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

Last updated: April 6, 2009
Sponsor: Sanofi
Overall Status: Completed

Phase

3

Condition

Obesity

Diabetes Prevention

Treatment

N/A

Clinical Study ID

NCT00325546
EFC6001
  • Ages > 18
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Body mass index (BMI)> 25 kg/m²

Exclusion

Exclusion Criteria:

  • Absence of stable weight (variation < 5 kg) within three months prior to screeningvisit),

  • 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 2consecutive visits from the screening to the inclusion visit,

  • Presence of secondary hypertension,

  • Patients with conditions/concomitant diseases making them non evaluable for theprimary efficacy endpoint (presence of any clinically significant endocrine diseaseaccording to the Investigator, obesity of known endocrine origin...)

  • Presence of any severe medical or psychological condition or chronicconditions/infections that in the opinion of the Investigator would compromise thepatient's safety or successful participation in the study,

  • Presence of any clinically significant abnormality according to the Investigator onthe ECG performed on the inclusion visit.

  • Presence or history of cancer within the past five years with the exception ofadequately treated localized basal cell skin cancer or in situ uterine cervicalcancer.

  • 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.

Study Design

Total Participants: 643
Study Start date:
April 01, 2006
Estimated Completion Date:
April 30, 2007

Connect with a study center

  • Sanofi-Aventis

    Shangai, 200040
    China

    Site Not Available

  • Sanofi-Aventis

    Seoul, 135-755
    Korea, Republic of

    Site Not Available

  • Sanofi-Aventis

    Taipei, 105
    Taiwan

    Site Not Available

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