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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00263042




Registration number
NCT00263042
Ethics application status
Date submitted
6/12/2005
Date registered
7/12/2005
Date last updated
20/05/2016

Titles & IDs
Public title
Comprehensive Rimonabant Evaluation Study of Cardiovascular ENDpoints and Outcomes
Scientific 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
Secondary ID [1] 0 0
2005-002942-20
Secondary ID [2] 0 0
EFC5826
Universal Trial Number (UTN)
Trial acronym
CRESCENDO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular Disease 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Rimonabant
Treatment: Drugs - Placebo (for Rimonabant)

Experimental: Rimonabant - Rimonabant 20 mg once daily

Placebo comparator: Placebo - Placebo (for Rimonabant) once daily.


Treatment: Drugs: Rimonabant
Tablet, oral administration

Treatment: Drugs: Placebo (for Rimonabant)
Tablet, oral administration
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
First occurrence of any of myocardial infarction, stroke or cardiovascular (CV) death
Timepoint [1] 0 0
From randomization up to common study end date (33-50 months)
Secondary outcome [1] 0 0
First occurrence of any of myocardial infarction, stroke, CV death, and CV hospitalization
Timepoint [1] 0 0
From randomization up to common study end date (33-50 months)
Secondary outcome [2] 0 0
All-cause mortality
Timepoint [2] 0 0
From randomization up to common study end date (33-50 months)

Eligibility
Key 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
Minimum age
55 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2009
Sample size
Target
Accrual to date
Final
18695
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
sanofi-aventis Australia & New Zealand administrative office - Macquarie Park
Recruitment postcode(s) [1] 0 0
- Macquarie Park
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
New Jersey
Country [2] 0 0
Argentina
State/province [2] 0 0
Buenos Aires
Country [3] 0 0
Austria
State/province [3] 0 0
Vienna
Country [4] 0 0
Belgium
State/province [4] 0 0
Diegem
Country [5] 0 0
Brazil
State/province [5] 0 0
Sao Paulo
Country [6] 0 0
Canada
State/province [6] 0 0
Quebec
Country [7] 0 0
Chile
State/province [7] 0 0
Santiago de Chile
Country [8] 0 0
China
State/province [8] 0 0
Shangaï
Country [9] 0 0
Colombia
State/province [9] 0 0
Santafe de Bogota
Country [10] 0 0
Czech Republic
State/province [10] 0 0
Praha
Country [11] 0 0
Denmark
State/province [11] 0 0
Horsholm
Country [12] 0 0
Finland
State/province [12] 0 0
Helsinki
Country [13] 0 0
France
State/province [13] 0 0
Paris
Country [14] 0 0
Germany
State/province [14] 0 0
Berlin
Country [15] 0 0
Greece
State/province [15] 0 0
Athens
Country [16] 0 0
Hong Kong
State/province [16] 0 0
Hong-Kong
Country [17] 0 0
Hungary
State/province [17] 0 0
Budapest
Country [18] 0 0
India
State/province [18] 0 0
Mumbai
Country [19] 0 0
Ireland
State/province [19] 0 0
Dublin
Country [20] 0 0
Israel
State/province [20] 0 0
Natanya
Country [21] 0 0
Italy
State/province [21] 0 0
Milano
Country [22] 0 0
Korea, Republic of
State/province [22] 0 0
Seoul
Country [23] 0 0
Malaysia
State/province [23] 0 0
Kuala Lumpur
Country [24] 0 0
Mexico
State/province [24] 0 0
Mexico
Country [25] 0 0
Netherlands
State/province [25] 0 0
Gouda
Country [26] 0 0
Norway
State/province [26] 0 0
Lysaker
Country [27] 0 0
Peru
State/province [27] 0 0
Lima
Country [28] 0 0
Philippines
State/province [28] 0 0
Makati City
Country [29] 0 0
Poland
State/province [29] 0 0
Warszawa
Country [30] 0 0
Portugal
State/province [30] 0 0
Porto Salvo
Country [31] 0 0
Romania
State/province [31] 0 0
Bucuresti
Country [32] 0 0
Russian Federation
State/province [32] 0 0
Moscow
Country [33] 0 0
Singapore
State/province [33] 0 0
Singapore
Country [34] 0 0
South Africa
State/province [34] 0 0
Midrand
Country [35] 0 0
Spain
State/province [35] 0 0
Madrid
Country [36] 0 0
Sweden
State/province [36] 0 0
Bromma
Country [37] 0 0
Switzerland
State/province [37] 0 0
Geneva
Country [38] 0 0
Taiwan
State/province [38] 0 0
Taipei
Country [39] 0 0
Thailand
State/province [39] 0 0
Bangkok
Country [40] 0 0
Tunisia
State/province [40] 0 0
Megrine
Country [41] 0 0
Turkey
State/province [41] 0 0
Istanbul
Country [42] 0 0
United Kingdom
State/province [42] 0 0
Guildford

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Sanofi
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT00263042
Trial related presentations / publications
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.
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.
Public notes

Contacts
Principal investigator
Name 0 0
Eric Topol, MD
Address 0 0
Scripps Clinic
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00263042