Effects of Lovaza on Lipoprotein Composition and Function in Mild Hypertriglyceridemia

NCT ID: NCT00959842

Last Updated: 2021-10-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2010-02-28

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).

Conditions

Hypertriglyceridemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lovaza

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

Group Type: EXPERIMENTAL

Lovaza

Intervention Type: DRUG

1 gram gel capsule 4 capsules per day for 8 weeks

Interventions

Lovaza

1 gram gel capsule 4 capsules per day for 8 weeks

Intervention Type: DRUG

Other Intervention Names

Omega-3 Fatty Acid; fish oil; Omacor

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: collaborator

Sanford Research

OTHER

Sponsor Role: lead

Responsible Party

William S. Harris

Adjunct Senior Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gregory C Shearer, PhD

Role: PRINCIPAL_INVESTIGATOR

Sanford Research/USD

Locations

Sanford Research/USD

Sioux Falls, South Dakota, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 25393536 (View on PubMed)

Other Identifiers

GSK - LVZ 112860

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

LVZ 112860

Identifier Type: -

Identifier Source: org_study_id