Obese Patients With or Without Comorbidities (RIO-North America)
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
1 other identifier
interventional
3,045
2 countries
51
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 obesity
Started Aug 2001
Typical duration for phase_3 obesity
51 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2001
CompletedFirst Submitted
Initial submission to the registry
January 23, 2002
CompletedFirst Posted
Study publicly available on registry
January 24, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2004
CompletedApril 20, 2009
April 1, 2009
2.7 years
January 23, 2002
April 17, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in body weight
Secondary Outcomes (1)
Metabolic parameters
Interventions
Eligibility Criteria
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
- Sanofilead
Study Sites (51)
Radiant Research
Birmingham, Alabama, 35209, United States
Radiant Research
Phoenix, Arizona, 85013, United States
East Bay Clinical Trial Center
Concord, California, 94520, United States
Feighner Research Institute
San Diego, California, 92121, United States
Scripps Clinic
San Diego, California, 92130, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598, United States
Ranch View Family Medicine
Highlands Ranch, Colorado, 80130, United States
Longmont Medical Research Network
Longmont, Colorado, 80501, United States
Health Core, Inc.
Newark, Delaware, 19713, United States
George Washington Univ. Wieght Mmgt Program
Washington D.C., District of Columbia, 20037, United States
Miami Research Associates
Miami, Florida, 33173, United States
Anchor Research Center
Naples, Florida, 34102, United States
Central Florida Clinical Solutions
Ocoee, Florida, 34761, United States
Orlando Clinical Research Center
Orlando, Florida, 32806, United States
Palm Beach Research Center
West Palm Beach, Florida, 33409, United States
Medical Dietetics, Inc.
Atlanta, Georgia, 30339, United States
Springfield Diabetes and Endocrine Center
Springfield, Illinois, 62704, United States
Medical Research Consortium
Indianapolis, Indiana, 46208, United States
Wichita Clinic, PA
Wichita, Kansas, 67208, United States
University of KY Internal Medicine
Lexington, Kentucky, 40536-9841, United States
Pennington Center
Baton Rouge, Louisiana, 70808, United States
JM Clinical Trials, Inc.
Swansea, Massachusetts, 02777, United States
Montana Medical Research, LLC
Missoula, Montana, 59804, United States
Endocrinology and Diabetes Consultants, PC
Dover, New Hampshire, 03820, United States
Radiant Research
Lawrenceville, New Jersey, 08648, United States
Lovelace Scientific Resources
Albuquerque, New Mexico, 87108, United States
Central New York Clinical Research
Manlius, New York, 13104, United States
Comprehensive Weight Control Program
New York, New York, 10021, United States
St. Luke's Roosevelt Hospital Center
New York, New York, 10025, United States
Center for Nutrition and Preventive Medicine
Charlotte, North Carolina, 28207, United States
Multi-Specialty Research Associates of North Carolina
Raleigh, North Carolina, 27609, United States
South Dayton Research Associates
Beavercreek, Ohio, 45431, United States
Lindner Clinical Trials Center
Cincinnati, Ohio, 45219, United States
Radiant Research
Columbus, Ohio, 43212, United States
Radiant Research
Portland, Oregon, 97201, United States
SFM Clinical Trials
Scotland, Pennsylvania, 17254, United States
Radiant Research
Wyomissing, Pennsylvania, 19610, United States
ClinSearch
Chattanooga, Tennessee, 37404, United States
Clinical Research Associates, Inc
Nashville, Tennessee, 37203, United States
Radiant Research
Austin, Texas, 78758, United States
Dallas Diabetes and Endocrine Center
Dallas, Texas, 75230, United States
nTouch Research
Houston, Texas, 77024, United States
Quality Research, Inc.
San Antonio, Texas, 78209, United States
Advanced Clinical Research
Salt Lake City, Utah, 84102, United States
Commonwealth Clinical Research Specialists (CCRS)
Richmond, Virginia, 23226, United States
Rainer Clinical Research Center, Inc.
Renton, Washington, 98055-5704, United States
Clinical Nutrition Clinic, University of Wisconsin
Madison, Wisconsin, 53705, United States
Corunna Medical Clinic
Corunna, Ontario, N0N1G0, Canada
Quarry Family Medicine Clinic
Kingston, Ontario, K7L3E4, Canada
Trial Management Group
Richmond Hill, Ontario, L4E3S8, Canada
Group North
Windsor, Ontario, N8X3V6, Canada
Related Publications (1)
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.
PMID: 16478899RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
ICD CSD
Sanofi
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 23, 2002
First Posted
January 24, 2002
Study Start
August 1, 2001
Primary Completion
April 1, 2004
Study Completion
April 1, 2004
Last Updated
April 20, 2009
Record last verified: 2009-04