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

Phase 3

Completed

• Conditions: Obesity

• Registration Number: NCT00325546
• Lead Sponsor: Sanofi

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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-04
• Study First Submitted: 2006-05-12
• Study First Submitted QC: 2006-05-12
• Study First Posted: 2006-05-15
• Primary Completion: 2007-04
• Study Completion: 2007-04
• Status Verified: 2009-04
• Last Update Submitted: 2009-04-06
• Last Update Posted: 2009-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 643

Inclusion Criteria

• Body mass index (BMI)> 25 kg/m²

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Absolute change in weight from baseline to month 9

Secondary Outcome Measures

Name	Time	Method
HDL-Cholesterol, triglycerides, fasting-insulin, fasting glucose, waist circumference(physical examination, vital signs, ECG, laboratory tests, adverse events).

Trial Locations

Locations (1)

Sanofi-Aventis; 🇨🇳 Taipei, Taiwan