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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00345410 |
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.
Condition | Intervention | Phase |
---|---|---|
Obesity Dyslipidemia |
Drug: AVE1625 B |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of Three Doses of AVE1625 in Abdominally Obese Patients With Atherogenic Dyslipidemia |
Enrollment: | 345 |
Study Start Date: | June 2006 |
Study Completion Date: | June 2007 |
Primary Completion Date: | June 2007 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Dyslipidemia consisting of :
Exclusion Criteria:
United States, New Jersey | |
Sanofi-aventis Administrative Office | |
Bridgewater, New Jersey, United States, 08807 |
Principal Investigator: | Julio ROSENSTOCK, MD | Dallas Diabetes and Endocrine Center 7777 Forest Lane, C-618 Dallas TX 75230 USA |
Responsible Party: | sanofi-aventis ( ICD Study Director ) |
Study ID Numbers: | DRI6412 |
Study First Received: | June 27, 2006 |
Last Updated: | December 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00345410 History of Changes |
Health Authority: | United States: Food and Drug Administration |
obesity and dyslipidemia |
Body Weight Signs and Symptoms Obesity Metabolic Diseases Nutrition Disorders |
Overweight Overnutrition Metabolic Disorder Dyslipidemias Lipid Metabolism Disorders |
Body Weight Signs and Symptoms Obesity Metabolic Diseases Nutrition Disorders |
Overweight Overnutrition Dyslipidemias Lipid Metabolism Disorders |