NCT00090103

Benign Prostatic Hyperplasia Trial With Dutasteride And Tamsulosin Combination Treatment

A Randomized, Double-blind, Parallel Group Study to Investigate the Efficacy and Safety of Treatment With Dutasteride (0.5mg) and Tamsulosin (0.4mg), Administered Once Daily for 4 Years, Alone and Combination, on the Improvement of Symptoms and Clinical Outcome in Men With Moderate to Severe Symptomatic Benign Prostatic Hyperplasia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 4,844 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: Male
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

This study will investigate the efficacy and safety of treatment with dutasteride and tamsulosin, administered once daily for 4 years, alone and in combination, on the improvement of symptoms and clinical outcome in men with moderate to severe symptomatic Benign Prostatic Hyperplasia (BPH). Study visits are every 3 months for up to 4 years (18 clinic visits). Transrectal ultrasound (TRUS) is done annually.

Detailed description

A randomised, double-blind, parallel group study to investigate the efficacy and safety of treatment with Dutasteride (0.5 mg) and Tamsulosin (0.4 mg), administered once daily for 4 years, alone and in combination, on the improvement of symptoms and clinical outcome in men with moderate to severe symptomatic benign prostatic hyperplasia.

Conditions

• Prostatic Hyperplasia

Interventions

Type	Name	Description
DRUG	dutasteride 0.5mg once daily for 4 years	combination or single agent
DRUG	tamsulosin 0.4mg once daily for 4 years	combination agent or single agent

Timeline

• Start date: 2003-11-01
• Primary completion: 2009-04-01
• Completion: 2009-04-01
• First posted: 2004-08-26
• Last updated: 2017-02-28
• Results posted: 2010-03-16

Locations

503 sites across 36 countries: United States, Argentina, Belgium, Brazil, Bulgaria, Canada, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Israel, Italy, Lithuania, Mexico, Netherlands, Norway, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Slovakia, South Africa, South Korea, Spain, Taiwan, Thailand, Tunisia, Turkey (Türkiye), United Kingdom