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

Primary Purpose

Obesity

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Rimonabant (SR141716)
Placebo
Sponsored by
Sanofi
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Obesity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sanofi-Aventis
  • Sanofi-Aventis
  • Sanofi-Aventis

Outcomes

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).

Full Information

First Posted
May 12, 2006
Last Updated
April 6, 2009
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00325546
Brief Title
Study of Weight-Reducing Effect and Safety of Rimonabant In Obesity in ASIA (RIO-ASIA)
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
April 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Sanofi

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
643 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Rimonabant (SR141716)
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Absolute change in weight from baseline to month 9
Secondary Outcome Measure Information:
Title
HDL-Cholesterol, triglycerides, fasting-insulin, fasting glucose, waist circumference(physical examination, vital signs, ECG, laboratory tests, adverse events).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ICD CSD
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis
City
Shangai
ZIP/Postal Code
200040
Country
China
Facility Name
Sanofi-Aventis
City
Seoul
ZIP/Postal Code
135-755
Country
Korea, Republic of
Facility Name
Sanofi-Aventis
City
Taipei
ZIP/Postal Code
105
Country
Taiwan

12. IPD Sharing Statement

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

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