- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00124332
STRADIVARIUS (Strategy To Reduce Atherosclerosis Development InVolving Administration of Rimonabant - the Intravascular Ultrasound Study)
April 17, 2009 updated by: Sanofi
Randomized, Multicenter, Double-Blind, Placebo-Controlled, Two-Arm Parallel Group Trial of Rimonabant 20-mg od, for Inhibition of Atherosclerosis Progression Assessed by IVUS (IntraVascular UltraSounds), in Overweight Patients With Clustering Risk Factors
The purpose of this study is to determine if rimonabant 20 mg once daily (od) administered during 18-20 months will reduce progression of coronary atherosclerosis as assessed by intravascular ultrasound (IVUS) when administered on top of standard behavioral and pharmacological therapy given as needed, in patients with abdominal obesity associated with current smoking and/or metabolic syndrome.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
839
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Macquarie Park, Australia
- sanofi-aventis, Australia
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Diegem, Belgium
- sanofi-aventis, Belgium
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Laval, Canada
- Sanofi-Aventis Administrative Office
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Paris, France
- Sanofi-Aventis, France
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Milano, Italy
- sanofi-aventis Italy
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Gouda, Netherlands
- sanofi-aventis, Netherlands
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Warszawa, Poland
- sanofi-aventis Poland
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Barcelona, Spain
- sanofi-aventis Spain
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Ohio
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Cleveland, Ohio, United States, 44195
- The Cleveland Clinic Foundation
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Written and signed informed consent
- Indication for coronary angiography
- Abdominal obesity defined by waist circumference > 88 cm in women or > 102 cm in men
- At least one of the two following conditions: *a) Metabolic syndrome as defined by the presence of at least two of the following additional risk factors: 1. Triglyceride level >= 150 mg/dL (1.69 mmol/L); 2. HDL cholesterol < 40 mg/dL (1.03 mmol/L) [men] or 50 mg/dL (1.28 mmol/L) [women]; 3. Fasting glucose >= 110 mg/dL (6.1 mmol/L); 4. High blood pressure (>= 140 mmHg systolic and/or >= 90 mmHg diastolic) at Screening visit, or current treatment by anti-hypertensive medication; *b) Currently smoking (> 10 cigarettes /day) and willing to stop
- Angiographic evidence of coronary heart disease as defined by at least 1 lesion in a native coronary artery that has >= 20% reduction in lumen diameter by angiographic visual estimation
- Presence of at least one coronary artery complying with the definition of "target vessel" for IVUS assessment
- Acceptation of the Baseline IVUS tape by the IVUS Core Laboratory
Exclusion Criteria:
- Age < 18 years
- Pregnant or breast-feeding women
- History of very low-calorie diet or surgical procedures for weight loss (eg, stomach stapling, bypass) within 6 months prior to screening visit
- Obesity of known endocrine origin
- Uncontrolled diabetes with HBA1c >10%
- 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
- Severe congestive heart failure (New York Heart Association [NYHA] Class III or IV)
- Clinically significant heart disease which in the opinion of the Investigator is likely to require coronary artery bypass graft (CABG), percutaneous coronary intervention (PCI), cardiac transplantation, surgical repair and/or replacement during the course of the study
- Angioplasty of a non-qualifying artery which is considered at high risk of acute complication or restenosis, during baseline catheterization
- >50% reduction in lumen diameter of the left main coronary artery by visual angiographic estimation
- Recent ST-elevation myocardial infarction (MI) <= 72 hours prior to randomization
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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change from baseline in percent atheroma volume (PAV)
Time Frame: Month 18 visit
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Month 18 visit
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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change from baseline in normalized total atheroma volume (TAV)
Time Frame: Month 18 visit
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Month 18 visit
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2005
Primary Completion (Actual)
October 1, 2007
Study Completion (Actual)
October 1, 2007
Study Registration Dates
First Submitted
July 26, 2005
First Submitted That Met QC Criteria
July 26, 2005
First Posted (Estimate)
July 27, 2005
Study Record Updates
Last Update Posted (Estimate)
April 20, 2009
Last Update Submitted That Met QC Criteria
April 17, 2009
Last Verified
April 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Coronary Disease
- Coronary Artery Disease
- Myocardial Ischemia
- Atherosclerosis
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Anti-Obesity Agents
- Cannabinoid Receptor Modulators
- Cannabinoid Receptor Antagonists
- Rimonabant
Other Study ID Numbers
- EFC5827
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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