Comprehensive Rimonabant Evaluation Study of Cardiovascular ENDpoints and Outcomes

Phase 3

Terminated

• Conditions: Cardiovascular Disease
• Interventions: Drug: Placebo (for Rimonabant); Drug: Rimonabant

• Registration Number: NCT00263042
• Lead Sponsor: Sanofi

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2005-12
• Study First Submitted: 2005-12-06
• Study First Submitted QC: 2005-12-06
• Study First Posted: 2005-12-07
• Primary Completion: 2009-04
• Study Completion: 2009-04
• Status Verified: 2016-04
• Disposition First Submitted: 2016-04-21
• Disposition First Submitted QC: 2016-04-21
• Last Update Submitted: 2016-04-21
• Disposition First Posted: 2016-05-20
• Last Update Posted: 2016-05-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 18695

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo (for Rimonabant)	Placebo (for Rimonabant) once daily.
Rimonabant	Rimonabant	Rimonabant 20 mg once daily

Primary Outcome Measures

Name	Time	Method
First occurrence of any of myocardial infarction, stroke or cardiovascular (CV) death	From randomization up to common study end date (33-50 months)

Secondary Outcome Measures

Name	Time	Method
All-cause mortality	From randomization up to common study end date (33-50 months)
First occurrence of any of myocardial infarction, stroke, CV death, and CV hospitalization	From randomization up to common study end date (33-50 months)

Trial Locations

Locations (2)

Sanofi-Aventis Administrative Office; 🇬🇧 Guildford, United Kingdom

sanofi-aventis Australia & New Zealand administrative office; 🇦🇺 Macquarie Park, New South Wales, Australia