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