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 - AUDITOR
- Conditions
- Overweight patients with additional risk factors. Atherosclerosis progression assessed by carotid artery intima-media thickness (CIMT).MedDRA version: 7.1Level: LLTClassification code 10003601
- Registration Number
- EUCTR2005-001612-49-GB
- Lead Sponsor
- Sanofi-Synthelabo Recherche
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 600
• 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 < 40 mg/dL (1.03 mmol/L)
[men] or 50 mg/dL (1.28 mmol/L) [women]
- Fasting glucose = 110 mg/dL (6.1 mmol/L)
- High blood pressure (= 140 mmHg systolic
and/or = 90 mmHg diastolic) at Screening
visit, or current treatment by anti-hypertensive
medication
• Ultrasonographic evidence at Screening
quantitative B-mode ultrasound imaging of a
minimal CIMT measurement = 0.7 mm in either of
the far walls of the common carotid artery, and
maximal CIMT measurement < 3 mm in any
carotid artery segment
• All 6 carotid artery segment B-mode ultrasound
images must allow for 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
• 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.<br><br>
- Secondary Outcome Measures
Name Time Method