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Lovaza Therapy of Peripheral Arterial Disease

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ClinicalTrials.gov Identifier: NCT00569686
Recruitment Status : Withdrawn (No subject meeting criteria)
First Posted : December 7, 2007
Last Update Posted : May 7, 2018
Sponsor:
Collaborator:
Reliant Pharmaceuticals
Information provided by (Responsible Party):
University of Virginia

Brief Summary:

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 or disease Intervention/treatment Phase
Peripheral Artery Disease Drug: lovaza Drug: placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Lovaza Therapy of Peripheral Arterial Disease
Study Start Date : September 2007
Estimated Primary Completion Date : December 2009
Estimated Study Completion Date : February 2010

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U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1
treatment with lovaza
Drug: lovaza
lovaza 4 gm po daily
Placebo Comparator: 2 Drug: placebo
placebo



Primary Outcome Measures :
  1. treatment of hypertriglyceridemia in patients with PAD with Lovaza will reduce or prevent progression of atherosclerotic plaque volume in the superficial femoral artery (SFA) by 2% over 1 year as compared to placebo. [ Time Frame: one year ]

Secondary Outcome Measures :
  1. show improved plaque characteristics, improved exercise calf muscle perfusion using first-pass contrast enhanced MRI and improved [ Time Frame: 1 year ]


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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female, any ethnicity, ages 55-75
  • Mild to moderate PAD (ankle brachial index (ABI) of 0.4-0.9 in either or both limbs)
  • Symptomatic intermittent claudication in either or both limbs
  • Hyperlipidemia treated with HMG-CoA reductase inhibition with persistent hypertriglyceridemia (triglycerides>200).

Exclusion Criteria:

  • Patients with critical limb ischemia
  • Moderate to severe chronic kidney disease (requiring hemodialysis or glomerular filtration rate (GFR) < 45 ml/min)
  • Contraindication to MRI (pacemakers, defibrillators, intraocular metal, certain intracerebral aneurysm clips, etc.)
  • Claustrophobia
  • Known allergy to gadolinium chelates
  • Patients with iron storage disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00569686


Locations
United States, Virginia
University of Virginia Health System
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
University of Virginia
Reliant Pharmaceuticals
Investigators
Principal Investigator: Christopher Kramer, MD University of Virginia Health System

Responsible Party: University of Virginia
ClinicalTrials.gov Identifier: NCT00569686     History of Changes
Other Study ID Numbers: 13107
First Posted: December 7, 2007    Key Record Dates
Last Update Posted: May 7, 2018
Last Verified: May 2018

Keywords provided by University of Virginia:
PAD
peripheral artery disease

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases