Atherosclerosis Underlying Development Assessed by Intima-Media Thickness in Patients on Rimonabant (Auditor) - Full Text View

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00228176

Purpose

Objectives:

Primary: To evaluate the effect of rimonabant 20-mg once daily in comparison with placebo, on the quantitative progression of atherosclerosis as assessed by carotid artery intima-media thickness (CIMT)
Secondary: To evaluate the safety and tolerability of the above rimonabant regimen in the study population of atherosclerosis patients.

Condition	Intervention	Phase
Carotid Artery Plaque Arteriosclerosis Obesity Metabolic Syndrome X	Drug: rimonabant (SR141716) Drug: placebo	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Randomized, Multicenter, Double-blind, Placebo-controlled, Two-arm Parallel Group Trial of Rimonabant 20-mg od, for Inhibition of Atherosclerosis Progression Assessed by Carotid Artery Intima-media Thickness (CIMT), in Overweight Patients With Additional Risk Factors

Resource links provided by NLM:

MedlinePlus related topics: Metabolic Syndrome Obesity

Drug Information available for: SR 141716A Rimonabant

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Average absolute change in CIMT in mm per subject from Baseline [ Time Frame: Month 30 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

First occurrence of any component of stroke/myocardial infarction (MI)/cardiovascular death [ Time Frame: study period ] [ Designated as safety issue: No ]
First occurrence of any component of stroke/MI/cardiovascular death/hospitalization for revascularization procedure, unstable angina, transient ischemic attack (TIA) [ Time Frame: study period ] [ Designated as safety issue: No ]

Enrollment:	661
Study Start Date:	August 2005
Study Completion Date:	April 2009
Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: rimonabant (SR141716) oral administration
2: Placebo Comparator	Drug: placebo oral administration

Detailed Description:

This is a Phase III, prospective, multicentre, multinational, randomized, double-blind, placebo-controlled, 2-arm parallel group trial (rimonabant 20-mg od vs placebo). There will be a three-stage screening process including successively a Screening visit, a Screening CIMT and a validation of the Screening CIMT by the Imaging Core Laboratory. Patients complying with all inclusion and exclusion criteria will be randomized in one of the 2 treatment groups less than two weeks after Screening visit. Study drug (rimonabant 20 mg od or matching placebo) will be administered during 30 to 32 months. At inclusion, patients will be counseled to follow a mild hypocaloric diet, to increase their exercise level, and to stop smoking (if smokers). Glucose/lipid parameters will be assessed at Baseline and every 6 months until the Month 30 visit. CIMT will be performed at Baseline and every 6 months until final assessment at Month 30 (primary endpoint).A post-treatment follow-up visit at Month 35 will allow the collection of all adverse events and cardiovascular outcomes occurring after last study drug administration

Eligibility

Ages Eligible for Study:	55 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Written and signed informed consent
Age greater than or equal to 55 years
Abdominal obesity defined by waist circumference > 88 cm (35 inches) in women and > 102 cm (40 inches) in men
Metabolic syndrome diagnosed on the basis of at least two of the following additional risk factors:
1. Triglyceride level equal to or greater than 150 mg/dL
2. HDL cholesterol less than 40 mg/dL in men or 50 mg/dL in women
3. Fasting glucose of equal to or greater than 110 mg/dL
4. High blood pressure defined as equal to or greater than 140 mmHg systolic and/or equal to or greater than 90 mmHg diastolic at screening visit or current treatment by antihypertensive medication.
Ultrasonographic evidence at Screening quantitative B-mode ultrasound imaging of a minimal CIMT measurement of greater than or equal to 0.7 mm in either of the far walls of the common carotid artery, and maximal CIMT measurement less than 3 mm in any carotid artery segment.
All 6 carotid artery segments must have ultrasound images for all CIMT measurements
Screening CIMT recording deemed to be of acceptable CIMT image quality, and demonstrating adherence to the CIMT interrogation protocol, as determined by the Imaging Core Laboratory's assessment.

Exclusion Criteria:

History of very low calorie diet or surgical procedures for weight loss within 6 months prior to screening visit
Obesity of known endocrine origin
Uncontrolled diabetes, i.e. with HbA1c > 10%
Anticipated survival less than 27 months
Presence of any severe medical or psychological condition, that in the opinion of the Investigator, would compromise the subject's safety or successful participation in the study
Presence of any other condition (e.g. geographic, social, or other), actual or anticipated, that the Investigator feels would restrict or limit the subject's participation for the duration of the study
Receipt of any investigational treatment (drug or device) within 30 days prior to Screening
Previous participation in a rimonabant study
Total occlusion of any carotid artery segment
Previous history of carotid intervention
Patient considered at high risk of carotid intervention during the next 27 months

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00228176

Locations

United States, New Jersey
Sanofi-aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
Canada
Sanofi-aventis Administrative Office
Laval, Canada
France
Sanofi-aventis Administrative Office
Paris, France
Netherlands
Sanofi-aventis Administrative Office
Gouda, Netherlands
Spain
Sanofi-aventis Administrative Office
Barcelona, Spain
United Kingdom
Sanofi-aventis Administrative Office
Guildford Surrey, United Kingdom

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Chair:

John JP Kastelein, MD

Amsterdam Medical Center

More Information

No publications provided

Responsible Party:	sanofi-aventis ( ICD )
Study ID Numbers:	EFC5828
Study First Received:	September 26, 2005
Last Updated:	July 17, 2009
ClinicalTrials.gov Identifier:	NCT00228176 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Sanofi-Aventis:

Metabolic syndrome
Carotid Atherosclerosis

Study placed in the following topic categories:

Atherosclerosis
Arterial Occlusive Diseases
Obesity
Metabolic Diseases
Metabolic Syndrome X
Disease Progression
Vascular Diseases
Central Nervous System Diseases
Overweight
Constriction, Pathologic
Arteriosclerosis
Brain Diseases

Cerebrovascular Disorders
Abdominal Obesity Metabolic Syndrome
Body Weight
Hyperinsulinism
Signs and Symptoms
Carotid Stenosis
Nutrition Disorders
Overnutrition
Insulin Resistance
Carotid Artery Diseases
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:

Atherosclerosis
Overweight
Arteriosclerosis
Brain Diseases
Cerebrovascular Disorders
Body Weight
Signs and Symptoms
Hyperinsulinism
Pathologic Processes
Syndrome
Nutrition Disorders
Cardiovascular Diseases
Arterial Occlusive Diseases

Obesity
Metabolic Syndrome X
Disease
Metabolic Diseases
Nervous System Diseases
Vascular Diseases
Central Nervous System Diseases
Carotid Stenosis
Overnutrition
Insulin Resistance
Glucose Metabolism Disorders
Carotid Artery Diseases

ClinicalTrials.gov processed this record on September 03, 2009