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| Sponsors and Collaborators: |
University of Virginia Reliant Pharmaceuticals |
| Information provided by: | University of Virginia |
| ClinicalTrials.gov Identifier: | NCT00569686 |
Purpose
Sixty patients with mild-to-moderate PAD (ABI 0.4-0.9) and hypertriglyceridemia (>200 mg/dl) already treated with statins will be imaged at baseline and randomized to Lovaza and placebo for 12 months. MR imaging will be repeated at the end of the 12-month period.
We hypothesize that treatment of hypertriglyceridemia in patients with PAD with Lovaza will reduce atherosclerotic plaque volume in the superficial femoral artery (SFA) by 2% over 1 year compared to placebo. Secondary aims will be to show improved plaque characteristics (thickened fibrous cap, reduced lipid-rich necrotic core, improved exercise calf muscle perfusion using first-pass contrast enhanced MRI and improved exercise treadmill performance with Lovaza compared to matching placebo.
| Condition | Intervention |
|
Peripheral Artery Disease |
Drug: lovaza Drug: placebo |
| MedlinePlus related topics: | Exercise and Physical Fitness Triglycerides |
| ChemIDplus related topics: | Omacor |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment |
| Official Title: | Lovaza Therapy of Peripheral Arterial Disease |
| Estimated Enrollment: | 60 |
| Study Start Date: | September 2007 |
| Estimated Study Completion Date: | December 2008 |
| Arms | Assigned Interventions |
|
1: Active Comparator
treatment with lovaza
|
Drug: lovaza
lovaza 4 gm po daily
|
| 2: Placebo Comparator |
Drug: placebo
placebo
|
Eligibility
| Ages Eligible for Study: | 40 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: jayne missel, RN CCRC | 434-243-7195 | jsm3s@virginia.edu |
| United States, Virginia | |||||
| University of Virginia Health System | Recruiting | ||||
| charlottesville, Virginia, United States, 22908 | |||||
| Sub-Investigator: anderson justin, MD | |||||
| Sub-Investigator: jehle alexander, MD | |||||
| Sub-Investigator: patrick norton, MD | |||||
| Sub-Investigator: klaus hagspiel, MD | |||||
| Sub-Investigator: amit patel, MD | |||||
| University of Virginia |
| Reliant Pharmaceuticals |
| Principal Investigator: | Christopher Kramer, MD | University of Virginia Health System |
More Information
| Responsible Party: | University of Virginia Health System ( Dr Christopher Kramer ) |
| Study ID Numbers: | 13107 |
| First Received: | December 6, 2007 |
| Last Updated: | June 4, 2008 |
| ClinicalTrials.gov Identifier: | NCT00569686 |
| Health Authority: | United States: Institutional Review Board |
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