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    The EU Clinical Trials Register currently displays   39219   clinical trials with a EudraCT protocol, of which   6426   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2010-019844-38
    Sponsor's Protocol Code Number:A6141116
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2010-09-13
    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 ConcernedGermany - BfArM
    A.2EudraCT number2010-019844-38
    A.3Full title of the trial
    A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED TRIAL EVALUATING THE SAFETY AND EFFICACY OF EARLY TREATMENT WITH EPLERENONE IN PATIENTS WITH ACUTE MYOCARDIAL INFARCTION
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A double-blind study, where patient could receive either an active drug
    (Eplerenone) or a dummy pill, with an aim to study if early treatment
    with Eplerenone is safe in patients with acute Myocardial Infarction.
    A.3.2Name or abbreviated title of the trial where available
    Reminder
    A.4.1Sponsor's protocol code numberA6141116
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01176968
    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 SponsorPfizer Inc., 235 East 42nd Street, New York, NY 10017, USA
    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 supportPfizer Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPfizer Inc
    B.5.2Functional name of contact pointClinical Trials.gov Call Center
    B.5.3 Address:
    B.5.3.1Street Address235 East 42nd Street
    B.5.3.2Town/ cityNew York
    B.5.3.3Post codeNY 10017
    B.5.3.4CountryUnited States
    B.5.4Telephone number+18007181021
    B.5.5Fax number+1303739 1119
    B.5.6E-mailClinicalTrials.gov_Inquiries@pfizer.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 Yes
    D.2.1.1.1Trade name Inspra®
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer bv
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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.3.4Pharmaceutical form Film-coated tablet
    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 INNeplerenone
    D.3.9.1CAS number 107724-20-9
    D.3.9.2Current sponsor codeSC-66110
    D.3.9.3Other descriptive namePregn-4-ene-7,21-dicarboxylic Acid,9,11-epoxy-17-hydroxy-3-oxo, γ-lactone, methyl ester,(7α,11α,17α)
    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) 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 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
    ACUTE MYOCARDIAL INFARCTION
    E.1.1.1Medical condition in easily understood language
    Heart Attack
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10000891
    E.1.2Term Acute myocardial infarction
    E.1.2System Organ Class 10007541 - Cardiac disorders
    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 study is:
    To assess the impact of eplerenone on cardiovascular mortality and morbidity in patients with acute myocardial infarction (STEMI) when initiated within the first 24 hours of onset of symptoms (preferably during the first 12 hours).
    E.2.2Secondary objectives of the trial
    The secondary objective is:
    To investigate the effect of eplerenone on serum biomarkers of collagen metabolism / myocardial fibrosis (eg, ICTP, PINP, PIIINP) and cardiovascular risk (eg, ADMA, adiponectin) and to potentially relate these measures to clinical outcomes.
    Safety will be assessed throughout the study by a Data and Safety Monitoring Board (DSMB), reviewing the incidence of nature of adverse events reported in each group.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subject eligibility should be reviewed and documented by an appropriately qualified member of the investigator's study team before subjects are included in the study. Subjects must meet all of the following inclusion criteria to be eligible for enrollment into this study.
    1. Evidence of a personally signed and dated Informed Consent Document obtained prior to the initiation of any study procedures and indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
    2. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
    3. Subjects must be male or non-pregnant female aged ≥ 18 years of age at the time informed consent is obtained.
    4. If the subject is female, she must be post-menopausal, or is surgically sterile, and is not lactating.
    5. Subjects must have experienced a myocardial infarction (STEMI) within the previous 24 hours confirmed by symptoms and ECG. STEMI is defined by:
    1. Chest pain/discomfort lasting for 20 minutes or more of ischaemic characteristics (epigastric or interscapular are included).
    2. ST segment elevation at the J point in two or more contiguous leads with the cut off points ≥ 0.2 mv in leads V1, V2 or V3 and ≥ 0.1 mv in other leads (contiguity in the frontal plane is defined by the lead sequence aVL, I, inverted aVR, II, aVF, III) or New left bundle branch block.
    3. Blood levels of cardiac enzymes are not required for a diagnosis of STEMI; however, if levels are available at time of randomization, then Troponin (I or T) OR creatine kinase (CK-MB, gender specific values should be used) must exceed the 99th percentile of normal of the laboratory performing the assay. Subjects randomized without subsequently elevated cardiac enzymes will continue in the study. A separate subgroup analysis will be performed.
    E.4Principal exclusion criteria
    Subjects presenting with any of the following will not be included in the study:
    1. The subject has received any investigational medication or used any investigational device within 30 days prior to the first dose of study medication or is actively participating in any investigational drug or device study, or is scheduled to receive an investigational drug other than eplerenone or to use an investigational device during the course of the study.
    2. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study. Subjects who have experienced a previous myocardial infarction may be included provided all other inclusion / exclusion criteria are met.
    3. Subjects with inability to follow protocol procedures according to the investigation.
    4. The subject has any condition which, in the opinion of the Investigator, makes
    participation in this study not in the best interest of the subject.
    5. The subject has a severe organic disorder or has had surgery or disease of the gastrointestinal tract which, in the opinion of the Investigator, may interfere with the
    absorption, pharmacokinetics, or elimination of the study drug.
    6. The subject has a co-morbid condition that would be expected to result in death during the next year (eg, terminal cancer, AIDS, etc) including subjects receiving immunosuppressive or antineoplastic therapy.
    7. The subject has current evidence of alcohol or drug abuse problems, which in the Investigator's opinion, precludes study participation.
    8. Subjects treated with eplerenone or other aldosterone antagonists within the past 1 month.
    9. The subject has an implanted cardiac defibrillator (ICD).
    10. The subject is awaiting cardiac transplant.
    11. The subject has uncontrolled hypotension (SBP<100mmHg).
    12. Subjects with eGFR ≤30ml/min (based on admission serum creatinine and the MDRD formula) or serum creatinine ≥220µmol/L.
    13. Subjects with a known low ejection fraction of less than 40% or any previous history of heart failure.
    14. Patients who have haemodynamically relevant aortic or mitral valve stenosis as judged by the investigator.
    15. Subjects with a diagnosis of hypertrophic cardiomyopathy.
    16. Subjects who have had cardiac surgery within 30 days prior to randomization.
    17. Concomitant use of potassium sparing diuretics (eg, spironolactone, triamterene or amiloride) or subjects who in the opinion of the investigator require treatment with potassium sparing diuretics.
    Use of potassium preparations or supplements will be allowed on a case by case basis at the discretion of the Investigator.
    18. Concomitant use of potent cytochrome p450 3A4 (CYP3A4) inhibitors, such as but not limited to: ketoconazole; itraconazole; nefazodone; troleandomycin; clarithromycin; ritonavir; nelfinavir (see Appendix 3 of the protocol).
    19. Concomitant use of cytochrome p450 3A4 (CYP3A4) inducers, such as but not limited to: St. John’s wort; rifampin; carbamazepine; phenytoin; phenobarbitol (see Appendix 3 of the protocol).
    20. Subjects who are likely to require treatment during the trial period with drugs not permitted by this protocol.
    21. Subjects 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.
    22. Subjects with a known sensitivity or intolerance to eplerenone, spironolactone or tablet excipients.
    23. Donation of blood or blood products for transfusion at any time during the trial or until 30 days after completion of treatment.
    24. Prisoners or subjects who are compulsorily detained (involuntary incarcerated) for treatment of either a psychiatric or physical illness must not be enrolled into this study.
    25. The subject has been previously admitted to the study.
    E.5 End points
    E.5.1Primary end point(s)
    Composite primary endpoint:
    Time to first event of cardiovascular mortality, re-hospitalization or extended initial hospital stay due to diagnosis of heart failure, sustained ventricular tachycardia or fibrillation, ejection fraction ≤ 40% after 1 month or BNP >200 pg/ml or NT-proBNP >450 pg/ml (age<50 years); >900 pg/ml (age 50-75 years) or >1800 pg/ml (age>75 years) after 1 month.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1 week, 4 weeks, 6 and 12 months
    E.5.2Secondary end point(s)
    1. Time to cardiovascular mortality.
    2. Time to diagnosis of heart failure.
    3. Time to first and each subsequent episode (after an event free interval
    of ≥ 48 hours) of
    sustained ventricular tachycardia or ventricular fibrillation.
    4. Time to first recorded ejection fraction of ≤ 40% (recorded 1 month
    or later postrandomization).
    5. Time to BNP >200 pg/ml or NT-proBNP >450, >900 or >1800 pg/ml
    for ages <50 years,
    50-75 years and >75 years, respectively (recorded 1 month or later
    post-randomization).
    6. Time to decision to provide an implantable cardioverter defibrillator
    (ICD) or cardiac resynchronization therapy (CRT).
    7. Time to second or subsequent non-fatal myocardial infarction.
    8. QRS duration at 6 months post-randomization.
    9. Left atrial diameter (recorded on each occasion an echocardiogram is
    conducted).
    10. Change in serum levels of biomarkers at 6 months postrandomization.
    Blood samples
    for biomarkers will be stored and analyzed post completion of the study.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1 week, 4 weeks, 6 and 12 months
    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 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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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
    Subjects will receive standard therapy (refer to protocol section 3)
    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 concerned14
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA63
    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
    Belgium
    Canada
    Czech Republic
    France
    Germany
    Greece
    Hungary
    Netherlands
    Poland
    Slovakia
    Spain
    Switzerland
    United Kingdom
    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
    As per Protocol
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months9
    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 months9
    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.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 708
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 304
    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 No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Under circumstances when the subject is unable to provide informed consent (eg, dosed with morphine or in significant distress), informed consent should be sought from a legally acceptable representative such as next of kin.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state150
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 962
    F.4.2.2In the whole clinical trial 1012
    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)
    No study drug will be provided after the patient’s participation in the study is completed.
    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 Decision2010-12-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-12-06
    P. End of Trial
    P.End of Trial StatusOngoing
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
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