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NCT00056407 · ClinicalTrials.gov registry record · Phase 3

"REDUCE" - A Clinical Research Study To Reduce The Incidence Of Prostate Cancer In Men Who Are At Increased Risk

A Phase 3 study of Neoplasms Prostate, sponsored by GlaxoSmithKline.

Completed
Registry status
Phase 3
Development phase
8,231
Enrollment target
20
Study locations

NCT00056407 is a Phase 3 study of Neoplasms Prostate that has completed, run by GlaxoSmithKline. The registered enrollment target is 8,231 participants, above the 1,736-participant average among 6 other Neoplasms Prostate trials with a reported enrollment target (374% higher). The trial reports 20 study locations across 5 states.

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The verdict

NCT00056407, a Phase 3 study of Neoplasms Prostate, has completed, sponsored by GlaxoSmithKline.

COMPLETED
Registry status
Phase 3
Development phase
8,231 participants
Enrollment target
20
Study locations

Study 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.

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG Dutasteride

Study Locations (20)

Arizona

  • GSK Investigational Site - Phoenix
  • GSK Investigational Site - Phoenix
  • GSK Investigational Site - Phoenix
  • GSK Investigational Site - Scottsdale
  • GSK Investigational Site - Sun City
  • GSK Investigational Site - Tucson
  • GSK Investigational Site - Tucson

California

  • GSK Investigational Site - Anaheim
  • GSK Investigational Site - Atherton
  • GSK Investigational Site - Culver City
  • GSK Investigational Site - Encino
  • GSK Investigational Site - Fountain Valley
  • GSK Investigational Site - Fresno

Alabama

  • GSK Investigational Site - Birmingham
  • GSK Investigational Site - Homewood
  • GSK Investigational Site - Huntsville
  • GSK Investigational Site - Mobile

Arkansas

  • GSK Investigational Site - Little Rock
  • GSK Investigational Site - Little Rock

Alaska

  • GSK Investigational Site - Anchorage

Trial Details

FieldValue
Enrollment Target 8,231 participants
Start Date 2003-03
Est. Completion 2009-04
Phase Phase 3

Sponsor

GlaxoSmithKline

1,345 total trials

What the Registry Record Tells You About NCT00056407

The ClinicalTrials.gov registry entry for NCT00056407 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 8,231 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 1,736-participant average among 6 other Neoplasms Prostate trials with a reported enrollment target (374% higher). The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Neoplasms Prostate appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT00056407 reports 20 study locations spanning 5 distinct geographic areas - top geographies include Arizona, California, Alabama.

Frequently Asked Questions

What is clinical trial NCT00056407 about?

NCT00056407 is a clinical study titled ""REDUCE" - A Clinical Research Study To Reduce The Incidence Of Prostate Cancer In Men Who Are At Increased Risk". 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 o...

What is the current status of trial NCT00056407?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 8,231 participants. The study started on 2003-03. Estimated completion is 2009-04.

What conditions does trial NCT00056407 study?

This clinical trial studies the following conditions: Neoplasms Prostate.

What interventions are being tested in trial NCT00056407?

The interventions under investigation include: Placebo (DRUG), Dutasteride (DRUG).

Who is sponsoring clinical trial NCT00056407?

This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00056407 being conducted?

This trial has 20 study locations across Alabama, Alaska, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.