Rimonabant in Obesity Over a 2-Year Duration (RIO-Europe)

Sanofi

Status and phase

Completed

Phase 3

Conditions

Obesity

Treatments

Drug: rimonabant (SR141716)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00386061

EFC4733

Details and patient eligibility

About

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.

Enrollment

1,507 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.