Clinical trial NCT01242527: Epanova® for Lowering Very High Triglycerides
Official title: Efficacy and Safety of Epanova® (Omefas) in Severe Hypertriglyceridemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Severe Hypertriglyceridemia
Keywords: dyslipidemia
hyperlipidemia
omega-3 carboxylic acid
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-11-17
Enrollment: 399
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of the study is to determine the efficacy of Epanova (omefas) compared to placebo in lowering serum triglycerides in subjects with severe hypertriglyceridemia.


Eligibility criteria: Inclusion Criteria:

* Men or women, \>=18 years of age.
* 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:

* Allergy or intolerance to omega-3 fatty acids, omega-3-acid ethyl esters, or fish.
* 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

Primary outcomes:
measure: Fasting Serum Triglycerides
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: National City
country: United States
state: California
city: Sacramento
country: United States
state: California
city: Manchester
country: United States
state: Connecticut
city: Coral Gables
country: United States
state: Florida
city: Hialeah
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Ocala
country: United States
state: Florida
city: St Petersburg
country: United States
state: Florida
city: Summerfield
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Addison
country: United States
state: Illinois
city: Chicago
country: United States
state: Illinois
city: Louisville
country: United States
state: Kentucky
city: Auburn
country: United States
state: Maine
city: Olive Branch
country: United States
state: Mississippi
city: High Point
country: United States
state: North Carolina
city: Salisbury
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Cincinnati
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Philadelphia
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Bristol
country: United States
state: Tennessee
city: Johnson City
country: United States
state: Tennessee
city: Kingsport
country: United States
state: Tennessee
city: San Antonio
country: United States
state: Texas
city: Norfolk
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
city: Olympia
country: United States
state: Washington
city: Copenhagen
country: Denmark
city: Gentofte
country: Denmark
city: Herlev
country: Denmark
city: Viborg
country: Denmark
city: Baja
country: Hungary
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Debrecen
country: Hungary
city: Debrecen
country: Hungary
city: Satoraljaujhely
country: Hungary
city: Szekesfehervar
country: Hungary
city: Szikszo
country: Hungary
city: Karnal
country: India
state: Haryana
city: Bangalore
country: India
state: Karnataka
city: Bangalore
country: India
state: Karnataka
city: Bangalore
country: India
state: Karnataka
city: Banswada
country: India
state: Karnataka
city: Indore
country: India
state: Madhya Pradesh
city: Pune
country: India
state: Maharashtra
city: Jaipur City
country: India
state: Rajasthan
city: Chennai
country: India
state: Tamil nadu
city: Surat
country: India
city: Amsterdam
country: Netherlands
city: Groningen
country: Netherlands
city: Rotterdam
country: Netherlands
city: Rotterdam
country: Netherlands
city: Utrecht
country: Netherlands
city: Moscow
country: Russian Federation
city: Novosibirsk
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: Kharkiv
country: Ukraine
city: Kharkiv
country: Ukraine
city: Kharkiv
country: Ukraine
city: Kiev
country: Ukraine
city: Kiev
country: Ukraine
city: Zaporizhzhya
country: Ukraine
Study officials:
affiliation: Omthera Pharmaceuticals, Inc
name: Michael H Davidson, MD, FACC
role: STUDY_DIRECTOR
References:
citation: 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.