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The primary objective was to assess the effect of SR141716 on weight loss and weight maintenance over a period of one year when prescribed with a hypocaloric diet in obese patients with or without comorbidities.
The main secondary objectives were to assess the effect of SR141716 on lipid parameters (HDL-C, TG), glucose tolerance status, the rate of patients with metabolic syndrome, waist circumference, glycemic parameters.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rimonabant (SR141716) | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| change in body weight from baseline to 1 year. |
| Measure | Description | Time Frame |
|---|---|---|
| HDL-C and TG from baseline to 1 year; ·patients (%) with improvement of glucose tolerance, patients (%) with NCEP-ATPIII metabolic syndrome at 1 year. |
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Inclusion Criteria:
Exclusion Criteria:
The investigator will evaluate whether there are other reasons why a patient may not participate.
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| Name | Affiliation | Role |
|---|---|---|
| ICD CSD | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanofi-Aventis | Bridgewater | New Jersey | 08807 | United States | ||
| Sanofi-Aventis |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15836887 | Result | Van Gaal LF, Rissanen AM, Scheen AJ, Ziegler O, Rossner S; RIO-Europe Study Group. Effects of the cannabinoid-1 receptor blocker rimonabant on weight reduction and cardiovascular risk factors in overweight patients: 1-year experience from the RIO-Europe study. Lancet. 2005 Apr 16-22;365(9468):1389-97. doi: 10.1016/S0140-6736(05)66374-X. | |
| 18417461 |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000077285 | Rimonabant |
| ID | Term |
|---|---|
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Brussels |
| Belgium |
| Sanofi-Aventis | Helsinki | Finland |
| Sanofi-Aventis | Paris | France |
| Sanofi-Aventis | Berlin | Germany |
| Sanofi-Aventis | Gouda | Netherlands |
| Sanofi-Aventis | Bromma | Sweden |
| Van Gaal LF, Scheen AJ, Rissanen AM, Rossner S, Hanotin C, Ziegler O; RIO-Europe Study Group. Long-term effect of CB1 blockade with rimonabant on cardiometabolic risk factors: two year results from the RIO-Europe Study. Eur Heart J. 2008 Jul;29(14):1761-71. doi: 10.1093/eurheartj/ehn076. Epub 2008 Apr 15. |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010880 |
| Piperidines |