Clinical trial NCT00386061: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Obesity
Keywords: Obesity
risk factors
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2006-10-11
Enrollment: 1507
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: change in body weight from baseline to 1 year.
Secondary outcomes:
measure: HDL-C and TG from baseline to 1 year; ·patients (%) with improvement of glucose tolerance, patients (%) with NCEP-ATPIII metabolic syndrome at 1 year.
Other outcomes:
Locations:
city: Bridgewater
country: United States
facility: Sanofi-Aventis
state: New Jersey
city: Brussels
country: Belgium
facility: Sanofi-Aventis
city: Helsinki
country: Finland
facility: Sanofi-Aventis
city: Paris
country: France
facility: Sanofi-Aventis
city: Berlin
country: Germany
facility: Sanofi-Aventis
city: Gouda
country: Netherlands
facility: Sanofi-Aventis
city: Bromma
country: Sweden
facility: Sanofi-Aventis
Study officials:
affiliation: Sanofi
name: ICD CSD
role: STUDY_DIRECTOR
References:
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.
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.