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)

Phase 4 Completed 715 enrolled Astellas Pharma Global Development, Inc.

RandomizedParallel-groupDouble-blindTreatment

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

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Mirabegron	Other / unclassified	50 mg	Oral
Background	Tamsulosin	Other / unclassified	0.4 mg	Oral

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

Timeline

Drugs

Indications