Overweight patients with additional risk factors. Atherosclerosis progression assessed by carotid artery intima-media thickness (CIMT). MedDRA version: 7.1 Level: LLT Classification code 10003601
Conditions
Sponsors
Sanofi-Synthelabo Recherche
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Written and signed informed consent • Age = 55 years • Abdominal obesity defined by waist circumference > 88 cm (35 inches) in women or > 102 cm (40 inches) in men • Metabolic syndrome diagnosed on the basis of at least two of the following additional risk factors: - Triglyceride level = 150 mg/dL (1.69 mmol/L) - HDL cholesterol =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • History of very low-calorie diet or surgical procedures for weight loss (eg, stomach stapling, bypass) within 6 months prior to Screening visit • Obesity of known endocrine origin • Uncontrolled diabetes, ie with HbA1c >10% • Anticipated survival < 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…) actual or anticipated, that the Investigator feels that 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 (carotid surgery, percutaneous carotid intervention…) • Patient considered at high risk of carotid intervention during the next 27 months (eg presence of ulcerative plaque or hemodynamically significant stenosis) • Pathology in near and / or far wall that causes acoustic shadowing of far wall CIMT in any arterial segment • Inability to define the carotid flow divider on either side • Anatomic variables (e.g., obscured vessels due to the mandibular angle, too deep or tortuous vessels) making CIMT measurement impossible in any arterial segment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect of rimonabant 20-mg once daily in comparison with placebo, on the quantitative progression of atherosclerosis as assessed by CIMT.;Secondary Objective: To evaluate the safety and tolerability of the above rimonabant regimen in the study population of atherosclerotic patients.;Primary end point(s): The primary efficacy endpoint is the absolute change in averaged per subject CIMT in mm from Baseline to Month 24. | — |
Countries
Spain, United Kingdom
Outcome results
None listed