Trial Review

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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
Trial website
Trial related presentations / publications
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

TypeCitations or Other Details
Journal Topol EJ, Bousser MG, Fox KA, Creager MA, Despres ... [More Details]

Results not provided in https://clinicaltrials.gov/study/NCT00263042