Atherosclerosis Underlying Development Assessed by Intima-Media Thickness in Patients on Rimonabant (AUDITOR)
Carotid Artery Plaque, Arteriosclerosis, Obesity
About this trial
This is an interventional treatment trial for Carotid Artery Plaque focused on measuring Metabolic syndrome, Carotid Atherosclerosis
Eligibility 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: 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
Sites / Locations
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Rimonabant
Placebo
Rimonabant 20 mg once daily
Placebo (for Rimonabant) once daily.