Study Details

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)

This trial is complete
The study has ended normally, and participants are no longer being examined or treated (that is, the last participant's last visit has occurred).

Clinicaltrials.gov ID

The unique identification code given to each clinical study upon registration at ClinicalTrials.gov.
NCT02656173

Astellas Study ID

The unique identification code given by the study sponsor.

178-MA-3016

EudraCT ID

The unique identification code given to each clinical study upon registration at EudraCT (European Union Drug Regulating Authorities Clinical Trials Database).

N/A

Condition

Overactive Bladder Disease

Phase

These clinical trials happen after a drug or treatment has been approved for patients to take. Clinical trials in phase 4 usually take place over many years because researchers want to learn about long term use and safety of a drug or treatment.

Phase 4

Age

40 years - N/A

Sex

Male

Product

N/A

Type

A type of clinical study in which participants are assigned to groups that receive one or more intervention/treatment (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

Interventional

Trial Dates

Jan 2016 - Jul 2017

Masking

Double (Participant, Investigator)

Enrollment number

568

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

Study summary

Study documents

Study Documents, including study results, are available after a study is completed or terminated, according to Astellas Transparency policy.

Get More Information

Would you like more information about clinical trial sites that are recruiting participants for 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)? Contact us by filling our your information to the right and we’ll respond to you.

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Locations

Site JP81053

Osaka, Japan

Site JP81027

Osaka, Japan

Site JP81021

Tokyo, Japan

Site JP81014

Tokyo, Japan

Site JP81005

Gunma, Japan

Site JP81056

Kanagawa, Japan

Site JP81008

Saitama, Japan

Site KR00003

Seoul, Republic of Korea

Site JP81007

Saitama, Japan

Site JP81046

Aichi, Japan

Site KR00001

Seoul, Republic of Korea

Site JP81020

Tokyo, Japan

Site JP81003

Hokkaido, Japan

Site JP81016

Tokyo, Japan

Site JP81045

Chiba, Japan

Site JP81010

Tokyo, Japan

Site JP81012

Tokyo, Japan

Site JP81015

Tokyo, Japan

Site JP81024

Kanagawa, Japan

Site JP81034

Osaka, Japan

Site JP81042

Fukuoka, Japan

Site KR00002

Seoul, Republic of Korea

Site JP81011

Tokyo, Japan

Site JP81025

Osaka, Japan

Site JP81036

Osaka, Japan

Site JP81033

Osaka, Japan

Site JP81040

Hyogo, Japan

Site KR00005

Seoul, Republic of Korea

Site JP81028

Osaka, Japan

Site JP81032

Osaka, Japan

Site JP81022

Tokyo, Japan

Site JP81029

Osaka, Japan

Site JP81041

Fukuoka, Japan

Site JP81050

Shizuoka, Japan

Site JP81001

Hokkaido, Japan

Site JP81013

Tokyo, Japan

Site JP81009

Chiba, Japan

Site JP81019

Tokyo, Japan

Site JP81030

Osaka, Japan

Site JP81038

Hyogo, Japan

Site JP81017

Tokyo, Japan

Site JP81037

Osaka, Japan

Site JP81051

Kochi, Japan

Site JP81044

Fukuoka, Japan

Site JP81052

Kochi, Japan

Site JP81031

Osaka, Japan

Site JP81043

Fukuoka, Japan

Site KR00004

Seoul, Republic of Korea

Site JP81039

Hyogo, Japan

Site JP81002

Hokkaido, Japan

Site JP81054

Osaka, Japan

Site JP81004

Gunma, Japan

Site JP81048

Fukuoka, Japan

Site JP81035

Osaka, Japan

Site JP81047

Kumamoto, Japan

Site JP81018

Tokyo, Japan

Site JP81026

Osaka, Japan

Site JP81006

Saitama, Japan