Clinical trial NCT00029861: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Obesity
Weight Loss
Keywords: Weight Loss
Obesity
Weight Reduction
Overweight
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2002-01-24
Enrollment: 3045
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


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

Primary outcomes:
measure: Change in body weight
Secondary outcomes:
measure: Metabolic parameters
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Radiant Research
state: Alabama
city: Phoenix
country: United States
facility: Radiant Research
state: Arizona
city: Concord
country: United States
facility: East Bay Clinical Trial Center
state: California
city: San Diego
country: United States
facility: Feighner Research Institute
state: California
city: San Diego
country: United States
facility: Scripps Clinic
state: California
city: Walnut Creek
country: United States
facility: Diablo Clinical Research, Inc.
state: California
city: Highlands Ranch
country: United States
facility: Ranch View Family Medicine
state: Colorado
city: Longmont
country: United States
facility: Longmont Medical Research Network
state: Colorado
city: Newark
country: United States
facility: Health Core, Inc.
state: Delaware
city: Washington
country: United States
facility: George Washington Univ. Wieght Mmgt Program
state: District of Columbia
city: Miami
country: United States
facility: Miami Research Associates
state: Florida
city: Naples
country: United States
facility: Anchor Research Center
state: Florida
city: Ocoee
country: United States
facility: Central Florida Clinical Solutions
state: Florida
city: Orlando
country: United States
facility: Orlando Clinical Research Center
state: Florida
city: West Palm Beach
country: United States
facility: Palm Beach Research Center
state: Florida
city: Atlanta
country: United States
facility: Medical Dietetics, Inc.
state: Georgia
city: Springfield
country: United States
facility: Springfield Diabetes and Endocrine Center
state: Illinois
city: Indianapolis
country: United States
facility: Medical Research Consortium
state: Indiana
city: Wichita
country: United States
facility: Wichita Clinic, PA
state: Kansas
city: Lexington
country: United States
facility: University of KY Internal Medicine
state: Kentucky
city: Baton Rouge
country: United States
facility: Pennington Center
state: Louisiana
city: Swansea
country: United States
facility: JM Clinical Trials, Inc.
state: Massachusetts
city: Missoula
country: United States
facility: Montana Medical Research, LLC
state: Montana
city: Dover
country: United States
facility: Endocrinology and Diabetes Consultants, PC
state: New Hampshire
city: Lawrenceville
country: United States
facility: Radiant Research
state: New Jersey
city: Albuquerque
country: United States
facility: Lovelace Scientific Resources
state: New Mexico
city: Manlius
country: United States
facility: Central New York Clinical Research
state: New York
city: New York
country: United States
facility: Comprehensive Weight Control Program
state: New York
city: New York
country: United States
facility: St. Luke's Roosevelt Hospital Center
state: New York
city: Charlotte
country: United States
facility: Center for Nutrition and Preventive Medicine
state: North Carolina
city: Raleigh
country: United States
facility: Multi-Specialty Research Associates of North Carolina
state: North Carolina
city: Beavercreek
country: United States
facility: South Dayton Research Associates
state: Ohio
city: Cincinnati
country: United States
facility: Lindner Clinical Trials Center
state: Ohio
city: Columbus
country: United States
facility: Radiant Research
state: Ohio
city: Portland
country: United States
facility: Radiant Research
state: Oregon
city: Scotland
country: United States
facility: SFM Clinical Trials
state: Pennsylvania
city: Wyomissing
country: United States
facility: Radiant Research
state: Pennsylvania
city: Chattanooga
country: United States
facility: ClinSearch
state: Tennessee
city: Nashville
country: United States
facility: Clinical Research Associates, Inc
state: Tennessee
city: Austin
country: United States
facility: Radiant Research
state: Texas
city: Dallas
country: United States
facility: Dallas Diabetes and Endocrine Center
state: Texas
city: Houston
country: United States
facility: nTouch Research
state: Texas
city: San Antonio
country: United States
facility: Quality Research, Inc.
state: Texas
city: Salt Lake City
country: United States
facility: Advanced Clinical Research
state: Utah
city: Richmond
country: United States
facility: Commonwealth Clinical Research Specialists (CCRS)
state: Virginia
city: Renton
country: United States
facility: Rainer Clinical Research Center, Inc.
state: Washington
city: Madison
country: United States
facility: Clinical Nutrition Clinic, University of Wisconsin
state: Wisconsin
city: Corunna
country: Canada
facility: Corunna Medical Clinic
state: Ontario
city: Kingston
country: Canada
facility: Quarry Family Medicine Clinic
state: Ontario
city: Richmond Hill
country: Canada
facility: Trial Management Group
state: Ontario
city: Windsor
country: Canada
facility: Group North
state: Ontario
Study officials:
affiliation: Sanofi
name: ICD CSD
role: STUDY_DIRECTOR
References:
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.