30, assign as 
Medication History 
If start date >= study med start date, assign as concomitant  
 
 
Partial 
Impute stop date as latest possible date (i.e. last day of month if day unknown or 31st 
December if day and month are unknown), then: 
If Informed consent date > medication end date ≥ Informed consent date -30, assign as 
medication history 
If stop date >= study med start date and start date <= end of treatment, assign as 
concomitant 
If stop date >= study med start date and start date > end of treatment, assign as post 
treatment 
 
Missing 
If stop date is missing could never be assumed a prior medication 
If start date <= end of treatment, assign as concomitant 
If start date > end of treatment, assign as post treatment 
 
 
 
Partial 
Known 
Impute start date as earliest possible date (i.e. first day of month if day unknown or 1st 
January if day and month are unknown), then: 
If Informed consent date > medication end date ≥ Informed consent date -30, assign as 
medication history 
If stop date >= study med start date and start date <= end of treatment, assign as 
concomitant 
If stop date >= study med start date and start date > end of treatment, assign as post 
treatment 


Arbor
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Statistical Analysis Plan
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Document:
2014-000674-18 Statistical Analysis Plan Version 7.0
Version Number:
7.0
Author:
Sonelca Southey, Angelo Castelnovo
Version Date:
13JAN2020
Template No.:  CS_TP_BS016 Revision 5
Reference:  CS_WI_BS005
Effective Date: 01Apr2018
Copyright © 2009, 2010, 2012, 2016, 2018 IQVIA. All rights reserved. The contents of this document are confidential and proprietary 
to IQVIA Holdings Inc. and its subsidiaries. Unauthorized use, disclosure or reproduction is strictly prohibited.
START 
DATE
STOP 
DATE
ACTION
Partial
Impute start date as earliest possible date (i.e. first day of month if day unknown or 1st
January if day and month are unknown) and impute stop date as latest possible date (i.e. 
last day of month if day unknown or 31st December if day and month are unknown), then:
If Informed consent date > medication end date ≥Informed consent date -30, assign as 
prior
If stop date >= study med start date and start date <= end of treatment, assign as 
concomitant
If stop date >= study med start date and start date > end of treatment, assign as post 
treatment
Missing
Impute start date as earliest possible date (i.e. first day of month if day unknown or 1st
January if day and month are unknown), then:
If stop date is missing could never be assumed a medication history
If start date <= end of treatment, assign as concomitant
If start date > end of treatment, assign as post treatment
Missing
Known
If Informed consent date > medication end date ≥Informed consent date -30, assign as 
medication history
If stop date >= study med start date, assign as concomitant
Cannot be assigned as ‘post treatment’
Partial
Impute stop date as latest possible date (i.e. last day of month if day unknown or 31st
December if day and month are unknown), then:
If Informed consent date > medication end date ≥Informed consent date -30, assign as 
medication history
If stop date >= study med start date, assign as concomitant
Cannot be assigned as ‘post treatment’
Missing
Assign as concomitant
MARKEDLY ABNORMAL CRITERIA
LAB 
CATEGORY
LAB NAME
SEX
LOW CRITERIA
HIGH 
CRITERIA
DERIVED CRITERIA 
LOW (USE FOR 
OUTPUTS)
DERIVED CRITERIA 
HIGH  (USE FOR 
OUTPUTS)
Hematology
Hemoglobin
M/F
< Baseline – 3 g/dL
--
<Baseline - 30 g/L
Hematology
Hematocrit
M/F
< 0.8 x Baseline
--
<0.8 x Baseline
Hematology
RBC count 
M/F
< 0.8 x Baseline
--
<0.8 x Baseline


 
 
 
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Version Date: 
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Template No.:  CS_TP_BS016 Revision 5 
Reference:  CS_WI_BS005 
Effective Date: 01Apr2018 
 
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to IQVIA Holdings Inc. and its subsidiaries. Unauthorized use, disclosure or reproduction is strictly prohibited. 
 
Hematology 
WBC count  
M/F 
< 2 x 103/mm3 
> 20 x 
103/mm3 
<2 x 10^9/L 
>20 x 10^9/L 
Hematology 
Platelet count 
M/F 
< 50 x 103/mm3 
> 700 x 
103/mm3 
<50 x 10^9/L 
>700 x 10^9/L 
Chemistry 
ALT 
M/F 
-- 
>3x ULN 
  
>3 x ULN 
Chemistry 
AST 
M/F 
-- 
>3x ULN 
 
>3 x ULN 
Chemistry 
GGT 
M/F 
-- 
>3x ULN 
  
>3 x ULN 
Chemistry 
Alkaline 
phosphatase 
M/F 
-- 
>3x ULN 
  
>3 x ULN 
Chemistry 
Total bilirubin 
M/F 
-- 
>2.0x ULN 
  
>2.0 x ULN 
Chemistry 
Albumin 
M/F 
<2.5 g/dL 
-- 
<25 g/L 
  
Chemistry 
Total protein 
M/F 
<0.8x LLN 
>1.2x ULN 
<0.8 x LLN 
>1.2 x ULN 
Chemistry 
Creatinine 
M/F 
-- 
>1.5 x 
Baseline 
  
>1.5 x Baseline 
Chemistry 
Sodium 
M/F 
<130 mEq/L 
>150 
mEq/L 
<130 mmol/L 
>150 mmol/L 
Chemistry 
Potassium 
M/F 
<3.0 mEq/L 
>6.0 
mEq/L 
<3.0 mmol/L 
>6.0 mmol/L 
Chemistry 
Blood Urea 
Nitrogen 
M/F 
-- 
>3x ULN 
  
>3 x ULN 
Chemistry 
Calcium 
M/F 
<0.8x LLN 
>1.2x ULN 
<0.8 x LLN 
>1.2 x ULN 
Chemistry 
Creatine 
kinase 
M/F 
-- 
>10x ULN 
  
>10 x ULN 
Chemistry 
Uric Acid 
M 
-- 
>10.5 
mg/dL 
  
>625 umol/L 
Chemistry 
Uric Acid 
F 
-- 
>8.5 
mg/dL 
  
>506 umol/L 
Urinalysis 
Blood 
M/F 
-- 
≥1+ 
  
>=1+ 
Urinalysis 
Glucose 
M/F 
-- 
≥1+ 
  
>=1+ 
Urinalysis 
Ketones 
M/F 
-- 
≥2+ 
  
>=2+ 
Urinalysis 
Casts 
M/F 
-- 
Any 
  
Any 
Urinalysis 
Casts 
M/F 
-- 
Any 
  
Any 
Urinalysis 
Microscopic 
RBCs* 
M/F 
-- 
≥5/hpf 
  
>=5/hpf 
Urinalysis 
Microscopic 
RBCs* 
M/F 
-- 
≥5/hpf 
  
>=5/hpf 
Urinalysis 
Microscopic 
WBC 
M/F 
-- 
≥20/hpf 
  
>=20/hpf 
Urinalysis 
pH 
M/F 
<=4 
>=8 
<=4 
>=8 


 
 
 
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Document: 
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Version Number: 
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Author: 
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Version Date: 
13JAN2020 
Template No.:  CS_TP_BS016 Revision 5 
Reference:  CS_WI_BS005 
Effective Date: 01Apr2018 
 
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to IQVIA Holdings Inc. and its subsidiaries. Unauthorized use, disclosure or reproduction is strictly prohibited. 
 
Urinalysis 
Protein 
M/F 
-- 
>=1+ 
  
>=1+ 
Urinalysis 
Specific 
Gravity 
M/F 
<1.005 
-- 
<1.005 
  
 
 


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Document:
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Version Number:
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Author:
Sonelca Southey, Angelo Castelnovo
Version Date:
13JAN2020
Template No.:  CS_TP_BS016 Revision 5
Reference:  CS_WI_BS005
Effective Date: 01Apr2018
Copyright © 2009, 2010, 2012, 2016, 2018 IQVIA. All rights reserved. The contents of this document are confidential and proprietary 
to IQVIA Holdings Inc. and its subsidiaries. Unauthorized use, disclosure or reproduction is strictly prohibited.
Z-SCORE CALCULATION USING CDC GROWTH CURVE
•
Step 1: Download the SAS program (cdc-source-code.sas[SAS -8KB]) and the reference data file 
(CDCref_d.sas7bdat). Do not alter these files, but move them to a folder (directory) that SAS can access.
•
Step 2: Create a libname statement in your SAS program to point at the folder location of 
‘CDCref_d.sas7bdat’. An example would be:
libname refdir 'c:\sas\growth charts\cdc\data';
Note the SAS code expects this name to be refdir; do not change this name.
•
Step 3: Set your existing dataset containing height, weight, sex, age and other variables into a 
temporary dataset, named mydata. Variables in your dataset should be renamed and coded as follows:
Table 1
Variable
Description
agemos
Child's age in months; must be present. The program assumes you know the number of months to the 
nearest day based on the dates of birth and examination. For example, if a child was born on Oct 1, 2007 
and was examined on Nov 15, 2011, the child’s age would be 1506 days or 49.48 months. In everyday 
usage, this age would be stated as 4 years or as 49 months. However, if 49 months were used as the age 
of all children who were between 49.0 and <50 months in your data, the estimated z-scores would be 
slightly too high because, on average, these children would be taller, weigh more, and have a higher BMI 
than children who are exactly 49.0 months of age. This bias would be greater if only completed years of 
age were known, and the age of all children between 4 and <5 years was represented as 48 months.
If age is known only as the completed number of months (as is data from NHANES 1988-1994 and 1999-
2010), consider adding 0.5 so that the maximum error would be 15 days. If age is given as the completed 
number of years, multiply by 12 and consider adding 6.
sex
Coded as 1 for boys and 2 for girls.


 
 
 
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Version Date: 
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Template No.:  CS_TP_BS016 Revision 5 
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Effective Date: 01Apr2018 
 
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to IQVIA Holdings Inc. and its subsidiaries. Unauthorized use, disclosure or reproduction is strictly prohibited. 
 
height 
Height in cm. This is either standing height (for children who are ≥ 24 months of age or recumbent length 
(for children < 24 months of age); both are input as height. If standing height was measured for some 
children less than 24 months of age, you should add 0.8 cm to these values (see page 8 
of http://www.cdc.gov/nchs/data/series/sr_11/sr11_246.pdf[PDF-5.4MB]). If recumbent length was 
measured for some children who are ≥ 24 months of age, subtract 0.8 cm. 
weight 
Weight (kg) 
bmi 
BMI (Weight (kg) /Height (m)2). If your data doesn’t contain BMI, the program calculates it. If BMI is 
present in your data, the program will not overwrite it. 
headcir 
Head circumference (cm) 
Z-scores and percentiles for variables that are not in mydata will be coded as missing (.) in the output dataset 
(named _cdcdata). Sex (coded as 1 for boys and 2 for girls) and agemos must be in mydata. It’s unlikely that the 
SAS code will overwrite other variables in your dataset, but you should avoid having variable names that begin with 
an underscore, such as _bmi. 
• 
Step 4: Copy and paste the following line into your SAS program after the line (or lines) in step #3. 
%include 'c:\sas\growth charts\cdc\data\CDC-source-code.sas'; run; 
If necessary, change this statement to point at the folder containing the downloaded ‘CDC-source-code.sas’ file. 
This tells your SAS program to run the statements in ‘CDC-source-code.sas’. 
• 
Step 5: Submit the %include statement. This will create a dataset, named _cdcdata, which contains all of 
your original variables along with z-scores, percentiles, and flags for extreme values. The names and 
descriptions of these new variables in _cdcdata are in Table 2. Additional information on the extreme z-
scores is given in a separate section that follows the “Example SAS Code”. 
Table 2: Z-Scores, percentiles, and extreme (biologically implausible, BIV) values in output dataset, _cdcdata 
Description 
Variable 
Cutoff for Extreme Z-
Scores 


 
 
 
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Version Date: 
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Template No.:  CS_TP_BS016 Revision 5 
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to IQVIA Holdings Inc. and its subsidiaries. Unauthorized use, disclosure or reproduction is strictly prohibited. 
 
Percentile 
Z-
score 
Modified Z-
score to 
Identify 
Extreme Values 
Flag for 
Extreme 
Values 
Low z-
score 
(Flag 
coded as -
1) 
High z-
score 
(Flag 
coded 
as +1) 
Weight-for-age for children 
between 0 and 239 (inclusive) 
months of age 
wapct 
waz 
_Fwaz 
_bivwt 
< -5 
> 8* 
Height-for-age for children 
between 0 and 239 (inclusive) 
months of age. 
hapct 
haz 
_Fhaz 
_bivht 
< -5 
>4* 
Weight-for-height for children 
with heights between 45 and 121 
cm (this height range 
approximately covers ages 0 to 6 
y) 
whpct 
whz 
_Fwhz 
_bivwh 
< -4 
>8* 
BMI-for-age for children between 
24 and 239 months of age 
bmipct 
bmiz 
_Fbmiz 
_bivbmi 
< -4 
>8* 
Head circumference-for-age for 
children between 0 and 35 
(inclusive) months of age 
headcpct 
headcz 
_Fheadcz 
_bivhc 
< -5 
>5 
* Changed in 2016. Additional information is below 
• 
Step 6: Examine the new dataset, _cdcdata, with PROC MEANS or some other procedure to verify that the 
z-scores and other variables have been created. If a variable in Table 1 was not in your original dataset (e.g., 
head circumference), the output dataset will indicate that all values for the percentiles and z-scores of this 
variable are missing. If values for other variables are unexpectedly missing, make sure that you’ve renamed, 
and recoded variables as indicated in Table 1 and that your SAS dataset is named mydata. The program 
should not modify your original data but will add new variables to your original dataset. 


 
 
 
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to IQVIA Holdings Inc. and its subsidiaries. Unauthorized use, disclosure or reproduction is strictly prohibited. 
 
Example SAS code corresponding to steps 2 to 6. You can simply cut and paste these lines into a SAS program, but 
you’ll need to change the libname and %include statements to point at the folders containing the downloaded files. 
libname refdir 'c:\sas\growth charts\cdc\data'; 
data mydata; set whatever-your-original-dataset-is-named; 
%include 'c:\sas\growth charts\cdc\data\CDC-source-code.sas'; 
proc means data=_cdcdata; run; 
 
 


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Statistical Analysis Plan
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Document:
2014-000674-18 Statistical Analysis Plan Version 7.0
Version Number:
7.0
Author:
Sonelca Southey, Angelo Castelnovo
Version Date:
13JAN2020
Template No.:  CS_TP_BS016 Revision 5
Reference:  CS_WI_BS005
Effective Date: 01Apr2018
Copyright © 2009, 2010, 2012, 2016, 2018 IQVIA. All rights reserved. The contents of this document are confidential and proprietary 
to IQVIA Holdings Inc. and its subsidiaries. Unauthorized use, disclosure or reproduction is strictly prohibited.
MONTE CARLO MARKOV CHAIN (MCMC)
MONTE CARLO MARKOV CHAIN (MCMC)
•
Step 1: PROC MI will be applied to create monotone data.
SUBJID – subject ID number
TRT – Treatment Arm – Placebo (TRT=4), AZM-L (TRT=1), AZM-M (TRT=2) and AZM-H (TRT=3))
TRT1 – AZM-L Arm
TRT2 – AZM-M Arm
TRT3 – AZM-H Arm
WGTGRP – Weight group (<50, >=50)
TANSGRP – Tanner Stage (< 3, >=3)
RACEGRP – Race Group (Black or African American, Non-Black or African American)
SCORE_0 - seDBP at time-point 0 (BASELINE, D1)
SCORE_1 - post-baseline visits 1(W2)
SCORE_2 - visit 2 (W4)
SCORE_3 – visit 3 (W6/final visit of DB phase)
SCORE_5 - visit 5 (w8/final visit of WD phase) 
proc mi data=datain out=datain_mono nimpute=100 seed=123; 
var trt1 trt2 trt3 wgtgrp tansgrp racegrp score_0 score_1 score_2 score_3 score_5;
mcmc chain=multiple impute=monotone;
run; 
proc sort data=datain_mono;
  by _Imputation_ trt;
run; 
•
Step 2: PROC MI will be applied to the monotone data to complete the imputation.
proc mi data=datain_mono out=datain_reg seed=465 nimpute=1; 
  by _imputation_ trt;
  var trt wgtgrp tansgrp racegrp score_0 score_1 score_2 score_3 score_5;
  class trt wgtgrp tansgrp racegrp;
  monotone regression; 
run; 
•
Step 3: Transform the imputed dataset so that for each subject, we will compute a change from Week 
6/Final Visit of the DB Phase to Week 8/Final Visit of Withdrawal Phase in the trough seated diastolic blood 
pressure (seDBP)
data datain_reg1;


 
 
 
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Ar14.001 
Statistical Analysis Plan 
Page 56 of 56 
 
Document: 
2014-000674-18 Statistical Analysis Plan Version 7.0 
Version Number: 
7.0 
Author: 
Sonelca Southey, Angelo Castelnovo 
Version Date: 
13JAN2020 
Template No.:  CS_TP_BS016 Revision 5 
Reference:  CS_WI_BS005 
Effective Date: 01Apr2018 
 
Copyright © 2009, 2010, 2012, 2016, 2018 IQVIA. All rights reserved. The contents of this document are confidential and proprietary 
to IQVIA Holdings Inc. and its subsidiaries. Unauthorized use, disclosure or reproduction is strictly prohibited. 
 
  set datain_reg; 
  score_c=score_5 - score_3; 
run; 
 
• 
Step 4: PROC MIXED  
proc mixed data=datain_reg1; 
  by _imputation_; 
  class trt; 
  model score_c= trt wgtgrp tansgrp racegrp score_3/solution covb; 
  ods output lsmestimates=est_mi; 
  lsmeans trt/diff=control('4') cl; 
  lsmestimate trt 'Pooled AZM vs Placebo' 1 1 1 -3/divisor=3 cl; 
  lsmestimate trt 'AZM-L vs Placebo' 1 0 0 -1; 
  lsmestimate trt 'AZM-M vs Placebo' 0 1 0 -1; 
  lsmestimate trt 'AZM-H vs Placebo' 0 0 1 -1; 
  lsmestimate trt 'AZM-L' 1 0 0 0; 
  lsmestimate trt 'AZM-M' 0 1 0 0; 
  lsmestimate trt 'AZM-H' 0 0 1 0; 
  lsmestimate trt 'Placebo' 0 0 0 1; 
  lsmestimate trt 'AZM-Pooled' 1 1 1 0/divisor=3 cl; 
run; 
 
• 
Step 5: Results from all ANCOVA analysis are then combined together for overall inference using PROC 
MIANALYZE 
proc sort data=est_mi; 
  by label; 
run; 
 
proc mianalyze data=est_mi; 
   ods output ParameterEstimates=parms; 
   modeleffects estimate; 
   stderr; 
   by label; 
run; 
 
 


Arbor
Ar14.001
Statistical Analysis Plan
Page 57 of 56
Document:
2014-000674-18 Statistical Analysis Plan Version 7.0
Version Number:
7.0
Author:
Sonelca Southey, Angelo Castelnovo
Version Date:
13JAN2020
Template No.:  CS_TP_BS016 Revision 5
Reference:  CS_WI_BS005
Effective Date: 01Apr2018
Copyright © 2009, 2010, 2012, 2016, 2018 IQVIA. All rights reserved. The contents of this document are confidential and proprietary 
to IQVIA Holdings Inc. and its subsidiaries. Unauthorized use, disclosure or reproduction is strictly prohibited.
ECG HIGH LOW CRITERIA
New normal limits for the pediatric electrocardiogram
P. R. Rijnbeek1, M. Witsenburg2, E. Schrama2, J. Hess3 and J. A. Kors1
1Institute of Medical Informatics, Faculty of Medicine and Health Sciences, Erasmus University, Rotterdam,
The Netherlands; 2Department of Paediatric Cardiology, Sophia Children’s Hospital, Rotterdam, The Netherlands;
3Department of Paediatric Cardiology and Congenital Heart Disease, Deutsches Herzzentrum Mu¨nchen, Munich,
Germany