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)

PHASE4CompletedINTERVENTIONAL
Enrollment

568

Participants

Timeline

Start Date

January 25, 2016

Primary Completion Date

July 21, 2017

Study Completion Date

July 21, 2017

Conditions
Overactive Bladder
Interventions
DRUG

Mirabegron

Oral tablet

DRUG

Placebo

Oral tablet

DRUG

Tamsulosin

Oral tablet

Trial Locations (58)

Unknown

Site JP81046, Aichi

Site JP81009, Chiba

Site JP81045, Chiba

Site JP81041, Fukuoka

Site JP81042, Fukuoka

Site JP81043, Fukuoka

Site JP81044, Fukuoka

Site JP81048, Fukuoka

Site JP81004, Gunma

Site JP81005, Gunma

Site JP81001, Hokkaido

Site JP81002, Hokkaido

Site JP81003, Hokkaido

Site JP81038, Hyōgo

Site JP81039, Hyōgo

Site JP81040, Hyōgo

Site JP81024, Kanagawa

Site JP81056, Kanagawa

Site JP81051, Kochi

Site JP81052, Kochi

Site JP81047, Kumamoto

Site JP81025, Osaka

Site JP81026, Osaka

Site JP81027, Osaka

Site JP81028, Osaka

Site JP81029, Osaka

Site JP81030, Osaka

Site JP81031, Osaka

Site JP81032, Osaka

Site JP81033, Osaka

Site JP81034, Osaka

Site JP81035, Osaka

Site JP81036, Osaka

Site JP81037, Osaka

Site JP81053, Osaka

Site JP81054, Osaka

Site JP81006, Saitama

Site JP81007, Saitama

Site JP81008, Saitama

Site JP81050, Shizuoka

Site JP81010, Tokyo

Site JP81011, Tokyo

Site JP81012, Tokyo

Site JP81013, Tokyo

Site JP81014, Tokyo

Site JP81015, Tokyo

Site JP81016, Tokyo

Site JP81017, Tokyo

Site JP81018, Tokyo

Site JP81019, Tokyo

Site JP81020, Tokyo

Site JP81021, Tokyo

Site JP81022, Tokyo

Site KR00001, Seoul

Site KR00002, Seoul

Site KR00003, Seoul

Site KR00004, Seoul

Site KR00005, Seoul

Sponsors
All Listed Sponsors
collaborator

Astellas Pharma Singapore Pte. Ltd.

INDUSTRY

lead

Astellas Pharma Inc

INDUSTRY

NCT02656173 - 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) | Biotech Hunter | Biotech Hunter