Atherosclerosis Underlying Development Assessed by Intima-Media Thickness in Patients on Rimonabant (AUDITOR)
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ClinicalTrials.gov Identifier: NCT00228176 |
Recruitment Status :
Terminated
(Company decision taken in light of demands by certain national health authorities)
First Posted : September 28, 2005
Last Update Posted : May 20, 2016
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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 or disease | Intervention/treatment | Phase |
---|---|---|
Carotid Artery Plaque Arteriosclerosis Obesity Metabolic Syndrome X | Drug: Rimonabant Drug: Placebo (for Rimonabant) | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 661 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
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 |
Study Start Date : | August 2005 |
Actual Primary Completion Date : | April 2009 |
Actual Study Completion Date : | April 2009 |

Arm | Intervention/treatment |
---|---|
Experimental: Rimonabant
Rimonabant 20 mg once daily
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Drug: Rimonabant
Tablet, oral administration
Other Names:
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Placebo Comparator: Placebo
Placebo (for Rimonabant) once daily.
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Drug: Placebo (for Rimonabant)
Tablet, oral administration |
- Absolute change from baseline in averaged per patient carotid artery intima-media thickness (CIMT) [ Time Frame: Month 30 ]
- First occurrence of any component of stroke/myocardial infarction (MI)/cardiovascular death [ Time Frame: From randomization to Month 35 ]
- First occurrence of any component of stroke/MI/cardiovascular death/hospitalization for revascularization procedure, unstable angina, transient ischemic attack (TIA) [ Time Frame: From randomization to Month 35 ]

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Ages Eligible for Study: | 55 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
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Metabolic syndrome diagnosed on the basis of at least two of the following additional risk factors:
- Triglyceride level equal to or greater than 150 mg/dL
- HDL cholesterol less than 40 mg/dL in men or 50 mg/dL in women
- Fasting glucose of equal to or greater than 110 mg/dL
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00228176
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 |
Study Chair: | John JP Kastelein, MD | Amsterdam UMC, location VUmc |
Responsible Party: | Sanofi |
ClinicalTrials.gov Identifier: | NCT00228176 |
Other Study ID Numbers: |
EFC5828 2005-001612-49 ( EudraCT Number ) |
First Posted: | September 28, 2005 Key Record Dates |
Last Update Posted: | May 20, 2016 |
Last Verified: | April 2016 |
Metabolic syndrome Carotid Atherosclerosis |
Carotid Stenosis Atherosclerosis Arteriosclerosis Metabolic Syndrome Insulin Resistance Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases Carotid Artery Diseases Cerebrovascular Disorders |
Brain Diseases Central Nervous System Diseases Nervous System Diseases Rimonabant Anti-Obesity Agents Cannabinoid Receptor Antagonists Cannabinoid Receptor Modulators Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |