Effects of Lovaza on Lipoprotein Composition and Function in Mild Hypertriglyceridemia

Hypertriglyceridemia Clinical Trial

— ELLF  

Official title:

Effects of Lovaza on Lipoprotein Composition and Function in Mild Hypertriglyceridemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00959842
• Other study ID #: LVZ 112860
• Secondary ID: GSK - LVZ 112860
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: September 2009
• Est. completion date: February 2010

Study information

• Verified date: September 2021
• Source: Sanford Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertriglyceridemia

Intervention

Drug:
• Lovaza
1 gram gel capsule 4 capsules per day for 8 weeks

Locations

Country	Name	City	State
United States	Sanford Research/USD	Sioux Falls	South Dakota

Sponsors (2)

Lead Sponsor	Collaborator
Sanford Research	GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HDL 15-HEPE	high density lipoprotein level of 15-HEPE	4 months