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

NCT01180764 | Withdrawn Phase 4

• 1 other identifier: 00040562
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Keywords

hypertriglyceridemia; omega-3 acid ethyl esters; high-density lipoproteins; fish oil

Outcome Measures

Primary Outcomes (1)

• HDL Composition

  HDL composition (protein and lipid) by size (gel filtration column)

  12 weeks

Secondary Outcomes (2)

• HDL cholesterol composition by density subfraction

  12 weeks

• Safety

  12 weeks

Study Arms (2)

Lovaza

EXPERIMENTAL

Lovaza 4g po qd

Drug: Lovaza (Omega-3 acid ethyl esters)

Placebo

PLACEBO COMPARATOR

Matching placebo

Drug: Placebo

Interventions

Lovaza (Omega-3 acid ethyl esters) DRUG

1g capsules, 4 capsules po daily

Also known as: Lovaza

Lovaza

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of Utah: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84108, United States

Location

MeSH Terms

Conditions

Hypertriglyceridemia

Interventions

Omacor

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Eliot A Brinton, MD

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 17, 2010
• First Posted: August 12, 2010
• Study Start: August 1, 2010
• Primary Completion: August 1, 2012
• Study Completion: October 1, 2012
• Last Updated: February 8, 2016

Record last verified: 2011-07

Locations

US (1)