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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
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.
Eligible Conditions
- Obesity
- Metabolic Syndrome
- Hardening of the Arteries
- Carotid Artery Plaque
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: RimonabantExperimental Treatment1 Intervention
Rimonabant 20 mg once daily
Group II: PlaceboPlacebo Group1 Intervention
Placebo (for Rimonabant) once daily.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rimonabant
FDA approved
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Who is running the clinical trial?
SanofiLead Sponsor
2,188 Previous Clinical Trials
4,032,513 Total Patients Enrolled
21 Trials studying Obesity
15,809 Patients Enrolled for Obesity
John JP Kastelein, MDStudy ChairAmsterdam UMC, location VUmc
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