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

This study has been terminated.
(Company decision taken in light of demands by certain national health authorities)
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00228176
First received: September 26, 2005
Last updated: July 17, 2009
Last verified: July 2009
  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 3

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


Further study details as provided by Sanofi:

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
Experimental: 1 Drug: rimonabant (SR141716)
oral administration
Placebo Comparator: 2 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Investigators
Study Chair: John JP Kastelein, MD Amsterdam Medical Center
  More Information

No publications provided by Sanofi

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: ICD, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00228176     History of Changes
Other Study ID Numbers: EFC5828
Study First Received: September 26, 2005
Last Updated: July 17, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi:
Metabolic syndrome
Carotid Atherosclerosis

Additional relevant MeSH terms:
Arteriosclerosis
Atherosclerosis
Obesity
Metabolic Syndrome X
Carotid Stenosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Rimonabant
Cannabinoid Receptor Antagonists
Cannabinoid Receptor Modulators
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on August 28, 2014