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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00263042
Recruitment Status : Terminated (Company decision taken in light of demands by certain national health authorities)
First Posted : December 7, 2005
Last Update Posted : May 20, 2016
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Cardiovascular Disease Drug: Rimonabant Drug: Placebo (for Rimonabant) Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18695 participants
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
Study Start Date : December 2005
Actual Primary Completion Date : April 2009
Actual Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 :
  1. 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) ]
  2. All-cause mortality [ Time Frame: From randomization up to common study end date (33-50 months) ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00263042

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

Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Sanofi Identifier: NCT00263042     History of Changes
Other Study ID Numbers: EFC5826
2005-002942-20 ( EudraCT Number )
First Posted: December 7, 2005    Key Record Dates
Last Update Posted: May 20, 2016
Last Verified: April 2016
Keywords provided by Sanofi:
Myocardial infarction
cerebrovascular accident
Additional relevant MeSH terms:
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Cardiovascular Diseases
Anti-Obesity Agents
Cannabinoid Receptor Antagonists
Cannabinoid Receptor Modulators
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs