Comprehensive Rimonabant Evaluation Study of Cardiovascular ENDpoints and Outcomes

Cardiovascular Disease Clinical Trial

— CRESCENDO  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00263042
• Other study ID #: EFC5826
• Status: Terminated
• Phase: Phase 3
• First received: December 6, 2005
• Last updated: August 27, 2009
• Start date: December 2005
• Est. completion date: April 2009

Study information

• Verified date: August 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health CanadaFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 18695
• Est. completion date: April 2009
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Intervention

Drug:
• rimonabant (SR141716)
20 mg once daily
• placebo
once daily

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Canada,  Chile,  China,  Colombia,  Czech Republic,  Denmark,  Finland,  France,  Germany,  Greece,  Hong Kong,  Hungary,  India,  Ireland,  Israel,  Italy,  Korea, Republic of,  Malaysia,  Mexico,  Netherlands,  Norway,  Peru,  Philippines,  Poland,  Portugal,  Romania,  Russian Federation,  Singapore,  South Africa,  Spain,  Sweden,  Switzerland,  Taiwan,  Thailand,  Tunisia,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	First occurrence of myocardial infarction, stroke, and cardiovascular (CV) death		study period	No
Secondary	First occurrence of myocardial infarction, stroke, CV death, and CV hospitalization		study period	No
Secondary	All-cause mortality		study period	No