A Study to Evaluate the Efficacy, Safety, and Tolerability of Mirabegron in Men With OAB Symptoms While Taking Tamsulosin Hydrochloride for Lower Urinary Tract Symptoms (LUTS) Due to Benign Prostatic Hyperplasia (BPH)

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).

Timeline

Start

2016-06-13

Primary completion

2018-08-14

Completion

2018-09-11

Outcome

Met primary endpoint

registry analysis (superiority test); Mirabegron vs Placebo; p = 0.039; Least Squares (LS) Mean of Difference -0.39 (95% CI -0.76 to -0.02); ANCOVA NCT02757768 ↗

Drugs

Indications