Lovaza Therapy of Peripheral Arterial Disease - Full Text View

Sponsor:	University of Virginia
Collaborator:	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

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Official Title:	Lovaza Therapy of Peripheral Arterial Disease

Resource links provided by NLM:

MedlinePlus related topics: Exercise and Physical Fitness Peripheral Arterial Disease Triglycerides

Drug Information available for: Omacor

U.S. FDA Resources

Further study details as provided by University of Virginia:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

show improved plaque characteristics, improved exercise calf muscle perfusion using first-pass contrast enhanced MRI and improved [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	September 2007
Estimated Study Completion Date:	February 2010
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 treatment with lovaza	Drug: lovaza lovaza 4 gm po daily
Placebo Comparator: 2	Drug: placebo placebo

Eligibility

Ages Eligible for Study:	40 Years to 80 Years
Genders Eligible for Study:	Both
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: 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

More Information

No publications provided

Responsible Party:	Dr Christopher Kramer, University of Virginia Health System
ClinicalTrials.gov Identifier:	NCT00569686 History of Changes
Other Study ID Numbers:	13107
Study First Received:	December 6, 2007
Last Updated:	March 3, 2010
Health Authority:	United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on February 12, 2012