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    Summary
    EudraCT Number:2016-002278-11
    Sponsor's Protocol Code Number:1245.110
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-06-03
    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 number2016-002278-11
    A.3Full title of the trial
    A phase III randomised, double-blind trial to evaluate efficacy and safety of once daily empagliflozin 10 mg compared to placebo, in patients with chronic Heart Failure with preserved Ejection Fraction (HFpEF).
    Sperimentazione di fase III, randomizzata, in doppio cieco per valutare l¿efficacia e la sicurezza di empagliflozin 10 mg una volta al giorno rispetto al placebo, in pazienti affetti da insufficienza cardiaca cronica con frazione di eiezione preservata (HFpEF).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    EMPagliflozin outcomE tRial in patients with chrOnic heaRt failure EMPEROR-Preserved
    Sperimentazione sul risultato di Empagliflozin in pazienti con insufficienza cardiaca cronica EMPEROR-Preservata
    A.3.2Name or abbreviated title of the trial where available
    EMPagliflozin outcomE tRial in patients with chrOnic heaRt failure EMPEROR-Preserved
    Sperimentazione sul risultato di Empagliflozin in pazienti con insufficienza cardiaca cronica EMPERO
    A.4.1Sponsor's protocol code number1245.110
    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 SponsorBOEHRINGER INGELHEIM INTERNATIONAL GMBH
    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 supportBoehringer Ingelheim International GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBoehringer Ingelheim Pharma GmbH & Co. KG
    B.5.2Functional name of contact pointCT Disclosure & Data Transparency
    B.5.3 Address:
    B.5.3.1Street AddressBinger Strasse 173
    B.5.3.2Town/ cityIngelheim am Rhein
    B.5.3.3Post code55216
    B.5.3.4CountryGermany
    B.5.4Telephone number0018002430127
    B.5.5Fax number0018008217119
    B.5.6E-mailclintriage.rdg@boehringer-ingelheim.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 JARDIANCE - 10 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (PVC/ALU) - 14 COMPRESSE
    D.2.1.1.2Name of the Marketing Authorisation holderBOEHRINGER INGELHEIM INTERNATIONAL GMBH
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 INNEMPAGLIFLOZIN
    D.3.9.1CAS number 864070-44-0
    D.3.9.2Current sponsor codeEMPAGLIFLOZIN
    D.3.9.4EV Substance CodeSUB35915
    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) 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
    Heart failure (HF) with preserved ejection fraction (EF).
    Insufficienza cardiaca (HF) con frazione di eiezione (FE) preservata.
    E.1.1.1Medical condition in easily understood language
    chronic (long-term) heart failure (HF)
    Insufficienza cardiaca (HF) cronica (di lunga durata)
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10008908
    E.1.2Term Chronic heart failure
    E.1.2System Organ Class 100000004849
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate superiority of empagliflozin 10 mg versus placebo in patients with symptomatic, chronic HF and preserved ejection fraction (LVEF > 40%) under stable treatment of HF symptoms.
    Dimostrare la superiorit¿ di empagliflozin 10 mg rispetto a placebo in pazienti affetti da insufficienza cardiaca (HF) cronica con frazione di eiezione preservata (FEVS >40%) sottoposti a trattamento stabile dei sintomi di HF.
    E.2.2Secondary objectives of the trial
    Not applicable
    Non applicabile.
    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: Drug concentration measurements and Pharmacokinetics (PK) substudy: PK sampling will be done from a limited number of randomised patients (approx 1650) at pre-selected sites. Pre-dose blood samples will be collected at Visit 4 and between 22 to 26 h after the most recent drug intake, to determine plasma empagliflozin trough concentrations. These samples will serve to determine steady state trough concentrations of empagliflozin.

    Altre tipologie di sottostudi
    specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: Le misurazioni di concentrazione del farmaco e il sottostudio sulla farmacocinetica (PK):la raccolta di campioni per la farmacocinetica (PK) sar¿ fatta su un numero limitato di pazienti randomizzati (circa 1650) in centri preselezionati. Campioni di sangue pre-dosati saranno raccolti alla Visita 4 e tra le 22 e le 26 ore dopo l'ultima assunzione del farmaco, per la determinazione del plasma empagliflozin nelle concentrazioni. Questi campioni serviranno per determinare le concentrazioni minime di empagliflozin allo stato stazionario.
    E.3Principal inclusion criteria
    - Patients with chronic HF diagnosed for at least 3 months before Visit 1 and currently in HF New York Heart Association (NYHA)class II-IV
    - Chronic HF with preserved EF defined as LVEF > 40 % per local reading (obtained by echocardiography, radionuclide ventriculography, invasive angiography, MRI or CT), and no prior measurement of LVEF = 40% under stable conditions. The EF must have been obtained and documented at Visit 1 or within 6 months prior to Visit 1, and more than 90 days after any Myocardial Infarction.
    - Elevated N-terminal of the prohormone brain natriuretic peptide (NT-proBNP) > 300 pg/ml for patients without AF, OR > 900 pg/ml for patients with AF, analysed at the Central laboratory at Visit 1
    - Patients must have at least one of the following evidence of HF:
    a) Structural heart disease (left atrial enlargement and/or left ventricular hypertrophy) documented by echocardiogram at Visit 1,
    OR
    b) Documented hospitalisation for HF (HHF) within 12 months prior to Visit 1
    - Oral diuretics, if prescribed to patient according to local guideline and discretion of the Investigator, should be stable for at least 1 week prior to Visit 2 (Randomisation)
    - eGFR (CKD-EPI)cr = 20 mL/min/1.73m2 at Visit 1
    - Pazienti con diagnosi di HF cronica per almeno 3 mesi prima della Visita 1 e attualmente in HF di classe II-IV secondo la New York Heart Association (NYHA).
    - HF cronica con FE preservata definita come FEVS >40 % secondo la lettura locale (ottenuta tramite ecocardiografia, ventriculografia con radionuclidi, angiografia invasiva, RMI o TAC) e nessuna misurazione pregressa di FEVS =40% in
    condizioni stabili. La FE deve essere stata ottenuta e documentata alla Visita 1 o entro 6 mesi prima della Visita 1 e più di 90 giorni dopo l'infarto del miocardio.
    - Livelli elevati di N-terminale-pro-peptide natriuretico cerebrale (NT-proBNP) >300 pg/ml per i pazienti senza FA, OPPURE >900 pg/ml per i pazienti affetti da FA, analizzati presso il
    laboratorio centrale alla Visita 1
    - I pazienti devono presentare almeno una delle seguenti evidenze di HF:
    a) Malattia cardiaca strutturale (ingrossamento del ventricolo sinistro e/o ipertrofia ventricolare sinistra) documentata da ecocardiogramma alla Visita 1, OPPURE
    b) Ricovero ospedaliero documentato per HF (HHF) nei 12 mesi precedenti la Visita 1
    - I diuretici orali, se prescritti al paziente in base alle linee guida locali e a discrezione dello sperimentatore, devono essere stabili per almeno 1 settimana prima della Visita 2 (randomizzazione)
    - tasso di filtrazione glomerulare (eGFR) (epidemiologia della malattia renale cronica [CKD-EPI])cr =20 ml/min/1,73 m2 alla Visita 1
    E.4Principal exclusion criteria
    1. Myocardial infarction, coronary artery bypass graft surgery or other major cardiovascular surgery, stroke or TIA in past 90 days prior to Visit 1
    2. Heart transplant recipient or listed for heart transplant
    3. Implantation of cardioverter defibrillator (ICD) within 3 months prior to Visit 1
    4. Implanted cardiac resynchronisation therapy (CRT)
    5. Cardiomyopathy based on infiltrative diseases (e.g. amyloidosis), accumulation diseases, muscular dystrophies, cardiomyopathy with reversible causes, hypertrophic
    obstructive cardiomyopathy or known pericardial constriction
    6. Any severe valvular heart disease expected to lead to
    surgery during the trial in the Investigator’s opinion
    7. Acute decompensated HF requiring intravenous (i.v.) diuretics, i.v. inotropes or i.v. vasodilators, or left ventricular assist device within 1 week from discharge to Visit 1, and during screening period until Visit 2 (Randomisation)
    8. Atrial fibrillation or atrial flutter with a resting heart rate > 110 bpm documented by ECG at Visit 2 (Randomisation)
    9. Systolic blood pressure (SBP) = 180 mmHg at Visit 2. If SBP >150 mmHg and <180 mmHg at Visit 2, the patient should be receiving at least 3 antihypertensive drugs
    10. Symptomatic hypotension and/or a SBP < 100 mmHg at Visit 1 or Visit 2
    1. L'infarto miocardico, intervento chirurgico di bypass aorto-coronarico o altri interventi di chirurgia cardiovascolare, ictus o TIA negli ultimi 90 giorni precedenti la Visita 1
    2. Destinatario di trapianto di cuore o in lista per trapianto di cuore
    3. Impianto di cardioverter defibrillatore (ICD) entro 3 mesi prima della Visita 1
    4. Impianto di terapia di risincronizzazione cardiaca (CRT)
    5. Cardiomiopatia sulla base di malattie infiltrative (ad esempio amiloidosi), malattie di accumulo, distrofie muscolari, cardiomiopatia con cause reversibili, cardiomiopatia ipertrofica ostruttiva o la conosciuta costrizione pericardica
    6. Qualsiasi grave malattia valvolare cardiaca che si aspetta debba portare ad un intervento chirurgico durante la sperimentazione secondo il giudizio dello sperimentatore
    7. acuta e scompensata insufficienza cardiaca (HF) che richiede diuretici per via endovenosa (i.v.), inotropi per via endovenosa o vasodilatatori per via endovenosa, o dispositivo per ventricolare sinistra entro 1 settimana dallo scaricamento della Visita 1, e durante il periodo di screening fino alla Visita 2 (randomizzazione)
    8. La fibrillazione atriale o flutter atriale con una frequenza cardiaca a riposo> 110 bpm documentata da ECG alla Visita 2 (randomizzazione)
    9. Pressione arteriosa sistolica (SBP) = 180 mmHg alla Visita 2. Se SBP> 150 mmHg e <180 mmHg alla Visita 2, il paziente dovrebbe ricevere almeno 3 farmaci antipertensivi
    10. Ipotensione sintomatica e / o di un SBP <100 mmHg alla Visita 1 o Visita 2
    E.5 End points
    E.5.1Primary end point(s)
    Time to first event of adjudicated CV death or adjudicated HHF in patients with Heart Failure with preserved Ejection Fraction (HFpEF).
    L'endpoint primario composito per questa sperimentazione è il tempo al primo evento di decesso CV convalidati o HHF convalidata in pazienti affetti da HFpEF.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Report time to event
    Tempo di reportistica dell'evento
    E.5.2Secondary end point(s)
    1. Occurrence of adjudicated HHF (first and recurrent),
    2. eGFR (CKD-EPI)cr slope of change from baseline

    Other secondary endpoints:
    - Time to first occurrence of sustained* reduction of =40% eGFR (CKDEPI)
    cr or o sustained eGFR (CKD-EPI)cr <15 mL/min/1.73 m2 for
    patients with baseline eGFR =30 mL/min/1.73 m2 o sustained eGFR
    (CKD-EPI)cr <10 mL/min/1.73 m2 for patients with baseline eGFR <30
    mL/min/1.73 m2
    *An eGFR (CDK-EPI)cr reduction is considered sustained, if it is
    determined by two or more consecutive post-baseline central laboratory measurements separated by at least 30 days (first to last of the consecutive eGFR values).
    - Time to first adjudicated HHF
    - Time to adjudicated CV death
    - Time to all-cause mortality
    - Time to onset of DM (defined as HbA1c =6.5% or as diagnosed by the Investigator) in patients with pre-DM defined as no history of DM and no HbA1c =6.5 before treatment, and a pre-treatment HbA1c value of = 5.7 and <6.5
    - Change from baseline in clinical summary score (HF symptoms and
    physical limitations domains) of the Kansas City Cardiomyopathy
    Questionnaire (KCCQ) at week 52
    - Occurrence of all-cause hospitalisation (first and recurrent)
    I principali endpoint secondari, che fanno parte della strategia di analisi, sono i seguenti:
    - Manifestazione di HHF convalidata (prima e ricorrente)
    - pendenza di variazione rispetto al basale di eGFR (CKD-EPI)cr
    Altri endpoint secondari sono:
    - Tempo alla prima manifestazione di riduzione sostenuta di eGFR
    (CKD-EPI)cr = 40% o
    o eGFR (CKD-EPI)cr sostenuta <15 ml/min/1,73 m2 per i pazienti con eGFR al basale =30 ml/min/1,73 m2
    o eGFR (CKD-EPI)cr sostenuta <10 ml/min/1,73 m2 per i pazienti con eGFR al basale <30 ml/min/1,73 m2
    - Tempo alla prima HHF convalidata
    - Tempo al decesso CV convalidato
    - Tempo al decesso per qualsiasi causa
    - Tempo all'insorgenza di diabete mellito (DM) in pazienti con pre-DM
    - Variazione rispetto al basale del punteggio clinico riepilogativo
    (sintomi di HF e domini di limitazioni fisiche) del Questionario di cardiomiopatia di Kansas City (KCCQ) alla settimana 52
    - Insorgenza di ricovero per qualsiasi causa (prima e ricorrente)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Report time to event
    Tempo di reportistica dell'evento
    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 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) No
    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 concerned11
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA149
    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
    China
    Colombia
    India
    Japan
    Korea, Republic of
    Mexico
    Singapore
    South Africa
    United States
    European Union
    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 years4
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months8
    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: 2063
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2063
    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 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 state96
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1495
    F.4.2.2In the whole clinical trial 4126
    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)
    The patient will continue treatment according to standard of care and prevailing guidelines.
    Il paziente continuer¿ il trattamento in base alle cure standard e alle linee guida prevalenti.
    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 Decision2017-08-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-06-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-04-15
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