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    Summary
    EudraCT Number:2020-004853-59
    Sponsor's Protocol Code Number:EX6018-4758
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-07-14
    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 ConcernedSpain - AEMPS
    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: Efectos de ziltivekimab en comparación con un placebo sobre los resultados cardiovasculares en participantes con enfermedad cardiovascular aterosclerótica establecida, enfermedad renal crónica e inflamación sistémica
    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: Estudio de investigación para evaluar el funcionamiento de ziltivekimab en comparación con un placebo en personas con enfermedad cardiovascular, enfermedad renal crónica e inflamación
    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 A/S
    B.1.3.4CountryDenmark
    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.5.6E-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.3.4Pharmaceutical form Solution for injection
    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.3.8INN - Proposed INNN/A
    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 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 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
    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
    Enfermedad cardiovascular aterosclerótica
    Enfermedad renal crónica
    Inflamación sistémica
    E.1.1.1Medical condition in easily understood language
    Cardiovascular disease
    Chronic kidney disease
    Inflammation
    Enfermedad cardiovascular
    Enfermedad renal crónica
    Inflamación
    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.
    Demostrar la superioridad de ziltivekimab 15 mg s.c. una vez al mes para reducir el riesgo de MACE-Evento adverso cardiovascular importante (definido por el criterio de valoración principal) en comparación con placebo, ambos añadidos al tratamiento habitual, en participantes con ECVA establecida, ERC e inflamación sistémica.
    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)
    -Demostrar superioridad de ziltivekimab 15 mg s.c. una vez al mes en comparación con placebo, ambos añadidos al tratamiento habitual, en participantes con ECVA establecida, ERC e inflamación sistémica, en cuanto a:
    •reducción riesgo MACE extendidos (definido por criterio valoración secundario)
    •reducción riesgo insuficiencia cardíaca (definido por criterio valoración secundario)
    •reducción mortalidad por cualquier causa
    •retraso de progresión de la ERC (definido por el criterio de valoración secundario)
    - Comparar el efecto de ziltivekimab 15 mg s.c. una vez al mes en comparación con placebo, ambos añadidos al tratamiento habitual, en participantes con ECVA establecida, ERC e inflamación sistémica, en cuanto a:
    •reducción de inflamación sistémica (definido por los criterios de valoración secundarios y exploratorios)
    •Mejora de los resultados reportados por los pacientes (PRO)
    •No aumento de las infecciones severas (definido por los criterios de seguridad secundarios)
    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 (tasa de filtración glomerular estimada) mayor o igual a 15 e inferior a 60 ml/min/1,73 m2 (utilizando la ecuación de creatinina del Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI]).
    - hs-CRP (proteina C reactiva de alta sensibilidad) en suero mayor o igual a 2 mg/l en la selección (visita 1).
    • Signos de ECVA por uno o más de los siguientes en los 5 años previos a la selección:
    a) Enfermedad coronaria, definida como al menos uno de lo siguiente:
    i. Antecedentes documentados de IM
    ii.Procedimiento previo de revascularización coronaria
    iii.Estenosis mayor o igual al 50 % en la arteria coronaria epicárdica principal documentada mediante cateterismo cardíaco o angiografía coronaria por TC
    b) Enfermedad cerebrovascular definida como al menos uno de lo siguiente:
    i. Ictus previo de origen aterosclerótico
    ii. Procedimiento previo de revascularización de la arteria carótida
    iii. Estenosis mayor o igual al 50 % en la arteria carótida documentada por angiografía convencional, angiografía por RM, angiografía por TC o ecografía Doppler
    c) Arteriopatía periférica (AP) sintomática, definida como al menos uno de lo siguiente:
    i. Claudicación intermitente con índice tobillo-brazo (ABI) inferior o igual a 0,90 en reposo
    ii. Claudicación intermitente con estenosis mayor o igual al 50 % en una arteria periférica (excluida la carótida) documentada mediante angiografía convencional, angiografía por RM, angiografía por TC o ecografía Doppler
    iii. Procedimiento previo de revascularización de una arteria periférica (excluida la carótida)
    iv. Amputación de extremidades inferiores en o por encima del tobillo por enfermedad aterosclerótica (excepto traumatismo u osteomielitis)
    E.4Principal exclusion criteria
    - Clinical evidence of, or suspicion of, active infection at the discretion of the 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).
    - Signos clínicos o sospecha de infección activa a criterio del investigador.
    - Infarto de miocardio, ictus u hospitalización por angina de pecho inestable o accidente isquémico transitorio en los 60 días previos a la aleatorización (visita 2).
    - Revascularización arterial coronaria, carotídea o periférica programada conocida el día de la selección (visita 1).
    - Cirugía cardíaca mayor, cirugía no cardíaca o endoscopia mayor (toracoscópica o laparoscópica) en los 60 días previos a la aleatorización (visita 2) o cualquier cirugía mayor programada en el momento de la aleatorización (visita 2).
    E.5 End points
    E.5.1Primary end point(s)
    1. 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)
    1. Tiempo transcurrido hasta la primera aparición de un MACE de 3 puntos, criterio de valoración combinado consistente en:
    - muerte de origen cardiovascular (Basado en eventos confirmados por el CAE (Comité adjudicación eventos), incluyendo causas de muerte indeterminadas)
    - infarto de miocardio (IM) no mortal (Basado en eventos confirmados por el CAE, solo infarto agudo de miocardio)
    - ictus no mortal (Basado en eventos confirmados por el CAE, incluido ictus isquémicos, hemorrágicos e indeterminados)
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. 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)
    1. Desde aleatorización (mes 0) al final del estudio (hasta 48 meses
    (La duración máxima del tratamiento depende de las tasas de eventos y
    se estima que sea aproximadamente de 48 meses, incluido un periodo de seguimiento de 3 meses)
    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 EAC-confirmed 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 EAC-confirmed events)
    19. Change in Short Form 36 (SF-36) Physical Component Score (PCS)
    1.Tiempo transcurrido hasta la primera aparición de un MACE extendido, criterio de valoración compuesto consistente en:
    - muerte de origen cardiovascular (Basado en eventos confirmados por el CAE, incluyendo causas de muerte indeterminadas)
    - infarto de miocardio (IM) no mortal (Basado en eventos confirmados por el CAE, solo infarto agudo de miocardio)
    - ictus no mortal (Basado en eventos confirmados por el CAE, incluido ictus isquémicos, hemorrágicos e indeterminados)
    - hospitalización por angina de pecho inestable con necesidad de revascularización coronaria urgente (Basado en eventos confirmados por el CAE
    2. Número de hospitalizaciones por insuficiencia cardíaca (Basado en eventos confirmados por el CAE) o visita urgente por insuficiencia cardíaca (Basado en eventos confirmados por el CAE).
    3. Tiempo hasta la aparición de muerte por cualquier causa (Basado en eventos confirmados por el CAE).
    4. Tiempo hasta primera aparición de un criterio de valoración de enfermedad renal crónica combinado consistente en lo siguiente:
    -aparición de una reducción persistente superior o igual al 40 % de la tasa de filtración glomerular estimada (eGFR) (CKD-EPI) en comparación con el valor basal ("Persistente" se define como 2 muestras consecutivas cumpliendo los criterios. Las 2 muestras deben estar separadas por al menos 4 semanas)
    - insuficiencia renal definida como:
    a) muerte de origen renal (Basado en eventos confirmados por el CAE, definido como una muerte no CV que se debe a las consecuencias directas de
    función renal severamente alterada. Causa indeterminada de muerte en los participantes con eGFR por debajo de 15 ml / min / 1,73 m ^ 2 se considerará muerte renal)
    b) aparición de eGFR persistente inferior a 15 ml/min/1,73 m2 (CKD-EPI) ("Persistente" se define como 2 muestras consecutivas cumpliendo los criterios. Las 2 muestras deben estar separadas por al menos 4 semanas)
    c) inicio de terapia de sustitución renal crónica (diálisis de mantenimiento o trasplante de riñón) (Basado en eventos confirmados por el CAE).
    5. Tiempo hasta la primera aparición de cada uno de los componentes individuales (Basado en eventos confirmados por el CAE) del criterio de valoración MACE extendido y el criterio de valoración renal compuesto
    6. Tiempo hasta la primera aparición de IM (solo IM agudo) (mortal y no mortal) (Basado en eventos confirmados por el CAE)
    7. Tiempo transcurrido hasta la primera aparición de un ictus (incluidos ictus isquémicos, hemorrágicos o indeterminado) (mortal y no mortal) (Basado en eventos confirmados por el CAE)
    8. Tiempo transcurrido hasta la primera aparición de un criterio de valoración MACE compuesto que consiste en:
    - mortalidad por todas las causas (Basado en eventos confirmados por el CAE)
    - IM no mortal (Basado en eventos confirmados por el CAE, solo IM agudo)
    - ictus no mortal (Basado en eventos confirmados por el CAE, incluidos ictus isquémicos, hemorrágicos e indeterminados)
    9. Tiempo hasta la primera aparición de un criterio de valoración renal compuesto expandido consistente en lo siguiente:
    - muerte de origen cardiovascular (Basado en eventos confirmados por el CAE, incluyendo causas de muerte indeterminadas)
    - aparición de una reducción persistente superior o igual al 40 % del eGFR (CKD-EPI) en comparación con el valor basal ("Persistente" se define como 2 muestras consecutivas cumpliendo los criterios. Las 2 muestras deben estar separadas por al menos 4 semanas)
    - insuficiencia renal definida como:
    a) muerte de origen renal (Basado en eventos confirmados por el CAE, definido como una muerte no CV que se debe a las consecuencias directas de
    función renal severamente alterada. Causa indeterminada de muerte en los participantes con eGFR por debajo de 15 ml / min / 1,73 m ^ 2 se considerará muerte renal)
    b) aparición de eGFR persistente inferior a 15 ml/min/1,73 m2 (CKD-EPI) ("Persistente" se define como 2 muestras consecutivas cumpliendo los criterios. Las 2 muestras deben estar separadas por al menos 4 semanas)
    c) inicio de terapia de sustitución renal crónica (diálisis de mantenimiento o trasplante de riñón) (Basado en eventos confirmados por el CAE).
    10. Tiempo hasta la primera aparición de revascularización coronaria
    11. Cambio relativa en la relación albúmina-creatinina en orina
    12. Cambio en el eGFR (CKD-EPI)
    13. Tasa de variación anual de eGFR (CKD-EPI) (total eGFR slope)
    14. Cambio en proteína C-reactiva de alta sensibilidad (hs-CRP)
    15. Cambio en NT-pro-BNP
    16. Cambio en la fracción de eyección ventricular izquierda (FEVI)
    17. Número de eventos de fibrilación auricular (búsqueda en MedDRA)
    18. Número de hospitalizaciones con infección como causa primaria (basado en
    Eventos confirmados por CAE) o muerte debida a infección (basado en Eventos confirmados por CAE)
    19. Cambio en la puntuación del componente físico (PCS) del formulario corto 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.Desde aleatorización (mes 0) a final estudio (hasta 48 meses (la duración máxima del tratamiento (tto) depende de las tasas de eventos y
    se estima que sea aproximadamente 48 meses, incluido periodo seguimiento de 3 meses)
    11- 12.Desde aleatorización (mes 0) hasta 24 meses
    13.Desde aleatorización (mes 0) a final estudio (hasta 48 meses (la duración máxima del tto depende de las tasas de eventos y
    se estima que sea aproximadamente 48 meses, incluido periodo seguimiento de 3 meses)
    14-16.Desde aleatoriz. (mes 0) hasta 24 meses
    17-18.Desde aleatoriz. (mes 0) a final estudio (hasta 48 meses (la duración máxima del tto depende de las tasas de eventos y
    se estima que sea aproximadamente 48 meses, incluido periodo seguimiento de 3 meses)
    19.Desde aleatoriz. (mes 0) hasta 24 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 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 Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    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 concerned7
    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 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
    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 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
    UVUP
    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 state100
    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
    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 Decision2021-10-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-10-05
    P. End of Trial
    P.End of Trial StatusOngoing
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