Status:
COMPLETED
Study of Weight-Reducing Effect and Safety of Rimonabant In Obesity in ASIA (RIO-ASIA)
Lead Sponsor:
Sanofi
Conditions:
Obesity
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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, ...
Eligibility Criteria
Inclusion
- Body mass index (BMI)\> 25 kg/m²
Exclusion
- 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.
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2007
Estimated Enrollment :
643 Patients enrolled
Trial Details
Trial ID
NCT00325546
Start Date
April 1 2006
End Date
April 1 2007
Last Update
April 7 2009
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Sanofi-Aventis
Shanghai, China, 200040
2
Sanofi-Aventis
Seoul, South Korea, 135-755
3
Sanofi-Aventis
Taipei, Taiwan, 105