Back to resultsRimonabant in Obesity Over a 2-Year Duration (RIO-Europe)
Primary Purpose
Obesity
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
rimonabant (SR141716)
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring Obesity, risk factors
Eligibility Criteria
Inclusion Criteria:
- body mass index (BMI) e30 kg/m2 in patients with or without comorbidities, or BMI >27 kg/m2 in patients with treated or untreated hypertension and/or treated or untreated dyslipidemia.
- stable body weight (variation <5 kg within 3 months prior to screening visit);
Exclusion Criteria:
- History of very low-calorie diet within 6 months prior to screening visit; or history of surgical procedures for body weight loss (eg, stomach stapling, bypass);
- Presence of any clinically significant psychiatric , neurological or endocrine disease
- Presence of treated or untreated type 1 or type 2 diabetes);
- SBP >165 mmHg and/or DBP >105 mmHg on 2 consecutive visits from the screening to the inclusion visit;
- History of myocardial infarction or unstable angina pectoris within 6 months prior to screening visit; and history of stroke within 6 months prior to screening visit;
- Administration of anti-obesity drugs or other drugs for body weight reduction within 3 months prior to screening visit;
The investigator will evaluate whether there are other reasons why a patient may not participate.
Sites / Locations
- Sanofi-Aventis
- Sanofi-Aventis
- Sanofi-Aventis
- Sanofi-Aventis
- Sanofi-Aventis
- Sanofi-Aventis
- Sanofi-Aventis
Outcomes
Primary Outcome Measures
change in body weight from baseline to 1 year.
Secondary Outcome Measures
HDL-C and TG from baseline to 1 year; ·patients (%) with improvement of glucose tolerance, patients (%) with NCEP-ATPIII metabolic syndrome at 1 year.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00386061
Brief Title
Rimonabant in Obesity Over a 2-Year Duration (RIO-Europe)
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Fixed-Dose, Multicenter Study of Weight-Reducing Effect and Safety of SR141716 in Obese Patients With or Without Comorbidities (RIO-Europe)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
October 2001 (undefined)
Primary Completion Date
June 2004 (Actual)
Study Completion Date
June 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sanofi
4. Oversight
5. Study Description
Brief Summary
The primary objective was to assess the effect of SR141716 on weight loss and weight maintenance over a period of one year when prescribed with a hypocaloric diet in obese patients with or without comorbidities.
The main secondary objectives were to assess the effect of SR141716 on lipid parameters (HDL-C, TG), glucose tolerance status, the rate of patients with metabolic syndrome, waist circumference, glycemic parameters.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Obesity, risk factors
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1507 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
rimonabant (SR141716)
Primary Outcome Measure Information:
Title
change in body weight from baseline to 1 year.
Secondary Outcome Measure Information:
Title
HDL-C and TG from baseline to 1 year; ·patients (%) with improvement of glucose tolerance, patients (%) with NCEP-ATPIII metabolic syndrome at 1 year.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
body mass index (BMI) e30 kg/m2 in patients with or without comorbidities, or BMI >27 kg/m2 in patients with treated or untreated hypertension and/or treated or untreated dyslipidemia.
stable body weight (variation <5 kg within 3 months prior to screening visit);
Exclusion Criteria:
History of very low-calorie diet within 6 months prior to screening visit; or history of surgical procedures for body weight loss (eg, stomach stapling, bypass);
Presence of any clinically significant psychiatric , neurological or endocrine disease
Presence of treated or untreated type 1 or type 2 diabetes);
SBP >165 mmHg and/or DBP >105 mmHg on 2 consecutive visits from the screening to the inclusion visit;
History of myocardial infarction or unstable angina pectoris within 6 months prior to screening visit; and history of stroke within 6 months prior to screening visit;
Administration of anti-obesity drugs or other drugs for body weight reduction within 3 months prior to screening visit;
The investigator will evaluate whether there are other reasons why a patient may not participate.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ICD CSD
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis
City
Bridgewater
State/Province
New Jersey
ZIP/Postal Code
08807
Country
United States
Facility Name
Sanofi-Aventis
City
Brussels
Country
Belgium
Facility Name
Sanofi-Aventis
City
Helsinki
Country
Finland
Facility Name
Sanofi-Aventis
City
Paris
Country
France
Facility Name
Sanofi-Aventis
City
Berlin
Country
Germany
Facility Name
Sanofi-Aventis
City
Gouda
Country
Netherlands
Facility Name
Sanofi-Aventis
City
Bromma
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
15836887
Citation
Van Gaal LF, Rissanen AM, Scheen AJ, Ziegler O, Rossner S; RIO-Europe Study Group. Effects of the cannabinoid-1 receptor blocker rimonabant on weight reduction and cardiovascular risk factors in overweight patients: 1-year experience from the RIO-Europe study. Lancet. 2005 Apr 16-22;365(9468):1389-97. doi: 10.1016/S0140-6736(05)66374-X. Erratum In: Lancet. 2005 Jul 30-Aug 5;366(9483):370.
Results Reference
result
PubMed Identifier
18417461
Citation
Van Gaal LF, Scheen AJ, Rissanen AM, Rossner S, Hanotin C, Ziegler O; RIO-Europe Study Group. Long-term effect of CB1 blockade with rimonabant on cardiometabolic risk factors: two year results from the RIO-Europe Study. Eur Heart J. 2008 Jul;29(14):1761-71. doi: 10.1093/eurheartj/ehn076. Epub 2008 Apr 15.
Results Reference
derived
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Rimonabant in Obesity Over a 2-Year Duration (RIO-Europe)
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