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Primary objective: to assess the effect of AVE1625 on weight loss over a period of 24 weeks in abdominally obese patients with atherogenic dyslipidemia. Secondary objectives: - To assess the dose effect relationship of AVE1625 on HDL-cholesterol and triglycerides plasma levels over a period of 24 weeks - To assess the efficacy of AVE1625 on secondary parameters such as waist circumference and other metabolic parameters over a period of 24 weeks - To assess the safety and tolerabillity of AVE1625 over a period of 24 weeks.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AVE1625 B | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute change from baseline in body weight at 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| - relative change from baseline to 24 weeks in plasma HDL-cholesterol and triglycerides levels ; - change from baseline to 24 weeks in waist circumference ; Other criteria: glycemic control parameters. | ||
| Safety: physical examination, vital signs, adverse events, ECG, laboratory tests. |
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Inclusion Criteria:
Abdominal obese patients with ·
Waist circumference > 102 cm in men and >88 cm in women
Dyslipidemia consisting of :
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Julio ROSENSTOCK, MD | Dallas Diabetes and Endocrine Center 7777 Forest Lane, C-618 Dallas TX 75230 USA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanofi-Aventis Administrative Office | Bridgewater | New Jersey | 08807 | United States |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| Pharmacokinetics: plasma AVE1625 concentrations |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |