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

Primary Purpose

Hypertriglyceridemia

Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Lovaza (Omega-3 acid ethyl esters)
Placebo
Sponsored by
University of Utah
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertriglyceridemia focused on measuring hypertriglyceridemia, omega-3 acid ethyl esters, high-density lipoproteins, fish oil

Eligibility Criteria

35 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Utah

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Lovaza

Placebo

Arm Description

Lovaza 4g po qd

Matching placebo

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

HDL cholesterol composition by density subfraction
HDL composition by density gradient ultracentrifugation
Safety
Transaminases and glucose levels

Full Information

First Posted
May 17, 2010
Last Updated
February 4, 2016
Sponsor
University of Utah
Collaborators
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT01180764
Brief Title
Effects of Lovaza on High Density Lipoprotein (HDL) Composition and Function in Hypertriglyceridemia
Official Title
Effects of Lovaza Monotherapy vs. Placebo on Composition and Function of HDL and Other Lipoproteins, and on Other Lipid-Related Parameters
Study Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Withdrawn
Why Stopped
Withdrawn for administrative reasons.
Study Start Date
August 2010 (undefined)
Primary Completion Date
August 2012 (Anticipated)
Study Completion Date
October 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University of Utah
Collaborators
GlaxoSmithKline

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertriglyceridemia
Keywords
hypertriglyceridemia, omega-3 acid ethyl esters, high-density lipoproteins, fish oil

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lovaza
Arm Type
Experimental
Arm Description
Lovaza 4g po qd
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching placebo
Intervention Type
Drug
Intervention Name(s)
Lovaza (Omega-3 acid ethyl esters)
Other Intervention Name(s)
Lovaza
Intervention Description
1g capsules, 4 capsules po daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo matching active lovaza, 1 g capsules, 4 capsules po daily
Primary Outcome Measure Information:
Title
HDL Composition
Description
HDL composition (protein and lipid) by size (gel filtration column)
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
HDL cholesterol composition by density subfraction
Description
HDL composition by density gradient ultracentrifugation
Time Frame
12 weeks
Title
Safety
Description
Transaminases and glucose levels
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eliot A Brinton, MD
Organizational Affiliation
University of Utah
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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