Obese Patients With Untreated Dyslipidemias (RIO-Lipids)
This study has been completed.
Sponsor:
Sanofi
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00029835
First received: January 23, 2002
Last updated: April 17, 2009
Last verified: April 2009
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Obesity Dyslipidemia |
Drug: Rimonabant (SR141716) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Sanofi:
Primary Outcome Measures:
- Change from baseline in body weight at 1 year.
Secondary Outcome Measures:
- Metabolic parameters
| Enrollment: | 1033 |
| Study Start Date: | September 2001 |
| Study Completion Date: | November 2003 |
| Primary Completion Date: | November 2003 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00029835
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Hide Study LocationsLocations
| United States, Arizona | |
| Clinic of Physicians and Surgeons, LTD | |
| Mesa, Arizona, United States, 85201 | |
| Arizona Clinical Research Center, Inc. | |
| Tucson, Arizona, United States, 85712 | |
| United States, California | |
| Irvine Center for Clinical Research (ICCR) | |
| Irvine, California, United States, 92618 | |
| Los Angeles Clinical Trials | |
| Los Angeles, California, United States, 90064 | |
| Apexute | |
| Santa Ana, California, United States, 92705 | |
| United States, Florida | |
| Clinical Research of South Florida | |
| Coral Gables, Florida, United States, 33134 | |
| Radiant Research | |
| Stuart, Florida, United States, 34996 | |
| United States, Illinois | |
| nTouch Research | |
| Peoria, Illinois, United States, 61602 | |
| United States, Indiana | |
| nTouch Research | |
| South Bend, Indiana, United States, 46601 | |
| United States, Kentucky | |
| Bluegrass Clinical Research, Inc. | |
| Louisville, Kentucky, United States, 40291 | |
| United States, Maryland | |
| Johns Hopkins Women's Research Core | |
| Lutherville, Maryland, United States, 21093 | |
| United States, Massachusetts | |
| Baystate Medical Center | |
| Springfield, Massachusetts, United States, 01199 | |
| United States, Minnesota | |
| Twin Cities Clinical Research | |
| Arden Hills, Minnesota, United States, 55126 | |
| Radiant Research | |
| Edina, Minnesota, United States, 55435 | |
| United States, Nebraska | |
| Women's Clinic of Lincoln, PC | |
| Lincoln, Nebraska, United States, 68510 | |
| United States, New Mexico | |
| New Mexico Clinical Research & Osteoporosis Center, Inc. | |
| Albuquerque, New Mexico, United States, 87106 | |
| United States, North Dakota | |
| Clinical Research Services | |
| Bismarck, North Dakota, United States, 58501 | |
| United States, Ohio | |
| University of Cincinnati College of Medicine | |
| Cincinnati, Ohio, United States, 45267-0559 | |
| United States, Pennsylvania | |
| Altoona Center for Clinical Research | |
| Duncansville, Pennsylvania, United States, 16635 | |
| Clinical Research Division | |
| Newtown, Pennsylvania, United States, 18940 | |
| Clinical Research Center of Reading, LLC | |
| West Reading, Pennsylvania, United States, 19611-1124 | |
| United States, South Carolina | |
| Medical University of South Carolina, Division of Clinical Pharmacology | |
| Charleston, South Carolina, United States, 29425 | |
| United States, Tennessee | |
| Nashville Medical Research Institute | |
| Nashville, Tennessee, United States, 37205 | |
| United States, Utah | |
| Radiant Research | |
| Salt Lake City, Utah, United States, 84111 | |
| United States, Virginia | |
| Clinical Research Center of Northern Virginia | |
| Falls Church, Virginia, United States, 22044 | |
| Hunter Holmes McGuire Medical Center Research Service (151) | |
| Richmond, Virginia, United States, 23249 | |
| United States, Washington | |
| Vancouver Medical Weight Loss Clinic | |
| Vancouver, Washington, United States, 98685 | |
| United States, West Virginia | |
| Addiction & Psychiatric Medicine Research | |
| Morgantown, West Virginia, United States, 26506-9300 | |
| Australia | |
| Sanofi-aventis Administrative Office | |
| Macquarie Park, Australia | |
| Canada | |
| Sanofi-aventis Administrative Office | |
| Laval, Canada | |
| Finland | |
| Sanofi-aventis Administrative Office | |
| Helsinki, Finland | |
| Italy | |
| Sanofi-aventis Administrative Office | |
| Milano, Italy | |
| Spain | |
| Sanofi-aventis Administrative Office | |
| Barcelona, Spain | |
| Sweden | |
| Sanofi-aventis Administrative Office | |
| Bromma, Sweden | |
| Switzerland | |
| Sanofi-aventis Administrative Office | |
| Geneva, Switzerland | |
Sponsors and Collaborators
Sanofi
Investigators
| Study Director: | ICD CSD | Sanofi |
More Information
Publications:
| Responsible Party: | ICD Study Director, sanofi-aventis |
| ClinicalTrials.gov Identifier: | NCT00029835 History of Changes |
| Other Study ID Numbers: | EFC4735 |
| Study First Received: | January 23, 2002 |
| Last Updated: | April 17, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Sanofi:
|
Obesity |
Additional relevant MeSH terms:
|
Obesity Dyslipidemias Overnutrition Nutrition Disorders Overweight |
Body Weight Signs and Symptoms Lipid Metabolism Disorders Metabolic Diseases |
ClinicalTrials.gov processed this record on June 17, 2013