Comprehensive Rimonabant Evaluation Study of Cardiovascular ENDpoints and Outcomes - Full Text View

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 )

First Received on December 6, 2005. Last Updated on August 27, 2009 History of Changes

Sponsor:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00263042

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:

MedlinePlus related topics: Heart Attack Obesity

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

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

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

Show 43 Study Locations

Sponsors and Collaborators

Sanofi-Aventis

Investigators

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

More Information

No publications provided by Sanofi-Aventis

Additional 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.

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.

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 - French Health Products Safety Agency

Keywords provided by Sanofi-Aventis:

Myocardial infarction
cerebrovascular accident
obesity

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 23, 2012