At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 378 enrolled
Drug / intervention
Dutasteride +1 moredrug
Likely dose
Not stated in 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.
Clinical Evaluation of Dutasteride in Benign Prostatic Hyperplasia: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Comparative Study of GI198745 (Dutasteride) in Subjects With Benign Prostatic Hyperplasia.
In Brief
A Phase 3 clinical trial evaluating Dutasteride and Placebo for Prostatic Hyperplasia. Completed, enrolled 378 participants across 26 sites.
Detailed Summary
This study will assess the efficacy and safety of GI198745 0.5mg given once daily for 52 weeks to Benign Prostatic Hyperplasia (BPH) patients.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstatic Hyperplasia
CountriesJapan
Collaborators--
Timeline
Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartFeb 2006
First PostedAug 2006
Primary CompletionDec 2007
Study CompletionDec 2007
TodayJul 2026
First PostedAug 29, 2006
Enrollment StartFeb 17, 2006
Primary CompletionDec 1, 2007
Study CompletionDec 6, 2007
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 19.8 years ago
Interventions
Dutasteridedrug
once daily
Placebodrug
once daily