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

NCT ID: NCT01180764

Last Updated: 2016-02-08

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2012-10-31

Brief 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.

Conditions

Hypertriglyceridemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Lovaza

Lovaza 4g po qd

Group Type: EXPERIMENTAL

Lovaza (Omega-3 acid ethyl esters)

Intervention Type: DRUG

1g capsules, 4 capsules po daily

Placebo

Matching placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo matching active lovaza, 1 g capsules, 4 capsules po daily

Interventions

Lovaza (Omega-3 acid ethyl esters)

1g capsules, 4 capsules po daily

Intervention Type: DRUG

Placebo

Placebo matching active lovaza, 1 g capsules, 4 capsules po daily

Intervention Type: DRUG

Other Intervention Names

Lovaza

Eligibility 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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: collaborator

University of Utah

OTHER

Sponsor Role: lead

Responsible Party

University of Utah

Principal Investigators

Eliot A Brinton, MD

Role: PRINCIPAL_INVESTIGATOR

University of Utah

Locations

University of Utah

Salt Lake City, Utah, United States

Countries

United States

Other Identifiers

00040562

Identifier Type: -

Identifier Source: org_study_id