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    Summary
    EudraCT Number:2016-001668-13
    Sponsor's Protocol Code Number:GE-012-106
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2017-07-31
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2016-001668-13
    A.3Full title of the trial
    Parallel-Group, Placebo-Controlled Randomized Study Investigating the Effect of Intravenous Iso-osmolar Iodinated Contrast Material Iodixanol (Visipaque™ Injection 320 mgI/mL) on Renal Function in Adults with Chronic Kidney Disease (CKD) Stage III or Stage IV Who Have Undergone Endovascular Aneurysm Repair (EVAR)
    Estudio aleatorizado, con grupos paralelos, controlado con placebo para investigar el efecto del medio de contraste intravenoso isoosmolar yodado iodixanol (Visipaque™ inyección de 320 mgI/ml) sobre la función renal en adultos con nefropatía crónica (NC) de estadio III o IV que han sido sometidos a reparación endovascular de aneurisma (EVAR)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to explore the renal safety of Visipaque Injection 320 mgI/mL in patients with chronic kidney disease.
    Estudio para explorar la seguridad renal de Visipaque Inyección 320 mgI / mL en pacientes con enfermedad renal crónica.
    A.4.1Sponsor's protocol code numberGE-012-106
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03119662
    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 SponsorGE Healthcare Ltd. and its Affiliates
    B.1.3.4CountryUnited Kingdom
    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 supportGE Healthcare Ltd. and its Affiliates
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGE Healthcare Ltd. and its Affiliates
    B.5.2Functional name of contact pointClinical Project Director
    B.5.3 Address:
    B.5.3.1Street AddressThe Grove Centre, White Lion Road
    B.5.3.2Town/ cityAmersham, Buckinghamshire
    B.5.3.3Post codeHP7 9LL
    B.5.3.4CountryUnited Kingdom
    B.5.6E-mailfiona.hattey@ge.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 VisipaqueTM
    D.2.1.1.2Name of the Marketing Authorisation holderGE Healthcare
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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 Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNIODIXANOL
    D.3.9.1CAS number 92339-11-2
    D.3.9.4EV Substance CodeSUB08213MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number320
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Chronic Kidney Disease
    Enfermedad Renal Crónica
    E.1.1.1Medical condition in easily understood language
    Chronic Kidney Disease
    Enfermedad Renal Crónica
    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 10076410
    E.1.2Term Chronic kidney disease stage 3
    E.1.2System Organ Class 100000070575
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10076411
    E.1.2Term Chronic kidney disease stage 4
    E.1.2System Organ Class 100000070575
    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 safety of intravenous (i.v.) iodinated iso-osmolar iodixanol (Visipaque™ Injection 320 mgI/mL) usage in contrast-enhanced computed tomography (CECT) for CKD stage III/IV patients by evaluating the incidence of acute kidney injury (AKI) stage ≥1, per acute kidney injury network (AKIN) serum creatinine (SCr) criteria [AKIN 2015] [Mehta et al. 2007], in patients undergoing CECT with iodixanol vs patients receiving placebo and undergoing nonenhanced computed tomography (NECT) and an additional non–contrast-enhanced ultrasound imaging modality.
    Demostrar la seguridad del uso del iodixanol intravenoso (i.v.) isoosmolar yodado (Visipaque™ inyección de 320 mgI/ml) en la tomografía computarizada realzada con contraste (TCRC) en pacientes con NC en estadio III/IV mediante la evaluación de la incidencia de lesión renal aguda (LRA) en estadio ≥1, según los criterios de creatinina sérica (SCr) de la red de trabajo de lesión renal aguda (AKIN) [AKIN 2015] [Mehta et al. 2007], en pacientes sometidos a TCRC con iodixanol en comparación con los pacientes que reciben placebo y se someten a una tomografía computarizada sin realce (TCSR) y una modalidad adicional de ecografía no realzada con contraste.
    E.2.2Secondary objectives of the trial
    To demonstrate the safety of i.v. iodinated iso-osmolar iodixanol (Visipaque™ Injection 320 mgI/mL) usage in CECT for CKD stage III/IV patients by evaluating of the incidence AKI stage ≥2, per AKIN SCr criteria [AKIN 2015] [Mehta et al. 2007], in patients undergoing CECT with iodixanol vs patients receiving placebo and undergoing NECT and an additional non–contrast-enhanced ultrasound imaging modality. Incidence of AKI by other definitions (standard definition of contrast induced nephropathy (CIN) [Mehran and Nikolsky 2006], and AKI stages ≥2 by Waikar criteria [Waikar and Bonventre 2009]) in patients undergoing CECT with iodixanol vs patients receiving placebo and undergoing NECT and an additional non–contrast-enhanced ultrasound imaging modality.
    Mortality and morbidity within 6 months of intervention in patients undergoing CECT with iodixanol vs. patients receiving placebo and undergoing NECT and an additional non–contrast-enhanced ultrasound imaging modality.
    Demostrar la seguridad del uso del iodixanol i.v. isoosmolar yodado (Visipaque™ inyección de 320 mgI/ml) en TCRC en pacientes con NC en estadio III/IV mediante evaluación
    de incidencia LRA en estadio ≥2, según CrS (AKIN) [AKIN 2015] [Mehta et al. 2007], en pacientes sometidos a TCRC con iodixanol en comparación con pacientes que reciben placebo y se someten a una TCSR y modalidad adicional de ecografía no realzada con contraste. incidencia de LRA según otras definiciones ( (NIC) [Mehran y Nikolsky 2006], y estadios de LRA ≥2 según Waikar [Waikar y Bonventre 2009]) en pacientes sometidos a TCRC con iodixanol en comparación con pacientes que reciben placebo y se someten a TCSR y modalidad adicional de ecografía no realzada con contraste. Morbimortalidad dentro de los 6 m posteriores a la intervención en pacientes sometidos a TCRC con iodixanol en comparación con pacientes que reciben placebo y se someten a TCSR y a modalidad adicional de ecografía no realzada con contraste.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    (1) Is ≥18 years of age at the time that written informed consent is obtained.
    (2) Is male or is a nonpregnant, nonlactating female who is either surgically sterile (has a documented bilateral tubal ligation or oophorectomy and/or documented hysterectomy) or is postmenopausal (cessation of menses for more than 1 year). Women of childbearing potential must use adequate contraception from Screening until 30 days after the Baseline Visit and must have a negative result for a urine human chorionic gonadotropin pregnancy test at the Baseline Visit.
    (3) Is an outpatient who has undergone successful EVAR and is scheduled for post-procedural imaging with CT.
    (4) Has previously completed his or her first post-EVAR surveillance CECT imaging examination (usually performed around 1-month).
    (5) Has a documented diagnosis of stage III or IV (defined as 30≤ estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m² and 15 ≤eGFR <30 mL/min/1.73 m², respectively, according to the Modification of Diet in Renal Disease [MDRD] equation) CKD and stable renal function (last 2 SCr values within ±0.5 mg/dL of each other, with the most recent value within 7 days prior to the scheduled CT examination and the preceding value within 1 to 12 months before that).
    (6) Is able to provide written informed consent.
    (7) Is able and willing to comply with all study procedures as described in the protocol.
    (1) Ser ≥18 años de edad en el momento en que se obtiene el consentimiento informado.
    (2) Ser hombre o mujer no embarazada ni lactante que o bien ha sido esterilizada quirúrgicamente (con una ligadura de trompas bilateral u ooforectomía documentada y/o histerectomía documentada) o es posmenopáusica (cese de la menstruación desde hace más de 1 año). Las mujeres fértiles deben utilizar anticoncepción adecuada desde la selección hasta 30 días después de la visita inicial y deben tener un resultado negativo en una prueba de embarazo de gonadotropina coriónica humana en la visita inicial.
    (3) Ser un paciente ambulatorio sometido con éxito a una EVAR y con una TAC programada después del procedimiento.
    (4) Haber completado previamente su primer examen de vigilancia mediante TCRC después de la EVAR (habitualmente realizado una vez transcurrido alrededor de 1 mes).
    (5) Tener un diagnóstico documentado de NC en estadio III o IV (definida como 30 ≤tasa de filtración glomerular estimada (TFGe) <60 ml/min/1,73 m² y 15 ≤TFGe <30 ml/min/1,73 m², respectivamente, según la ecuación de la modificación de la dieta en la nefropatía [MDRD]) y una función renal estable (últimos 2 valores de SCr dentro del intervalo de ±0,5 mg/dl entre ellos, con el valor más reciente dentro de los 7 días anteriores al examen de TAC programado, y el valor precedente dentro del período comprendido entre el mes y los 12 meses anteriores a ese momento).
    (6) Poder otorgar su consentimiento informado por escrito.
    (7) Poder y estar dispuesto a cumplir con todos los procedimientos descritos en el protocolo.
    E.4Principal exclusion criteria
    (1) Is pregnant, lactating, is possibly pregnant, or is actively trying to conceive during the study period.
    (2) Is a patient for whom an endoleak has already been discovered.
    (3) Is a patient who is undergoing surveillance following a Thoracic Endovascular Repair (TEVAR)
    (4) Has a known or suspected history of immediate or delayed hypersensitivity (including but not limited to hives, anaphylactoid or cardiovascular reactions, laryngeal edema, and bronchospasm) to iodine or any iodinated contrast medium.
    (5) Is using metformin (e.g., Glucophage®) that cannot be discontinued for the period of 24 hours prior to the Baseline Visit and for at least 48 hours after the imaging procedure (renal function must be evaluated before metformin is resumed).
    (6) Has been exposed to any intravascular iodinated contrast medium in the 7 days prior to the Baseline Visit.
    (7) Has congestive heart failure (New York Heart Association [NYHA] Class IV) or hepatic failure/liver cirrhosis according to the investigator’s judgement.
    (8) Has stage V CKD, defined as eGFR <15 mL/min/1.73 m² according to the MDRD equation.
    (9) Has a pre-existing requirement for renal dialysis.
    (10) Has undergone percutaneous transluminal renal angioplasty (PTRA) within 12 months before the index EVAR procedure or is scheduled to undergo PTRA during the study period.
    (11) Has any clinically active, serious, life-threatening disease, medical, or significant psychiatric condition; has a life expectancy of less than 6 months; or is, in the Investigator's opinion, unsuitable for participation in the study for any reason.
    (12) Has been enrolled in another clinical study within the 30 days prior to the Screening Visit or is planned to enroll in another clinical study within the duration of this study.
    (13) Has been previously enrolled in this study.
    (14) Is using i.v. vasopressor or inotropic medications.
    (15) Has used nonsteroidal anti-inflammatory drugs (NSAIDs) or any nephrotoxic medication within 48 hours of the Baseline Visit or will do so within 72 hours after the CT procedure (renal function must be evaluated before any nephrotoxic medication is resumed) – with the exception of acetylsalicylic acid (Aspirin) at a dose of ≤100 mg daily (QD).
    (16) Has been hospitalized within 30 days prior to Screening Visit for any reason other than practical purposes for management of tests or diagnostic assessments.
    Criterios de exclusión:
    Los pacientes deberán ser excluidos de la participación en este ensayo si cumplen alguno de los criterios siguientes:
    (1) Estar embarazada, amamantando o posiblemente embarazada, o si está tratando activamente de concebir durante el periodo del estudio.
    (2) Ser un paciente en el que ya se haya descubierto una endofuga.
    (3) Ser un paciente que está sometido a vigilancia después de una reparación endovascular torácica (TEVAR)
    (4) Tener antecedentes conocidos o presuntos de hipersensibilidad inmediata o retardada (lo que incluye, entre otros, urticaria, reacciones seudoanafilácticas o cardiovasculares, edema de laringe y broncoespasmo) al yodo o a cualquier medio de contraste yodado.
    (5) Estar utilizando metformina (por ejemplo, Glucophage®) que no se puede interrumpir durante el periodo de 24 horas anterior a la
    visita inicial y durante al menos 48 horas después del procedimiento de exploración por imágenes (se debe evaluar la función renal antes de retomar la metformina).
    (6) Haber estado expuesto a cualquier medio de contraste intravascular yodado en los 7 días anteriores a la visita inicial.
    (7) Tener insuficiencia cardíaca congestiva (Clase IV de la New York Heart Association (Asociación del corazón de Nueva York) [NYHA]) o insuficiencia hepática o cirrosis hepática según el criterio del investigador.
    (8) Tener NC en estadio V, definida como una TFGe <15 ml/min/1,73 m² según la ecuación de MDRD.
    (9) Presentar una necesidad preexistente de diálisis renal.
    (10) Haber sido sometido a angioplastia renal transluminal percutánea (ARTP) en los 12 meses anteriores al procedimiento de EVAR inicial o si está programada una ARTP durante el período del estudio.
    (11) Tener una enfermedad clínicamente activa, grave, potencialmente mortal, o una afección psiquiátrica significativa; tener una expectativa de vida de menos de 6 meses, o, según la opinión del investigador, su participación en el estudio no es adecuada por cualquier motivo.
    (12) Haber sido incluido en otro estudio clínico en los 30 días anteriores a la visita de selección o si planea incluirse en otro estudio clínico durante el tiempo de duración de este estudio.
    (13) Haber sido incluido en este estudio previamente.
    (14) Estar utilizando medicamentos vasopresores o inotrópicos i.v.
    (15) Haber utilizado medicamentos antiinflamatorios no esteroideos (AINE) o cualquier medicación nefrotóxica en las 48 horas anteriores a la visita inicial o si lo hará en las 72 horas siguientes al procedimiento de TAC (deberá evaluarse la función renal antes de retomar cualquier tipo de medicación nefrotóxica) – a excepción del ácido acetilsalicílico (aspirina) a una dosis ≤100 mg al día (1 vez al día).
    (16) Haber sido hospitalizado en los 30 días anteriores a la visita de selección por cualquier motivo que no fuera para fines prácticos de realización de pruebas o evaluaciones diagnósticas.
    E.5 End points
    E.5.1Primary end point(s)
    Incidence of AKI stage ≥1 (AKIN SCr criteria) following an i.v. injection of iodinated iso-osmolar contrast material iodixanol (Visipaque™ Injection 320 mgI/mL) or saline in patients with CKD stage III/IV assessed at 48 hours post-baseline (Follow-up 1).
    Incidencia de LRA en estadio ≥1 (criterios de SCr de AKIN) después de una inyección i.v. de medio de contraste isoosmolar yodado iodixanol (Visipaque™ inyección de 320 mgI/ml) o solución salina en pacientes con NC en estadio III/IV evaluada 48 horas después del inicio (seguimiento 1).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Incidence of AKI stage ≥1 (AKIN SCr criteria) at 48 hours post-baseline (Follow-up 1)
    Incidencia de LRA en estadio ≥1 (criterios de SCr de AKIN) evaluada 48 horas después del inicio (seguimiento 1).
    E.5.2Secondary end point(s)
    - Incidence of AKI stage ≥2 (by AKIN SCr criteria) following an i.v. injection of iodinated iso-osmolar contrast material iodixanol (Visipaque™ Injection 320 mgI/mL) or saline in patients with CKD stage III/IV assessed at 48 hours post-baseline (Follow-up 1).
    - Incidence of AKI (by standard definition of CIN [Mehran and Nikolsky 2006]) following an i.v. injection of iodinated iso-osmolar contrast material iodixanol (Visipaque™ Injection 320 mgI/mL) or saline in patients with CKD stage III/IV assessed at 48 hours post-baseline (Follow-up 1).
    - Incidence of AKI stage ≥2 (by Waikar criteria [Waikar and Bonventre 2009]) following i.v. administration of iodinated iso-osmolar contrast material iodixanol (Visipaque™ Injection 320 mgI/mL) or saline in patients with CKD stage III/IV assessed at 48 hours post-baseline (Follow-up 1).
    - Mortality and morbidity (i.e. critical events, including EVAR-related post-baseline events, as adjudicated by the CEAC) assessed at 6 months (Follow-up 3) in patients with CKD stage III/IV.
    - Blinded independent assessment of image quality/diagnostic confidence using a 5-point scale.
    - Incidencia de LRA en estadio ≥2 (criterios de SCr de AKIN) después de una inyección i.v. de medio de contraste isoosmolar yodado iodixanol (Visipaque™ inyección de 320 mgI/ml) o solución salina en pacientes con NC en estadio III/IV evaluada 48 horas después del inicio (seguimiento 1).
    - Incidencia de LRA (según la definición estándar de la NIC [Mehran y Nikolsky 2006]) después de una inyección i.v. de medio de contraste isoosmolar yodado iodixanol (Visipaque™ inyección de 320 mgI/ml) o solución salina en pacientes con NC en estadio III/IV evaluada 48 horas después del inicio (seguimiento 1).
    - Incidencia de LRA en estadio ≥2 (según los criterios de Waikar [Waikar y Bonventre 2009]) después de la administración i.v. de medio de contraste isoosmolar yodado iodixanol (Visipaque™inyección de 320 mgI/ml) o solución salina en pacientes con NC en estadio III/IV evaluada 48 horas después del inicio (seguimiento 1).
    - Morbimortalidad (es decir, acontecimientos críticos, incluidos los acontecimientos relacionados con la EVAR después del inicio, según la validación del CVAC) evaluadas a los 6 meses (seguimiento 3) en pacientes con NC en estadio III/IV.
    - Evaluación independiente con enmascaramiento de la calidad de la imagen/confianza diagnóstica utilizando una escala de 5 puntos.
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Incidence of AKI stage ≥2 (by AKIN SCr criteria)
    at 48 hours post-baseline (Follow-up 1).
    - Incidence of AKI (by standard definition of CIN [Mehran and Nikolsky 2006]) at 48 hours post-baseline (Follow-up 1)
    - Incidence of AKI stage ≥2 (by Waikar criteria [Waikar and Bonventre 2009]) at 48 hours post-baseline (Follow-up 1)
    - Mortality and morbidity
    assessed at 6 months (Follow-up 3)
    Incidencia de LRA (según la definición estándar de la NIC [Mehran y Nikolsky 2006]) después de una inyección i.v. de medio de contraste isoosmolar yodado iodixanol (Visipaque™ inyección de 320 mgI/ml) o solución salina en pacientes con NC en estadio III/IV evaluada 48 horas después del inicio (seguimiento 1).
    - Incidencia de LRA en estadio ≥2 (según Waikar [Waikar y Bonventre 2009]) después de administración i.v. de medio de contraste isoosmolar yodado iodixanol (Visipaque™inyección de 320 mgI/ml) o solución salina en pacientes con NC en estadio III/IV evaluada 48 horas después del inicio (seguimiento 1). Morbimortalidad (e.d. acontecimientos críticos, incluidos acontecimientos relacionados con la EVAR después del inicio, según validación del CVAC) evaluadas a los 6 meses (seguimiento 3)
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA40
    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
    Belgium
    Canada
    France
    Germany
    Greece
    Hungary
    Netherlands
    Poland
    Spain
    United Kingdom
    United States
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    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: 466
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 698
    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 state35
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 582
    F.4.2.2In the whole clinical trial 1164
    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)
    Standard care
    Atención estándar
    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 Decision2017-10-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-10-19
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2018-09-13
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