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Lovaza Therapy of Peripheral Arterial Disease

Primary Purpose

Peripheral Artery Disease

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
lovaza
placebo
Sponsored by
University of Virginia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Artery Disease focused on measuring PAD, peripheral artery disease

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Virginia Health System

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1

2

Arm Description

treatment with lovaza

Outcomes

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.

Secondary Outcome Measures

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

Full Information

First Posted
December 6, 2007
Last Updated
May 1, 2018
Sponsor
University of Virginia
Collaborators
Reliant Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00569686
Brief Title
Lovaza Therapy of Peripheral Arterial Disease
Official Title
Lovaza Therapy of Peripheral Arterial Disease
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Withdrawn
Why Stopped
No subject meeting criteria
Study Start Date
September 2007 (undefined)
Primary Completion Date
December 2009 (Anticipated)
Study Completion Date
February 2010 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Virginia
Collaborators
Reliant Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Artery Disease
Keywords
PAD, peripheral artery disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
treatment with lovaza
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
lovaza
Intervention Description
lovaza 4 gm po daily
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
show improved plaque characteristics, improved exercise calf muscle perfusion using first-pass contrast enhanced MRI and improved
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Kramer, MD
Organizational Affiliation
University of Virginia Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Virginia Health System
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Lovaza Therapy of Peripheral Arterial Disease

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