Comprehensive Rimonabant Evaluation Study of Cardiovascular ENDpoints and Outcomes - Full Text View

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00263042

Purpose

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

MedlinePlus related topics: Heart Attack Obesity

Drug Information available for: Rimonabant SR 141716A

U.S. FDA Resources

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

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

First occurrence of myocardial infarction, stroke, and cardiovascular (CV) death [ Time Frame: study period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

First occurrence of myocardial infarction, stroke, CV death, and CV hospitalization [ Time Frame: study period ] [ Designated as safety issue: No ]
All-cause mortality [ Time Frame: study period ] [ Designated as safety issue: No ]

Estimated Enrollment:	17000
Study Start Date:	December 2005
Estimated Study Completion Date:	February 2009
Estimated 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
2: Placebo Comparator	Drug: placebo once daily

Eligibility

Ages Eligible for Study:	55 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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:
- Recent (within 3 years)documented heart attack
- Documented symptomatic coronary artery disease
- Recent (within 3 years) ischemic cerebrovascular episode (stroke or TIA)
- Documented symptomatic peripheral arterial disease
Major risk factors:
- Documented type 2 diabetes mellitus
- Metabolic syndrome (NCEP criteria)
- Asymptomatic cerebrovascular, renal, or peripheral arterial disease, or past abdominal aortic aneurysm repair
- Elevated high-sensitivity C-reactive protein
- Age > or = 65 years for males, age > or = 70 years for females

Exclusion Criteria:

Obesity of known endocrine origin
Pregnant or breastfeeding women
Very low calorie diet or weight loss surgery within past 6 months
Presence of any severe medical or psychological condition that, in the opinion of the investigator, would compromise the patient's safe participation, including uncontrolled serious psychiatric illness
Likely cardiovascular intervention within next 1 month
Allergy to rimonabant or excipients, or prior participation in a rimonabant trial
Receipt of investigational product within past 30 days

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00263042

Show 43 Study Locations

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Chair:	Eric Topol, MD	Scripps Clinic
Principal Investigator:	Deepak L. Bhatt, MD	Cleveland Clinic

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	sanofi-aventis ( ICD study director )
Study ID Numbers:	EFC5826
Study First Received:	December 6, 2005
Last Updated:	November 7, 2008
ClinicalTrials.gov Identifier:	NCT00263042
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada; France: Afssaps - French Health Products Safety Agency

Keywords provided by Sanofi-Aventis:

Myocardial infarction
cerebrovascular accident
obesity

Study placed in the following topic categories:

Obesity
Cerebral Infarction
Stroke
Infarction
Myocardial Infarction

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009