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Obese Patients With Untreated Dyslipidemias (RIO-Lipids)

Primary Purpose

Obesity, Dyslipidemia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Rimonabant (SR141716)
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 - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

BMI must be greater than 27 and less than 40 Patients with untreated dyslipidemia Stable weight (variation of less than 5 kg within 3 months prior to screening visit)

Sites / Locations

  • Clinic of Physicians and Surgeons, LTD
  • Arizona Clinical Research Center, Inc.
  • Irvine Center for Clinical Research (ICCR)
  • Los Angeles Clinical Trials
  • Apexute
  • Clinical Research of South Florida
  • Radiant Research
  • nTouch Research
  • nTouch Research
  • Bluegrass Clinical Research, Inc.
  • Johns Hopkins Women's Research Core
  • Baystate Medical Center
  • Twin Cities Clinical Research
  • Radiant Research
  • Women's Clinic of Lincoln, PC
  • New Mexico Clinical Research & Osteoporosis Center, Inc.
  • Clinical Research Services
  • University of Cincinnati College of Medicine
  • Altoona Center for Clinical Research
  • Clinical Research Division
  • Clinical Research Center of Reading, LLC
  • Medical University of South Carolina, Division of Clinical Pharmacology
  • Nashville Medical Research Institute
  • Radiant Research
  • Clinical Research Center of Northern Virginia
  • Hunter Holmes McGuire Medical Center Research Service (151)
  • Vancouver Medical Weight Loss Clinic
  • Addiction & Psychiatric Medicine Research
  • Sanofi-aventis Administrative Office
  • Sanofi-aventis Administrative Office
  • Sanofi-aventis Administrative Office
  • Sanofi-aventis Administrative Office
  • Sanofi-aventis Administrative Office
  • Sanofi-aventis Administrative Office
  • Sanofi-aventis Administrative Office

Outcomes

Primary Outcome Measures

Change from baseline in body weight at 1 year.

Secondary Outcome Measures

Metabolic parameters

Full Information

First Posted
January 23, 2002
Last Updated
April 17, 2009
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00029835
Brief Title
Obese Patients With Untreated Dyslipidemias
Acronym
RIO-Lipids
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Fixed-Dose, Multi-Center Study of Weight-Reducing Effect and Safety in Obese Patients With Untreated Dyslipidemias
Study Type
Interventional

2. Study Status

Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
September 2001 (undefined)
Primary Completion Date
November 2003 (Actual)
Study Completion Date
November 2003 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Sanofi

4. Oversight

5. Study Description

Brief Summary
To assess the effect on weight loss and weight maintenance over a period of one year when prescribed with a hypocaloric diet in obese patients with untreated dyslipidemia

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1033 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Rimonabant (SR141716)
Primary Outcome Measure Information:
Title
Change from baseline in body weight at 1 year.
Secondary Outcome Measure Information:
Title
Metabolic parameters

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
BMI must be greater than 27 and less than 40 Patients with untreated dyslipidemia Stable weight (variation of less than 5 kg within 3 months prior to screening visit)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ICD CSD
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Clinic of Physicians and Surgeons, LTD
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85201
Country
United States
Facility Name
Arizona Clinical Research Center, Inc.
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Irvine Center for Clinical Research (ICCR)
City
Irvine
State/Province
California
ZIP/Postal Code
92618
Country
United States
Facility Name
Los Angeles Clinical Trials
City
Los Angeles
State/Province
California
ZIP/Postal Code
90064
Country
United States
Facility Name
Apexute
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
Clinical Research of South Florida
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Radiant Research
City
Stuart
State/Province
Florida
ZIP/Postal Code
34996
Country
United States
Facility Name
nTouch Research
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61602
Country
United States
Facility Name
nTouch Research
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46601
Country
United States
Facility Name
Bluegrass Clinical Research, Inc.
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40291
Country
United States
Facility Name
Johns Hopkins Women's Research Core
City
Lutherville
State/Province
Maryland
ZIP/Postal Code
21093
Country
United States
Facility Name
Baystate Medical Center
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01199
Country
United States
Facility Name
Twin Cities Clinical Research
City
Arden Hills
State/Province
Minnesota
ZIP/Postal Code
55126
Country
United States
Facility Name
Radiant Research
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
Facility Name
Women's Clinic of Lincoln, PC
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68510
Country
United States
Facility Name
New Mexico Clinical Research & Osteoporosis Center, Inc.
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
Clinical Research Services
City
Bismarck
State/Province
North Dakota
ZIP/Postal Code
58501
Country
United States
Facility Name
University of Cincinnati College of Medicine
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267-0559
Country
United States
Facility Name
Altoona Center for Clinical Research
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Clinical Research Division
City
Newtown
State/Province
Pennsylvania
ZIP/Postal Code
18940
Country
United States
Facility Name
Clinical Research Center of Reading, LLC
City
West Reading
State/Province
Pennsylvania
ZIP/Postal Code
19611-1124
Country
United States
Facility Name
Medical University of South Carolina, Division of Clinical Pharmacology
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Nashville Medical Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Facility Name
Radiant Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84111
Country
United States
Facility Name
Clinical Research Center of Northern Virginia
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22044
Country
United States
Facility Name
Hunter Holmes McGuire Medical Center Research Service (151)
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
Facility Name
Vancouver Medical Weight Loss Clinic
City
Vancouver
State/Province
Washington
ZIP/Postal Code
98685
Country
United States
Facility Name
Addiction & Psychiatric Medicine Research
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506-9300
Country
United States
Facility Name
Sanofi-aventis Administrative Office
City
Macquarie Park
Country
Australia
Facility Name
Sanofi-aventis Administrative Office
City
Laval
Country
Canada
Facility Name
Sanofi-aventis Administrative Office
City
Helsinki
Country
Finland
Facility Name
Sanofi-aventis Administrative Office
City
Milano
Country
Italy
Facility Name
Sanofi-aventis Administrative Office
City
Barcelona
Country
Spain
Facility Name
Sanofi-aventis Administrative Office
City
Bromma
Country
Sweden
Facility Name
Sanofi-aventis Administrative Office
City
Geneva
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
16291982
Citation
Despres JP, Golay A, Sjostrom L; Rimonabant in Obesity-Lipids Study Group. Effects of rimonabant on metabolic risk factors in overweight patients with dyslipidemia. N Engl J Med. 2005 Nov 17;353(20):2121-34. doi: 10.1056/NEJMoa044537.
Results Reference
result

Learn more about this trial

Obese Patients With Untreated Dyslipidemias

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