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    Summary
    EudraCT Number:2020-004853-59
    Sponsor's Protocol Code Number:EX6018-4758
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2021-10-22
    Trial 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 number2020-004853-59
    A.3Full title of the trial
    ZEUS - Effects of ziltivekimab versus placebo on cardiovascular outcomes in participants with established atherosclerotic cardiovascular disease, chronic kidney disease and systemic inflammation
    ZEUS - Effetti di ziltivekimab versus placebo sugli esiti cardiovascolari in soggetti con malattia cardiovascolare aterosclerotica accertata, patologia renale cronica e infiammazione sistemica
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    ZEUS – A research study to look at how ziltivekimab works compared to placebo in people with cardiovascular disease, chronic kidney disease and inflammation
    ZEUS - Uno studio di ricerca per esaminare come funziona ziltivekimab rispetto al placebo nelle persone con malattie cardiovascolari, malattie renali croniche e infiammazione
    A.3.2Name or abbreviated title of the trial where available
    ZEUS
    ZEUS
    A.4.1Sponsor's protocol code numberEX6018-4758
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1259-3422
    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 SponsorNOVO NORDISK. S.P.A.
    B.1.3.4CountryItaly
    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 supportNovo Nordisk A/S
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovo Nordisk A/S
    B.5.2Functional name of contact pointClinical Transparency (1452)
    B.5.3 Address:
    B.5.3.1Street AddressNovo Allé
    B.5.3.2Town/ cityBagsværd
    B.5.3.3Post code2880
    B.5.3.4CountryDenmark
    B.5.4Telephone number004544448888
    B.5.5Fax number004544490555
    B.5.6E-mailclinicaltrials@novonordisk.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 nameZiltivekimab B 15 mg/mL DV3430- C1
    D.3.2Product code [.]
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeziltivekimab
    D.3.9.3Other descriptive nameziltivekimab
    D.3.9.4EV Substance CodeSUB204133
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 placeboSolution for injection in pre-filled syringe
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Atherosclerotic cardiovascular disease
    Chronic kidney disease
    Systemic inflammation
    Malattia cardiovascolare aterosclerotica
    Malattia renale cronica
    Infiammazione sistemica
    E.1.1.1Medical condition in easily understood language
    Cardiovascular disease
    Chronic kidney disease
    Inflammation
    Malattia cardiovascolare
    Malattia renale cronica
    Infiammazione
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10051615
    E.1.2Term Atherosclerotic cardiovascular disease
    E.1.2System Organ Class 100000004866
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.1
    E.1.2Level PT
    E.1.2Classification code 10064848
    E.1.2Term Chronic kidney disease
    E.1.2System Organ Class 10038359 - Renal and urinary disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10067394
    E.1.2Term hs-CRP increased
    E.1.2System Organ Class 100000004848
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10011418
    E.1.2Term CRP increased
    E.1.2System Organ Class 100000004848
    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 the superiority of ziltivekimab 15 mg s.c. once-monthly in reducing the risk of MACE (as defined by the primary endpoint) compared to placebo, both added to standard of care, in participants with established ASCVD, CKD and systemic inflammation.
    Dimostrare la superiorità di ziltivekimab 15 mg s.c. una volta al mese nella riduzione del rischio di MACE (secondo quanto definito dall’endpoint primario) rispetto al placebo, entrambi aggiunti alla terapia standard, in partecipanti con ASCVD accertata, MRC e infiammazione sistemica.
    E.2.2Secondary objectives of the trial
    - To demonstrate the superiority of ziltivekimab 15 mg s.c. once-monthly compared to placebo, both added to standard of care, in participants with established ASCVD, CKD and systemic inflammation, with regards to
    the following:
    • reducing the risk of expanded MACE (as defined by the confirmatory secondary endpoint)
    • reducing the risk of heart failure (as defined by the confirmatory secondary endpoint)
    • reducing all-cause mortality
    • delaying the progression of CKD (as defined by the confirmatory secondary endpoint)
    - To compare the effects of ziltivekimab 15 mg s.c. once-monthly versus placebo, both added to standard of care, in participants with established ASCVD, CKD and systemic inflammation, with regards to the following:
    • reducing systemic inflammation (defined by the secondary and exploratory endpoints)
    • improving patient reported outcomes (PRO)
    • not increasing severe infections (as defined by secondary safety endpoints)
    - Dimostrare la superiorità di ziltivekimab 15 mg s.c. una volta al mese rispetto al placebo, entrambi aggiunti alla terapia standard, in partecipanti con ASCVD accertata, MRC e infiammazione sistemica, in relazione a quanto segue:
    • riduzione rischio di MACE espanso (secondo quanto definito dall’endpoint secondario di conferma)
    • riduzione rischio di insufficienza cardiaca (secondo quanto definito dall’endpoint secondario di conferma)
    • riduzione della mortalità per qualsiasi causa
    • ritardata progressione di MRC (come definito dall’endpoint secondario di conferma)
    Confrontare gli effetti di ziltivekimab 15 mg s.c. una volta al mese rispetto al placebo, entrambi aggiunti allo standard di cura in relazione a:
    • riduzione dell’infiammazione sistemica (secondo quanto definito dagli endpoint secondari ed esplorativi)
    • miglioramento degli esiti riferiti dal paziente (PRO)
    • mancato aumento delle infezioni gravi (secondo quanto definito dagli endpoint di sicurezza secondari)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - eGFR greater than or equal to 15 and below 60 mL/min/1.73 m^2 (using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation)
    - Serum hs-CRP greater than or equal to 2 mg/L at screening (visit 1)
    - Evidence of ASCVD by one or more of the following within the last 5 years from screening:
    a) Coronary heart disease defined as at least one of the following:
    i. Documented history of MI
    ii. Prior coronary revascularisation procedure
    iii. greater than or equal to 50% stenosis in major epicardial coronary artery documented by cardiac catheterisation or CT coronary angiography
    b) Cerebrovascular disease defined as at least one of the following:
    i. Prior stroke of atherosclerotic origin
    ii. Prior carotid artery revascularisation procedure
    iii. greater than or equal to 50% stenosis in carotid artery documented by X-ray angiography, MR angiography, CT angiography or Doppler ultrasound.
    c) Symptomatic peripheral artery disease (PAD) defined as at least one of the following:
    i. Intermittent claudication with an ankle-brachial index (ABI) below or equal to 0.90 at rest
    ii. Intermittent claudication with a greater than or equal to 50% stenosis in peripheral artery (excluding carotid) documented by X-ray angiography, MR angiography, CT angiography or Doppler ultrasound
    iii. Prior peripheral artery (excluding carotid) revascularisation procedure
    iv. Lower extremity amputation at or above ankle due to atherosclerotic disease (excluding e.g. trauma or osteomyelitis).
    - eGFR > 15 e <60 ml/min/1,73 m2 (utilizzando l’equazione della creatinina della Collaborazione epidemiologica – malattia renale cronica [CKD-EPI]).
    - hs-CRP sierica > 2 mg/l allo screening (visita 1).
    - Evidenza di ASCVD in base a uno o più dei seguenti parametri entro gli ultimi 5 anni dallo screening:
    a) Cardiopatia coronarica definita come almeno una delle seguenti condizioni:
    i. Anamnesi documentata di IM.
    ii. Precedente procedura di rivascolarizzazione coronarica.
    iii. Stenosi =50% nell’arteria coronaria epicardica maggiore documentata mediante cateterismo cardiaco o angio-TC coronarica.
    b) Malattia cerebrovascolare definita come almeno una delle seguenti condizioni:
    i. Precedente ictus di origine aterosclerotica.
    ii. Precedente procedura di rivascolarizzazione dell’arteria carotide.
    iii. Stenosi =50% nell’arteria carotide documentata mediante angiografia tradizionale, angio-RM, angio-TC o ecodoppler.
    c) Arteriopatia periferica (PAD) sintomatica definita come almeno una delle seguenti condizioni:
    i. Claudicatio intermittens con indice caviglia-braccio (ABI) =0,90 a riposo.
    ii. Claudicatio intermittens con stenosi =50% nell’arteria periferica (esclusa la carotide) documentata mediante angiografia tradizionale, angio-RM, angio-TC o ecodoppler.
    iii. Precedente procedura di rivascolarizzazione arteriosa periferica (esclusa la carotide)
    iv. Amputazione degli arti inferiori alla caviglia o sopra a causa di aterosclerotica malattia (esclusi ad esempio traumi o osteomielite).
    E.4Principal exclusion criteria
    - Clinical evidence of, or suspicion of, active infection at the discretion ofthe investigator.
    - Myocardial infarction, stroke, hospitalisation for unstable angina pectoris, or transient ischaemic attack within 60 days prior to randomisation (visit 2).
    - Planned coronary, carotid or peripheral artery revascularisation known on the day of screening (visit 1).
    - Major cardiac surgical, non-cardiac surgical, or major endoscopic procedure (thoracoscopic or laparoscopic) within the past 60 days prior to randomisation (visit 2) or any major surgical procedure planned at the time of randomisation (visit 2).
    - Evidenza clinica di, o sospetto di, infezione attiva a discrezione dello sperimentatore.
    - Infarto del miocardio, ictus, ricovero per angina pectoris instabile o attacco ischemico transitorio nei 60 giorni precedenti alla randomizzazione (visita 2).
    - Prevista rivascolarizzazione arteriosa coronarica, carotidea o periferica nota il giorno dello screening (visita 1).
    - Intervento chirurgico cardiaco maggiore, chirurgico non cardiaco o procedura endoscopica maggiore (toracoscopica o laparoscopica) negli ultimi 60 giorni prima della randomizzazione (visita 2) o qualsiasi intervento chirurgico maggiore programmato al momento della randomizzazione (visita 2).
    E.5 End points
    E.5.1Primary end point(s)
    Time to first occurrence of 3-point MACE, a composite endpoint consisting of:
    - CV death ( Based on EAC-confirmed events, including undetermined cause of death)
    - non-fatal MI ( Based on EAC-confirmed events, acute MI only)
    - non-fatal stroke ( Based on EAC-confirmed events, including ischaemic, haemorrhagic and undetermined stroke)
    Tempo al primo episodio di MACE a 3 punti, un endpoint composito costituito da:
    • morte CV (in base a eventi confermati dall’EAC; comprensivo di causa indeterminata del decesso)
    • IM non fatale (in base a eventi confermati dall’EAC; solo IM acuto)
    • ictus non fatale (in base a eventi confermati dall’EAC; comprensivo di ictus ischemico, emorragico e indeterminato)
    E.5.1.1Timepoint(s) of evaluation of this end point
    From randomisation (month 0) to end-of-study (up to 48 months (Maximum treatment duration is dependent on event rates and is estimated to be approximately 48 months including a 3-month follow-up period)
    Dalla randomizzazione (mese 0) alla fine dello studio fino a 48 mesi (la durata massima del trattamento dipende dai tassi di eventi e si stima essere attorno ai 48 mesi, incluso un periodo di follow-up di 3 mesi).
    E.5.2Secondary end point(s)
    1. Time to first occurrence of expanded MACE, a composite endpoint consisting of:
    - CV death (Based on EAC-confirmed events, including undetermined cause of death)
    - non-fatal MI ( Based on EAC-confirmed events, acute MI only)
    - non-fatal stroke ( Based on EAC-confirmed events, including ischaemic, haemorrhagic and undetermined stroke)
    - hospitalisation for unstable angina pectoris requiring urgent coronary
    revascularisation ( Based on EAC-confirmed events)
    2. Number of hospitalisations for heart failure (Based on EAC-confirmed events) or urgent heart failure visit (Based on EAC-confirmed events)
    3. Time to occurrence of all-cause mortality (Based on EAC-confirmed events)
    4. Time to first occurrence of a composite CKD endpoint consisting of:
    - onset of persistent ("Persistent" is defined as 2 consecutive samples meeting the criteria. The 2 samples must be at least 4 weeks apart) greater than or equal to 40% reduction in eGFR (CKD-EPI) compared with baseline
    - kidney failure defined as:
    a) death from kidney failure (Based on EAC-confirmed events, defined as a non-CV death that is due to the direct consequences of severely impaired kidney function. Undetermined cause of death in participants with eGFR below15 mL/min/1.73 m^2 will be considered kidney death)
    b) onset of persistent ("Persistent" is defined as 2 consecutive samples meeting the criteria. The 2 samples must be at least 4 weeks apart) eGFR below 15 mL/min/1.73 m^2 (CKD-EPI)
    c) initiation of chronic kidney replacement therapy (maintenance dialysis or kidney transplantation) (Based on EAC-confirmed events)
    5. Time to first occurrence of each of the individual components (Based on EAC-confirmed events) of the expanded MACE endpoint and the kidney composite endpoint
    6. Time to first occurrence of MIs (acute MI only) (fatal and non-fatal) (Based on EAC-confirmed events)
    7. Time to first occurrence of stroke (including ischaemic, haemorrhagic and undetermined stroke) (fatal and non-fatal) (Based on EACconfirmed events)
    8. Time to first occurrence of a composite MACE endpoint consisting of:
    - all-cause mortality (Based on EAC-confirmed events)
    - non-fatal MI (Based on EAC-confirmed events, acute MI only),
    - non-fatal stroke (Based on EAC-confirmed events, including ischaemic, haemorrhagic and undetermined stroke)
    9. Time to first occurrence of an expanded composite kidney endpoint consisting of:
    - CV death (Based on EAC-confirmed events, including undetermined cause of death)
    - onset of persistent ("Persistent" is defined as 2 consecutive samples meeting the criteria. The 2 samples must be at least 4 weeks apart) greater than or equal to 40% reduction in eGFR (CKD-EPI) compared with baseline
    - kidney failure defined as:
    a) death from kidney failure (Based on EAC-confirmed events, defined as a non-CV death that is due to the direct consequences of severely impaired kidney function. Undetermined cause of death in participants with eGFR below 15 mL/min/1.73 m^2 will be considered kidney death)
    b) onset of persistent ("Persistent" is defined as 2 consecutive samples meeting the criteria. The 2 samples must be at least 4 weeks apart) eGFR below 15 mL/min/1.73 m^2 (CKD-EPI)
    c) initiation of chronic kidney replacement therapy (maintenance dialysis or kidney transplantation)(Based on EAC-confirmed events)
    10. Time to first occurrence of coronary revascularisation
    11. Relative change in UACR
    12. Change in eGFR (CKD-EPI)
    13. Annual rate of change in eGFR (CKD-EPI) (total eGFR slope)
    14. Change in hs-CRP
    15. Change in NT-pro-BNP
    16. Change in left ventricular ejection fraction (LVEF)
    17. Number of events of atrial fibrillation (MedDRA search)
    18. Number of hospitalisations with infection as primary cause (Based on EAC-confirmed events) or death due to infection (Based on EACconfirmed events)
    19. Change in Short Form 36 (SF-36) Physical Component Score (PCS)
    Tempo al primo episodio di MACE espanso, un endpoint composito costituito da:
    • morte CV (in base a eventi confermati dall’EAC, cioè comitato di validazione degli eventi, comprensivo di causa indeterminata del decesso)
    • IM non fatale (in base a eventi confermati dall’EAC, solo IM acuto)
    • ictus non fatale ( in base a eventi confermati dall’EAC, comprensivo di ictus ischemico, emorragico e indeterminato)
    • ricovero per angina pectoris instabile che richiede rivascolarizzazione coronarica urgente (in base a eventi confermati dall’EAC, comprensivo di ictus ischemico)
    Numero di ricoveri per insufficienza cardiaca o visita urgente per insufficienza cardiaca (in base a eventi confermati dall’EAC)
    Tempo al verificarsi di mortalità per qualsiasi causa (in base a eventi confermati dall’EAC)
    Tempo al primo episodio di un endpoint MRC composito, costituito da:
    - comparsa di una riduzione persistente di =40% dell’eGFR (CKD-EPI) rispetto al basale (“persistente” si riferisce a 2 campioni consecutivi che soddisfano i criteri. Tra i 2 campioni devono intercorrere almeno 4 settimane)
    - insufficienza renale definita come:
    - decesso per insufficienza renale (in base a eventi confermati dall’EAC, definito come morte non CV dovuta a conseguenze dirette della grave compromissione della funzionalità renale. Una causa indeterminata di decesso nei partecipanti con eGFR <15 ml/min/1,73 m2 sarà considerata morte renale)
    - comparsa di eGFR persistente <15 ml/min/1,73 m2 (CKD-EPI)
    - inizio di terapia sostitutiva renale cronica (dialisi di mantenimento o trapianto di rene), in base a eventi confermati dall’EAC
    Tempo al primo episodio di ciascuno dei singoli componenti di endpoint MACE espanso e di endpoint renale composito (in base a eventi confermati dall’EAC)
    Tempo alla prima manifestazione di IM acuto (fatale e non fatale)
    Tempo al primo episodio di ictus (fatale e non fatale), comprensivo di ictus ischemico, emorragico e indeterminato, in base a eventi confermati dall’EAC
    Tempo al primo episodio di un endpoint MACE composito, costituito da:
    • mortalità per qualsiasi causa (in base a eventi confermati dall'EAC)
    • IM non fatale acuto (in base a eventi confermati dall'EAC
    • ictus non fatale (in base a eventi confermati dall'EAC, comprensivo di ictus ischemico, emorragico e indeterminato)
    Tempo al primo episodio di endpoint renale composito espanso costituito da:
    • morte CV (in base a eventi confermati dall'EAC, comprensivo di causa indeterminata del decesso)
    • comparsa di una riduzione persistente di =40% dell’eGFR (CKD-EPI) rispetto al basale
    • insufficienza renale definita come:
    • decesso per insufficienza renale (in base a eventi confermati dall'EAC, definito come morte non CV dovuta a conseguenze dirette della grave compromissione della funzionalità renale. Una causa indeterminata di decesso nei partecipanti con eGFR <15 ml/min/1,73 m2 sarà considerata morte renale)
    • comparsa di eGFR persistente <15 ml/min/1,73 m2 (CKD-EPI)
    • inizio di terapia sostitutiva renale cronica
    (dialisi di mantenimento o trapianto di rene) (in base a eventi confermati dall'EAC)
    Tempo al primo episodio di rivascolarizzazione coronarica
    Variazione relativa del rapporto albumina-creatinina nelle urine (UACR)
    Variazione dell’eGFR (CKD-EPI)
    Tasso annuale di variazione nell’eGFR (CKD-EPI) (pendenza totale dell’eGFR)
    Variazione di hs-CRP
    Variazione della frazione N-terminale del pro-peptide natriuretico cerebrale (NT-pro-BNP)
    Variazione della frazione di eiezione ventricolare sinistra (FEVS)
    Numero di eventi di fibrillazione atriale (ricerca MedDRA)
    Numero di ricoveri ospedalieri con infezione come causa primaria o decesso dovuto a infezione (in base a eventi confermati dall’EAC)
    Variazione del punteggio della componente fisica (PCS) del Modulo breve a 36 voci (SF-36)
    E.5.2.1Timepoint(s) of evaluation of this end point
    1.- 10. From randomisation (month 0) to end-of-study (up to 48 months (Maximum treatment duration is dependent on event rates and is estimated to be approximately 48 months including a 3-month follow-up period.)
    11.- 12. From randomisation (month 0) to (24 months)
    13. From randomisation (month 0) to end-of-study (up to 48 months (Maximum treatment duration is dependent on event rates and is estimated to be approximately 48 months including a 3-month follow-up period.)
    14.- 16. From randomisation (month 0) to (24 months)
    17.-18. From randomisation (month 0) to end-of-study (up to 48 months (Maximum treatment duration is dependent on event rates and is estimated to be approximately 48 months including a 3-month follow-up period.)
    19. From randomisation (month 0) to (24 months)
    1.- 10. Dalla randomizzazione (mese 0) alla fine dello studio (fino a 48 mesi (la durata massima del trattamento dipende dai tassi di eventi ed è stimata in circa 48 mesi compreso un periodo di follow-up di 3 mesi).
    11.- 12. Dalla randomizzazione (mese 0) a (24 mesi)
    13. Dalla randomizzazione (mese 0) alla fine dello studio (fino a 48 mesi (la durata massima del trattamento dipende dai tassi di eventi ed è stimata in circa 48 mesi compreso un periodo di follow-up di 3 mesi).
    14.- 16. Dalla randomizzazione (mese 0) a (24 mesi)
    17.-18. Dalla randomizzazione (mese 0) alla fine dello studio (fino a 48 mesi (la durata massima del trattamento dipende dai tassi di eventi ed è stimata in circa 48 mesi compreso un periodo di follow-up di 3 mesi).
    19. Dalla randomizzazione (mese 0) a (24 mesi)
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) 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 concerned21
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA156
    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
    India
    Israel
    Japan
    Korea, Republic of
    Malaysia
    Mexico
    Russian Federation
    Serbia
    South Africa
    Taiwan
    Turkey
    Ukraine
    United States
    European Union
    United Kingdom
    Argentina
    E.8.7Trial has a data monitoring committee No
    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
    LSLV
    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 months1
    E.8.9.1In the Member State concerned days14
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial days14
    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: 1250
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 4950
    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 state180
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1760
    F.4.2.2In the whole clinical trial 6200
    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
    nessuno
    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 Decision2021-08-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-06-17
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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