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

Withdrawn before enrolling · Phase 4 · Has a placebo group

Conditions studied: Hypertriglyceridemia

In brief

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.

Key facts

Study ID

NCT01180764

Run by

University of Utah

People needed

0

Starts

2010-08-01

Expected to finish

2012-10-01

Last updated by the study team

2016-02-08

Who can join

Age: 35 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Fasting TG 500-2000 mg/dL (off of TG-lowering medications-see below)
• Age 35-75 years

You may not qualify if…

• 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

Where it is running

• University of Utah — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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