Phase 2
N=15
Effects of Lovaza on Lipoprotein Composition and Function in Mild Hypertriglyceridemia
Hypertriglyceridemia
Bottom Line
View on ClinicalTrials.gov: NCT00959842 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Oct 2021
Primary outcome: Primary: HDL 15-HEPE — 3.7; 10.4 nmol/mmol phospholipid
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Lovaza (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sanford Research
- Primary completion
- Feb 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY HDL 15-HEPE |
3.7; 10.4 | — |
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).
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 8.0%)
- History of a cardiovascular event
- Past revascularization procedure
- Past aortic aneurysm or an aortic dissection =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
Data sourced from ClinicalTrials.gov (NCT00959842). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.