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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00029848
Other study ID # EFC4736
Secondary ID
Status Completed
Phase Phase 3
First received January 23, 2002
Last updated April 17, 2009
Start date October 2001
Est. completion date May 2004

Study information

Verified date April 2009
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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 Type 2 Diabetes


Recruitment information / eligibility

Status Completed
Enrollment 1045
Est. completion date May 2004
Est. primary completion date May 2004
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility - BMI must be greater than 27 and less than 40

- Treated Type 2 Diabetes on single therapy treatment for at least 1 year

- Stable weight (variation of less than 5 kg within 3 months prior to screening visit)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Rimonabant (SR141716)


Locations

Country Name City State
Argentina Sanofi-aventis Administrative Office Buenos Aires
Belgium Sanofi-aventis Administrative Office Diegem
Canada Sanofi-aventis Administrative Office Laval
Czech Republic Sanofi-aventis Administrative Office Praha
Finland Sanofi-aventis Administrative Office Helsinki
France Sanofi-aventis Administrative Office Paris
Germany Sanofi-aventis Administrative Office Berlin
Netherlands Sanofi-aventis Administrative Office Gouda
Poland Sanofi-aventis Administrative office Warszawa
United Kingdom Sanofi-aventis Administrative Office Guildford Surrey
United States Lovelace Scientific Resources Albuquerque New Mexico
United States Twin Cities Clinical Research Arden Hills Minnesota
United States Androscoggin Cardiology Associates Auburn Maine
United States CSRA Partners in Health, Inc. Augusta Georgia
United States Innovative Clinical Trials Birmingham Alabama
United States TriCities Medical Reseach Bristol Tennessee
United States Medical University of South Carolina, Division of Clinical Pharmacology Charleston South Carolina
United States Center for Nutrition and Preventive Medicine Charlotte North Carolina
United States MFP Research, Inc. Cincinnati Ohio
United States Radiant Research Cincinnati Ohio
United States Clinical Research of South Florida Coral Gables Florida
United States Endocrinology and Diabetes Consultants, PC Dover New Hampshire
United States Southern California Prevention and Research Center Inc. (SPARC) Encino California
United States MediSphere Medical Research Center, LLC Evansville Indiana
United States Phase III Clinical Research Fall River Massachusetts
United States North East Clinical Research Hamden Connecticut
United States Physicians Research Group Indianapolis Indiana
United States Jackson Downey, MD Jacksonville Florida
United States Jacksonville Center for Clinical Research Jacksonville Florida
United States Jacksonville Center for Clinical Research Jacksonville Florida
United States Kansas University Medical Center Kansas City Kansas
United States Gulf States Clinical Trails, LLC Kenner Louisiana
United States DMI Helathcare Group Largo Florida
United States Lovelace Scientific Resources Las Vegas Nevada
United States nTouch Research Marietta Georgia
United States Radiant Reseach-Moorestown Moorestown New Jersey
United States Costal Carolina Research Center Mt. Pleasant South Carolina
United States Endocrine and Diabetes Ogden Utah
United States University of Oklahoma Health Sciences Center Oklahoma City Oklahoma
United States Orlando Clinical Research Center Orlando Florida
United States University Clinical Research Pembroke Pines Florida
United States Lovelace Scientific Resources Phoenix Arizona
United States Radiant Research Portland Oregon
United States National Clinical Research Richmond Virginia
United States Salem Veterans Affairs Medical Center (151) Salem Virginia
United States Diabetes $ Glandular Disease Clinic, PA San Antonio Texas
United States Anderson Clinical Research San Bernardino California
United States Comprehensive NeuroScience, Inc. Sarasota Florida
United States Medical Research Institute Slidell Louisiana
United States JM Clinical Trials, Inc. Swansea Massachusetts
United States Advanced Clinicla Therapeutics, LLC Tucson Arizona
United States The Chase Wellness Center, Inc. Virginia Beach Virginia
United States Diablo Clinical Research, Inc. Walnut Creek California
United States Metabolic Research Institute West Palm Beach Florida
United States Physician Clinical Research Service White Plains New York

Sponsors (1)

Lead Sponsor Collaborator
Sanofi

Countries where clinical trial is conducted

United States,  Argentina,  Belgium,  Canada,  Czech Republic,  Finland,  France,  Germany,  Netherlands,  Poland,  United Kingdom, 

References & Publications (1)

Scheen AJ, Finer N, Hollander P, Jensen MD, Van Gaal LF; RIO-Diabetes Study Group. Efficacy and tolerability of rimonabant in overweight or obese patients with type 2 diabetes: a randomised controlled study. Lancet. 2006 Nov 11;368(9548):1660-72. Erratum — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change in body weight
Secondary Metabolic parameters
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