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Sponsors and Collaborators: |
University of Virginia Reliant Pharmaceuticals |
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Information provided by: | University of Virginia |
ClinicalTrials.gov Identifier: | NCT00569686 |
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 |
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Peripheral Artery Disease |
Drug: lovaza Drug: placebo |
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 2010 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
treatment with lovaza
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Drug: lovaza
lovaza 4 gm po daily
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2: Placebo Comparator |
Drug: placebo
placebo
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Ages Eligible for Study: | 40 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: jayne missel, RN BSN 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 |
Principal Investigator: | Christopher Kramer, MD | University of Virginia Health System |
Responsible Party: | University of Virginia Health System ( Dr Christopher Kramer ) |
Study ID Numbers: | 13107 |
Study First Received: | December 6, 2007 |
Last Updated: | February 12, 2009 |
ClinicalTrials.gov Identifier: | NCT00569686 History of Changes |
Health Authority: | United States: Institutional Review Board |
PAD peripheral artery disease |
Peripheral Vascular Diseases Vascular Diseases |
Peripheral Vascular Diseases Vascular Diseases Cardiovascular Diseases |