At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 568 enrolled
Drug / intervention
Mirabegron +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 4 clinical trial evaluating Mirabegron, Placebo, and 1 other intervention for Overactive Bladder. Completed, enrolled 568 participants across 58 sites in 2 countries.
Detailed Summary
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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOveractive Bladder
CountriesJapan, South Korea
CollaboratorsAstellas Pharma Singapore Pte. Ltd.
Timeline
Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedJan 2016
Enrollment StartJan 2016
Primary CompletionJul 2017
TodayJul 2026
First PostedJan 14, 2016
Enrollment StartJan 25, 2016
Primary CompletionJul 21, 2017
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 10.5 years ago
Interventions
Mirabegrondrug
Oral tablet
Placebodrug
Oral tablet
Tamsulosindrug
Oral tablet