Completed
PHASE3
INTERVENTIONAL
NCT00662909
A Study to Assess Efficacy and Safety of the Beta-3 Agonist Mirabegron (YM178) in Patients With Symptoms of Overactive Bladder
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief Summary
The study is intended to test the efficacy, safety and tolerability of two doses of mirabegron against placebo to treat patients with symptoms of overactive bladder
Interventions
Name:
Mirabegron
Type:
DRUG
Description:
Oral
Name:
Placebo
Type:
DRUG
Description:
Oral
Primary Outcomes
Measure:
Change From Baseline to End of Treatment (Final Visit) in Mean Number of Incontinence Episodes Per 24 Hours
TimeFrame:
Baseline and Week 12 (Final Visit)
Description:
The average number of incontinence episodes (any involuntary leakage of urine) per day was derived from the number of incontinence episodes recorded by the patient in a micturition diary for 3-days before the Baseline and Week 12 clinic visits. Least Squares (LS) Means were generated from an analysis of covariance (ANCOVA) model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.
Measure:
Change From Baseline to End of Treatment (Final Visit) in Mean Number of Micturitions Per 24 Hours
TimeFrame:
Baseline and Week 12
Description:
The average number of micturitions (urinations) per 24 hours was derived from the number of times a patient urinates (excluding incontinence only episodes) per day recorded by the patient in a micturition diary for 3-days before the Baseline and Week 12 clinic visits. LS Means generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.
Trial Information
NCT ID
NCT00662909
Status
Completed
Study Type
INTERVENTIONAL
Phases
PHASE3
Sponsor
Astellas Pharma Inc
Last Updated
December 15, 2025