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

• Status: Terminated
• Trial end date: 2009-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Rimonabant

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