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

Launched by SANOFI · May 12, 2006

Keywords

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Gender

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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.