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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)
Information provided by (Responsible Party):
Sanofi Identifier:
First received: December 6, 2005
Last updated: April 21, 2016
Last verified: April 2016

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 Drug: Placebo (for Rimonabant) Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 any of myocardial infarction, stroke or cardiovascular (CV) death [ Time Frame: From randomization up to common study end date (33-50 months) ]

Secondary Outcome Measures:
  • 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) ]

Enrollment: 18695
Study Start Date: December 2005
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rimonabant
Rimonabant 20 mg once daily
Drug: Rimonabant
Tablet, oral administration
Other Names:
  • SR141716
  • Acomplia
Placebo Comparator: Placebo
Placebo (for Rimonabant) once daily.
Drug: Placebo (for Rimonabant)
Tablet, oral administration

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.

Ages Eligible for Study:   55 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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:

    • 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 identifier: NCT00263042

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Sanofi Identifier: NCT00263042     History of Changes
Other Study ID Numbers: EFC5826
2005-002942-20 ( EudraCT Number )
Study First Received: December 6, 2005
Last Updated: April 21, 2016

Keywords provided by Sanofi:
Myocardial infarction
cerebrovascular accident

Additional relevant MeSH terms:
Cardiovascular Diseases
Cannabinoid Receptor Antagonists
Cannabinoid Receptor Modulators
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs processed this record on August 18, 2017