At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 4, Double-Blind, Randomized, Placebo-Controlled, Multi-Center Study to Evaluate the Efficacy, Safety, and Tolerability of Mirabegron in Men With Overactive Bladder (OAB) Symptoms While Taking the Alpha Blocker Tamsulosin Hydrochloride for Lower Urinary Tract Symptoms (LUTS) Due to Benign Prostatic Hyperplasia (BPH)
In Brief
A Phase 4 clinical trial evaluating Mirabegron, Placebo, and 1 other intervention for Benign Prostatic Hyperplasia and Overactive Bladder. Completed, enrolled 715 participants across 79 sites in 9 countries.
Detailed Summary
The purpose of the study was to assess the efficacy, safety, and tolerability of mirabegron versus placebo in men with overactive bladder (OAB) symptoms while taking tamsulosin hydrochloride for lower urinary tract symptoms (LUTS) due to Benign Prostatic Hyperplasia (BPH).
Study Details
Timeline
Interventions
Participants received initial dose of 25 mg of mirabegron (oral tablet) which was increased to 50 mg after 4 weeks.
Participants received initial dose of 25 mg of matching placebo (oral tablet) which was increased to 50 mg after 4 weeks.
Participants received once daily treatment with tamsulosin hydrochloride 0.4 mg (oral tablet) throughout the study.