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

Phase 4

Withdrawn

• Conditions: Hypertriglyceridemia
• Interventions: Drug: Lovaza (Omega-3 acid ethyl esters); Drug: Placebo

• Registration Number: NCT01180764
• Lead Sponsor: University of Utah

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-05-17
• Study Start: 2010-08
• Study First Submitted QC: 2010-08-10
• Study First Posted: 2010-08-12
• Status Verified: 2011-07
• Primary Completion: 2012-08
• Study Completion: 2012-10
• Last Update Submitted: 2016-02-04
• Last Update Posted: 2016-02-08

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lovaza	Lovaza (Omega-3 acid ethyl esters)	Lovaza 4g po qd
Placebo	Placebo	Matching placebo

Primary Outcome Measures

Name	Time	Method
HDL Composition	12 weeks	HDL composition (protein and lipid) by size (gel filtration column)

Secondary Outcome Measures

Name	Time	Method
HDL cholesterol composition by density subfraction	12 weeks	HDL composition by density gradient ultracentrifugation
Safety	12 weeks	Transaminases and glucose levels

Trial Locations

Locations (1)

University of Utah; 🇺🇸 Salt Lake City, Utah, United States