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    Summary
    EudraCT Number:2005-003351-12
    Sponsor's Protocol Code Number:A6141079
    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:2005-10-14
    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 number2005-003351-12
    A.3Full title of the trial
    The effect of eplerenone versus placebo on cardiovascular mortality and heart failure hospitalization in subjects with NYHA Class II Chronic Systolic Heart Failure
    A.3.2Name or abbreviated title of the trial where available
    N/A
    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 Kft.
    B.1.3.4CountryHungary
    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.2.1.1.1Trade name Inspra
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 (7<,11<,17<)-9,11-epoxy-17-hydroxy-3-oxopregn-4-ene-7,21-dicarboxylate©-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 hospitalization (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
    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 ischemic or non-ischemic etiology:
    a) Duration: at least 4 weeks
    b) Left ventricular ejection fraction (LVEF): ≤30% by echocardiography, contrast
    ventriculography or nuclear imaging
    c) Functional Capacity: Usually NYHA II (in the investigator’s opinion)
    d) Treatments (for ACE inhibitors, ARBs and b-blockers, optimal target or maximal
    tolerated dose [see Appendix 1 of the protocol] unless contraindicated):
    i) Angiotensin converting enzyme (ACE) inhibitors and/or angiotensin receptor
    blockers (ARBs)
    ii) b-blocker
    iii) Diuretic, if clinically indicated to reduce fluid retention
    4. Serum potassium (K+) level ≤5.0mmol/L
    5. Estimated glomerular filtration rate (eGFR) >30 ml/min/1.73m2 (see Appendix 2 of the protocol)
    6. Randomization must occur no later than 90 days from the date of admission for index cardiovascular (CV) hospitalization. (If clinically stable, the subject may be randomized during this index cardiovascular (CV) hospitalization.)
    E.4Principal exclusion criteria
    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 randomization
    3. Patients, who in the opinion of the investigator, require treatment with eplerenone or spironolactone
    4. Patients, who in the opinion of the investigator, require treatment with potassium-sparing diuretics or potassium supplements
    5. History of hypersensitivity to eplerenone or spironolactone
    6. Evidence of cardiogenic shock
    7. Intra-aortic balloon pump or other mechanical assist device
    8. Patients awaiting cardiac transplantation
    9. Serum potassium > 5.0 mmol/L within 24 hours prior to randomization
    10. Estimated glomerular filtration rate (eGFR) ≤30 ml/min/1.73m2 within 24 hours prior to randomization (see Appendix 2 of the protocol)
    11. 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
    12. Patients with significant hepatic disease, defined as follows:
    EITHER
    h. Aspartate aminotransferase (AST) >3 times the upper limit of normal
    AND/OR
    i. Alanine aminotransferase (ALT) >3 times the upper limits of normal
    AND/OR
    j. Known positive serology for viral hepatitis
    13. 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 composite of cardiovascular (CV) mortality and heart failure (HF) hospitalization.

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

    Hospitalization for HF is defined as follows:

    1. Admission to an emergency room, observation unit and/or inpatient facility for at least 24 hours

    AND

    2. HF or suspicion of HF must be a reason for admission, (i.e. an admitting diagnosis)

    AND

    3. At least one symptom must be present:
    • Increased dyspnea (at rest and/or with exertion)
    • Increased orthopnea
    • Paroxysmal nocturnal dyspnea
    • Weight gain
    • Increased fatigue
    • Decreased exercise tolerance

    AND

    4. At least one clinical or radiologic sign must be present:
    • S3 gallop
    • Post-tussive rales
    • Jugular venous distension
    • Hepatojugular reflux
    • Increased peripheral edema
    • Pulmonary venous congestion or pleural effusion documented by chest radiography (if performed as part of routine clinical practice)

    AND

    5. At least one treatment must be instituted:
    • Increased dose (≥ 50%) of oral diuretic
    • New oral diuretic
    • Intravenous diuretic
    • Intravenous vasodilator
    • Intravenous inotrope

    AND

    6. The patient must be discharged on an oral diuretic to minimize fluid retention
    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 No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Parallel-group trial
    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 years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years5
    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 state70
    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)
    Subjects will only be given drug during their participation in the trial
    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 Decision2005-11-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-11-02
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-01-24
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