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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00363311 |
The purpose of this study is to examine the effect of dutasteride on the inhibition of low-risk, localized prostate cancer progression in men who would otherwise receive no active therapy (expectant management).
Condition | Intervention | Phase |
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Prostate Cancer |
Drug: Dutasteride Drug: Matching placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled Trial Assessing the Efficacy and Safety of Dutasteride in Extending the Time to Progression of Low-Risk, Localized Prostate Cancer in Men Who Are Candidates for or Undergoing Expectant Management |
Enrollment: | 302 |
Study Start Date: | July 2006 |
Estimated Study Completion Date: | March 2010 |
Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Placebo: Placebo Comparator
Matching placebo
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Drug: Matching placebo
Matching placebo
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Dutasteride: Active Comparator
Dutasteride 0.5mg
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Drug: Dutasteride
Dutasteride 0.5mg
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Ages Eligible for Study: | 50 Years to 80 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
Drugs with antiandrogenic properties within the past 6 months (e.g,. spironolactone, flutamide, bicalutamide, *cimetidine, *ketoconazole, metronidazole, progestational agents) NOTE: Use of dietary and herbal supplements (e.g., selenium, Vitamin E, saw palmetto) during the study is discouraged but not prohibited. All dietary and herbal supplement usage will be recorded in the CRF.
Severe BPH symptoms as manifested by IPSS symptom score (calculated using the first 7 questions only) of
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | AVO105948 |
Study First Received: | August 11, 2006 |
Last Updated: | August 20, 2009 |
ClinicalTrials.gov Identifier: | NCT00363311 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Dutasteride Prostate Cancer Expectant management REDEEM |
Dutasteride Prostatic Diseases Genital Neoplasms, Male Disease Progression |
Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms |
Dutasteride Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Prostatic Diseases Genital Neoplasms, Male |
Enzyme Inhibitors Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms Pharmacologic Actions |