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

Hypertriglyceridemia Clinical Trial

Official title:

Effects of Lovaza Monotherapy vs. Placebo on Composition and Function of HDL and Other Lipoproteins, and on Other Lipid-Related Parameters

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01180764
• Other study ID #: 00040562
• Status: Withdrawn
• Phase: Phase 4
• First received: May 17, 2010
• Last updated: February 4, 2016
• Start date: August 2010
• Est. completion date: October 2012

Study information

• Verified date: July 2011
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertriglyceridemia

Intervention

Drug:
• Lovaza (Omega-3 acid ethyl esters)
1g capsules, 4 capsules po daily
• Placebo
Placebo matching active lovaza, 1 g capsules, 4 capsules po daily

Locations

Country	Name	City	State
United States	University of Utah	Salt Lake City	Utah

Sponsors (2)

Lead Sponsor	Collaborator
University of Utah	GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HDL Composition	HDL composition (protein and lipid) by size (gel filtration column)	12 weeks	No
Secondary	HDL cholesterol composition by density subfraction	HDL composition by density gradient ultracentrifugation	12 weeks	No
Secondary	Safety	Transaminases and glucose levels	12 weeks	Yes