Carotid Artery PlaquePhase 3AUDITORNCT00228176
Atherosclerosis Underlying Development Assessed by Intima-Media Thickness in Patients on Rimonabant
A Phase 3 study testing Rimonabant in people with Carotid Artery Plaque and Arteriosclerosis, run by Sanofi at 6 sites in 6 countries.
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… Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Carotid Artery Plaque, Arteriosclerosis, Obesity
- What is being tested?
- Rimonabant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 661 participants
- Where
- 6 sitesin 6 countries
- Study dates
- Aug 2005to Apr 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
6 sites in 6 countries.
6 sites in 6 countries
United States1 site
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, 08807
United Kingdom1 site
Sanofi-Aventis Administrative Office
Guildford Surrey
About this study
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
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.
Read the 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
- Conditions
- Carotid Artery Plaque, Arteriosclerosis, Obesity, Metabolic Syndrome X
- Being tested
- Rimonabant, Placebo (for Rimonabant)
- Keywords
- Metabolic syndrome, Carotid Atherosclerosis
- Medical subject headings
- Carotid Stenosis, Arteriosclerosis, Obesity, Metabolic Syndrome, Carotid Artery Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RimonabantDrug
Also called SR141716, Acomplia
Tablet, oral administration
Placebo (for Rimonabant)Drug
Tablet, oral administration
| Study group | Role | What they receive |
|---|---|---|
| Rimonabant | Experimental | Rimonabant 20 mg once daily Receives: Drug: Rimonabant |
| Placebo | Placebo comparator | Placebo (for Rimonabant) once daily. Receives: Drug: Placebo (for Rimonabant) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute change from baseline in averaged per patient carotid artery intima-media thickness (CIMT)
Measured: Month 30
Secondary outcomes (2)
First occurrence of any component of stroke/myocardial infarction (MI)/cardiovascular death
Measured: From randomization to Month 35
First occurrence of any component of stroke/MI/cardiovascular death/hospitalization for revascularization procedure, unstable angina, transient ischemic attack (TIA)
Measured: From randomization to Month 35
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2005 (estimated)
- Study startAug 2005
- Primary completionApr 2009
- Study completionApr 2009
Why it stopped: Company decision taken in light of demands by certain national health authorities
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Carotid Artery PlaqueStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 661 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John JP Kastelein, MD, Study chair, Amsterdam UMC, location VUmc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00228176
- Sponsor's protocol ID
- EFC5828
- Other IDs
- 2005-001612-49, 2005
- Acronym
- AUDITOR
- Status last verified
- Apr 2016
- First submitted
- 26 Sep 2005
- Last updated
- 20 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 21610270
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00228176
- Acronym / sponsor ID
- AUDITOR / EFC5828
- Conditions
- Carotid Artery Plaque, Arteriosclerosis, Obesity, Metabolic Syndrome X
- Keywords
- Metabolic syndrome, Carotid Atherosclerosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Company decision taken in light of demands by certain national health authorities
- Enrolment
- 661 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Aug 2005
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 28 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rimonabant | Experimental | Drug: RimonabantRimonabant 20 mg once daily |
| Placebo | Placebo comparator | Drug: Placebo (for Rimonabant)Placebo (for Rimonabant) once daily. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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:
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RimonabantAlso: SR141716, AcompliaTablet, oral administration | Drug | Rimonabant |
| Placebo (for Rimonabant)Tablet, oral administration | Drug | Placebo |
Primary outcome
Absolute change from baseline in averaged per patient carotid artery intima-media thickness (CIMT)
Time frame: Month 30
2 secondary outcomes
First occurrence of any component of stroke/myocardial infarction (MI)/cardiovascular death
Time frame: From randomization to Month 35
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
Results and safety
The study was stopped early (reason given: Company decision taken in light of demands by certain national health authorities). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2016.
- Results publication: PubMed 21610270O'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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John JP Kastelein, MD study chair
Amsterdam UMC, location VUmc
6 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rimonabant in people with Carotid Artery Plaque and Arteriosclerosis, run by Sanofi at 6 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Canada, France, Netherlands, Spain and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Company decision taken in light of demands by certain national health authorities). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute change from baseline in averaged per patient carotid artery intima-media thickness (CIMT) (time frame: Month 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00228176, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2016.