Phase 4CompletedAge-related condition
A Phase 4 Study to Evaluate the Efficacy, Safety, and Tolerability of Mirabegron in Male Subjects With Overactive Bladder (OAB) Symptoms, While Taking the Alpha Blocker for Benign Prostatic Hypertrophy (BPH)
A Phase 4, Double-blind, Randomized, Placebo-controlled Multicenter Study to Evaluate the Efficacy and Safety of Mirabegron in Japanese and Korean Male Patients With Overactive Bladder Under Treatment With the α-Blocker Tamsulosin for Benign Prostatic Hyperplasia
- Sponsor
- Astellas Pharma Inc (Industry)
- Enrollment
- 568 enrolled
- Conditions
- Overactive Bladder
- Interventions
- Mirabegron; Placebo; Tamsulosin
- Ages
- adults, older adults
- Registry
- NCT02656173
Full record on ClinicalTrials.gov
From the registry
The primary objective of the study was to investigate the efficacy of mirabegron versus placebo in male patients with OAB symptoms while taking the alpha blocker, tamsulosin, for BPH.
Primary outcomes
- Change From Baseline to End of Treatment (EoT) in Mean Number of Micturitions Per 24 Hours
- Change From Baseline to Weeks 4, 8, 12 in Mean Number of Micturitions Per 24 Hours
History
Last registry update
Results first posted
Primary completion
Started
Registered