Study to Compare the Efficacy and Safety of Combination Treatment With Dutasteride and Tamsulosin With Tamsulosin Monotherapy, in Men With Moderate to Severe Benign Prostatic Hyperplasia

PHASE3CompletedINTERVENTIONAL
Enrollment

607

Participants

Timeline

Start Date

February 10, 2014

Primary Completion Date

March 3, 2017

Study Completion Date

March 3, 2017

Conditions
Prostatic Hyperplasia
Interventions
DRUG

Dutasteride 0.5mg capsules

Dutasteride 0.5mg capsules will be supplied as plain, oblong, opaque, dull yellow soft gelatin capsules.

DRUG

Dutasteride placebo capsules

Dutasteride placebo will be supplied as plain, oblong, opaque, dull yellow soft gelatin capsules.

DRUG

Tamsulosin 0.2mg tablets

Commercially available tamsulosin 0.2mg tablets will be supplied.

DRUG

Disintegrating placebo tamsulosin tablet

Disintegrating placebo tamsulosin tablet will be supplied for the run-in period.

Trial Locations (46)

333

GSK Investigational Site, Tau-Yuan

613

GSK Investigational Site, Chiayi City

704

GSK Investigational Site, Tainan City

970

GSK Investigational Site, Hualien City

23142

GSK Investigational Site, New Taipei City

71004

GSK Investigational Site, Tainan City

83301

GSK Investigational Site, Kaohsiung Hsien

100020

GSK Investigational Site, Beijing

100191

GSK Investigational Site, Beijing

100730

GSK Investigational Site, Beijing

200025

GSK Investigational Site, Shanghai

200030

GSK Investigational Site, Shanghai

200032

GSK Investigational Site, Shanghai

200040

GSK Investigational Site, Shanghai

200433

GSK Investigational Site, Shanghai

215004

GSK Investigational Site, Suzhou

310003

GSK Investigational Site, Hangzhou

400037

GSK Investigational Site, Chongqing

430030

GSK Investigational Site, Wuhan

510120

GSK Investigational Site, Guangzhou

Unknown

GSK Investigational Site, Xiame

GSK Investigational Site, Shenyang

GSK Investigational Site, Kaohsiung City

810-0001

GSK Investigational Site, Fukuoka

811-0120

GSK Investigational Site, Fukuoka

651-1145

GSK Investigational Site, Hyōgo

226-0025

GSK Investigational Site, Kanagawa

252-0143

GSK Investigational Site, Kanagawa

530-0013

GSK Investigational Site, Osaka

874-0937

GSK Investigational Site, Ōita

343-0845

GSK Investigational Site, Saitama

150-0002

GSK Investigational Site, Tokyo

184-0005

GSK Investigational Site, Tokyo

400-0124

GSK Investigational Site, Yamanashi

614-735

GSK Investigational Site, Busan

700-712

GSK Investigational Site, Daegu

501-757

GSK Investigational Site, Gwangju

405-760

GSK Investigational Site, Incheon

561-712

GSK Investigational Site, Jeonju

110-744

GSK Investigational Site, Seoul

135-710

GSK Investigational Site, Seoul

135-720

GSK Investigational Site, Seoul

136-705

GSK Investigational Site, Seoul

138-736

GSK Investigational Site, Seoul

150-713

GSK Investigational Site, Seoul

156-707

GSK Investigational Site, Seoul

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT02058368 - Study to Compare the Efficacy and Safety of Combination Treatment With Dutasteride and Tamsulosin With Tamsulosin Monotherapy, in Men With Moderate to Severe Benign Prostatic Hyperplasia | Biotech Hunter | Biotech Hunter