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Obese Patients With or Without Comorbidities (RIO-North America)

Primary Purpose

Obesity, Weight Loss

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 prevention trial for Obesity focused on measuring Weight Loss, Obesity, Weight Reduction, Overweight

Eligibility Criteria

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

Stable weight (variation of less than 5 kg within 3 months prior to screening visit) BMI (Body Mass Index) of 30 or greater in patients with or without comorbidities, or BMI greater than 27 in patients with treated or untreated hypertension and/or treated or untreated dyslipidemia

Sites / Locations

  • Radiant Research
  • Radiant Research
  • East Bay Clinical Trial Center
  • Feighner Research Institute
  • Scripps Clinic
  • Diablo Clinical Research, Inc.
  • Ranch View Family Medicine
  • Longmont Medical Research Network
  • Health Core, Inc.
  • George Washington Univ. Wieght Mmgt Program
  • Miami Research Associates
  • Anchor Research Center
  • Central Florida Clinical Solutions
  • Orlando Clinical Research Center
  • Palm Beach Research Center
  • Medical Dietetics, Inc.
  • Springfield Diabetes and Endocrine Center
  • Medical Research Consortium
  • Wichita Clinic, PA
  • University of KY Internal Medicine
  • Pennington Center
  • JM Clinical Trials, Inc.
  • Montana Medical Research, LLC
  • Endocrinology and Diabetes Consultants, PC
  • Radiant Research
  • Lovelace Scientific Resources
  • Central New York Clinical Research
  • Comprehensive Weight Control Program
  • St. Luke's Roosevelt Hospital Center
  • Center for Nutrition and Preventive Medicine
  • Multi-Specialty Research Associates of North Carolina
  • South Dayton Research Associates
  • Lindner Clinical Trials Center
  • Radiant Research
  • Radiant Research
  • SFM Clinical Trials
  • Radiant Research
  • ClinSearch
  • Clinical Research Associates, Inc
  • Radiant Research
  • Dallas Diabetes and Endocrine Center
  • nTouch Research
  • Quality Research, Inc.
  • Advanced Clinical Research
  • Commonwealth Clinical Research Specialists (CCRS)
  • Rainer Clinical Research Center, Inc.
  • Clinical Nutrition Clinic, University of Wisconsin
  • Corunna Medical Clinic
  • Quarry Family Medicine Clinic
  • Trial Management Group
  • Group North

Outcomes

Primary Outcome Measures

Change in body weight

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
NCT00029861
Brief Title
Obese Patients With or Without Comorbidities (RIO-North America)
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Fixed-Dose, Multicenter Study of Weight-Reducing and Prevention of Weight Regain Effects and Safety 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
August 2001 (undefined)
Primary Completion Date
April 2004 (Actual)
Study Completion Date
April 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Sanofi

4. Oversight

5. Study Description

Brief Summary
To assess the effects of weight loss and weight maintenance over a period of two years when prescribed with a hypocaloric diet in obese patients with or without comorbidities

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Weight Loss
Keywords
Weight Loss, Obesity, Weight Reduction, Overweight

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
3045 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Rimonabant (SR141716)
Primary Outcome Measure Information:
Title
Change in body weight
Secondary Outcome Measure Information:
Title
Metabolic parameters

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Stable weight (variation of less than 5 kg within 3 months prior to screening visit) BMI (Body Mass Index) of 30 or greater in patients with or without comorbidities, or BMI greater than 27 in patients with treated or untreated hypertension and/or treated or untreated dyslipidemia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ICD CSD
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Radiant Research
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Radiant Research
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
East Bay Clinical Trial Center
City
Concord
State/Province
California
ZIP/Postal Code
94520
Country
United States
Facility Name
Feighner Research Institute
City
San Diego
State/Province
California
ZIP/Postal Code
92121
Country
United States
Facility Name
Scripps Clinic
City
San Diego
State/Province
California
ZIP/Postal Code
92130
Country
United States
Facility Name
Diablo Clinical Research, Inc.
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Ranch View Family Medicine
City
Highlands Ranch
State/Province
Colorado
ZIP/Postal Code
80130
Country
United States
Facility Name
Longmont Medical Research Network
City
Longmont
State/Province
Colorado
ZIP/Postal Code
80501
Country
United States
Facility Name
Health Core, Inc.
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
George Washington Univ. Wieght Mmgt Program
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
Miami Research Associates
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Facility Name
Anchor Research Center
City
Naples
State/Province
Florida
ZIP/Postal Code
34102
Country
United States
Facility Name
Central Florida Clinical Solutions
City
Ocoee
State/Province
Florida
ZIP/Postal Code
34761
Country
United States
Facility Name
Orlando Clinical Research Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Palm Beach Research Center
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
Facility Name
Medical Dietetics, Inc.
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30339
Country
United States
Facility Name
Springfield Diabetes and Endocrine Center
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62704
Country
United States
Facility Name
Medical Research Consortium
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46208
Country
United States
Facility Name
Wichita Clinic, PA
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67208
Country
United States
Facility Name
University of KY Internal Medicine
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536-9841
Country
United States
Facility Name
Pennington Center
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
Facility Name
JM Clinical Trials, Inc.
City
Swansea
State/Province
Massachusetts
ZIP/Postal Code
02777
Country
United States
Facility Name
Montana Medical Research, LLC
City
Missoula
State/Province
Montana
ZIP/Postal Code
59804
Country
United States
Facility Name
Endocrinology and Diabetes Consultants, PC
City
Dover
State/Province
New Hampshire
ZIP/Postal Code
03820
Country
United States
Facility Name
Radiant Research
City
Lawrenceville
State/Province
New Jersey
ZIP/Postal Code
08648
Country
United States
Facility Name
Lovelace Scientific Resources
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87108
Country
United States
Facility Name
Central New York Clinical Research
City
Manlius
State/Province
New York
ZIP/Postal Code
13104
Country
United States
Facility Name
Comprehensive Weight Control Program
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
St. Luke's Roosevelt Hospital Center
City
New York
State/Province
New York
ZIP/Postal Code
10025
Country
United States
Facility Name
Center for Nutrition and Preventive Medicine
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Multi-Specialty Research Associates of North Carolina
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States
Facility Name
South Dayton Research Associates
City
Beavercreek
State/Province
Ohio
ZIP/Postal Code
45431
Country
United States
Facility Name
Lindner Clinical Trials Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Radiant Research
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43212
Country
United States
Facility Name
Radiant Research
City
Portland
State/Province
Oregon
ZIP/Postal Code
97201
Country
United States
Facility Name
SFM Clinical Trials
City
Scotland
State/Province
Pennsylvania
ZIP/Postal Code
17254
Country
United States
Facility Name
Radiant Research
City
Wyomissing
State/Province
Pennsylvania
ZIP/Postal Code
19610
Country
United States
Facility Name
ClinSearch
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
Clinical Research Associates, Inc
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Radiant Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78758
Country
United States
Facility Name
Dallas Diabetes and Endocrine Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
nTouch Research
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Facility Name
Quality Research, Inc.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78209
Country
United States
Facility Name
Advanced Clinical Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84102
Country
United States
Facility Name
Commonwealth Clinical Research Specialists (CCRS)
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23226
Country
United States
Facility Name
Rainer Clinical Research Center, Inc.
City
Renton
State/Province
Washington
ZIP/Postal Code
98055-5704
Country
United States
Facility Name
Clinical Nutrition Clinic, University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States
Facility Name
Corunna Medical Clinic
City
Corunna
State/Province
Ontario
ZIP/Postal Code
N0N1G0
Country
Canada
Facility Name
Quarry Family Medicine Clinic
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L3E4
Country
Canada
Facility Name
Trial Management Group
City
Richmond Hill
State/Province
Ontario
ZIP/Postal Code
L4E3S8
Country
Canada
Facility Name
Group North
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8X3V6
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
16478899
Citation
Pi-Sunyer FX, Aronne LJ, Heshmati HM, Devin J, Rosenstock J; RIO-North America Study Group. Effect of rimonabant, a cannabinoid-1 receptor blocker, on weight and cardiometabolic risk factors in overweight or obese patients: RIO-North America: a randomized controlled trial. JAMA. 2006 Feb 15;295(7):761-75. doi: 10.1001/jama.295.7.761. Erratum In: JAMA. 2006 Mar 15;295(11):1252.
Results Reference
result

Learn more about this trial

Obese Patients With or Without Comorbidities (RIO-North America)

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