NCT00029835

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

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,033

participants targeted

Target at P75+ for phase_3 obesity

Timeline
Completed

Started Sep 2001

Geographic Reach
8 countries

35 active sites

Status
completed

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

September 1, 2001

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 23, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 24, 2002

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2003

Completed
Last Updated

April 20, 2009

Status Verified

April 1, 2009

Enrollment Period

2.2 years

First QC Date

January 23, 2002

Last Update Submit

April 17, 2009

Conditions

Keywords

Obesity

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in body weight at 1 year.

Secondary Outcomes (1)

  • Metabolic parameters

Interventions

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
* 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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (35)

Clinic of Physicians and Surgeons, LTD

Mesa, Arizona, 85201, United States

Location

Arizona Clinical Research Center, Inc.

Tucson, Arizona, 85712, United States

Location

Irvine Center for Clinical Research (ICCR)

Irvine, California, 92618, United States

Location

Los Angeles Clinical Trials

Los Angeles, California, 90064, United States

Location

Apexute

Santa Ana, California, 92705, United States

Location

Clinical Research of South Florida

Coral Gables, Florida, 33134, United States

Location

Radiant Research

Stuart, Florida, 34996, United States

Location

nTouch Research

Peoria, Illinois, 61602, United States

Location

nTouch Research

South Bend, Indiana, 46601, United States

Location

Bluegrass Clinical Research, Inc.

Louisville, Kentucky, 40291, United States

Location

Johns Hopkins Women's Research Core

Lutherville, Maryland, 21093, United States

Location

Baystate Medical Center

Springfield, Massachusetts, 01199, United States

Location

Twin Cities Clinical Research

Arden Hills, Minnesota, 55126, United States

Location

Radiant Research

Edina, Minnesota, 55435, United States

Location

Women's Clinic of Lincoln, PC

Lincoln, Nebraska, 68510, United States

Location

New Mexico Clinical Research & Osteoporosis Center, Inc.

Albuquerque, New Mexico, 87106, United States

Location

Clinical Research Services

Bismarck, North Dakota, 58501, United States

Location

University of Cincinnati College of Medicine

Cincinnati, Ohio, 45267-0559, United States

Location

Altoona Center for Clinical Research

Duncansville, Pennsylvania, 16635, United States

Location

Clinical Research Division

Newtown, Pennsylvania, 18940, United States

Location

Clinical Research Center of Reading, LLC

West Reading, Pennsylvania, 19611-1124, United States

Location

Medical University of South Carolina, Division of Clinical Pharmacology

Charleston, South Carolina, 29425, United States

Location

Nashville Medical Research Institute

Nashville, Tennessee, 37205, United States

Location

Radiant Research

Salt Lake City, Utah, 84111, United States

Location

Clinical Research Center of Northern Virginia

Falls Church, Virginia, 22044, United States

Location

Hunter Holmes McGuire Medical Center Research Service (151)

Richmond, Virginia, 23249, United States

Location

Vancouver Medical Weight Loss Clinic

Vancouver, Washington, 98685, United States

Location

Addiction & Psychiatric Medicine Research

Morgantown, West Virginia, 26506-9300, United States

Location

Sanofi-aventis Administrative Office

Macquarie Park, Australia

Location

Sanofi-aventis Administrative Office

Laval, Canada

Location

Sanofi-aventis Administrative Office

Helsinki, Finland

Location

Sanofi-aventis Administrative Office

Milan, Italy

Location

Sanofi-aventis Administrative Office

Barcelona, Spain

Location

Sanofi-aventis Administrative Office

Bromma, Sweden

Location

Sanofi-aventis Administrative Office

Geneva, Switzerland

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

ObesityDyslipidemias

Interventions

Rimonabant

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsLipid Metabolism DisordersMetabolic Diseases

Intervention Hierarchy (Ancestors)

PyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPiperidines

Study Officials

  • ICD CSD

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 23, 2002

First Posted

January 24, 2002

Study Start

September 1, 2001

Primary Completion

November 1, 2003

Study Completion

November 1, 2003

Last Updated

April 20, 2009

Record last verified: 2009-04

Locations