CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 253 enrolled
Drug / intervention
Dutasteride 0.5mg capsule +1 moredrug
Likely dose
Dutasteride 0.5mg capsulefrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00527605
NCT00527605Phase 3Completed
CompareCT.gov

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

GlaxoSmithKline·interventional·Posted Sep 11, 2007·Updated Mar 21, 2012

In Brief

A Phase 3 clinical trial evaluating Dutasteride 0.5mg capsule and Dutasteride matched placebo for Benign Prostatic Hyperplasia and Prostatic Hyperplasia. Completed, enrolled 253 participants across 12 sites.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBenign Prostatic Hyperplasia, Prostatic Hyperplasia
CountriesChina
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 11, 2007
Enrollment StartOct 1, 2007
Primary CompletionMar 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 18.8 years ago

Interventions

Dutasteride 0.5mg capsuledrug

Dutasteride 0.5mg once daily orally

Dutasteride matched placebodrug

Dutasteride matched placebo once daily orally