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Atherosclerosis Underlying Development Assessed by Intima-Media Thickness in Patients on Rimonabant (AUDITOR Trial)

Phase 3
Waitlist Available
Research Sponsored by Sanofi
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
All Individual Drugs Already Approved
Pivotal Trial

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
  • Atherosclerosis
  • Obesity
  • Metabolic Syndrome
  • Arteriosclerosis
  • Hardening of the Arteries

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

Find a Location

Who is running the clinical trial?

SanofiLead Sponsor
2,215 Previous Clinical Trials
4,046,469 Total Patients Enrolled
21 Trials studying Obesity
15,809 Patients Enrolled for Obesity
John JP Kastelein, MDStudy ChairAmsterdam UMC, location VUmc
~33 spots leftby Dec 2025
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