Viewing Study NCT00056407



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Last Modification Date: 2024-10-26 @ 9:08 AM
Study NCT ID: NCT00056407
Status: COMPLETED
Last Update Posted: 2016-09-23
First Post: 2003-03-11

Brief Title: REDUCE - A Clinical Research Study To Reduce The Incidence Of Prostate Cancer In Men Who Are At Increased Risk
Sponsor: GlaxoSmithKline
Organization: GlaxoSmithKline

Study Overview

Official Title: A Randomized Double-Blind Placebo-Controlled Parallel Group Study of the Efficacy and Safety of Dutasteride 05 mg Administered Orally Once Daily for Four Years to Reduce the Risk of Biopsy-Detectable Prostate Cancer
Status: COMPLETED
Status Verified Date: 2016-08
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: REDUCE
Brief Summary: This 4-year study will compare how safe and effective an oral investigational medicine is compared to placebo in preventing the development of prostate cancer in men that are defined by the study entrance criteria as being at an increased risk for prostate cancer Study visits to the clinic will occur every 6 months for up to 4 years 10 clinic visits and a prostate biopsy will be performed at 2 and 4 years of treatment
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None