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

Utah System of Higher Education (USHE)

Status and phase

Withdrawn

Phase 4

Conditions

Hypertriglyceridemia

Treatments

Drug: Placebo

Drug: Lovaza (Omega-3 acid ethyl esters)

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01180764

00040562

Details and patient eligibility

About

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.

Sex

All

Ages

35 to 75 years old

Volunteers

No Healthy Volunteers

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