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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00239967 |
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.
Condition | Intervention | Phase |
---|---|---|
Dyslipidemia Obesity |
Drug: Rimonabant (SR141716) Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | A Randomized, Double-Blind, Two-Arm Placebo-Controlled, Parallel-Group, Multicenter Study of Rimonabant 20 mg Once Daily in the Treatment of Atherogenic Dyslipidemia in Abdominally Obese Patients |
Enrollment: | 803 |
Study Start Date: | May 2005 |
Study Completion Date: | February 2007 |
Primary Completion Date: | February 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:
Exclusion Criteria:
United States, New Jersey | |
Sanofi-aventis Administrative Office | |
Bridgewater, New Jersey, United States, 08807 | |
Australia | |
Sanofi-aventis Administrative Office | |
Macquarie Park, Australia | |
Brazil | |
Sanofi-aventis Administrative Office | |
Sao Paulo, Brazil | |
Canada | |
Sanofi-aventis Administrative Office | |
Laval, Canada | |
Denmark | |
Sanofi-aventis Administrative Office | |
Horsholm, Denmark | |
Hong Kong | |
Sanofi-aventis Administrative Office | |
Causeway Bay, Hong Kong | |
Italy | |
Sanofi-aventis Administrative Office | |
Milano, Italy | |
Korea, Republic of | |
Sanofi-aventis Administrative Office | |
Seoul, Korea, Republic of | |
Malaysia | |
Sanofi-aventis Administrative Office | |
Kuala Lumpur, Malaysia | |
Mexico | |
Sanofi-aventis Administrative Office | |
Mexico, Mexico | |
Singapore | |
Sanofi-aventis Administrative Office | |
Singapore, Singapore | |
South Africa | |
Sanofi-aventis Administrative Office | |
Midrand, South Africa | |
Sweden | |
Sanofi-aventis Administrative Office | |
Bromma, Sweden | |
Taiwan | |
Sanofi-aventis Administrative Office | |
Taipei, Taiwan |
Study Director: | ICD CSD | Sanofi-Aventis |
Responsible Party: | sanofi-aventis ( ICD Study Director ) |
Study ID Numbers: | EFC5823 |
Study First Received: | October 13, 2005 |
Last Updated: | April 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00239967 History of Changes |
Health Authority: | United States: Food and Drug Administration; Australia: Department of Health and Ageing Therapeutic Goods Administration; Canada: Health Canada; Sweden: Medical Products Agency |
dyslipidemia obesity |
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 |