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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00263042 |
The primary objective is to show whether rimonabant reduces the risk of a heart attack (MI), stroke, or death from an MI or stroke in patients with abdominal obesity with other cardiovascular (CV) risk factors. The secondary objective is to show whether rimonabant reduces the risk of MI, stroke, CV death, or CV hospitalization in these patients.
Condition | Intervention | Phase |
---|---|---|
Cardiovascular Disease |
Drug: rimonabant (SR141716) Drug: placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Randomized, Multinational, Multicenter, Double-Blind, Placebo-Controlled, Two-Arm Parallel Group Trial of Rimonabant 20 mg OD for Reducing the Risk of Major Cardiovascular Events in Abdominally Obese Patients With Clustering Risk Factors |
Estimated Enrollment: | 17000 |
Study Start Date: | December 2005 |
Study Completion Date: | April 2009 |
Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator |
Drug: rimonabant (SR141716)
20 mg once daily
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2: Placebo Comparator |
Drug: placebo
once daily
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Ages Eligible for Study: | 55 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Waist circumference >102 cm (40 inches) males, >88 cm (35 inches) females, with one coronary heart disease (CHD) equivalent or two major risk factors for cardiovascular disease.
CHD equivalents:
Major risk factors:
Exclusion Criteria:
Study Chair: | Eric Topol, MD | Scripps Clinic |
Principal Investigator: | Deepak L. Bhatt, MD | Cleveland Clinic |
Responsible Party: | sanofi-aventis ( ICD study director ) |
Study ID Numbers: | EFC5826 |
Study First Received: | December 6, 2005 |
Last Updated: | May 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00263042 History of Changes |
Health Authority: | United States: Food and Drug Administration; Canada: Health Canada; France: Afssaps - French Health Products Safety Agency |
Myocardial infarction cerebrovascular accident obesity |
Obesity Cerebral Infarction Stroke Infarction Myocardial Infarction |
Cardiovascular Diseases |