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The purpose of this study is to assess the effect of rimonabant 20 mg on HDL (high density lipoprotein) cholesterol and on TG (triglycerides) plasma levels over a period of one year when prescribed with a hypocaloric diet (600 kcal deficit per day) in abdominally obese patients with atherogenic dyslipidemia (low HDL and/or high TG plasma levels). The secondary objectives are to evaluate specific metabolic parameters, visceral fat (in selected sites), safety and tolerability of rimonabant 20 mg.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rimonabant (SR141716) | Drug | |||
| Placebo | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| HDL cholesterol and TG plasma levels over a period of one year. |
| Measure | Description | Time Frame |
|---|---|---|
| Cholesterol content of HDL2 and HDL3 subfractions,HDL particle size,ApoB,ApoA1,ApoCIII, FFA, indeces of LDL size,hs-CRP,adipokines, fasting glycemia and insulinemia, HbA1c),waist and weight measurements,visceral fat measured by CT scan |
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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 |
|---|---|---|---|---|---|---|
| Sanofi-aventis Administrative Office | Bridgewater | New Jersey | 08807 | United States | ||
| Sanofi-aventis Administrative Office |
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| Macquarie Park |
| Australia |
| Sanofi-aventis Administrative Office | São Paulo | Brazil |
| Sanofi-aventis Administrative Office | Laval | Canada |
| Sanofi-aventis Administrative Office | Hørsholm | Denmark |
| Sanofi-aventis Administrative Office | Causeway Bay | Hong Kong |
| Sanofi-aventis Administrative Office | Milan | Italy |
| Sanofi-aventis Administrative Office | Kuala Lumpur | Malaysia |
| Sanofi-aventis Administrative Office | México | Mexico |
| Sanofi-aventis Administrative Office | Singapore | Singapore |
| Sanofi-aventis Administrative Office | Midrand | South Africa |
| Sanofi-aventis Administrative Office | Seoul | South Korea |
| Sanofi-aventis Administrative Office | Bromma | Sweden |
| Sanofi-aventis Administrative Office | Taipei | Taiwan |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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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