Comprehensive Rimonabant Evaluation Study of Cardiovascular ENDpoints and Outcomes

Phase 3TerminatedNCT00263042

Sanofi18,695 enrolled

Overview

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.

The estimated study duration per patient is 36 to 53 months. All patients will be followed from randomization until a common study end date, which will occur when the last patient has been followed for 33 months.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

18,695

Conditions

Cardiovascular Disease

Interventions

RimonabantDRUG

Tablet, oral administration

Placebo (for Rimonabant)DRUG

Tablet, oral administration

Eligibility

Sex: ALLMin age: 55 Years

Medical Language ↔ Plain English

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

Locations (43)

Outcomes

Primary Outcomes

First occurrence of any of myocardial infarction, stroke or cardiovascular (CV) death

Time frame: From randomization up to common study end date (33-50 months)

Secondary Outcomes

First occurrence of any of myocardial infarction, stroke, CV death, and CV hospitalization

Time frame: From randomization up to common study end date (33-50 months)

All-cause mortality

Time frame: From randomization up to common study end date (33-50 months)

Data from ClinicalTrials.gov

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