Overview

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

Status:
Completed
Trial end date:
2007-04-01
Target enrollment:
0
Participant gender:
All
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
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Sanofi
Treatments:
Rimonabant
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.