Trials / Completed
CompletedNCT02656173
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
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 568 (actual)
- Sponsor
- Astellas Pharma Inc · Industry
- Sex
- Male
- Age
- 40 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Mirabegron | Oral tablet |
| DRUG | Placebo | Oral tablet |
| DRUG | Tamsulosin | Oral tablet |
Timeline
- Start date
- 2016-01-25
- Primary completion
- 2017-07-21
- Completion
- 2017-07-21
- First posted
- 2016-01-14
- Last updated
- 2024-11-12
- Results posted
- 2018-09-18
Locations
58 sites across 2 countries: Japan, South Korea
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02656173. Inclusion in this directory is not an endorsement.