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This study has been withdrawn prior to enrollment.
(Withdrawn for administrative reasons.)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

May 17, 2010
July 27, 2011
August 2010
August 2012   (final data collection date for primary outcome measure)
HDL Composition [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
HDL composition (protein and lipid) by size (gel filtration column)
Same as current
Complete list of historical versions of study NCT01180764 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Effects of Lovaza on High Density Lipoprotein (HDL) Composition and Function in Hypertriglyceridemia
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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Hypertriglyceridemia
  • Drug: Lovaza (Omega-3 acid ethyl esters)
    1g capsules, 4 capsules po daily
    Other Name: Lovaza
  • Drug: Placebo
    Placebo matching active lovaza, 1 g capsules, 4 capsules po daily
  • Experimental: Lovaza
    Lovaza 4g po qd
    Intervention: Drug: Lovaza (Omega-3 acid ethyl esters)
  • Placebo Comparator: Placebo
    Matching placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
26
October 2012
August 2012   (final data collection date for primary outcome measure)

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
Both
35 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01180764
00040562
No
Eliot A. Brinton, MD, University of Utah
University of Utah
GlaxoSmithKline
Principal Investigator: Eliot A Brinton, MD University of Utah
University of Utah
July 2011

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