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    Summary
    EudraCT Number:2015-002168-17
    Sponsor's Protocol Code Number:BAY94-8862/16275
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2021-05-27
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2015-002168-17
    A.3Full title of the trial
    Studio multicentrico, randomizzato, in doppio cieco, a gruppi paralleli, con doppio double dummy, controllato con un farmaco attivo, per valutare l¿efficacia e la sicurezza di finerenone in confronto ad eplerenone sulla morbilit¿ e mortalit¿ in pazienti affetti da insufficienza cardiaca cronica e ridotta frazione di eiezione dopo recente episodio di scompenso, dell¿insufficienza cardiaca ed altri fattori di rischio aggiuntivi, o diabete di tipo 2 o nefropatia cronica od entrambi
    ¿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.-FINESSE-HF¿
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacia e sicurezza di finerenone in soggetti con insufficienza cardiaca cronica ad alto rischio di recidiva di scompenso acuto
    Efficacy and safety of finerenone in subjects with chronic heart failure at high risk of recurrent heart failure decompensation
    A.3.2Name or abbreviated title of the trial where available
    FINESSE-HF
    FINESSE-HF
    A.4.1Sponsor's protocol code numberBAY94-8862/16275
    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 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 HealtCare 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/ cityBerlino
    B.5.3.3Post code13342
    B.5.3.4CountryGermany
    B.5.4Telephone number000
    B.5.5Fax number000
    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 m
    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.3.9.4EV 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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 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 m
    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.3.9.4EV 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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 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 Eplerenone25mgFilm-coatedTablets Teva UK Limited
    D.2.1.1.2Name of the Marketing Authorisation holderPL 00289/1696
    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.3.4Pharmaceutical 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 codeEPLERENONE
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 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 Eplerenone50mgFilm-coatedTablets Teva UK Limited PL 00289/1697
    D.2.1.1.2Name of the Marketing Authorisation holderTEVA UK
    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.3.2Product code Eplerenone
    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 codeEPLERENONE
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 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
    insufficienza cardiaca cronica e ridotta frazione di eiezione dopo recente episodio di scompenso, dell¿insufficienza cardiaca ed altri fattori di rischio aggiuntivi, o diabete di tipo 2 o nefropatia cronica od entrambi
    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)
    CHF (riduzione della capicit¿ di funzionamento del cuore), DM tipo 2 (difetto della produzione di insulina) e CKD (disfunzioni nell'attivit¿ di filtraggio dei reni di tossine ed altri prodotti di scar
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.1
    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 23.1
    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 20.0
    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 21.1
    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 23.1
    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 timeto 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).
    ¿ Dimostrare la superiorit¿ di finerenone rispetto all¿eplerenone nel ritardare il tempo alla prima comparsa dell¿endpoint composito, definito come morte cardiovascolare (CV) od ospedalizzazione per scompenso cardiaco (HF), in pazienti affetti da insufficienza cardiaca cronica (CHF) (classe II-IV secondo la New York Heart Association [NYHA]) e ridotta frazione di eiezione dopo un recente episodio acuto di scompenso che presentino altri fattori di rischio, quali diabete mellito di tipo 2 (T2DM) e/o nefropatia cronica (CKD).
    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.
    Gli obiettivi secondari di questo studio sono quelli di dimostrare la superiorit¿ di finerenone rispetto ad eplerenone in relazione a ciascuno dei seguenti fattori:
    ¿ Numero totale di ricoveri in ospedale (od equivalenti) per scompenso cardiaco
    ¿ Tempo al primo ricovero in ospedale (o equivalente) per scompenso cardiaco
    ¿ Tempo alla mortalit¿ per tutte le cause
    ¿ Tempo alla prima comparsa dell¿endpoint renale composito: esordio di insufficienza renale o cospicua diminuzione della velocit¿ di filtrazione glomerulare stimata (eGFR) =40% rispetto al basale per almeno 4 settimane, o morte renale.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives

    Other types of substudies
    Specify title, date and version of each substudy with relative objectives: Biomarkers Substudy

    Altre tipologie di sottostudi
    specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: Sottostudio Biomarcatori
    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 anytime 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/orChronic 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
    • Diagnosi di CHF, di classe II-IV secondo la NYHA, e frazione di eiezione documentata =40%
    • Accesso non programmato ai servizi d’urgenza (ambulatorio od ospedale, compreso il pronto soccorso) a causa di segni e sintomi di scompenso nelle 2 settimane precedenti la randomizzazione (considerata come l’evento indice)
    • Somministrazione endovenosa (IV) della terapia decongestionante in qualsiasi momento durante l’accessoe/o il ricovero in pronto soccorso per il trattamento dell’evento indice
    • BNP (peptide natriuretico di tipo B) >400 pg/mL o NT-proBNP (N-terminale del pro-ormone del BNP) >1200 pg/mL in ritmo sinusale, e BNP >600 pg/mL o NT-proBNP >1800 pg/mL in fibrillazione atriale, in qualsiasi momento a partire dall’evento indice, fino al più tardi allo screening; i valori di BNP possono essere utilizzati per l’inclusione solo se il soggetto non sta assumendo farmaci concomitanti che influenzino la loroaccuratezza.
    • Diabete mellito di tipo 2 (T2DM) nella loro anamnesi oppure allo screening (vedere il Paragrafo di riferimento nel protocollo per ulteriori particolari)
    e/o:
    nefropatia cronica (CKD) (vedere il Paragrafo di riferimento nel protocollo per ulteriori particolari) con funzione renale moderatamente ridotta, definita come una velocità di filtrazione glomerulare stimata (eGFR) compresa fra 30 e 60 mL/min/1,73 m² allo screening (calcolata utilizzando l’equazione localmente approvata e convalidata); è concessa una rivalutazione
    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
    • Scompenso cardiaco acuto de novo oppure cardiopatia infiammatoria acuta, ad esempio miocardite acuta, entro 3 mesi prima della randomizzazione
    • Sindrome coronarica acuta (ACS), compresa l’angina instabile, infarto miocardico senza sopraslivellamento del tratto ST (NSTEMI) o infarto miocardico con sopraslivellamento del tratto ST (STEMI) o bypass dell’arteria coronarica (CABG), angioplastica percutanea (PCI), impianto di un dispositivo per la resincronizzazione cardiaca (CRT) o un dispositivo di modulazione della contrattilità cardiaca (CCM) o angioplastica carotidea 3 mesi prima della randomizzazione.
    • Ictus o attacco ischemico transitorio entro 3 mesi prima della randomizzazione
    • Shock cardiogeno alla randomizzazione prima della prima assunzione del farmaco in studio
    • Eventuali cause primarie di HF programmate per un intervento chirurgico, ad esempio grave stenosi aortica
    • Anamnesi di trapianto cardiaco o necessità di un trapianto cardiaco o presenza di dispositivo di assistenza al ventricolo sinistro
    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 variabile principale di efficacia è costituita dal tempo alla prima comparsa dell’endpoint composito primario: morte CV; ricovero in ospedale per HF.
    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
    Da Visita 1 fino alla fine studio in base alla definizione di chiusura dello studio, da 18 a 36 mesi circa
    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 failureo Sustained decrease in eGFR =40% relative to baseline over at least 4 weekso Renal death
    ¿ Numero totale di ospedtalizzazioni (o equivalente) per HF¿Tempo alla prima ospedalizzazione (o equivalente) per HF¿Tempo a "all-cause mortality" ¿Tempo a primo evento di endpoint renale composito - Comparsa di insufficienza renale - Diminuzione rilevante di eGFR =40% rispetto al basale in almeno 4 settimane - Morte renale
    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
    Da Visita 1 fino alla fine studio in base alla definizione di chiusura dello studio, da 18 a 36 mesi circa
    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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    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 concerned20
    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 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
    Australia
    Brazil
    Canada
    Chile
    China
    Colombia
    Hong Kong
    Israel
    Japan
    Korea, Republic of
    Mexico
    New Zealand
    Russian Federation
    Saudi Arabia
    Singapore
    South Africa
    Austria
    Belgium
    Bulgaria
    Denmark
    Finland
    France
    Germany
    Greece
    Hungary
    Ireland
    Italy
    Lithuania
    Netherlands
    Norway
    Poland
    Portugal
    Spain
    Czechia
    Argentina
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    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 years3
    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: 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
    atients unable to sign can be consented by legally acceptable representative / guardian / parent
    Eventuali Pazienti incapaci di firmare verranno supportati da idoneo Rappresentante/Tutore/Testimone Imparziale
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state175
    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
    NA
    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 Decision2015-11-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-10-09
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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