Lovaza Therapy of Peripheral Arterial Disease - Tabular View

Tracking Information

First Received Date ^ICMJE

December 6, 2007

Last Updated Date

September 2, 2009

Start Date ^ICMJE

September 2007

Estimated Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00569686 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Lovaza Therapy of Peripheral Arterial Disease

Official Title ^ICMJE

Lovaza Therapy of Peripheral Arterial Disease

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.

Detailed Description

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment

Condition ^ICMJE

Peripheral Artery Disease

Intervention ^ICMJE

Drug: lovaza
Drug: placebo

Study Arms / Comparison Groups

Active Comparator: treatment with lovaza

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2010

Estimated Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

40 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: jayne missel, RN BSN CCRC

434-243-7195

jsm3s@virginia.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00569686

Responsible Party

Dr Christopher Kramer, University of Virginia Health System

Study ID Numbers ^ICMJE

13107

Study Sponsor ^ICMJE

University of Virginia

Collaborators ^ICMJE

Reliant Pharmaceuticals

Investigators ^ICMJE

Principal Investigator:

Christopher Kramer, MD

University of Virginia Health System

Information Provided By

University of Virginia

Verification Date

September 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP