Epanova® for Lowering Very High Triglycerides
EVOLVE
Efficacy and Safety of Epanova® (Omefas) in Severe Hypertriglyceridemia
1 other identifier
interventional
399
7 countries
68
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2011
Shorter than P25 for phase_2
68 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 15, 2010
CompletedFirst Posted
Study publicly available on registry
November 17, 2010
CompletedStudy Start
First participant enrolled
January 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2012
CompletedResults Posted
Study results publicly available
September 6, 2013
CompletedAugust 4, 2016
June 1, 2016
1.2 years
November 15, 2010
June 26, 2013
June 24, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Fasting Serum Triglycerides
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
12 weeks
Study Arms (4)
placebo
PLACEBO COMPARATOREpanova 2 g
EXPERIMENTALEpanova 3 g
EXPERIMENTALEpanova 4 g
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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.
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (68)
Unknown Facility
National City, California, 91950, United States
Unknown Facility
Sacramento, California, 95823, United States
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Manchester, Connecticut, 06040, United States
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Coral Gables, Florida, 33134, United States
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Hialeah, Florida, 33012, United States
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Miami, Florida, 33169, United States
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Ocala, Florida, 34471, United States
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St. Petersburg, Florida, 33709, United States
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Summerfield, Florida, 34461, United States
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Atlanta, Georgia, 30328, United States
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Addison, Illinois, 60101, United States
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Chicago, Illinois, 60654, United States
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Louisville, Kentucky, 40213, United States
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Auburn, Maine, 04210, United States
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Olive Branch, Mississippi, 38654, United States
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High Point, North Carolina, 27262, United States
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Salisbury, North Carolina, 28144, United States
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Cincinnati, Ohio, 45212, United States
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Cincinnati, Ohio, 45246, United States
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Columbus, Ohio, 43213, United States
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Oklahoma City, Oklahoma, 73103, United States
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Philadelphia, Pennsylvania, 19104, United States
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Philadelphia, Pennsylvania, 19446, United States
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Bristol, Tennessee, 37620, United States
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Johnson City, Tennessee, 37604, United States
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Kingsport, Tennessee, 37660, United States
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San Antonio, Texas, 78215, United States
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Norfolk, Virginia, 23502, United States
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Richmond, Virginia, 23294, United States
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Olympia, Washington, 98502, United States
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Copenhagen, 2100, Denmark
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Gentofte Municipality, 2820, Denmark
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Herlev, 2730, Denmark
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Viborg, 8800, Denmark
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Baja, 6500, Hungary
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Budapest, 1062, Hungary
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Budapest, 1115, Hungary
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Budapest, 1125, Hungary
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Debrecen, 4032, Hungary
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Debrecen, 4043, Hungary
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Sátoraljaújhely, 3980, Hungary
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Székesfehérvár, 8000, Hungary
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Szikszó, 3800, Hungary
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Karnāl, Haryana, 132001, India
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Bangalore, Karnataka, 560003, India
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Bangalore, Karnataka, 560054, India
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Bangalore, Karnataka, India
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Banswada, Karnataka, 560043, India
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Indore, Madhya Pradesh, 452014, India
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Pune, Maharashtra, 411005, India
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Jaipur, Rajasthan, 302015, India
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Chennai, Tamil Nadu, 600010, India
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Surat, 395007, India
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Amsterdam, 1105AZ, Netherlands
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Groningen, 9711SG, Netherlands
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Rotterdam, 3004BA, Netherlands
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Rotterdam, 3021HC, Netherlands
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Utrecht, 3584CX, Netherlands
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Moscow, 129090, Russia
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Novosibirsk, 630068, Russia
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Saint Petersburg, 192288, Russia
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Saint Petersburg, 196084, Russia
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Kharkiv, 61037, Ukraine
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Kharkiv, 61039, Ukraine
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Kharkiv, 61176, Ukraine
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Kiev, 03115, Ukraine
Unknown Facility
Kiev, 03680, Ukraine
Unknown Facility
Zaporizhzhya, 69118, Ukraine
Related Publications (1)
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.
PMID: 24528690DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Torbjörn Lundström, Medical Science Director
- Organization
- AstraZeneca Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Michael H Davidson, MD, FACC
Omthera Pharmaceuticals, Inc
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 15, 2010
First Posted
November 17, 2010
Study Start
January 1, 2011
Primary Completion
March 1, 2012
Study Completion
April 1, 2012
Last Updated
August 4, 2016
Results First Posted
September 6, 2013
Record last verified: 2016-06