Effects of Lovaza on High Density Lipoprotein (HDL) Composition and Function in Hypertriglyceridemia
Information source: University of Utah
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertriglyceridemia
Intervention: Lovaza (Omega-3 acid ethyl esters) (Drug); Placebo (Drug)
Phase: Phase 4
Status: Withdrawn
Sponsored by: University of Utah Official(s) and/or principal investigator(s): Eliot A Brinton, MD, Principal Investigator, Affiliation: University of Utah
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.
Clinical Details
Official title: Effects of Lovaza Monotherapy vs. Placebo on Composition and Function of HDL and Other Lipoproteins, and on Other Lipid-Related Parameters
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: HDL Composition
Secondary outcome: HDL cholesterol composition by density subfractionSafety
Eligibility
Minimum age: 35 Years.
Maximum age: 75 Years.
Gender(s): Both.
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
Locations and Contacts
University of Utah, Salt Lake City, Utah 84108, United States
Additional Information
Starting date: August 2010
Last updated: July 27, 2011
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