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

Primary Purpose

Carotid Artery Plaque, Arteriosclerosis, Obesity

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Rimonabant
Placebo (for Rimonabant)
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carotid Artery Plaque focused on measuring Metabolic syndrome, Carotid Atherosclerosis

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Criteria: 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

Sites / Locations

  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Rimonabant

Placebo

Arm Description

Rimonabant 20 mg once daily

Placebo (for Rimonabant) once daily.

Outcomes

Primary Outcome Measures

Absolute change from baseline in averaged per patient carotid artery intima-media thickness (CIMT)

Secondary Outcome Measures

First occurrence of any component of stroke/myocardial infarction (MI)/cardiovascular death
First occurrence of any component of stroke/MI/cardiovascular death/hospitalization for revascularization procedure, unstable angina, transient ischemic attack (TIA)

Full Information

First Posted
September 26, 2005
Last Updated
April 21, 2016
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00228176
Brief Title
Atherosclerosis Underlying Development Assessed by Intima-Media Thickness in Patients on Rimonabant
Acronym
AUDITOR
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Terminated
Why Stopped
Company decision taken in light of demands by certain national health authorities
Study Start Date
August 2005 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
April 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 thickness (CIMT) Secondary: To evaluate the safety and tolerability of the above rimonabant regimen in the study population of atherosclerosis patients.
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 screening process including successively a Screening visit, a Screening CIMT and a validation of the Screening CIMT by the Imaging Core Laboratory. Patients complying with all inclusion and exclusion criteria will be randomized in one of the 2 treatment groups less than two weeks after Screening visit. Study drug (rimonabant 20 mg od or matching placebo) will be administered during 30 to 32 months. At inclusion, patients will be counseled to follow a mild hypocaloric diet, to increase their exercise level, and to stop smoking (if smokers). Glucose/lipid parameters will be assessed at Baseline and every 6 months until the Month 30 visit. CIMT will be performed at Baseline and every 6 months until final assessment at Month 30 (primary endpoint).A post-treatment follow-up visit at Month 35 will allow the collection of all adverse events and cardiovascular outcomes occurring after last study drug administration

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carotid Artery Plaque, Arteriosclerosis, Obesity, Metabolic Syndrome X
Keywords
Metabolic syndrome, Carotid Atherosclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
661 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rimonabant
Arm Type
Experimental
Arm Description
Rimonabant 20 mg once daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo (for Rimonabant) once daily.
Intervention Type
Drug
Intervention Name(s)
Rimonabant
Other Intervention Name(s)
SR141716, Acomplia
Intervention Description
Tablet, oral administration
Intervention Type
Drug
Intervention Name(s)
Placebo (for Rimonabant)
Intervention Description
Tablet, oral administration
Primary Outcome Measure Information:
Title
Absolute change from baseline in averaged per patient carotid artery intima-media thickness (CIMT)
Time Frame
Month 30
Secondary Outcome Measure Information:
Title
First occurrence of any component of stroke/myocardial infarction (MI)/cardiovascular death
Time Frame
From randomization to Month 35
Title
First occurrence of any component of stroke/MI/cardiovascular death/hospitalization for revascularization procedure, unstable angina, transient ischemic attack (TIA)
Time Frame
From randomization to Month 35

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John JP Kastelein, MD
Organizational Affiliation
Amsterdam UMC, location VUmc
Official's Role
Study Chair
Facility Information:
Facility Name
Sanofi-Aventis Administrative Office
City
Bridgewater
State/Province
New Jersey
ZIP/Postal Code
08807
Country
United States
Facility Name
Sanofi-Aventis Administrative Office
City
Laval
Country
Canada
Facility Name
Sanofi-Aventis Administrative Office
City
Paris
Country
France
Facility Name
Sanofi-Aventis Administrative Office
City
Gouda
Country
Netherlands
Facility Name
Sanofi-Aventis Administrative Office
City
Barcelona
Country
Spain
Facility Name
Sanofi-Aventis Administrative Office
City
Guildford Surrey
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
21610270
Citation
O'Leary DH, Reuwer AQ, Nissen SE, Despres JP, Deanfield JE, Brown MW, Zhou R, Zabbatino SM, Job B, Kastelein JJ, Visseren FL; AUDITOR investigators. Effect of rimonabant on carotid intima-media thickness (CIMT) progression in patients with abdominal obesity and metabolic syndrome: the AUDITOR Trial. Heart. 2011 Jul;97(14):1143-50. doi: 10.1136/hrt.2011.223446. Epub 2011 May 24.
Results Reference
result

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Atherosclerosis Underlying Development Assessed by Intima-Media Thickness in Patients on Rimonabant

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