Study of Weight-Reducing Effect and Safety of Rimonabant In Obesity in ASIA (RIO-ASIA)

Study Overview
=================
Brief Summary
-----------------
Primary : effect on weight loss and weight maintenance over 9 months when prescribed with a hypocaloric diet in obese patients. Secondary : effect on HDL-Cholesterol, triglycerides, fasting-insulin, fasting glucose, waist circumference - safety and tolerability

Official Title
-----------------
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Fixed-Dose (Rimonabant 20mg), Multi-National, Multicentre Study of Weight-Reducing Effect and Safety of Rimonabant in Obese Patients With or Without Comorbidities

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Drug: Rimonabant (SR141716)
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Body mass index (BMI)> 25 kg/m² Exclusion Criteria: Absence of stable weight (variation < 5 kg) within three months prior to screening visit), Absence of effective contraceptive method for females of childbearing potential, Presence of treated or untreated type 1 or type 2 diabetes, Systolic blood pressure > 165 mm Hg and/or diastolic blood pressure > 105 mm Hg on 2 consecutive visits from the screening to the inclusion visit, Presence of secondary hypertension, Patients with conditions/concomitant diseases making them non evaluable for the primary efficacy endpoint (presence of any clinically significant endocrine disease according to the Investigator, obesity of known endocrine origin...) Presence of any severe medical or psychological condition or chronic conditions/infections that in the opinion of the Investigator would compromise the patient's safety or successful participation in the study, Presence of any clinically significant abnormality according to the Investigator on the ECG performed on the inclusion visit. Presence or history of cancer within the past five years with the exception of adequately treated localized basal cell skin cancer or in situ uterine cervical cancer. Related to previous or concomitant medications : Drugs affecting weight (e.g., sibutramine, orlistat, herbal preparations, etc). Antidiabetic drugs. Related to laboratory findings: Positive test for hepatitis B surface antigen and/or hepatitis C antibody. Abnormal TSH level (TSH > ULN or < LLN). Positive urine pregnancy test.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Rimonabant (SR141716)|nan|
|Drug: Placebo|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute change in weight from baseline to month 9 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HDL-Cholesterol, triglycerides, fasting-insulin, fasting glucose, waist circumference(physical examination, vital signs, ECG, laboratory tests, adverse events). |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Obesity