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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00056407 |
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.
Condition | Intervention | Phase |
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Prostate Cancer |
Drug: Dutasteride |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy and Safety of Dutasteride 0.5 mg Administered Daily for Four Years to Reduce the Risk of Biopsy-Dectectable Prostate Cancer |
Estimated Enrollment: | 8000 |
Study Start Date: | March 2003 |
Ages Eligible for Study: | 50 Years to 75 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | ARI40006 |
Study First Received: | March 11, 2003 |
Last Updated: | January 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00056407 |
Health Authority: | United States: Food and Drug Administration; Sweden: Medical Products Agency; Canada: Health Canada |
Prostate cancer prevention BPH enlarged prostate |
PSA prostate cancer prostate |
Dutasteride Prostatic Diseases Genital Neoplasms, Male |
Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms |
Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Pharmacologic Actions |