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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Status: Withdrawn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 subfraction

Safety

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

Page last updated: August 23, 2015

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