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    Summary
    EudraCT Number:2005-003351-12
    Sponsor's Protocol Code Number:A6141079
    National Competent Authority:Greece - EOF
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-07-28
    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 ConcernedGreece - EOF
    A.2EudraCT number2005-003351-12
    A.3Full title of the trial
    THE EFFECT OF EPLERENONE VERSUS PLACEBO ON CARDIOVASCULAR MORTALITY AND HEART FAILURE HOSPITALISATION IN SUBJECTS WITH NYHA CLASS II CHRONIC SYSTOLIC HEART FAILURE (EMPHASIS-HF)
    A.3.2Name or abbreviated title of the trial where available
    EMPHASIS-HF
    A.4.1Sponsor's protocol code numberA6141079
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberN/A
    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 SponsorPfizer Hellas AE
    B.1.3.4CountryGreece
    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 Information not present in EudraCT
    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 nameInspra
    D.3.2Product code N/A
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNEplerenone
    D.3.9.1CAS number 107724-20-9
    D.3.9.3Other descriptive nameMethyl hydrogen (7α,11α,17α)-9,11-epoxy-17-hydroxy-3-oxopregn-4-ene-7,21-dicarboxylateγ-lactone
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 placeboFilm-coated tablet
    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
    Chronic systolic heart failure
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.0
    E.1.2Level LLT
    E.1.2Classification code 10008908
    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 of this trial is to evaluate the efficacy and safety of eplerenone plus standard heart failure (HF) therapy versus placebo plus standard HF therapy on the cumulative incidence of cardiovascular (CV) mortality and HF hospitalisation (a composite primary endpoint).
    E.2.2Secondary objectives of the trial
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial:
    1. Written informed consent obtained prior to the initiation of any study procedures
    2. Male or female subjects, ≥ 60 years of age at the time informed consent is obtained
    3. Chronic systolic heart failure (HF) of either ischaemic or non-ischaemic aetiology:

    a. Duration: at least 4 weeks

    b. Left ventricular ejection fraction (LVEF): ≤ 30% by echocardiography, contrast ventriculography, magnetic resonance imaging or nuclear imaging, based on local clinical practice. The most recent measurement within 6 months prior to randomisation must be used.

    c. Functional Capacity: Currently NYHA II (in the investigator’s opinion)

    d. Treatments (for ACE inhibitors, ARBs and b-blockers, optimal target or maximal tolerated dose unless contraindicated):

    · Angiotensin converting enzyme (ACE) inhibitors and/or angiotensin receptor blockers (ARBs)

    · β-blocker

    · Diuretic, if clinically indicated to reduce fluid retention

    4. Serum potassium (K+) level ≤ 5.0mmol/L within 24 hours prior to randomisation

    5. Estimated glomerular filtration rate (eGFR) >30 ml/min/1.73m2 within 24 hours prior to randomisation.

    6. Randomisation must occur no later than 90 days from the date of admission for index cardiovascular (CV) hospitalisation. (If clinically stable, the subject may be randomised during this index cardiovascular (CV) hospitalisation.)

    7. If the subject is a female of childbearing potential, she must:

    a. Have a negative serum pregnancy within 72 hours prior to the first dose of study drug
    AND
    b. Agree to use an adequate form of contraception (Abstinence will not be considered an acceptable form of contraception.)
    E.4Principal exclusion criteria
    Subjects presenting with any of the following will not be included in the trial:

    1. Patients with severe chronic systolic heart failure, defined as patients who demonstrate symptoms usually at rest despite optimal medical therapy

    2. Patients with a myocardial infarction complicated by left ventricular systolic dysfunction and clinical heart failure within 30 days prior to randomisation

    3. Patients with stroke within 30 days prior to randomisation

    4. Patients who have had cardiac surgery within 30 days prior to randomisation

    5. Patients who have had percutaneous coronary intervention (PCI) within 30 days prior to randomisation

    6. Patients, who in the opinion of the investigator, require treatment with eplerenone, spironolactone or potassium canrenoate

    7. Patients with uncontrolled hypertension, defined as having a systolic blood pressure ≥ 180 mmHg and/or a diastolic blood pressure ≥ 110 mmHg

    8. Patients with symptomatic hypotension or having a systolic blood pressure ≤ 85 mmHg

    9. Patients, who in the opinion of the investigator, require treatment with potassium-sparing diuretics or potassium supplements

    10. History of hypersensitivity to eplerenone or spironolactone

    11. Evidence of cardiogenic shock

    12. Patients in whom the primary cause of heart failure is valve disease, pericardial disease or an obstructive or restrictive cardiomyopathy .

    13. Intra-aortic balloon pump or other mechanical assist device

    14. Patients awaiting cardiac transplantation

    15. Serum potassium > 5.0 mmol/L within 24 hours prior to randomisation

    16. Estimated glomerular filtration rate (eGFR) ≤30 ml/min/1.73m2 within 24 hours prior to randomisation.

    17. Concomitant use of potent cytochrome p450 3A4 (CYP3A4) inhibitors, such as but not limited to:
    a. Ketoconazole
    b. Itraconazole
    c. Nefazodone
    d. Troleandomycin
    e. Clarithromycin
    f. Ritonavir
    g. Nelfinavir


    18. Concomitant use of cytochrome p450 3A4 (CYP3A4) inducers, such as but not limited to:
    a. St. John’s Wort
    b. Rifampin
    c. Carbamazepine
    d. Phenytoin
    e. Phenobarbitol

    19. Hemoglobin <10g/dL

    20. Patients with preexisting significant hepatic disease (for example, known positive serology for viral hepatitis) or aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 3 times the upper limits of normal

    21. Patients status-post gastric bypass surgery, partial gastrectomy or other surgery of the gastrointestinal tract that may interfere with the absorption of eplerenone
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the first occurrence of cardiovascular (CV) mortality and heart failure (HF) hospitalisation.

    Cardiovascular (CV) mortality is defined as death due to:
    Heart Failure
    Myocardial infarction
    Cardiac arrhythmia
    Stroke/cerebral vascular accident (CVA) or transient ischaemic attack (TIA)
    Other CV cause (e.g., aneurysm or pulmonary embolism)

    Hospitalisation for HF
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Information not present in EudraCT
    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 Yes
    E.8.2.3.1Comparator description
    Standard Therapy
    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.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    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
    As per protocol.
    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 days
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state80
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1292
    F.4.2.2In the whole clinical trial 2584
    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)
    As per protocol
    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 Decision2006-11-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-01-30
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-01-24
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