Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2/PHASE3
399 participants
INTERVENTIONAL
2011-01-31
2012-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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placebo
placebo
4 capsules (1g) daily for 12 weeks
Epanova 2 g
omefas
2 capsules (1g) + 2 placebo daily for 12 weeks
Epanova 3 g
omefas
3 capsules (1g) + 1 placebo daily for 12 weeks
Epanova 4 g
omefas
4 capsules (1g)daily for 12 weeks
Interventions
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placebo
4 capsules (1g) daily for 12 weeks
omefas
2 capsules (1g) + 2 placebo daily for 12 weeks
omefas
3 capsules (1g) + 1 placebo daily for 12 weeks
omefas
4 capsules (1g)daily for 12 weeks
Eligibility Criteria
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Inclusion Criteria
* Very high serum TG values in the range \>=500 mg/dL and \<2000 mg/dL (\>=5.65 mmol/L and \<22.60 mmol/L)
Exclusion Criteria
* Known lipoprotein lipase impairment or deficiency or apolipoprotein C-II deficiency or familial dysbetalipoproteinemia.
* Unable to discontinue use of omega-3 drugs/supplements.
* Unable to discontinue use of bile acid sequestrants, fibrates or niacin (other than niacin-containing vitamins \<200 mg), or any supplement used to alter lipid metabolism.
* Women who are pregnant, lactating, or planning to become pregnant. Women of childbearing potential who are not using acceptable contraceptive methods.
* Use of tamoxifen, estrogens or progestins that has not been stable for \>4 weeks prior to Visit 1.
* Use of oral or injected corticosteroids or anabolic steroids.
* History of pancreatitis.
* History of symptomatic gallstone disease, unless treated with cholecystectomy.
* Uncontrolled diabetes.
* Uncontrolled hypothyroidism or thyroid stimulating hormone (TSH).
* History of cancer (other than basal cell carcinoma) in the past 2 years.
* Cardiovascular event (i.e., myocardial infarction, acute coronary syndrome, new onset angina, stroke, transient ischemic attack, unstable congestive heart failure requiring a change in treatment) or revascularization procedure within six months prior to Visit 1.
* Use of anticoagulants (e.g. warfarin \[Coumadin®\], coumarin, heparin, enoxaparin, clopidogrel).
* Presence of an aortic aneurysm or resection of an aortic aneurysm within six months prior to Visit 1.
* Recent history (within six months prior to Visit 1) or current significant nephrotic syndrome, pulmonary, hepatic, biliary, gastrointestinal or immunologic disease.
* Poorly controlled hypertension.
* Any of the following laboratory criteria: serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST), glucose, glomerular filtration rate (GFR), platelet count,or hemoglobin outside of study range.
* Recent history (past 12 months) of drug abuse or alcohol abuse.
* Exposure to any investigational product, within 4 weeks prior to Visit 1.
* Presence of 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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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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National City, California, United States
Sacramento, California, United States
Manchester, Connecticut, United States
Coral Gables, Florida, United States
Hialeah, Florida, United States
Miami, Florida, United States
Ocala, Florida, United States
St. Petersburg, Florida, United States
Summerfield, Florida, United States
Atlanta, Georgia, United States
Addison, Illinois, United States
Chicago, Illinois, United States
Louisville, Kentucky, United States
Auburn, Maine, United States
Olive Branch, Mississippi, United States
High Point, North Carolina, United States
Salisbury, North Carolina, United States
Cincinnati, Ohio, United States
Cincinnati, Ohio, United States
Columbus, Ohio, United States
Oklahoma City, Oklahoma, United States
Philadelphia, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Bristol, Tennessee, United States
Johnson City, Tennessee, United States
Kingsport, Tennessee, United States
San Antonio, Texas, United States
Norfolk, Virginia, United States
Richmond, Virginia, United States
Olympia, Washington, United States
Copenhagen, , Denmark
Gentofte Municipality, , Denmark
Herlev, , Denmark
Viborg, , Denmark
Baja, , Hungary
Budapest, , Hungary
Budapest, , Hungary
Budapest, , Hungary
Debrecen, , Hungary
Debrecen, , Hungary
Sátoraljaújhely, , Hungary
Székesfehérvár, , Hungary
Szikszó, , Hungary
Karnāl, Haryana, India
Bangalore, Karnataka, India
Bangalore, Karnataka, India
Bangalore, Karnataka, India
Banswada, Karnataka, India
Indore, Madhya Pradesh, India
Pune, Maharashtra, India
Jaipur, Rajasthan, India
Chennai, Tamil Nadu, India
Surat, , India
Amsterdam, , Netherlands
Groningen, , Netherlands
Rotterdam, , Netherlands
Rotterdam, , Netherlands
Utrecht, , Netherlands
Moscow, , Russia
Novosibirsk, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Kharkiv, , Ukraine
Kharkiv, , Ukraine
Kharkiv, , Ukraine
Kiev, , Ukraine
Kiev, , Ukraine
Zaporizhzhya, , Ukraine
Countries
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References
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Kastelein JJ, Maki KC, Susekov A, Ezhov M, Nordestgaard BG, Machielse BN, Kling D, Davidson MH. Omega-3 free fatty acids for the treatment of severe hypertriglyceridemia: the EpanoVa fOr Lowering Very high triglyceridEs (EVOLVE) trial. J Clin Lipidol. 2014 Jan-Feb;8(1):94-106. doi: 10.1016/j.jacl.2013.10.003. Epub 2013 Oct 14.
Other Identifiers
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OM-EPA-003
Identifier Type: -
Identifier Source: org_study_id
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