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    Summary
    EudraCT Number:2013-004682-14
    Sponsor's Protocol Code Number:OM-EPA-011
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-01-29
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2013-004682-14
    A.3Full title of the trial
    A 12-Week, Randomized, Double-Blind, Olive Oil-Controlled Phase 3 Study to Assess the Efficacy and Safety of EPANOVA™ in Subjects With Severe Hypertriglyceridemia (EVOLVE II)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to assess the effectiveness and safety of EPANOVA™ in patients who have severe hypertriglyceridemia, when compared to treatment with olive oil over 12 weeks
    A.4.1Sponsor's protocol code numberOM-EPA-011
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02009865
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorOmthera Pharmaceuticals, 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 supportOmthera Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedpace
    B.5.2Functional name of contact pointRegulatory Submissions Manager
    B.5.3 Address:
    B.5.3.1Street Address5375 Medpace Way
    B.5.3.2Town/ cityCincinnati
    B.5.3.3Post code45227
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1513579-9911
    B.5.5Fax number+1513579-0444
    B.5.6E-mailc.grawe@medpace.com
    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
    D.3.4Pharmaceutical form Capsule, soft
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNA
    D.3.9.2Current sponsor codeOmefas
    D.3.9.3Other descriptive nameOMEGA-3 FATTY ACIDS
    D.3.9.4EV Substance CodeSUB32453
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    D.3.11.9Recombinant medicinal product No
    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, soft
    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
    E.1.1.1Medical condition in easily understood language
    High triglyceride levels in the blood
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level LLT
    E.1.2Classification code 10020870
    E.1.2Term Hypertriglyceridemia
    E.1.2System Organ Class 100000004861
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objectives of the study are:
    • To determine the efficacy of Epanova 2 g daily compared to olive oil 2 g daily for 12 weeks in lowering serum triglyceride (TG) levels in subjects with severe hypertriglyceridemia (TG levels ≥500 mg/dL [5.65 mMol/L] and <2500 mg/dL [28.25 mMol/L])
    • To determine the safety and tolerability of Epanova.
    E.2.2Secondary objectives of the trial
    The secondary objectives are:
    • To determine the effect of Epanova 2 g daily compared to olive oil 2 g daily for 12 weeks in lowering serum TG levels in subjects with at least 1 qualifying TG >885 mg/dL (10 mMol/L) and <2500 mg/dL (28.25 mMol/L);
    • To determine the effects of Epanova 2 g daily compared to olive oil 2 g daily for 12 weeks in lowering TG levels in subjects with Fredrickson Type V hyperlipidemia (TG/very low-density lipoprotein cholesterol [VLDL-C] ≥6);
    • To determine the effect of Epanova on non-high-density lipoprotein cholesterol (non-HDL-C) and high-density lipoprotein cholesterol (HDL-C).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Understanding of the study procedures, willingness to adhere to the study schedule, and agreement to participate in the study by giving written informed consent prior to screening;
    2. Willing to use an appropriate and effective method of contraception;
    3. Qualifying (average of Visit 1 or 1a + Visit 2 + Visit 2a [repeat measurement]) serum TG ≥500 mg/dL (5.65 mMol/L) and <2500 mg/dL (28.25 mMol/L);
    4. Body mass index ≥20 kg/m2;
    5. Untreated dyslipidemia or dyslipidemia treated with a statin, CAI, or statin-CAI combination that has been stable for 6 weeks prior to randomization;
    6. Willingness to maintain current physical activity level and follow the TLC diet throughout the study.
    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;
    3. Known non-responder to omega-3 or fenofibrate therapy;
    4. Use of any prescription medications containing EPA and/or DHA (eg, Lovaza® or Vascepa®) within 8 weeks prior to randomization. Up to 1 g capsule/day of an omega-3 dietary supplement will be permitted;
    5. 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 Visit 1;
    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 in the 4 weeks prior to Visit 1;
    8. History of hospitalization for pancreatitis in the last 5 years;
    9. Uncontrolled diabetes (hemoglobin A1c >10%);
    10. Uncontrolled hypothyroidism or thyroid-stimulating hormone >5 mIU/L;
    11. History of cancer (other than basal cell carcinoma) in the past 2 years;
    12. Cardiovascular event (ie, myocardial infarction, acute coronary syndrome, new onset angina, stroke, transient heart attack, unstable congestive heart failure requiring a change in treatment), revascularization procedure or vascular surgery within 6 months of randomization;
    13. Use of simvastatin 80 mg or Vytorin 10/80 mg;
    14. Recent history (within 6 months of randomization) of significant nephrotic syndrome, pulmonary, hepatic, biliary, gastrointestinal, or immunologic disease;
    15. Poorly controlled hypertension (systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ≥110 mmHg) at two consecutive visits prior to randomization at Visit 3;
    16. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 × the upper limit of normal;
    17. Exposure to any investigational product within 4 weeks of Visit 1; or
    18. Any condition or therapy which, in the opinion of the Investigator, might pose a risk to the subject or make participation in the study not in the subject’s best interest.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy variable is percent change in TG from baseline to Week 12 endpoint.
    The primary efficacy variable will also be evaluated for the following subgroups:
    • Subjects with at least 1 qualifying TG >885 mg/dL (10 mMol/L) and
    • Subjects with Fredrickson Type V (TG/VLDL-C ≥6).

    Safety assessments will include adverse events, clinical laboratory parameters (chemistry, hematology, and urinalysis), 12-lead ECGs, vital signs, and physical examinations. Additionally, serious adverse events (SAEs) and adverse events leading to discontinuation will be recorded.
    E.5.1.1Timepoint(s) of evaluation of this end point
    For lipid parameters (TG, non-HDL-C, HDL-C, TC, LDL-C, VLDL-C, and TC:HDL-C ratio) baseline will be defined as the mean of the measurement at Visit 3 (Week 0) and the last 2 qualifying measurements from Visits 1, 1a, 2, and 2a. Week 12 endpoint will be defined as the average of the measurements at Visit 5 (Week 10) and Visit 6 (Week 12). If both the Visit 5 (Week 10) measurement and the Visit 6 (Week 12) measurement are missing, Week 12 endpoint will be defined as the last measurement after the first dose of study drug.

    All analyses of safety during the double-blind period will be conducted on the safety population.
    E.5.2Secondary end point(s)
    The secondary efficacy variables are percent changes in non-HDL-C and HDL-C from baseline to Week 12 endpoint.
    The tertiary efficacy parameters include:
    • Percent changes in LDL-C, TC, VLDL-C, and TC:HDL-C ratio from baseline to Week 12 endpoint;
    • Percent changes in apo A-I, apo A-V, apo B, apo C-III, and RLP-C from baseline to Week 12 endpoint;
    • Percent changes in Lp(a) and Lp-PLA2 from baseline to Week 12 endpoint;
    • Changes in adiponectin and leptin from baseline to Week 12 endpoint; and
    • Change in plasma concentrations and RBC membrane content of fatty acids including EPA, DHA, AA, and DPA from baseline to Week 12 endpoint.
    E.5.2.1Timepoint(s) of evaluation of this end point
    For lipid parameters (TG, non-HDL-C, HDL-C, TC, LDL-C, VLDL-C, and TC:HDL-C ratio) baseline will be defined as the mean of the measurement at Visit 3 (Week 0) and the last 2 qualifying measurements from Visits 1, 1a, 2,
    and 2a. Week 12 endpoint will be defined as the average of the measurements at Visit 5 (Week 10) and Visit 6 (Week 12). If both the Visit 5 (Week 10) measurement and the Visit 6 (Week 12) measurement are missing, Week 12 endpoint will be defined as the last measurement after the first dose of study drug.
    For all other efficacy parameters, baseline will be the Visit 3 (Week 0) measurement, and Week 12 endpoint will be the Visit 6 (Week 12) measurement. If the Week 12 measurement is missing, Week 12 endpoint will be the last measurement after the first dose of study drug.
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    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 No
    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.8.2.4Number of treatment arms in the trial2
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA17
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Canada
    Denmark
    Netherlands
    Czech Republic
    Hungary
    Russian Federation
    United States
    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
    LVLS
    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 months10
    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 months0
    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.1.2.1Number of subjects for this age range: 98
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 18
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state27
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 48
    F.4.2.2In the whole clinical trial 116
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    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 Decision2014-04-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-03-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-12-23
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