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

April 6, 2009 updated by: Sanofi

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

643

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shangai, China, 200040
        • Sanofi-Aventis
  • Korea, Republic of
      • Seoul, Korea, Republic of, 135-755
        • Sanofi-Aventis
  • Taiwan
      • Taipei, Taiwan, 105
        • Sanofi-Aventis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Absolute change in weight from baseline to month 9

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Primary Completion (Actual)

April 1, 2007

Study Completion (Actual)

April 1, 2007

Study Registration Dates

First Submitted

May 12, 2006

First Submitted That Met QC Criteria

May 12, 2006

First Posted (Estimate)

May 15, 2006

Study Record Updates

Last Update Posted (Estimate)

April 7, 2009

Last Update Submitted That Met QC Criteria

April 6, 2009

Last Verified

April 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EFC6001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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