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

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
William S. Harris, Sanford Research
ClinicalTrials.gov Identifier:
NCT00959842
First received: August 14, 2009
Last updated: May 28, 2013
Last verified: May 2013
  Purpose

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).


Condition Intervention Phase
Hypertriglyceridemia
Drug: Lovaza
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of Lovaza on Lipoprotein Composition and Function in Mild Hypertriglyceridemia

Resource links provided by NLM:


Further study details as provided by Sanford Research:

Primary Outcome Measures:
  • The primary endpoint will be the effect of treatment on lipoprotein binding to target cells. [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Performance of VLDL as a substrate for lipolysis. [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Plasma LpL mass and activity. [ Time Frame: one year ] [ Designated as safety issue: No ]
  • VLDL, LDL, HDL oxylipin and fatty acid content [ Time Frame: one year ] [ Designated as safety issue: No ]

Enrollment: 15
Study Start Date: September 2009
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lovaza
Lovaza was given as the only agent; there was no comparator agent or arm
Drug: Lovaza
1 gram gel capsule 4 capsules per day for 8 weeks
Other Names:
  • Omega-3 Fatty Acid
  • fish oil
  • Omacor
  • Lovaza

  Eligibility

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00959842

Locations
United States, South Dakota
Sanford Research/USD
Sioux Falls, South Dakota, United States, 57105
Sponsors and Collaborators
Sanford Research
GlaxoSmithKline
Investigators
Principal Investigator: Gregory C Shearer, PhD Sanford Research/USD
  More Information

No publications provided

Responsible Party: William S. Harris, Adjunct Senior Scientist, Sanford Research
ClinicalTrials.gov Identifier: NCT00959842     History of Changes
Other Study ID Numbers: LVZ 112860, GSK - LVZ 112860
Study First Received: August 14, 2009
Last Updated: May 28, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Sanford Research:
hypertriglyceridemia
Omega-3 Fatty Acids
Lipoprotein
Statin
Lovaza

Additional relevant MeSH terms:
Hypertriglyceridemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on September 18, 2014