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Effects of Lovaza on Lipoprotein Composition and Function in Mild Hypertriglyceridemia (ELLF)

Primary Purpose

Hypertriglyceridemia

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Lovaza
Sponsored by
Sanford Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertriglyceridemia focused on measuring hypertriglyceridemia, Omega-3 Fatty Acids, Lipoprotein, Statin, Lovaza

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18-79 years
  • Stable does of statins ≥ 8 weeks prior to screening
  • Good health by medical history, physical exam, electrocardiogram, laboratory test (e.g., serum chem., urinalysis)
  • Mean fasting serum triglyceride of two most recent tests in medical record ≥ 200 and < 500 mg/dL
  • Mean LDL-cholesterol of two most recent tests in medical record ≤ 1.1 × NCEP ATP III goal

Exclusion Criteria:

  • Medications, vitamin pills, nutritional supplements or herbal preparations deemed exclusionary per primary investigator for possible interference
  • Poorly controlled diabetes mellitus (e.g. [HbA1c] > 8.0%)
  • History of a cardiovascular event
  • Past revascularization procedure
  • Past aortic aneurysm or an aortic dissection < 6 months prior to screening
  • History of pancreatitis
  • Sensitivity to any statin OR to omega-3 fatty acids or fish products
  • Poorly controlled hypertension (i.e.: >=160 systolic (resting) and/or >=100 diastolic (resting)) at 2 consecutive visits
  • Serum Creatinine ≥ 2.0 mg/dL
  • Serum transaminase > 1.5 × upper limit of normal (ULN); including aspartate aminotransferase [AST] or alanine aminotransferase [ALT]; 31 U/L for AST, 45 U/L for ALT
  • Creatine Kinase (CK) > 3.0 × ULN
  • Taking other triglyceride lowering drugs (e.g., niacin, fibrates) or fish oil supplements providing more than 500 mg of EPA+DHA per day
  • Contraindications for Lovaza per product insert
  • Women who are pregnant or nursing

Sites / Locations

  • Sanford Research/USD

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lovaza

Arm Description

Lovaza was given as the only agent; there was no comparator agent or arm

Outcomes

Primary Outcome Measures

HDL 15-HEPE
high density lipoprotein level of 15-HEPE

Secondary Outcome Measures

Full Information

First Posted
August 14, 2009
Last Updated
September 23, 2021
Sponsor
Sanford Research
Collaborators
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00959842
Brief Title
Effects of Lovaza on Lipoprotein Composition and Function in Mild Hypertriglyceridemia
Acronym
ELLF
Official Title
Effects of Lovaza on Lipoprotein Composition and Function in Mild Hypertriglyceridemia
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
February 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sanford Research
Collaborators
GlaxoSmithKline

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will build upon a previous finding that showed a triglyceride lowering effect of prescription omega-3 in combined therapy with statins. The proposed study will use a simple change from baseline design on 15 subjects who are hypertriglyceridemic on stable statin therapy. The protocol involves 3 study visits; each involve drawing a blood sample: day 1 - screening (blood draw for qualification and safety); day 7 - before taking prescription omega-3 fatty acids (Lovaza, 4 capsules/d; GlaxoSmithKline), day 63 -after taking prescription omega-3 fatty acids (Lovaza, 4 capsules/d; GlaxoSmithKline). The proposed study will include up to 15 subjects and will utilize several different measures of lipoprotein structure and function. The investigators will measure functional parameters such as the binding affinity of lipoproteins before and after treatment with omega-3 fatty acids. The investigators will also measure fatty acid, oxylipin and apolipoprotein content of plasma, very-low-density lipoprotein (VLDL), low-density lipoprotein (LDL) and high-density lipoprotein (HDL).
Detailed Description
This study will build upon a previous finding that showed a triglyceride lowering effect of prescription omega-3 in combined therapy with statins. The proposed study will use a simple change from baseline design on 15 subjects who are hypertriglyceridemic on stable statin therapy. The protocol involves 3 study visits; each involve drawing a blood sample: day 1 - screening (blood draw for qualification and safety); day 7 - before taking prescription omega-3 fatty acids (Lovaza, 4 capsules/d; GlaxoSmithKline), day 63 -after taking prescription omega-3 fatty acids (Lovaza, 4 capsules/d; GlaxoSmithKline). The proposed study will include up to 15 subjects and will utilize several different measures of lipoprotein structure and function. The investigators will measure functional parameters such as the binding affinity of lipoproteins before and after treatment with omega-3 fatty acids. The investigators will also measure fatty acid, oxylipin and apolipoprotein content of plasma, very-low-density lipoprotein (VLDL), low-density lipoprotein (LDL) and high-density lipoprotein (HDL).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertriglyceridemia
Keywords
hypertriglyceridemia, Omega-3 Fatty Acids, Lipoprotein, Statin, Lovaza

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lovaza
Arm Type
Experimental
Arm Description
Lovaza was given as the only agent; there was no comparator agent or arm
Intervention Type
Drug
Intervention Name(s)
Lovaza
Other Intervention Name(s)
Omega-3 Fatty Acid, fish oil, Omacor
Intervention Description
1 gram gel capsule 4 capsules per day for 8 weeks
Primary Outcome Measure Information:
Title
HDL 15-HEPE
Description
high density lipoprotein level of 15-HEPE
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18-79 years Stable does of statins ≥ 8 weeks prior to screening Good health by medical history, physical exam, electrocardiogram, laboratory test (e.g., serum chem., urinalysis) Mean fasting serum triglyceride of two most recent tests in medical record ≥ 200 and < 500 mg/dL Mean LDL-cholesterol of two most recent tests in medical record ≤ 1.1 × NCEP ATP III goal Exclusion Criteria: Medications, vitamin pills, nutritional supplements or herbal preparations deemed exclusionary per primary investigator for possible interference Poorly controlled diabetes mellitus (e.g. [HbA1c] > 8.0%) History of a cardiovascular event Past revascularization procedure Past aortic aneurysm or an aortic dissection < 6 months prior to screening History of pancreatitis Sensitivity to any statin OR to omega-3 fatty acids or fish products Poorly controlled hypertension (i.e.: >=160 systolic (resting) and/or >=100 diastolic (resting)) at 2 consecutive visits Serum Creatinine ≥ 2.0 mg/dL Serum transaminase > 1.5 × upper limit of normal (ULN); including aspartate aminotransferase [AST] or alanine aminotransferase [ALT]; 31 U/L for AST, 45 U/L for ALT Creatine Kinase (CK) > 3.0 × ULN Taking other triglyceride lowering drugs (e.g., niacin, fibrates) or fish oil supplements providing more than 500 mg of EPA+DHA per day Contraindications for Lovaza per product insert Women who are pregnant or nursing
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory C Shearer, PhD
Organizational Affiliation
Sanford Research/USD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sanford Research/USD
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25393536
Citation
Newman JW, Pedersen TL, Brandenburg VR, Harris WS, Shearer GC. Effect of omega-3 fatty acid ethyl esters on the oxylipin composition of lipoproteins in hypertriglyceridemic, statin-treated subjects. PLoS One. 2014 Nov 13;9(11):e111471. doi: 10.1371/journal.pone.0111471. eCollection 2014.
Results Reference
derived

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Effects of Lovaza on Lipoprotein Composition and Function in Mild Hypertriglyceridemia

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