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Lovaza Therapy of Peripheral Arterial Disease

NCT00569686 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2018-05-07

No results posted yet for this study

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.

Conditions

Interventions

DRUG

lovaza

lovaza 4 gm po daily

DRUG

placebo

placebo

Sponsors & Collaborators

  • Reliant Pharmaceuticals

    collaborator INDUSTRY

  • University of Virginia

    lead OTHER

Principal Investigators

  • Christopher Kramer, MD · University of Virginia Health System

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2009-12-31
Completion
2010-02-28

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00569686 on ClinicalTrials.gov