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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rimonabant (SR141716) | Drug | |||
| Placebo | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| change from baseline in percent atheroma volume (PAV) | Month 18 visit |
| Measure | Description | Time Frame |
|---|---|---|
| change from baseline in normalized total atheroma volume (TAV) | Month 18 visit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ICD CSD | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States | ||
| sanofi-aventis, Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18387931 | Result | Nissen SE, Nicholls SJ, Wolski K, Rodes-Cabau J, Cannon CP, Deanfield JE, Despres JP, Kastelein JJ, Steinhubl SR, Kapadia S, Yasin M, Ruzyllo W, Gaudin C, Job B, Hu B, Bhatt DL, Lincoff AM, Tuzcu EM; STRADIVARIUS Investigators. Effect of rimonabant on progression of atherosclerosis in patients with abdominal obesity and coronary artery disease: the STRADIVARIUS randomized controlled trial. JAMA. 2008 Apr 2;299(13):1547-60. doi: 10.1001/jama.299.13.1547. Epub 2008 Apr 1. |
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| Macquarie Park |
| Australia |
| sanofi-aventis, Belgium | Diegem | Belgium |
| Sanofi-Aventis Administrative Office | Laval | Canada |
| sanofi-aventis, France | Paris | France |
| sanofi-aventis Italy | Milan | Italy |
| sanofi-aventis, Netherlands | Gouda | Netherlands |
| sanofi-aventis Poland | Warsaw | Poland |
| sanofi-aventis Spain | Barcelona | Spain |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000077285 | Rimonabant |
| ID | Term |
|---|---|
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010880 | Piperidines |
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