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WithdrawnNCT00569686Updated May 7, 2018

Lovaza Therapy of Peripheral Arterial Disease

An interventional study of lovaza and placebo in Peripheral Artery Disease, sponsored by University of Virginia. Withdrawn at 1 site in United States. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-05-07.

Sponsored by University of Virginia · Not applicable, Interventional, and Treatment

Why this study was withdrawn
No subject meeting criteria
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
40 Years to 80 Years
Sex
All
01

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.

02

Conditions studied

  • Peripheral Artery Disease

Keywords

  • PAD
  • peripheral artery disease
03

In context

Peripheral Arterial Disease

1,542 studies on the registry are indexed under Peripheral Arterial Disease; 282 are open to participants now.

Browse Peripheral Arterial Disease studies →

Lead sponsor

University of Virginia is the lead sponsor of 653 studies on the registry; 134 are open to participants now.

Of its 60 completed or terminated interventional studies of FDA-regulated products, 41 (68%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
0 participants (actual)

Study arms

  • Active comparator
    1

    treatment with lovaza

    Drug: lovaza

  • Placebo comparator
    2

    Drug: placebo

Interventions

  • Druglovaza

    lovaza 4 gm po daily

  • Drugplacebo

    placebo

06

What researchers measure

Primary outcomes

  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 outcomes

  1. show improved plaque characteristics, improved exercise calf muscle perfusion using first-pass contrast enhanced MRI and improved

    Time frame: 1 year

07

Study locations

1 site
  • University of Virginia Health System
    Charlottesville, Virginia 22908, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 7, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00569686
Lead sponsor
University of Virginia
Collaborators
Reliant Pharmaceuticals
Responsible party
Sponsor
First posted
Dec 7, 2007
Start date
Sep 2007
Primary completion
Dec 2009 (estimated)
Completion
Feb 2010 (estimated)
Last update
May 7, 2018

Study contacts

Christopher Kramer, MD
principal investigator · University of Virginia Health System

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in May 2018. You cannot join it, but the record below documents what was studied.

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