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    Summary
    EudraCT Number:2014-001069-28
    Sponsor's Protocol Code Number:D5881C00004
    National Competent Authority:Lithuania - SMCA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2014-08-20
    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 ConcernedLithuania - SMCA
    A.2EudraCT number2014-001069-28
    A.3Full title of the trial
    A Long-Term Outcomes Study to Assess STatin Residual Risk Reduction with EpaNova in HiGh Cardiovascular Risk PatienTs with Hypertriglyceridemia (STRENGTH)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Long-Term Outcomes Study to Assess STatin Residual Risk Reduction with EpaNova in HiGh Cardiovascular Risk PatienTs with Hypertriglyceridemia (STRENGTH)
    A.3.2Name or abbreviated title of the trial where available
    STRENGTH
    A.4.1Sponsor's protocol code numberD5881C00004
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02104817
    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 SponsorAstraZeneca AB
    B.1.3.4CountrySweden
    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 supportAstraZeneca AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstraZeneca
    B.5.2Functional name of contact pointInformation Center
    B.5.3 Address:
    B.5.3.1Street AddressPepparedsleden 1
    B.5.3.2Town/ cityMölndal
    B.5.3.3Post code43183
    B.5.3.4CountrySweden
    B.5.6E-mailinformation.center@astrazeneca.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.3.2Product code Epanova
    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/g milligram(s)/gram
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number800
    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 persistent Hypertriglyceridemia in High Cardiovascular Risk
    Patients
    E.1.1.1Medical condition in easily understood language
    High triglyceride levels in the blood in patients with high cardiovascular
    risk
    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 20.1
    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 objective is to evaluate the effectiveness of adding Epanova to statin therapy (with or without ezetimibe) for lowering MACE (cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, emergent/elective coronary revascularization, or hospitalization for unstable angina) in high cardiovascular risk patients with persistent hypertriglyceridemia and low HDL-cholesterol (HDL-C)
    E.2.2Secondary objectives of the trial
    NA
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Pharmacogenetics Research, D5881C00004, V1.0 March 2014
    The objective of this research is to collect and store DNA for exploratory
    research into genes/genetic variation that may influence response (i.e.,
    distribution, safety, tolerability and efficacy) to omega-3 fatty acids and
    other cardiovascular medications and/or susceptibility to and/or
    prognosis of cardiovascular, metabolic and related diseases.
    E.3Principal inclusion criteria
    1. Men or women, ≥18 years of age.
    2. Patient must be on a stable diet and statin* therapy at least 4 weeks prior to randomization
    (Visit 2) and meet the following criteria, where the qualifying lipid parameters should be obtained from the same visit:
    a. LDL-C <100 mg/dL (<2.59 mmol/L). Patient will also qualify if LDL-C ≥100 mg/dL (≥2.59 mmol/L) and if on a high-intensity or maximally tolerated moderate- or lowintensity statin dose, with or without ezetimibe therapy, for at least 4 weeks (see Appendix D). The maximum tolerated dosage of a statin is defined as the approved dose
    per local label that the patient can tolerate without unacceptable adverse effects such as muscle aches/pain/weakness or elevations in liver enzymes or creatine kinase (CK) that are determined by the investigator to be clinically relevant and due to statin therapy.
    b. TG level ≥180 and <500 mg/dL (≥2.03 and <5.65 mmol/L) and HDL-C <42 mg/dL (1.09 mmol/L) for men or HDL-C <47 mg/dL (1.22 mmol/L) for women.
    3. Patient is at high risk for a future cardiovascular event if at least one of the following criteria (3a, 3b or 3c)* is present via patient history, physical exam, or medical records at the time of screening:
    a. Any atherosclerotic CVD as defined by one or more of the following:
     previous clinical myocardial infarction (MI) ≥30 days prior to randomization
     percutaneous coronary intervention (PCI) including balloon angioplasty and coronary stenting ≥ 6 months prior to randomization
     coronary artery bypass grafting (CABG) ≥30 days prior to randomization
     coronary angiogram including computed tomography angiogram (CTA) showing ≥50% stenosis in at least one native or graft vessel
     anginal symptoms with a defect documented by stress testing with nuclear perfusion imaging or a wall motion abnormality determined by stress echocardiogram
     asymptomatic coronary ischemia documented by stress testing with nuclear perfusion imaging or by stress echocardiogram
     peripheral vascular disease with symptoms of claudication and ankle brachial index <0.9 performed by a vascular lab or angiogram (including CTA) showing ≥50% stenosis)
     history of peripheral arterial revascularization (surgical or percutaneous) ≥30 days prior to randomization
     carotid endarterectomy, carotid stenting or more than or equal to 50% stenosis in a carotid artery
    determined by carotid ultrasound or angiogram ≥30 days prior to randomization
     history of abdominal aortic aneurysm confirmed by imaging diagnosed ≥30 days prior to randomization
     ischemic stroke ≥30 days prior to randomization
     coronary calcium score >300 Agatston units (AU).
    b. History of diabetes mellitus (type 1 or 2) and ≥40 years of age for men and ≥50 years of age for women, plus one of the following risk factors:
     chronic cigarette smoking at screening (at least 1 cigarette per day for > 1 month)
     history of hypertension (blood pressure >140/90 mm Hg) or taking antihypertensive medication
     high-sensitivity C-reactive protein (hs-CRP) > 2.0 mg/L (19.05 nmol/L) determined at Visit 1
     history of albuminuria (urinary albumin:creatinine ratio [ACR] >30 mg/g).
    c. Male patients >50 years of age or females >60 years of age, with at least one of the following risk factors:
     family history (mother, father or sibling) of premature coronary heart disease (father or brother <55 years of age, mother or sister <65 years of age)
     chronic cigarette smoking at screening (at least 1 cigarette per day for > 1 month)
     hs-CRP >2.0 mg/L (19.05 nmol/L) determined at Visit 1
     impaired renal function as estimated using the Chronic Kidney Disease Epidemiology Collaboration formula for glomerular filtration rate (eGFR) <45 mL/min per 1.73 m2
    (patients on dialysis are excluded).
     coronory calcium score >300 Agatston units (AU) at any time in the past.
    *If patient will meet CVD secondary prevention criteria (3a) AND primary prevention
    criteria (3b and/or 3c) at the same time, then patient will be considered as meeting CVD secondary prevention criteria (3a) for the purpose of identifying the inclusion criteria for that patient.
    4. Patient must have been on a stable diet prior to randomization and willing to follow the NCEP TLC diet, or equivalent diet, throughout the study.
    Note a) A Patiet can, in specific circumstances, be re-screened. For details, see section 6.4 of the protocol.
    E.4Principal exclusion criteria
    1. Allergy or intolerance to omega-3- carboxylic acids, omega-3 fatty acids, omega-3-acid ethyl esters, or corn oil.
    2. Known hypersensitivity to fish and/or shellfish.
    3. Use of fibrates, bile acid sequestrants, or niacin or its analogues (>250 mg/day) within 4 weeks prior to Visit 2. Patients taking these agents may be considered for inclusion in the study if these therapies have been discontinued for 4 weeks or more prior to Visit 2. However, niacin or its analogues at a dose less than or equal to 250 mg/day is permissible.
    4. Statin naïve at Visit 1.
    5. Use of simvastatin 80 mg or ezetimibe/simvastatin 10/80 mg within 4 weeks prior to Visit 2. Patients taking these agents may be considered for inclusion in the study if these therapies have been discontinued and replaced with a protocol acceptable statin treatment that is stabilized for 4 weeks or more prior to Visit 2.
    6. Use of any prescription medications containing eicosapentaenoic acid (EPA) and/or docosahexaenoic acid (DHA), e.g. Lovaza® or Vascepa®, within 4 weeks prior to Visit 2. Patients taking these agents may be considered for inclusion in the study if these therapies have been discontinued for 4 weeks or more prior to Visit 2.
    7. More than one capsule/day (any dose) of omega-3 dietary supplements. Patients taking >1 capsule/day of omega-3 supplements before Visit 1 DO NOT require a washout period but must agree to reduce the number of capsules per day to no more than 1 capsule of 1 g promptly after signing the informed consent. No new omega-3 supplements are permitted following initiation of screening procedures at Visit 1.
    8. Use of prescription or over-the-counter (OTC) weight loss drugs at any time after Visit 1.
    9. Chronic use of oral corticosteroids during screening (acute use for inflammation for example
    from poison ivy, or intranasal or inhaled steroids for allergies/asthma, or intraarticular
    injections are allowed).
    10. Use of tamoxifen, estrogens, progestins, or testosterone, that has not been stable for >4 weeks at Visit 1, or is unstable prior to Visit 2.
    11. Known lipoprotein lipase impairment or deficiency, or apolipoprotein C-II deficiency.
    12. Hemoglobin A1c (Hb A1c) >12% at Visit 1.
    13. Poorly controlled hypertension (resting blood pressure ≥180 mm Hg systolic and/or ≥100 mm Hg diastolic) at two consecutive visits prior to randomization at Visit 2.
    14. Uncontrolled hypothyroidism, or thyroid stimulating hormone (TSH) >2.0 times upper limit of normal (ULN) at Visit 1. Patients who are clinically euthyroid, on stable thyroid replacement therapy for 2 months prior to Visit 1 are allowed.
    15. History of cancer (except non-melanoma skin cancer, or carcinoma in situ of cervix) within the previous two years.
    16. Patients on dialysis.
    17. Females who are pregnant, planning to be pregnant during the study period, lactating, or women of childbearing potential who are not using an acceptable method of contraception. A woman is considered of childbearing potential if she is not surgically sterile or if her last menstrual period was <12 months prior to Visit 1. Acceptable methods of contraception for this study include use of double barrier contraception, intrauterine device, all oral, patch, etc. hormonal contraceptives as long as dose and type is stable for 3 months prior to Visit 1. In addition, true abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject.
    18. Creatine kinase >5.0 times ULN; aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >3.0 times ULN; or total bilirubin (TBL) >2.0 times ULN (except with a confirmed diagnosis of Gilbert’s disease), at Visit 1. A diagnosis of non-alcoholic fatty liver disease (NAFLD) or non-alcoholic steatohepatitis (NASH) with stable elevations
    of AST and/or ALT (>3.0 times ULN) is eligible for participation in the study.
    19. Excessive use of alcohol or other substance abuse that in the investigator’s opinion would jeopardize the patient’s participation in the study or interpretation of the data.
    20. Exposure to any investigational agent within 4 weeks prior to Visit 1, including previous enrollment or randomization in this study.
    21. Previous clinical myocardial infarction (MI) <30 days prior to randomization.
    22. Percutaneous coronary intervention (PCI) including balloon angioplasty and coronary stenting<6 months prior to randomization.
    23. Coronary artery bypass grafting (CABG) <30 days prior to randomization.
    24. History of peripheral arterial revascularization (surgical or percutaneous) <30 days prior to randomization.
    25. Carotid endarterectomy or more than or equal to 50% stenosis in a carotid artery determined by carotid ultrasound or angiogram <30 days prior to randomization.
    26. History of abdominal aortic aneurysm diagnosed <30 days prior to randomization.
    27. Ischemic stroke <30 days prior to randomization.
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome measure is the time to first occurrence of any component of the composite of MACE. Patients will remain in the study until the required number of patients with MACE has occurred. We anticipate that patients will be in the study for 3-5 years. Patients who discontinue investigational product (IP) will continue to be assessed as specified per the protocol.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Visit 3-14, Months 3, 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
    E.5.2Secondary end point(s)
    KEY secondary outcome measures include:
    - The composite measure of CV events that include the first occurence of cardiac death (including death due to acute myocardial infarction, sudden cardiac death and death due to cardiovascular procedures), non-fatal MI, and non-fatal stroke.
    - The composite measure of coronary events that include the first occurence of cardiovascular death, non-fatal MI, emergent/elective coronary revascularization, or hospitalization for unstable angina.
    - Time to CV Death.

    Other secondary outcome measures include:
    a) Emergent/elective coronary revascularization
    b) Hospitalization for unstable angina
    c) Fatal or non-fatal MI
    d) Non-fatal MI
    e) Fatal or non-fatal stroke
    f) Non-fatal stroke
    g) All-cause death

    Tertiary outcome measures will include:
    - The first occurence of new onset atrial fibrillation (AF)
    - The composite measure of total thrombotic events that include the first occurence of documented coronary stent thrombosis, any systemic thromboembolism including arterial stent (except coronary) thrombosis or venous thromboembolism (VTE), i.e. deep vein thrmobosis (DVT) and/or pulmonary embolism (PE)
    - First occurence of a heart failure event.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Visit 3-14, Months 3, 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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 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 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.8.2.4Number 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 concerned15
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA191
    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
    Argentina
    Australia
    Belgium
    Brazil
    Canada
    China
    Czech Republic
    Denmark
    Estonia
    Hungary
    Italy
    Japan
    Korea, Republic of
    Lithuania
    Mexico
    Netherlands
    New Zealand
    Poland
    Russian Federation
    South Africa
    Taiwan
    Ukraine
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    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
    When 1600 primary efficacy endpoints have been identified
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years7
    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: 5200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 7800
    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 state372
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 6500
    F.4.2.2In the whole clinical trial 13000
    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 Decision2014-09-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-08-21
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2020-05-15
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