Comprehensive Rimonabant Evaluation Study of Cardiovascular ENDpoints and Outcomes (CRESCENDO)

This study has been terminated.
(Company decision taken in light of demands by certain national health authorities)
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00263042
First received: December 6, 2005
Last updated: August 27, 2009
Last verified: August 2009
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Sanofi:

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 ]

Enrollment: 18695
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
Active Comparator: 1 Drug: rimonabant (SR141716)
20 mg once daily
Placebo Comparator: 2 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 43 Study Locations
Sponsors and Collaborators
Sanofi
Investigators
Study Chair: Eric Topol, MD Scripps Clinic
Principal Investigator: Deepak L. Bhatt, MD The Cleveland Clinic
  More Information

No publications provided by Sanofi

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: ICD study director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00263042     History of Changes
Other Study ID Numbers: EFC5826
Study First Received: December 6, 2005
Last Updated: August 27, 2009
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Sanofi:
Myocardial infarction
cerebrovascular accident
obesity

Additional relevant MeSH terms:
Cardiovascular Diseases
Rimonabant
Cannabinoid Receptor Antagonists
Cannabinoid Receptor Modulators
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 28, 2014