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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00232297 |
Primary objective:
Secondary objectives:
Condition | Intervention | Phase |
---|---|---|
Arrhythmia Tachycardia, Ventricular Ventricular Fibrillation |
Drug: SSR149744C |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Double Blind Placebo Controlled Dose Ranging Study of the Efficacy and Safety of SSR149744C 100 OR 300 mg for the Prevention of Ventricular Arrhythmia-Triggered ICD Interventions |
Enrollment: | 153 |
Study Start Date: | June 2005 |
Study Completion Date: | February 2007 |
Primary Completion Date: | February 2007 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 21 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
MAIN CRITERIA (non-exhaustive list):
United States, New Jersey | |
Sanofi-Aventis Administrative Office | |
Bridgewater, New Jersey, United States, 08807 | |
Belgium | |
Sanofi-Aventis Administrative Office | |
Diegem, Belgium | |
Canada | |
Sanofi-Aventis Administrative Office | |
Laval, Canada | |
Czech Republic | |
Sanofi-Aventis Administrative Office | |
Praha, Czech Republic | |
Germany | |
Sanofi-Aventis Administrative Office | |
Berlin, Germany | |
Italy | |
Sanofi-Aventis Administrative Office | |
Milano, Italy | |
Netherlands | |
Sanofi-Aventis Administrative Office | |
Gouda, Netherlands | |
Switzerland | |
Sanofi-Aventis Administrative Office | |
Geneva, Switzerland |
Study Director: | ICD CSD | Sanofi-Aventis |
Responsible Party: | sanofi-aventis ( ICD Study Director ) |
Study ID Numbers: | DRI5349 |
Study First Received: | October 3, 2005 |
Last Updated: | December 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00232297 |
Health Authority: | United States: Food and Drug Administration; Germany: Federal Institute for Drugs and Medical Devices; Italy: The Italian Medicines Agency |
Tachycardia, Ventricular Ventricular Fibrillation Defibrillators Implantable Arrhythmia Anti-arrhythmia agents |
Heart Diseases Tachycardia Paroxysmal ventricular fibrillation |
Tachycardia, Ventricular Ventricular Fibrillation Arrhythmias, Cardiac |
Pathologic Processes Cardiovascular Diseases |