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

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ClinicalTrials.gov 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

View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Sanofi

Study Description

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.

Study Design

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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

U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

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) ]

Eligibility Criteria

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

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 ClinicalTrials.gov identifier (NCT number): NCT00263042

Locations

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United States, New Jersey
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
Argentina
Sanofi-Aventis Administrative Office
Buenos Aires, Argentina
Australia, New South Wales
sanofi-aventis Australia & New Zealand administrative office
Macquarie Park, New South Wales, Australia
Austria
Sanofi-Aventis Administrative Office
Vienna, Austria
Belgium
Sanofi-Aventis Administrative Office
Diegem, Belgium
Brazil
Sanofi-Aventis Administrative Office
Sao Paulo, Brazil
Canada, Quebec
Sanofi-Aventis Administrative Office
Laval, Quebec, Canada
Chile
Sanofi-Aventis Administrative Office
Santiago de Chile, Chile
China
Sanofi-Aventis Administrative Office
Shangaï, China
Colombia
Sanofi-Aventis Administrative Office
Santafe de Bogota, Colombia
Czech Republic
Sanofi-Aventis Administrative Office
Praha, Czech Republic
Denmark
Sanofi-Aventis Administrative Office
Horsholm, Denmark
Finland
Sanofi-Aventis Administrative Office
Helsinki, Finland
France
Sanofi-Aventis Administrative Office
Paris, France
Germany
Sanofi-Aventis Administrative Office
Berlin, Germany
Greece
Sanofi-Aventis Administrative Office
Athens, Greece
Hong Kong
Sanofi-Aventis Administrative Office
Hong-Kong, Hong Kong
Hungary
Sanofi-Aventis Administrative Office
Budapest, Hungary
India
Sanofi-Aventis Administrative Office
Mumbai, India
Ireland
Sanofi-Aventis Administrative Office
Dublin, Ireland
Israel
Sanofi-Aventis Administrative Office
Natanya, Israel
Italy
Sanofi-Aventis Administrative Office
Milano, Italy
Korea, Republic of
Sanofi-Aventis Administrative Office
Seoul, Korea, Republic of
Malaysia
Sanofi-Aventis Administrative Office
Kuala Lumpur, Malaysia
Mexico
Sanofi-Aventis Administrative Office
Mexico, Mexico
Netherlands
Sanofi-Aventis Administrative Office
Gouda, Netherlands
Norway
Sanofi-Aventis Administrative Office
Lysaker, Norway
Peru
Sanofi-Aventis Administrative Office
Lima, Peru
Philippines
Sanofi-Aventis Administrative Office
Makati City, Philippines
Poland
Sanofi-Aventis Administrative Office
Warszawa, Poland
Portugal
Sanofi-Aventis Administrative Office
Porto Salvo, Portugal
Romania
Sanofi-Aventis Administrative Office
Bucuresti, Romania
Russian Federation
Sanofi-Aventis Administrative Office
Moscow, Russian Federation
Singapore
Sanofi-Aventis Administrative Office
Singapore, Singapore
South Africa
Sanofi-Aventis Administrative Office
Midrand, South Africa
Spain
Sanofi-Aventis Administrative Office
Madrid, Spain
Sweden
Sanofi-Aventis Administrative Office
Bromma, Sweden
Switzerland
Sanofi-Aventis Administrative Office
Geneva, Switzerland
Taiwan
Sanofi-Aventis Administrative Office
Taipei, Taiwan
Thailand
Sanofi-Aventis Administrative Office
Bangkok, Thailand
Tunisia
Sanofi-Aventis Administrative Office
Megrine, Tunisia
Turkey
Sanofi-Aventis Administrative Office
Istanbul, Turkey
United Kingdom
Sanofi-Aventis Administrative Office
Guildford, United Kingdom

Sponsors and Collaborators

Sanofi

Investigators

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Study Chair:	Eric Topol, MD	Scripps Clinic
Principal Investigator:	Deepak L. Bhatt, MD	The Cleveland Clinic

More Information

Publications of Results:

Topol EJ, Bousser MG, Fox KA, Creager MA, Despres JP, Easton JD, Hamm CW, Montalescot G, Steg PG, Pearson TA, Cohen E, Gaudin C, Job B, Murphy JH, Bhatt DL; CRESCENDO Investigators. Rimonabant for prevention of cardiovascular events (CRESCENDO): a randomised, multicentre, placebo-controlled trial. Lancet. 2010 Aug 14;376(9740):517-23. doi: 10.1016/S0140-6736(10)60935-X.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Bhatia G, Bansal V, Harismendy O, Schork NJ, Topol EJ, Frazer K, Bafna V. A covering method for detecting genetic associations between rare variants and common phenotypes. PLoS Comput Biol. 2010 Oct 14;6(10):e1000954. doi: 10.1371/journal.pcbi.1000954.

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Responsible Party:	Sanofi
ClinicalTrials.gov Identifier:	NCT00263042
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 obesity

Additional relevant MeSH terms:

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Cardiovascular Diseases Rimonabant Anti-Obesity Agents Cannabinoid Receptor Antagonists Cannabinoid Receptor Modulators	Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs

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