NCT00527605

Dutasteride 0.5mg For The Treatment Of Chinese Patients With Benign Prostatic Hyperplasia (BPH)

A Randomized, Double-blind, Placebo-controlled, Six-month Parallel-group Study to Assess Efficacy and Safety of Dutasteride 0.5mg Once Daily in Chinese Patients With Benign Prostatic Hyperplasia (BPH), Followed by a 12-month Open-label Treatment Phase

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 253 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: Male
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

This randomized, double-blind, placebo-controlled, six-month parallel-group study assess efficacy and safety of dutasteride 0.5mg once daily in Chinese patients with Benign Prostatic Hyperplasia (BPH) , followed by a 12-month open-label treatment phase

Conditions

• Benign Prostatic Hyperplasia
• Prostatic Hyperplasia

Interventions

Type	Name	Description
DRUG	Dutasteride 0.5mg capsule	Dutasteride 0.5mg once daily orally
DRUG	Dutasteride matched placebo	Dutasteride matched placebo once daily orally

Timeline

• Start date: 2007-10-01
• Primary completion: 2009-03-01
• Completion: 2009-03-01
• First posted: 2007-09-11
• Last updated: 2012-03-21
• Results posted: 2010-03-11

Locations

12 sites across 1 country: China