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

This study has been withdrawn prior to enrollment.
(Withdrawn for administrative reasons.)
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
University of Utah
ClinicalTrials.gov Identifier:
NCT01180764
First received: May 17, 2010
Last updated: July 27, 2011
Last verified: July 2011
History of Changes
  Purpose

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 Intervention Phase
Hypertriglyceridemia
 Drug: Lovaza (Omega-3 acid ethyl esters)
Drug: Placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Utah:

Primary Outcome Measures:
  • HDL Composition [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    HDL composition (protein and lipid) by size (gel filtration column)


Secondary Outcome Measures:
  • HDL cholesterol composition by density subfraction [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    HDL composition by density gradient ultracentrifugation

  • Safety [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Transaminases and glucose levels


Estimated Enrollment: 26
Study Start Date: August 2010
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   35 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Eliot A. Brinton, MD, University of Utah
ClinicalTrials.gov Identifier: NCT01180764     History of Changes
Other Study ID Numbers: 00040562
Study First Received: May 17, 2010
Last Updated: July 27, 2011
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on June 17, 2013