Effects of Lovaza on High Density Lipoprotein (HDL) Composition and Function in Hypertriglyceridemia

February 4, 2016 updated by: University of Utah

Effects of Lovaza Monotherapy vs. Placebo on Composition and Function of HDL and Other Lipoproteins, and on Other Lipid-Related Parameters

Study hypothesis: Lovaza (purified prescription fish oil) is likely to help HDL (the "good cholesterol") work better.

Study summary: We are testing effects of Lovaza versus placebo, on various aspects of HDL and other lipoproteins, in patients with high triglyceride levels.

Study funding: This study is being funded by an investigator-initiated research grant from Glaxo Smith Kline.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Utah
      • Salt Lake City, Utah, United States, 84108
        • University of Utah

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Fasting TG 500-2000 mg/dL (off of TG-lowering medications-see below)
  • Age 35-75 years

Exclusion criteria:

  • Use of Lovaza (2g/d or more) or high-dose dietary supplement omega-3 oil (4g/d or more) in the past 2 months
  • Use of lipid therapy (statin, ezetimibe, fibrate, BAS, or niacin at therapeutic dose, 1g/d or higher) in the past 3 weeks (washout of prior therapy permitted)
  • Anticipated need to change type or dose of BP medicine (all types allowed), of lipid-active diabetes medication (thiazolidinedione), of oral estrogen (BCP or HRT), or glucocorticoid during the study (16 + 2 weeks = 18 weeks total)
  • Excess ethanol consumption (regular intake >4 drinks/d, or binges of >8 drinks at once for men, half these levels for women)
  • Poorly controlled diabetes mellitus (A1c >9%)
  • History of acute or chronic pancreatitis
  • Use of exenatide (Byetta) or sitagliptin (Januvia), medications believed to increase the risk of acute pancreatitis
  • History of significant unexplained or uncontrolled bleeding or bruising
  • Poorly controlled blood pressure (>140/90mmHg, with or without treatment)
  • Poorly controlled thyroid disease (TSH outside of normal range)
  • Hepatic disease (ALT > 2.5x ULN, Dx of hepatitis or cirrhosis)
  • Any contraindication or prior adverse reaction to Lovaza
  • Active cancer (except basal cell or squamous cell skin cancer)
  • Pregnancy, plan/desire to become pregnant, breast feeding
  • Inability or unwillingness to provide informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Matching placebo
Drug: Placebo
Placebo matching active lovaza, 1 g capsules, 4 capsules po daily
EXPERIMENTAL: Lovaza
Lovaza 4g po qd
Drug: Lovaza (Omega-3 acid ethyl esters)
1g capsules, 4 capsules po daily
Other Names:
  • Lovaza

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HDL Composition
Time Frame: 12 weeks
HDL composition (protein and lipid) by size (gel filtration column)
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HDL cholesterol composition by density subfraction
Time Frame: 12 weeks
HDL composition by density gradient ultracentrifugation
12 weeks
Safety
Time Frame: 12 weeks
Transaminases and glucose levels
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Utah

Collaborators

GlaxoSmithKline

Investigators

  • Principal Investigator: Eliot A Brinton, MD, University of Utah

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (ANTICIPATED)

August 1, 2012

Study Completion (ANTICIPATED)

October 1, 2012

Study Registration Dates

First Submitted

May 17, 2010

First Submitted That Met QC Criteria

August 10, 2010

First Posted (ESTIMATE)

August 12, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

February 8, 2016

Last Update Submitted That Met QC Criteria

February 4, 2016

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00040562

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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