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Withdrawn Not applicable Interventional

Lovaza Therapy of Peripheral Arterial Disease

ClinicalTrials.gov ID: NCT00569686

Public ClinicalTrials.gov record NCT00569686. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 17, 2026, 6:54 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT00569686
Recruitment status
Withdrawn
Study type
Interventional
Phase
Not applicable
Lead sponsor
University of Virginia
Other
Enrollment
Not listed

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
40 Years to 80 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Aug 31, 2007
Primary completion
Nov 30, 2009
Completion
Jan 31, 2010
Last update posted
May 6, 2018

2007 – 2010

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
University of Virginia Health System Charlottesville Virginia 22908

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00569686, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 6, 2018 · Synced Sep 17, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00569686 live on ClinicalTrials.gov.

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