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

A Randomized, Double-blind, Parallel Group Study to Compare the Efficacy and Safety of Combination Treatment With Dutasteride (0.5mg) and Tamsulosin (0.2mg) With Tamsulosin (0.2mg) Monotherapy, Administered Once Daily for 2 Years, on the Improvement of Symptoms and Health Outcomes in Men With Moderate to Severe Benign Prostatic Hyperplasia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 607 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: Male
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

This is a multicentre, randomised, double-blind, parallel group study in Asian subjects. The aim of the study is to investigate whether combination therapy with dutasteride and tamsulosin is more effective than tamsulosin monotherapy for the improvement of symptoms and health outcomes in an at risk population of benign prostatic hyperplasia (BPH) clinical progression including older men (\>=50 years), with moderate-severe symptoms of BPH, enlarged prostates (\>=30 cubicentimeter \[cc\]) and prostate specific antigen (PSA) \>= 1.5 nanograms per milliliter (ng/mL). Each subject who met the eligibility criteria at screening will enter a four-week single-blind, placebo run-in period following which each subject will be randomised into a 2 year double-blind treatment phase. The total study duration for each subject will be up to 110 weeks.

Conditions

• Prostatic Hyperplasia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2014-02-10
• Primary completion: 2017-03-03
• Completion: 2017-03-03
• First posted: 2014-02-10
• Last updated: 2019-04-05
• Results posted: 2019-04-05

Locations

46 sites across 4 countries: China, Japan, South Korea, Taiwan