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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00029835




Registration number
NCT00029835
Ethics application status
Date submitted
23/01/2002
Date registered
24/01/2002
Date last updated
20/04/2009

Titles & IDs
Public title
Obese Patients With Untreated Dyslipidemias
Scientific title
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Fixed-Dose, Multi-Center Study of Weight-Reducing Effect and Safety in Obese Patients With Untreated Dyslipidemias
Secondary ID [1] 0 0
EFC4735
Universal Trial Number (UTN)
Trial acronym
RIO-Lipids
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 0 0
Dyslipidemia 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Blood 0 0 0 0
Other blood disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from baseline in body weight at 1 year.
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Metabolic parameters
Timepoint [1] 0 0

Eligibility
Key inclusion criteria
* BMI must be greater than 27 and less than 40
* Patients with untreated dyslipidemia
* Stable weight (variation of less than 5 kg within 3 months prior to screening visit)
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

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 analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2001
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2003
Sample size
Target
Accrual to date
Final
1033
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Sanofi-aventis 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
Arizona
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United States of America
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California
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United States of America
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Florida
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United States of America
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Illinois
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United States of America
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Indiana
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United States of America
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Kentucky
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United States of America
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Maryland
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United States of America
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Massachusetts
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United States of America
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Minnesota
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United States of America
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Nebraska
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United States of America
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New Mexico
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United States of America
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North Dakota
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United States of America
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Ohio
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United States of America
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Pennsylvania
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United States of America
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South Carolina
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United States of America
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Tennessee
Country [17] 0 0
United States of America
State/province [17] 0 0
Utah
Country [18] 0 0
United States of America
State/province [18] 0 0
Virginia
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United States of America
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Washington
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United States of America
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West Virginia
Country [21] 0 0
Canada
State/province [21] 0 0
Laval
Country [22] 0 0
Finland
State/province [22] 0 0
Helsinki
Country [23] 0 0
Italy
State/province [23] 0 0
Milano
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Spain
State/province [24] 0 0
Barcelona
Country [25] 0 0
Sweden
State/province [25] 0 0
Bromma
Country [26] 0 0
Switzerland
State/province [26] 0 0
Geneva

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

Ethics approval
Ethics application status

Summary
Brief summary
To assess the effect on weight loss and weight maintenance over a period of one year when prescribed with a hypocaloric diet in obese patients with untreated dyslipidemia
Trial website
https://clinicaltrials.gov/study/NCT00029835
Trial related presentations / publications
Despres JP, Golay A, Sjostrom L; Rimonabant in Obesity-Lipids Study Group. Effects of rimonabant on metabolic risk factors in overweight patients with dyslipidemia. N Engl J Med. 2005 Nov 17;353(20):2121-34. doi: 10.1056/NEJMoa044537.
Public notes

Contacts
Principal investigator
Name 0 0
ICD CSD
Address 0 0
Sanofi
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/NCT00029835