Status:
TERMINATED
Atherosclerosis Underlying Development Assessed by Intima-Media Thickness in Patients on Rimonabant
Lead Sponsor:
Sanofi
Conditions:
Carotid Artery Plaque
Arteriosclerosis
Eligibility:
All Genders
55+ years
Phase:
PHASE3
Brief 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 ...
Detailed Description
This is a Phase III, prospective, multicentre, multinational, randomized, double-blind, placebo-controlled, 2-arm parallel group trial (rimonabant 20-mg od vs placebo). There will be a three-stage scr...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
661 Patients enrolled
Trial Details
Trial ID
NCT00228176
Start Date
August 1 2005
End Date
April 1 2009
Last Update
May 20 2016
Active Locations (6)
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1
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
2
Sanofi-Aventis Administrative Office
Laval, Canada
3
Sanofi-Aventis Administrative Office
Paris, France
4
Sanofi-Aventis Administrative Office
Gouda, Netherlands