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    Summary
    EudraCT Number:2015-002168-17
    Sponsor's Protocol Code Number:BAY94-8862/16275
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2015-10-30
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2015-002168-17
    A.3Full title of the trial
    A multicenter, randomized, double-blind, double-dummy, parallel-group, active-controlled study to evaluate the efficacy and safety of finerenone compared to eplerenone on morbidity and mortality in patients with chronic heart failure and reduced ejection fraction after recent heart failure decompensation and additional risk factors, either type 2 diabetes mellitus or chronic kidney disease or both.
    Ensayo multicéntrico, aleatorizado, doble ciego, con doble simulación, de grupos paralelos, con control activo, para evaluar la eficacia y seguridad de finerenone comparada con eplerenona sobre la morbilidad y mortalidad en pacientes con insuficiencia cardiaca crónica con fracción de eyección reducida tras una reciente descompensación, y con factores de riesgo adicionales como diabetes mellitus tipo 2 o enfermedad renal crónica moderada, o ambas
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and safety of finerenone in subjects with chronic heart failure at high risk of recurrent heart failure decompensation
    Eficacia y seguridad de finerenone en sujetos con insuficiencia cardíaca crónica y riesgo alto de descompensación por insuficiencia cardíaca recurrente
    A.3.2Name or abbreviated title of the trial where available
    FINESSE-HF
    A.4.1Sponsor's protocol code numberBAY94-8862/16275
    A.5.4Other Identifiers
    Name:Results StatementNumber:No subjects were recruited, no results available
    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 SponsorBayer HealthCare AG
    B.1.3.4CountryGermany
    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 supportBayer HealthCare AG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBayer HealthCare AG
    B.5.2Functional name of contact pointBayer Clinical Trials Contact
    B.5.3 Address:
    B.5.3.1Street AddressCTP Team/Ref:"EU CTR" / Bayer Pharma AG
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post code13342
    B.5.3.4CountryGermany
    B.5.4Telephone number0034.900102372
    B.5.6E-mailclinical-trials-contact@bayerhealthcare.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 nameBAY 94-8862 IR tablet 10 mg
    D.3.2Product code BAY 94-8862 coated tablet 10 mg
    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 INNFinerenone
    D.3.9.1CAS number 1050477-31-0
    D.3.9.2Current sponsor codeBAY 94-8862 micronized
    D.3.9.3Other descriptive nameBAY 94-8862
    D.3.9.4EV Substance CodeSUB30924
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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.IMP: 2
    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 nameBAY 94-8862 IR tablet 20 mg
    D.3.2Product code BAY 94-8862 coated tablet 20 mg
    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 INNFinerenone
    D.3.9.1CAS number 1050477-31-0
    D.3.9.2Current sponsor codeBAY 94-8862 micronized
    D.3.9.3Other descriptive nameBAY 94-8862
    D.3.9.4EV Substance CodeSUB30924
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    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 Eplerenone 25 mg Film-coated Tablets
    D.2.1.1.2Name of the Marketing Authorisation holderTeva UK 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 nameEplerenone 25 mg Film-coated Tablets
    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.3.9.3Other descriptive nameEPLERENONE
    D.3.9.4EV Substance CodeSUB06574MIG
    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.IMP: 4
    D.1.2 and D.1.3IMP RoleComparator
    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 Eplerenone 50 mg Film-coated Tablets
    D.2.1.1.2Name of the Marketing Authorisation holderTeva UK 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 nameEplerenone 50 mg Film-coated Tablets
    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.3.9.3Other descriptive nameEPLERENONE
    D.3.9.4EV Substance CodeSUB06574MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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
    D.8 Placebo: 2
    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
    D.8 Placebo: 3
    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
    Subjects with chronic heart failure and reduced ejection fraction after recent heart failure decompensation and additional risk factors, either type 2 diabetes mellitus or chronic kidney disease or both
    Pacientes con insuficiencia cardiaca crónica con fracción de eyección reducida tras una reciente descompensación, y con factores de riesgo adicionales como diabetes mellitus tipo 2 o enfermedad renal crónica moderada, o ambas
    E.1.1.1Medical condition in easily understood language
    CHF (reduction of the pumping capacity of the heart), DM type 2 (body's ineffective use of insulin) and CKD (kidneys fail to adequately filter toxins and waste products from the blood)
    ICC(corazón reduce su capacidad de bombear la sangre),DM Tipo 2(uso ineficiente de la insulina en el cuerpo)y ERC(riñón no puede filtrar adecuadamente las toxinas y los productos de desecho en sangre)
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level LLT
    E.1.2Classification code 10076410
    E.1.2Term Chronic kidney disease stage 3
    E.1.2System Organ Class 100000004857
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level LLT
    E.1.2Classification code 10045242
    E.1.2Term Type II diabetes mellitus
    E.1.2System Organ Class 100000004861
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level LLT
    E.1.2Classification code 10066498
    E.1.2Term Cardiac failure chronic aggravated
    E.1.2System Organ Class 100000004849
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level LLT
    E.1.2Classification code 10076408
    E.1.2Term Chronic kidney disease stage 1
    E.1.2System Organ Class 100000004857
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level LLT
    E.1.2Classification code 10076409
    E.1.2Term Chronic kidney disease stage 2
    E.1.2System Organ Class 100000004857
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Demonstrate the superiority of finerenone to eplerenone in delaying time to first occurrence of the composite endpoint, defined as cardiovascular (CV) death or hospitalization for heart failure (HF), in patients with chronic heart failure (CHF) (NYHA class II-IV) and reduced ejection fraction after recent heart failure decompensation who have additional risk factors, i.e. type 2 diabetes mellitus (T2DM) and/or or chronic kidney disease (CKD).
    Demostrar la superioridad de finerenone respecto a eplerenona en la prolongación del tiempo transcurrido hasta la primera aparición del criterio de valoración compuesto, definido como muerte cardiovascular (CV) u hospitalización por insuficiencia cardíaca (IC), en sujetos con ICC (clase II-IV de la NYHA) y fracción de eyección reducida tras una reciente descompensación de la insuficiencia cardíaca y factores de riesgo adicionales, es decir, diabetes mellitus de tipo 2 (DMT2) y/o enfermedad renal crónica (ERC).
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are to determine the superiority of finerenone to eplerenone with regard to the following:
    - Total number of hospitalizations (or equivalent) for HF
    - Time to first hospitalization (or equivalent) for HF
    - All-cause mortality
    - Time to first occurrence of composite renal endpoint: onset of kidney failure, or sustained decrease in estimated glomerular filtration rate (eGFR) >= 40% relative to baseline over at least 4 weeks, or renal death.
    Los objetivos secundarios de este estudio son determinar la superioridad de finerenone frente a eplerenona en lo que respecta a:
    - Número total de hospitalizaciones (o equivalente) por IC
    - Tiempo transcurrido hasta la primera hospitalización (o equivalente) por IC
    - Tiempo transcurrido hasta la mortalidad por cualquier causa
    - Tiempo transcurrido hasta la primera aparición del criterio de valoración compuesto: aparición de insuficiencia renal o reducción sostenida de la filtración glomerular estimada (FGe) >= 40 % respecto al periodo basal durante al menos 4 semanas o muerte por causas renales.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Women of childbearing potential can only be included in the study if a pregnancy test is negative at Screening and if they agree to use adequate contraception. Adequate contraception is defined as any combination of at least 2 effective methods of birth control, of which at least one is a physical barrier (e.g. condoms with hormonal contraception or implants or combined oral contraceptives, certain intrauterine devices). Women are considered post-menopausal and not of childbearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or 6 months of spontaneous amenorrhea with serum follicle-stimulating hormone (FSH) levels >40 mIU/mL [for US only: and estradiol <20 pg/mL] or have had surgical treatment such as bilateral tubal ligation, bilateral ovariectomy, or hysterectomy.
    - Diagnosis of CHF, NYHA class II-IV, and documented ejection fraction of <=40%
    - Unscheduled emergency presentation to emergency services (outpatient or hospital, including the emergency department ) due to signs and/or symptoms of HF decompensation in the 2 weeks preceding randomization (considered as index event)
    - Administration of intravenous (IV) decongestive therapy at any time during presentation and/or admission to emergency services for the treatment of the index event
    - BNP >400 pg/mL or NT-proBNP >1200 pg/mL in sinus rhythm, and BNP >600 pg/mL or NT-proBNP >1800 pg/mL in atrial fibrillation, at any time starting with the index event, at the latest at screening; ; BNP values are not applicable for subjects taking angiotensin receptor-neprilysin inhibitors (ARNIs)
    - Type 2 diabetes mellitus (T2DM) in their medical history or at screening
    and/or
    Chronic kidney disease (CKD) with moderately reduced kidney function, defined as an estimated glomerular filtration rate (eGFR) between 30 and 60 mL/min/1.73 m² at screening (calculated using the locally approved and validated equation); one reassessment allowed
    - Las mujeres con capacidad reproductora solo podrán ser incluidas en el estudio si tienen un resultado negativo en una prueba de embarazo realizada en la selección y si aceptan utilizar un método anticonceptivo aceptable. Los métodos anticonceptivos aceptables se definen como cualquier combinación de al menos 2 métodos anticonceptivos eficaces, de los que al menos uno sea una barrera física (p. ej., preservativos con métodos anticonceptivos hormonales o implantes o anticonceptivos orales combinados, determinados dispositivos intrauterinos). Se considera que las mujeres son posmenopáusicas y sin capacidad reproductora si han tenido 12 meses de amenorrea natural (espontánea) con un perfil clínico adecuado (p. ej., edad adecuada, antecedentes de síntomas vasomotores) o 6 meses de amenorrea espontánea con niveles séricos de folitropina (FSH) > 40 mUI/ml (para EE. UU. solo: y estradiol < 20 pg/ml) o se han sometido a tratamiento quirúrgico como ligadura de trompas bilateral, ovariectomía bilateral o histerectomía.
    - Diagnóstico de ICC, clase II-IV de la NYHA, y fracción de eyección documentada <= 40 %
    -Visita no programada a urgencias (ambulatorias u hospitalarias, incluido el servicio de urgencias) por signos y/o síntomas de descompensación de la IC en las 2 semanas previas a la aleatorización (considerado acontecimiento inicial).
    - Administración intravenosa (i.v.) de tratamiento descongestivo (p. ej., diuréticos, nitratos, fármacos inotrópicos) en cualquier momento durante el cuadro clínico inicial y/o ingreso en el servicio de urgencias para el tratamiento del acontecimiento índice.
    - BNP > 400 pg/ml o NT-proBNP > 1200 pg/ml en ritmo sinusal y BNP > 600 pg/ml o NT-proBNP > 1800 pg/ml en la fibrilación auricular, en cualquier momento a partir del acontecimiento índice, y como muy tarde en la selección; los valores de BNP no son aplicables a los sujetos que reciban inhibidores del receptor de la angiotensina y de neprilisina (IRAN).
    - Diabetes mellitus de tipo 2 (DMT2) en sus antecedentes médicos o en la selección (véase la sección 16.2 para obtener más información)
    y/o:
    Enfermedad renal crónica (ERC) con función renal moderadamente reducida, definida como una filtración glomerular estimada (FGe) de entre 30 y 60 ml/min/1,73 m2 en la selección (calculada con la ecuación localmente aprobada y validada, p. ej., CKD-EPI, MDRD, ecuación japonesa); se permite una revaluación.
    E.4Principal exclusion criteria
    - Acute de-novo heart failure or acute inflammatory heart disease, e.g. acute myocarditis, within 3 months prior to randomization
    - Acute coronary syndrome, including unstable angina, non-ST segment elevation myocardial infarction (NSTEMI) or ST segment elevation myocardial infarction (STEMI), or major CV surgery including coronary artery bypass graft (CABG), percutaneous coronary intervention (PCI), implantation of a cardiac resynchronization therapy(CRT) device or cardiac contractility modulation (CCM) device, or carotid angioplasty within 3 months prior to randomization
    - Stroke or transient ischemic cerebral attack within 3 months prior to randomization
    - Cardiogenic shock at randomization, prior to first intake of study drug
    - Any primary cause of HF scheduled for surgery , e.g. valve disease such as severe aortic stenosis
    - History of heart transplant or need for heart transplantation; presence or need of left ventricular assist device
    - Insuficiencia cardíaca aguda de novo o cardiopatía inflamatoria aguda, p. ej., miocarditis aguda, en los 3 meses previos a la aleatorización.
    - Síndrome coronario agudo, incluidos angina inestable, IMSEST o IMEST o cirugía CV mayor, incluido injerto de bypass de la arteria coronaria (CABG), intervención coronaria percutánea (ICP), implantación de un dispositivo de tratamiento de resincronización cardíaca (TRC) o un dispositivo de modulación de la contractilidad cardíaca (MCC) o angioplastia carotídea en los 3 meses previos a la aleatorización.
    - Ictus o accidente isquémico transitorio cerebral en los 3 meses previos a la aleatorización.
    - Choque cardiogénico en la aleatorización, antes de la primera administración del fármaco del estudio.
    - Cualquier causa primaria de IC programada para cirugía, p. ej., valvulopatía como estenosis aórtica grave.
    - Antecedentes de trasplante cardíaco o necesidad de trasplante cardíaco; presencia o necesidad de dispositivo de asistencia ventricular izquierda.
    E.5 End points
    E.5.1Primary end point(s)
    Time to the first occurrence of the primary composite endpoint, consisting of the following components:
    - CV death
    - Hospitalization for HF
    La variable principal de la eficacia es el tiempo transcurrido hasta la primera aparición del criterio principal de valoración compuesto, formado por los siguientes componentes:
    - Muerte por causa CV
    - Hospitalización por IC.
    E.5.1.1Timepoint(s) of evaluation of this end point
    From randomization (Visit 1) until the end of study following the study termination decision, approximately from 18 to 36 months
    Desde la aleatorización (visita 1) hasta el fin del estudio tras la decisión de finalización del estudio, aproximadamente de 18 a 36 meses
    E.5.2Secondary end point(s)
    Secondary efficacy variables will be as follows:
    - Total number of hospitalizations (or equivalent) for HF
    - Time to first hospitalization (or equivalent) for HF
    - Time to all-cause mortality
    - Time to first occurrence of composite renal endpoint:
    o Onset of kidney failure
    o Sustained decrease in eGFR >=40% relative to baseline over at least 4 weeks
    o Renal death
    Las variables secundarias de la eficacia serán las siguientes:
    - Número total de hospitalizaciones (o equivalente) por IC
    - Tiempo transcurrido hasta la primera hospitalización (o equivalente) por IC
    - Tiempo transcurrido hasta la mortalidad por cualquier causa.
    - Tiempo transcurrido hasta la primera aparición del criterio de valoración renal compuesto, formado por los siguientes componentes:
    o Aparición de insuficiencia renal
    o Reducción mantenida de la FGe >= 40 % respecto al valor basal
    o Muerte por causas renales
    E.5.2.1Timepoint(s) of evaluation of this end point
    From randomization (Visit 1) until the end of study following the study termination decision, approximately from 18 to 36 months
    Desde la aleatorización (visita 1) hasta el fin del estudio tras la decisión de finalización del estudio, aproximadamente de 18 a 36 meses
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    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 Yes
    E.8.1.7.1Other trial design description
    Doble enmascaramiento
    double-dummy
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    eplerenona
    eplerenone
    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 concerned17
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA250
    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
    Austria
    Belgium
    Brazil
    Bulgaria
    Canada
    Chile
    China
    Colombia
    Czech Republic
    Denmark
    Finland
    France
    Germany
    Greece
    Hong Kong
    Hungary
    Ireland
    Israel
    Italy
    Japan
    Korea, Republic of
    Lithuania
    Mexico
    Netherlands
    New Zealand
    Norway
    Poland
    Portugal
    Russian Federation
    Saudi Arabia
    Singapore
    South Africa
    Spain
    Sweden
    Switzerland
    Taiwan
    Turkey
    United Kingdom
    United States
    Vietnam
    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
    LVLS
    ültima visita del último sujeto
    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 months34
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months36
    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: 1944
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 3946
    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 Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Patients unable to sign can be consented by legally acceptable representative / guardian / parent
    Los pacientes que no pueden firmar se puede obtener el consentimiento por el representante legal / tutor / padres
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state231
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 2600
    F.4.2.2In the whole clinical trial 5890
    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
    Ninguno
    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 Decision2015-12-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-12-10
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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