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| Sponsor: | Sanofi-Aventis |
|---|---|
| Information provided by: | Sanofi-Aventis |
| ClinicalTrials.gov Identifier: | NCT00124332 |
Purpose
The purpose of this study is to determine if rimonabant 20 mg once daily (od) administered during 18-20 months will reduce progression of coronary atherosclerosis as assessed by intravascular ultrasound (IVUS) when administered on top of standard behavioral and pharmacological therapy given as needed, in patients with abdominal obesity associated with current smoking and/or metabolic syndrome.
| Condition | Intervention | Phase |
|---|---|---|
|
Coronary Atherosclerosis |
Drug: Rimonabant (SR141716) Drug: Placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Randomized, Multicenter, Double-Blind, Placebo-Controlled, Two-Arm Parallel Group Trial of Rimonabant 20-mg od, for Inhibition of Atherosclerosis Progression Assessed by IVUS (IntraVascular UltraSounds), in Overweight Patients With Clustering Risk Factors |
| Enrollment: | 839 |
| Study Start Date: | January 2005 |
| Study Completion Date: | October 2007 |
| Primary Completion Date: | October 2007 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Ohio | |
| The Cleveland Clinic Foundation | |
| Cleveland, Ohio, United States, 44195 | |
| Australia | |
| sanofi-aventis, Australia | |
| Macquarie Park, Australia | |
| Belgium | |
| sanofi-aventis, Belgium | |
| Diegem, Belgium | |
| Canada | |
| Sanofi-Aventis Administrative Office | |
| Laval, Canada | |
| France | |
| sanofi-aventis, France | |
| Paris, France | |
| Italy | |
| sanofi-aventis Italy | |
| Milano, Italy | |
| Netherlands | |
| sanofi-aventis, Netherlands | |
| Gouda, Netherlands | |
| Poland | |
| sanofi-aventis Poland | |
| Warszawa, Poland | |
| Spain | |
| sanofi-aventis Spain | |
| Barcelona, Spain | |
| Study Director: | ICD CSD | Sanofi-Aventis |
More Information
| Responsible Party: | ICD Study Director, sanofi-aventis |
| ClinicalTrials.gov Identifier: | NCT00124332 History of Changes |
| Other Study ID Numbers: | EFC5827 |
| Study First Received: | July 26, 2005 |
| Last Updated: | April 17, 2009 |
| Health Authority: | United States: Food and Drug Administration |
|
Atherosclerosis Coronary Artery Disease Myocardial Ischemia Arteriosclerosis Arterial Occlusive Diseases |
Vascular Diseases Cardiovascular Diseases Coronary Disease Heart Diseases |