Clinical trial NCT00029835: Obese Patients With Untreated Dyslipidemias
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Obesity
Dyslipidemia
Keywords: Obesity
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2002-01-24
Enrollment: 1033
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 untreated dyslipidemia


Eligibility 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)

Primary outcomes:
measure: Change from baseline in body weight at 1 year.
Secondary outcomes:
measure: Metabolic parameters
Other outcomes:
Locations:
city: Mesa
country: United States
facility: Clinic of Physicians and Surgeons, LTD
state: Arizona
city: Tucson
country: United States
facility: Arizona Clinical Research Center, Inc.
state: Arizona
city: Irvine
country: United States
facility: Irvine Center for Clinical Research (ICCR)
state: California
city: Los Angeles
country: United States
facility: Los Angeles Clinical Trials
state: California
city: Santa Ana
country: United States
facility: Apexute
state: California
city: Coral Gables
country: United States
facility: Clinical Research of South Florida
state: Florida
city: Stuart
country: United States
facility: Radiant Research
state: Florida
city: Peoria
country: United States
facility: nTouch Research
state: Illinois
city: South Bend
country: United States
facility: nTouch Research
state: Indiana
city: Louisville
country: United States
facility: Bluegrass Clinical Research, Inc.
state: Kentucky
city: Lutherville
country: United States
facility: Johns Hopkins Women's Research Core
state: Maryland
city: Springfield
country: United States
facility: Baystate Medical Center
state: Massachusetts
city: Arden Hills
country: United States
facility: Twin Cities Clinical Research
state: Minnesota
city: Edina
country: United States
facility: Radiant Research
state: Minnesota
city: Lincoln
country: United States
facility: Women's Clinic of Lincoln, PC
state: Nebraska
city: Albuquerque
country: United States
facility: New Mexico Clinical Research & Osteoporosis Center, Inc.
state: New Mexico
city: Bismarck
country: United States
facility: Clinical Research Services
state: North Dakota
city: Cincinnati
country: United States
facility: University of Cincinnati College of Medicine
state: Ohio
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
city: Newtown
country: United States
facility: Clinical Research Division
state: Pennsylvania
city: West Reading
country: United States
facility: Clinical Research Center of Reading, LLC
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina, Division of Clinical Pharmacology
state: South Carolina
city: Nashville
country: United States
facility: Nashville Medical Research Institute
state: Tennessee
city: Salt Lake City
country: United States
facility: Radiant Research
state: Utah
city: Falls Church
country: United States
facility: Clinical Research Center of Northern Virginia
state: Virginia
city: Richmond
country: United States
facility: Hunter Holmes McGuire Medical Center Research Service (151)
state: Virginia
city: Vancouver
country: United States
facility: Vancouver Medical Weight Loss Clinic
state: Washington
city: Morgantown
country: United States
facility: Addiction & Psychiatric Medicine Research
state: West Virginia
city: Macquarie Park
country: Australia
facility: Sanofi-aventis Administrative Office
city: Laval
country: Canada
facility: Sanofi-aventis Administrative Office
city: Helsinki
country: Finland
facility: Sanofi-aventis Administrative Office
city: Milano
country: Italy
facility: Sanofi-aventis Administrative Office
city: Barcelona
country: Spain
facility: Sanofi-aventis Administrative Office
city: Bromma
country: Sweden
facility: Sanofi-aventis Administrative Office
city: Geneva
country: Switzerland
facility: Sanofi-aventis Administrative Office
Study officials:
affiliation: Sanofi
name: ICD CSD
role: STUDY_DIRECTOR
References:
citation: Despres JP, Golay A, Sjostrom L; Rimonabant in Obesity-Lipids Study Group. Effects of rimonabant on metabolic risk factors in overweight patients with dyslipidemia. N Engl J Med. 2005 Nov 17;353(20):2121-34. doi: 10.1056/NEJMoa044537.