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Epanova® for Lowering Very High Triglycerides (EVOLVE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01242527
Recruitment Status : Completed
First Posted : November 17, 2010
Results First Posted : September 6, 2013
Last Update Posted : August 4, 2016
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Severe Hypertriglyceridemia Drug: placebo Drug: omefas Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 399 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Epanova® (Omefas) in Severe Hypertriglyceridemia
Study Start Date : January 2011
Actual Primary Completion Date : March 2012
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Triglycerides

Arm Intervention/treatment
Placebo Comparator: placebo Drug: placebo
4 capsules (1g) daily for 12 weeks

Experimental: Epanova 2 g Drug: omefas
2 capsules (1g) + 2 placebo daily for 12 weeks

Experimental: Epanova 3 g Drug: omefas
3 capsules (1g) + 1 placebo daily for 12 weeks

Experimental: Epanova 4 g Drug: omefas
4 capsules (1g)daily for 12 weeks

Primary Outcome Measures :
  1. Fasting Serum Triglycerides [ Time Frame: 12 weeks ]
    The primary endpoints are the differences in mean percent changes from baseline to end-of-treatment in triglycerides between placebo and the 2g/day, 3g/day and 4g/day Epanova groups

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01242527

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Sponsors and Collaborators
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Study Director: Michael H Davidson, MD, FACC Omthera Pharmaceuticals, Inc
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: AstraZeneca Identifier: NCT01242527    
Other Study ID Numbers: OM-EPA-003
First Posted: November 17, 2010    Key Record Dates
Results First Posted: September 6, 2013
Last Update Posted: August 4, 2016
Last Verified: June 2016
Keywords provided by AstraZeneca:
omega-3 carboxylic acid
Additional relevant MeSH terms:
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Lipid Metabolism Disorders
Metabolic Diseases