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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00325546
First received: May 12, 2006
Last updated: April 6, 2009
Last verified: April 2009
  Purpose

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


Condition Intervention Phase
Obesity
Drug: Rimonabant (SR141716)
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Fixed-Dose (Rimonabant 20mg), Multi-National, Multicentre Study of Weight-Reducing Effect and Safety of Rimonabant in Obese Patients With or Without Comorbidities

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Absolute change in weight from baseline to month 9

Secondary Outcome Measures:
  • HDL-Cholesterol, triglycerides, fasting-insulin, fasting glucose, waist circumference(physical examination, vital signs, ECG, laboratory tests, adverse events).

Enrollment: 643
Study Start Date: April 2006
Study Completion Date: April 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00325546

Locations
China
Sanofi-Aventis
Shangai, China, 200040
Korea, Republic of
Sanofi-Aventis
Seoul, Korea, Republic of, 135-755
Taiwan
Sanofi-Aventis
Taipei, Taiwan, 105
Sponsors and Collaborators
Sanofi
Investigators
Study Director: ICD CSD Sanofi
  More Information

No publications provided

Responsible Party: ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00325546     History of Changes
Other Study ID Numbers: EFC6001
Study First Received: May 12, 2006
Last Updated: April 6, 2009
Health Authority: China: Ministry of Health
South Korea: Korea Food and Drug Administration (KFDA)
Taiwan: Department of Health

Keywords provided by Sanofi:
Obesity

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on April 22, 2014