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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01180764
Recruitment Status : Withdrawn (Withdrawn for administrative reasons.)
First Posted : August 12, 2010
Last Update Posted : February 8, 2016
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Hypertriglyceridemia Drug: Lovaza (Omega-3 acid ethyl esters) Drug: Placebo Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Lovaza Monotherapy vs. Placebo on Composition and Function of HDL and Other Lipoproteins, and on Other Lipid-Related Parameters
Study Start Date : August 2010
Estimated Primary Completion Date : August 2012
Estimated Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Triglycerides
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Lovaza
Lovaza 4g po qd
Drug: Lovaza (Omega-3 acid ethyl esters)
1g capsules, 4 capsules po daily
Other Name: Lovaza
Placebo Comparator: Placebo
Matching placebo
Drug: Placebo
Placebo matching active lovaza, 1 g capsules, 4 capsules po daily


Outcome Measures

Primary Outcome Measures :
  1. HDL Composition [ Time Frame: 12 weeks ]
    HDL composition (protein and lipid) by size (gel filtration column)


Secondary Outcome Measures :
  1. HDL cholesterol composition by density subfraction [ Time Frame: 12 weeks ]
    HDL composition by density gradient ultracentrifugation

  2. Safety [ Time Frame: 12 weeks ]
    Transaminases and glucose levels


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01180764


Locations
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84108
Sponsors and Collaborators
University of Utah
GlaxoSmithKline
Investigators
Principal Investigator: Eliot A Brinton, MD University of Utah
More Information

Responsible Party: Eliot A. Brinton, MD, University of Utah
ClinicalTrials.gov Identifier: NCT01180764     History of Changes
Other Study ID Numbers: 00040562
First Posted: August 12, 2010    Key Record Dates
Last Update Posted: February 8, 2016
Last Verified: July 2011

Keywords provided by University of Utah:
hypertriglyceridemia
omega-3 acid ethyl esters
high-density lipoproteins
fish oil

Additional relevant MeSH terms:
Hypertriglyceridemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases