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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00174863 |
To evaluate the efficacy of SR31747 given at 75 or 125mg per day versus placebo in androgen prostate cancer patient without distant metastases with Time to Clinical progression as main objective and PSA parameters, Tumor response, survival , safety,Tumor-related symptoms deterioration Quality of Life, PK analysis as secondary objectives
Condition | Intervention | Phase |
---|---|---|
Prostatic Neoplasm |
Drug: SR31747A |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Evaluation of Two Doses of SR31747A (75 mg and 125 mg) in Non-Metastatic Androgen-Independent Prostate Cancer. Randomized, Double-Blind, Placebo Controlled Phase II Study |
Enrollment: | 232 |
Study Start Date: | October 2003 |
Study Completion Date: | August 2006 |
Primary Completion Date: | August 2006 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Australia, New South Wales | |
sanofi-aventis Australia & New Zealand administrative office | |
Macquarie Park, New South Wales, Australia | |
Belgium | |
Sanofi-Aventis Administrative Office | |
Diegem, Belgium | |
Canada | |
Sanofi-Aventis Administrative Office | |
Laval, Canada | |
Chile | |
Sanofi-Aventis Administrative Office | |
Santiago, Chile | |
Czech Republic | |
Sanofi-Aventis Administrative Office | |
Praha, Czech Republic | |
France | |
Sanofi-Aventis Administrative Office | |
Paris, France | |
Italy | |
Sanofi-Aventis Administrative Office | |
Milano, Italy | |
Mexico | |
Sanofi-Aventis Administrative Office | |
Mexico, Mexico | |
Netherlands | |
Sanofi-Aventis Administrative Office | |
Gouda, Netherlands | |
Poland | |
Sanofi-Aventis Administrative Office | |
Warszawa, Poland | |
Portugal | |
Sanofi-Aventis Administrative Office | |
Porto Salvo, Portugal | |
Spain | |
Sanofi-Aventis Administrative Office | |
Barcelona, Spain | |
United Kingdom | |
Sanofi-Aventis Administrative Office | |
Guilford Surrey, United Kingdom |
Study Chair: | B. TOMBAL, MD | UCL St Luc, Bruxelles BELGIUM |
Responsible Party: | sanofi-aventis ( ICD Study Director ) |
Study ID Numbers: | EFC5378 |
Study First Received: | September 13, 2005 |
Last Updated: | December 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00174863 |
Health Authority: | Canada: Health Canada; Poland: Ministry of Health; Belgium: Directorate general for the protection of Public health: Medicines |
Prostatic Diseases Genital Neoplasms, Male Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms |
Neoplasms Neoplasms by Site |