Status:
WITHDRAWN
Effects of Lovaza on High Density Lipoprotein (HDL) Composition and Function in Hypertriglyceridemia
Lead Sponsor:
University of Utah
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Hypertriglyceridemia
Eligibility:
All Genders
35-75 years
Phase:
PHASE4
Brief Summary
Study hypothesis: Lovaza (purified prescription fish oil) is likely to help HDL (the "good cholesterol") work better. Study summary: We are testing effects of Lovaza versus placebo, on various aspect...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Fasting TG 500-2000 mg/dL (off of TG-lowering medications-see below)
- Age 35-75 years
- Exclusion criteria:
- Use of Lovaza (2g/d or more) or high-dose dietary supplement omega-3 oil (4g/d or more) in the past 2 months
- Use of lipid therapy (statin, ezetimibe, fibrate, BAS, or niacin at therapeutic dose, 1g/d or higher) in the past 3 weeks (washout of prior therapy permitted)
- Anticipated need to change type or dose of BP medicine (all types allowed), of lipid-active diabetes medication (thiazolidinedione), of oral estrogen (BCP or HRT), or glucocorticoid during the study (16 + 2 weeks = 18 weeks total)
- Excess ethanol consumption (regular intake \>4 drinks/d, or binges of \>8 drinks at once for men, half these levels for women)
- Poorly controlled diabetes mellitus (A1c \>9%)
- History of acute or chronic pancreatitis
- Use of exenatide (Byetta) or sitagliptin (Januvia), medications believed to increase the risk of acute pancreatitis
- History of significant unexplained or uncontrolled bleeding or bruising
- Poorly controlled blood pressure (\>140/90mmHg, with or without treatment)
- Poorly controlled thyroid disease (TSH outside of normal range)
- Hepatic disease (ALT \> 2.5x ULN, Dx of hepatitis or cirrhosis)
- Any contraindication or prior adverse reaction to Lovaza
- Active cancer (except basal cell or squamous cell skin cancer)
- Pregnancy, plan/desire to become pregnant, breast feeding
- Inability or unwillingness to provide informed consent
Exclusion
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01180764
Start Date
August 1 2010
End Date
October 1 2012
Last Update
February 8 2016
Active Locations (1)
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1
University of Utah
Salt Lake City, Utah, United States, 84108