Clinical trial NCT00410514: A Study of Mirabegron (YM178) in Men With Lower Urinary Tract Symptoms (LUTS) and Bladder Outlet Obstruction (BOO)
Official title: A Phase 2, Randomized, Double-blind, Parallel Group, Placebo Controlled, Multi-center Study to Evaluate the Urodynamics and Safety of YM178 in Male Subjects With Lower Urinary Tract Symptoms (LUTS) and Bladder Outlet Obstruction (BOO)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lower Urinary Tract Symptoms
Bladder Outlet Obstruction
Keywords: Beta-3 Receptor Agonist
YM178
Men
Lower Urinary Tract Symptoms
Bladder Outlet Obstruction
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2006-12-13
Enrollment: 200
Sex: MALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study examined the safety, tolerability, and efficacy of mirabegron (YM178) compared to placebo.


Eligibility criteria: Inclusion Criteria:

* Men 45 years of age or older
* Documented bladder outlet obstruction

Exclusion Criteria:

* History of urinary retention
* Symptomatic and recurrent urinary tract infection (UTI)

Primary outcomes:
measure: Change From Baseline to End of Treatment in Maximum Flow Rate (Qmax)
timeFrame: Baseline and Week 12
measure: Change From Baseline to End of Treatment in Detrusor Pressure at Maximum Flow Rate (PdetQmax)
timeFrame: Baseline and Week 12
Secondary outcomes:
measure: Change From Baseline to End of Treatment in Bladder Contractile Index (BCI)
timeFrame: Baseline and Week 12
measure: Change From Baseline to End of Treatment in Bladder Voiding Efficiency (BVE)
timeFrame: Baseline and Week 12
measure: Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in Postvoid Residual Volume (PVR)
timeFrame: Baseline and Weeks 1, 4, 8 and 12
measure: Safety Assessed by Adverse Events (AEs), Electrocardiogram (ECG), Vital Signs, Physical Exam and Laboratory Tests
timeFrame: From first dose to within 30 days after last dose of double blind study medication (up to 16 weeks).
measure: Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in International Prostate Symptoms Score (IPSS) Total Score
timeFrame: Baseline and Weeks 1, 4, 8 and 12
measure: Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in International Prostate Symptoms Score (IPSS) Voiding Score
timeFrame: Baseline and Weeks 1, 4, 8 and 12
measure: Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in International Prostate Symptoms Score (IPSS) Storage Symptom Score
timeFrame: Baseline and Weeks 1, 4, 8 and 12
measure: Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in Patient Perception of Bladder Condition (PPBC)
timeFrame: Baseline and Weeks 1, 4, 8 and 12
measure: Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in Mean Number of Micturitions Per 24 Hours
timeFrame: Baseline and Weeks 1, 4, 8 and 12
measure: Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in Mean Number of Urgency Episodes With Urgency Severity ≥ 3 Per 24 Hours
timeFrame: Baseline and Weeks 1, 4, 8 and 12
measure: Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in Mean Number of Incontinence Episodes Per 24 Hours
timeFrame: Baseline and Weeks 1, 4, 8 and 12
measure: Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in Mean Voided Volume Per Micturition
timeFrame: Baseline and Weeks 1, 4, 8 and 12
measure: Change From Baseline to Weeks 4, 8, 12 and End of Treatment in International Consultation on Incontinence Questionnaire - Male Lower Urinary Tract Symptom (ICIQ MLUTS) Total Symptom Score
timeFrame: Baseline and Weeks 4, 8 and 12
measure: Change From Baseline to Weeks 4, 8, 12 and End of Treatment in International Consultation on Incontinence Questionnaire - Male Lower Urinary Tract Symptom (ICIQ MLUTS) Total Bother Score
timeFrame: Baseline and Weeks 4, 8 and 12
measure: Change From Baseline to Weeks 4, 8, 12 and End of Treatment in International Consultation on Incontinence Questionnaire - Lower Urinary Tract Symptom Quality of Life (ICIQ-LUTSqol) Symptom Score
timeFrame: Baseline and Weeks 4, 8 and 12
measure: Change From Baseline to Weeks 4, 8, 12 and End of Treatment in International Consultation on Incontinence Questionnaire - Lower Urinary Tract Symptom Quality of Life (ICIQ-LUTSqol) Overall Symptom Interference of Life Score
timeFrame: Baseline and Weeks 4, 8 and 12
Other outcomes:
Locations:
city: Tuscon
country: United States
state: Arizona
city: Atherton
country: United States
state: California
city: Culver City
country: United States
state: California
city: Fresno
country: United States
state: California
city: San Diego
country: United States
state: California
city: Torrance
country: United States
state: California
city: Middlebury
country: United States
state: Connecticut
city: Tallahassee
country: United States
state: Florida
city: Des Moines
country: United States
state: Iowa
city: Shreveport
country: United States
state: Louisiana
city: Watertown
country: United States
state: Massachusetts
city: Garden City
country: United States
state: New York
city: Winston Salem
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Virginia Beach
country: United States
state: Virginia
city: Victoria
country: Canada
state: British Columbia
city: Victoria
country: Canada
state: British Columbia
city: Winnipeg
country: Canada
state: Manitoba
city: St John
country: Canada
state: New Brunswick
city: Halifax
country: Canada
state: Nova Scotia
city: Kitchener
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Chicoutimi
country: Canada
state: Quebec
city: Chicoutimi
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
city: Pointe-Claire
country: Canada
state: Quebec
city: Sherbrooke
country: Canada
state: Quebec
Study officials:
affiliation: Astellas Pharma US, Inc.
name: Use Central Contact
role: STUDY_DIRECTOR
References:
citation: Nitti VW, Rosenberg S, Mitcheson DH, He W, Fakhoury A, Martin NE. Urodynamics and safety of the beta(3)-adrenoceptor agonist mirabegron in males with lower urinary tract symptoms and bladder outlet obstruction. J Urol. 2013 Oct;190(4):1320-7. doi: 10.1016/j.juro.2013.05.062. Epub 2013 May 30.