[E]PANOVA Combined With a [S]TATIN in [P]ATIENTS With HYPERT[R]IGLYCER[I]DEMIA to Reduce Non-HDL CHOLES[T]EROL
NCT ID: NCT01408303
Last Updated: 2014-12-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
646 participants
INTERVENTIONAL
2011-08-31
2012-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Olive Oil
olive oil: 4 g/day + prescription statin
Olive oil, 4g
Olive oil: 4 x 1 g capsule daily for 6 weeks + prescription statin
Epanova, 2 g
omega-3-carboxylic acids, 2g/day + prescription statin
omega-3-carboxylic acids, 2g
Epanova: 2 x 1 g capsule + olive oil 2 x 1 g capsule daily for 6 weeks + prescription statin
Epanova, 4 g
omega-3-carboxylic acids, 4g/day + prescription statin
omega-3-carboxylic acids, 4g
Epanova: 4 x 1 g capsule daily for 6 weeks + prescription statin
Interventions
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Olive oil, 4g
Olive oil: 4 x 1 g capsule daily for 6 weeks + prescription statin
omega-3-carboxylic acids, 2g
Epanova: 2 x 1 g capsule + olive oil 2 x 1 g capsule daily for 6 weeks + prescription statin
omega-3-carboxylic acids, 4g
Epanova: 4 x 1 g capsule daily for 6 weeks + prescription statin
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Fasting triglyceride (TG) level ≥200 mg/dL and \<500 mg/dL.
3. The subject is a high risk for a future cardiovascular event.
4. The subject is treated with a statin and at or near LDL-C goal.
Exclusion Criteria
2. Use of fibrates, bile acid sequestrants, or niacin or its analogues (greater than 200 mg/d) during screening.
3. Use of simvastatin 80 mg or Vytorin10/80 mg during screening.
4. Use of any eicosapentaenoic acid (EPA) or docosahexaenoic acid (DHA) products.
5. Use of any supplement for the purpose of lowering plasma cholesterol during screening.
6. Use of weight loss drugs or programs during screening.
7. Use of erythromycin, telithromycin, clarithromycin, cyclosporine, itraconazole, ketoconazole, protease inhibitors, or nefazodone during screening.
8. Use of anticoagulants during screening.
9. Use of oral or injected corticosteroids during screening.
10. Use of tamoxifen, estrogens, progestins, or testosterone, that has not been stable for \>4 weeks at Visit 1, or is unstable during screening.
11. Use of \>750 mL/d grapefruit juice during screening.
12. Known lipoprotein lipase impairment or deficiency, or apolipoprotein C-II deficiency or familial dysbetalipoproteinemia.
13. History of pancreatitis.
14. Type I diabetes mellitus, use of insulin, or HbA1c \>10% at Visit 1.
15. Poorly controlled hypertension
16. Uncontrolled hypothyroidism, or thyroid stimulating hormone (TSH) \>1.5xULN at Visit 2.
17. Recent history or current significant nephrotic syndrome, pulmonary, hepatic, biliary, gastrointestinal or immunologic disease.
18. History of cancer (except non-melanoma skin cancer, or carcinoma in situ of cervix) within the previous two years.
19. Females who are pregnant, planning to be pregnant during the study period, lactating, or women of childbearing potential who are not using an acceptable method of contraception.
20. Creatine kinase \>5.0 times upper limit of normal (ULN); aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>2.5 times ULN at Visit 2.
21. Current or recent history (past 12 months) of drug or alcohol abuse.
22. Exposure to any investigational agent within 4 weeks prior to Visit 1.
23. Any other condition the investigator believes would interfere with the subject's ability to provide informed consent, comply with study instructions, or which might confound the interpretation of the study results or put the subject at undue risk.
18 Years
ALL
No
Sponsors
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Omthera Pharmaceuticals, Inc
INDUSTRY
Medpace, Inc.
INDUSTRY
AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Michael H Davidson, MD, FACC
Role: STUDY_DIRECTOR
Omthera Pharmaceuticals, Inc
Locations
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Muscle Shoals, Alabama, United States
Chandler, Arizona, United States
Phoenix, Arizona, United States
Little Rock, Arkansas, United States
Encinitas, California, United States
Lomita, California, United States
Los Angeles, California, United States
Sacramento, California, United States
San Diego, California, United States
Spring Valley, California, United States
Westlake Village, California, United States
Colorado Springs, Colorado, United States
Denver, Colorado, United States
Brandon, Florida, United States
Clearwater, Florida, United States
Coral Gables, Florida, United States
Hialeah, Florida, United States
Jacksonville, Florida, United States
Jacksonville, Florida, United States
Jupiter, Florida, United States
Melbourne, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
New Port Richey, Florida, United States
Ocala, Florida, United States
Orlando, Florida, United States
Oviedo, Florida, United States
Ponte Vedra, Florida, United States
St. Petersburg, Florida, United States
Addison, Illinois, United States
Chicago, Illinois, United States
Oakbrook Terrace, Illinois, United States
Indianapolis, Indiana, United States
Newton, Kansas, United States
Wichita, Kansas, United States
Wichita, Kansas, United States
Louisville, Kentucky, United States
Madisonville, Kentucky, United States
Auburn, Maine, United States
Oxon Hill, Maryland, United States
Troy, Michigan, United States
Edina, Minnesota, United States
Chesterfield, Missouri, United States
Kansas City, Missouri, United States
St Louis, Missouri, United States
Butte, Montana, United States
Las Vegas, Nevada, United States
Berlin, New Jersey, United States
Endwell, New York, United States
New Windsor, New York, United States
Rochester, New York, United States
Cary, North Carolina, United States
Charlotte, North Carolina, United States
Hickory, North Carolina, United States
High Point, North Carolina, United States
Raleigh, North Carolina, United States
Raleigh, North Carolina, United States
Salisbury, North Carolina, United States
Statesville, North Carolina, United States
Winston-Salem, North Carolina, United States
Cincinnati, Ohio, United States
Cincinnati, Ohio, United States
Cincinnati, Ohio, United States
Cincinnati, Ohio, United States
Columbus, Ohio, United States
Lyndhurst, Ohio, United States
Marion, Ohio, United States
Oklahoma City, Oklahoma, United States
Tulsa, Oklahoma, United States
Eugene, Oregon, United States
Harleysville, Pennsylvania, United States
Jersey Shore, Pennsylvania, United States
Lansdale, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Mt. Pleasant, South Carolina, United States
Rapid City, South Dakota, United States
Bristol, Tennessee, United States
Gray, Tennessee, United States
Kingsport, Tennessee, United States
Corpus Christi, Texas, United States
Houston, Texas, United States
Katy, Texas, United States
San Antonio, Texas, United States
Murray, Utah, United States
Salt Lake City, Utah, United States
Norfolk, Virginia, United States
Richmond, Virginia, United States
Olympia, Washington, United States
Countries
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References
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Dunbar RL, Nicholls SJ, Maki KC, Roth EM, Orloff DG, Curcio D, Johnson J, Kling D, Davidson MH. Effects of omega-3 carboxylic acids on lipoprotein particles and other cardiovascular risk markers in high-risk statin-treated patients with residual hypertriglyceridemia: a randomized, controlled, double-blind trial. Lipids Health Dis. 2015 Sep 2;14:98. doi: 10.1186/s12944-015-0100-8.
Maki KC, Orloff DG, Nicholls SJ, Dunbar RL, Roth EM, Curcio D, Johnson J, Kling D, Davidson MH. A highly bioavailable omega-3 free fatty acid formulation improves the cardiovascular risk profile in high-risk, statin-treated patients with residual hypertriglyceridemia (the ESPRIT trial). Clin Ther. 2013 Sep;35(9):1400-11.e1-3. doi: 10.1016/j.clinthera.2013.07.420. Epub 2013 Aug 30.
Other Identifiers
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OM-EPA-004
Identifier Type: OTHER
Identifier Source: secondary_id
NCT01408303
Identifier Type: OTHER
Identifier Source: secondary_id
OM-EPA-004
Identifier Type: -
Identifier Source: org_study_id