Status:
COMPLETED
Effects of Lovaza on Lipoprotein Composition and Function in Mild Hypertriglyceridemia
Lead Sponsor:
Sanford Research
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Hypertriglyceridemia
Eligibility:
All Genders
18-79 years
Phase:
PHASE1
PHASE2
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 base...
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 base...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00959842
Start Date
September 1 2009
End Date
February 1 2010
Last Update
October 20 2021
Active Locations (1)
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1
Sanford Research/USD
Sioux Falls, South Dakota, United States, 57105