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    Summary
    EudraCT Number:2010-024064-18
    Sponsor's Protocol Code Number:OM-EPA-003
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-04-26
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedDenmark - DHMA
    A.2EudraCT number2010-024064-18
    A.3Full title of the trial
    Efficacy and Safety of Epanova® in Severe Hypertriglyceridemia
    A.3.2Name or abbreviated title of the trial where available
    EVOLVE
    A.4.1Sponsor's protocol code numberOM-EPA-003
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorOmthera Pharmaceutical Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameEpanova (Omefas)
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product Yes
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Severe hypertriglyceridemia defined as serum triglyceride (TG) values ≥500 and <2000 mg/dL (≥5.65 mmol/L and <22.60 mmol/L).
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13.1
    E.1.2Level LLT
    E.1.2Classification code 10020870
    E.1.2Term Hypertriglyceridemia
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy and safety of Epanova in 332 subjects with severe hypertriglyceridemia defined as serum triglyceride (TG) values ≥500 and <2000 mg/dL (≥5.65 mmol/L and <22.60 mmol/L). The primary efficacy analyses will evaluate the effects of each dose of Epanova, relative to placebo, on fasting serum TG levels after 12 weeks of treatment. The primary safety and tolerability evaluation will be the review of the adverse events at each dose, compared to placebo.
    E.2.2Secondary objectives of the trial
    The secondary objective is to assess the effects of each dose of Epanova on fasting levels of non-high-density lipoprotein cholesterol (non-HDL-C) and high-density lipoprotein cholesterol (HDL-C).
    The tertiary objectives are to assess and or evaluate the effects of each dose of Epanova on other lipid parameters including total cholesterol (TC), LDL-C, TC : HDL-C ratio, and very low-density lipoprotein (VLDL) cholesterol; apolipoprotein A-I (apo A-I), apolipoprotein B (apo B), apolipoprotein C-III (apo C–III), and remnant lipoprotein cholesterol (RLP-C); lipoprotein particles (sizes, concentrations and subfractions for VLDL, LDL and HDL); HbA1c; the proportion of subjects who achieve TG <500 mg/dL at Week 12; plasma EPA, DHA, and arachidonic acid (AA); lipoprotein-associated phospholipase A2 (Lp-PLA2) and high sensitivity C-reactive protein (hs-CRP); other safety parameters including blood pressure, routine chemistry and hematology tests, urinalyses, and electrocardiograms
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Men or women, ≥18 years of age.
    2. Serum TG values in the range ≥500 mg/dL and <2000 mg/dL (≥5.65 mmol/L and <22.60 mmol/L) for the average of Visits 2 and 3 (Weeks -2 and -1). Repeat of Visit 3 test is allowed (Visit 3a), and the average of Visit 2 (Week -2) + Visit 3 (Week -1) + Visit 3a (repeat visit) is used as the criterion.
    3. Body mass index ≥20 kg/m2.
    4. Untreated dyslipidemia, or use of a statin or cholesterol absorption inhibitor, or their combination, if stable for 6 weeks at Visit 2 (Week -2) and prior to randomization.
    5. Willing to restrict consumption of fish to no more than twice per week during the study.
    6. Willingness to maintain current activity level and follow TLC diet.
    E.4Principal exclusion criteria
    1. Allergy or intolerance to omega-3 fatty acids, omega-3-acid ethyl esters, or fish.
    2. Known lipoprotein lipase impairment or deficiency or apolipoprotein C-II deficiency or familial dysbetalipoproteinemia.
    3. Unable to discontinue use of omega-3 drugs/supplements at Week -8 (Visit 1).
    4. 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, including but not limited to: dietary fiber supplements, red rice yeast supplements, garlic supplements, soy isoflavone supplements, sterol/stanol products, or policosanols at Week -4 (Visit 1).
    5. Women who are pregnant, lactating, or planning to become pregnant. Women of childbearing potential who are not using acceptable contraceptive methods. A woman is considered of childbearing potential if she is not surgically sterile or is less than 1 year since last menstrual period. Examples of acceptable contraceptive methods include abstinence, intrauterine device (IUD) or double barrier method. Estrogen-containing contraceptives are excluded.
    6. Use of tamoxifen, estrogens or progestins that has not been stable for >4 weeks at Visit 1, or is unstable prior to randomization.
    7. Use of oral or injected corticosteroids or anabolic steroids at Visit 1 or prior to randomization.
    8. History of pancreatitis.
    9. History of symptomatic gallstone disease, unless treated with cholecystectomy.
    10. Uncontrolled diabetes (HbA1c ≥9).
    11. Uncontrolled hypothyroidism or thyroid stimulating hormone (TSH) >5 mIU/L.
    12. History of cancer (other than basal cell carcinoma) in the past 2 years.
    13. 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 prior six months at Visit 1, or prior to randomization.
    14. Use of anticoagulants (e.g. warfarin [Coumadin®], coumarin, heparin, enoxaparin, clopidogrel).
    15. Presence of an aortic aneurysm or resection of an aortic aneurysm within prior six months at Visit 1, or prior to randomization.
    16. Recent history (within prior six months at Visit 1 or prior to randomization) of significant nephrotic syndrome, pulmonary, hepatic, biliary, gastrointestinal or immunologic disease.
    17. Poorly controlled hypertension (resting blood pressure ≥160 mm Hg systolic and/or ≥100 mm Hg diastolic) at two consecutive visits prior to randomization at Visit 4.
    18. Any of the following laboratory criteria: serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3x the upper limit of normal (ULN), fasting serum glucose >200 mg/dL, calculated glomerular filtration rate (GFR) <30 ml/min, platelet counts <60 x 109/L, or hemoglobin <10.0 g/dL.
    19. Recent history (past 12 months) of drug abuse or alcohol abuse. Alcohol abuse will be defined as >14 drinks per week (1 drink = 12 oz beer, 5 oz wine, or 1.5 oz hard liquor).
    20. Exposure to any investigational product within 4 weeks prior to Visit 1, or prior to randomization.
    21. 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.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint for each arm is the percent change in TG levels from baseline (average of Weeks -2, -1 and 0) to the end-of-treatment (average of Weeks 10 and 12).
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA18
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    the last visit of the last subject
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state35
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 120
    F.4.2.2In the whole clinical trial 332
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2011-03-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-03-29
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-02-06
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