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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This study has been withdrawn prior to enrollment.
(Withdrawn for administrative reasons.)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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Dyslipidemias
Hyperlipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on November 20, 2014