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    Summary
    EudraCT Number:2017-000537-31
    Sponsor's Protocol Code Number:MK-7264-027
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-01-23
    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 number2017-000537-31
    A.3Full title of the trial
    A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 12-Month Study to Evaluate the Efficacy and Safety of MK-7264 in Adult Participants with Chronic Cough (PN027)
    Estudio en fase 3, aleatorizado, doble ciego, controlado con placebo y de 12 meses de duración para evaluar la eficacia y la seguridad de MK-7264 en participantes adultos con tos crónica (PN027)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    MK-7264 phase 3 study in adult participants with chronic cough (PN027)
    Estudio en fase 3 de MK-7264 en participantes adultos con tos crónica (PN027)
    A.4.1Sponsor's protocol code numberMK-7264-027
    A.5.4Other Identifiers
    Name:IND NumberNumber:123007
    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 SponsorMerck Sharp & Dohme Corp.
    B.1.3.4CountryUnited States
    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 supportMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMerck Sharp & Dohme de España S.A.
    B.5.2Functional name of contact pointInvestigación Clínica
    B.5.3 Address:
    B.5.3.1Street AddressC/ Josefa Valcárcel, 38
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28037
    B.5.3.4CountrySpain
    B.5.4Telephone number+34913210600
    B.5.5Fax number+34913210590
    B.5.6E-mailensayos_clinicos@merck.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.3.2Product code MK-7264
    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 INNMK-7264
    D.3.9.1CAS number 1015787-98-0
    D.3.9.2Current sponsor codeMK-7264
    D.3.9.3Other descriptive nameAF-219
    D.3.9.4EV Substance CodeSUB184344
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number45
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.2Product code MK-7264
    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 INNMK-7264
    D.3.9.1CAS number 1015787-98-0
    D.3.9.2Current sponsor codeMK-7264
    D.3.9.3Other descriptive nameAF-219
    D.3.9.4EV Substance CodeSUB184344
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 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 placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Chronic Cough
    Tos crónica
    E.1.1.1Medical condition in easily understood language
    Chronic Cough
    Tos crónica
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10066656
    E.1.2Term Chronic cough
    E.1.2System Organ Class 100000004855
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    - To evaluate the efficacy of MK-7264 in reducing cough frequency as measured over a 24-hour period
    - To evaluate the safety and tolerability of MK-7264
    -Evaluar la eficacia de MK-7264 en la reducción de la frecuencia de la tos medida durante un período de 24 horas
    -Evaluar la seguridad y tolerabilidad de MK-7264
    E.2.2Secondary objectives of the trial
    - To evaluate the efficacy of MK-7264 in reducing cough frequency as measured while awake during a 24-hour period
    - To evaluate the efficacy of MK-7264 based on the proportion of participants with a clinically significant reduction from baseline in 24-hour coughs per hour
    - To evaluate the efficacy of MK-7264 in improving self-rated cough severity
    - To evaluate the ability of MK-7264 to provide a clinically significant improvement in cough specific quality of life
    -Evaluar la eficacia de MK-7264 en la reducción de la frecuencia de la tos medida estando despierto durante un período de 24 horas
    -Evaluar la eficacia de MK-7264 basándose en el porcentaje de participantes con una disminución clínicamente significativa de la tos por hora durante 24 horas con respecto al momento basal
    -Evaluar la eficacia de MK-7264 para mejorar la intensidad de la tos autoevaluada
    -Evaluar la capacidad de MK-7264 de producir una mejoría clínicamente significativa de la calidad de vida específica de la tos
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Merck will conduct Future Biomedical Research on DNA. Such research is for biomarker testing to address emergent questions not described elsewhere in the protocol (as part of the main trial) and will only be conducted on specimens from appropriately consented subjects. The objective of collecting specimens for Future Biomedical Research is to explore and identify biomarkers that inform the scientific understanding of diseases and/or their therapeutic treatments. The overarching goal is to use such information to develop safer, more effective drugs, and/or to ensure that subjects receive the correct dose of the correct drug at the correct time.
    El promotor realizará investigaciones biomédicas futuras con las muestras de ADN. Estas investigaciones tendrán por objeto el análisis de biomarcadores con el fin de abordar aspectos nuevos que no se describen en otras partes del protocolo (como parte del ensayo principal) y solo se llevarán a cabo en muestras de los participantes que hayan otorgado el consentimiento correspondiente. El objetivo de la obtención de muestras para futura investigación biomédica consiste en estudiar e identificar biomarcadores que proporcionen información a los científicos sobre las enfermedades o sus tratamientos. El objetivo primordial es utilizar tal información para desarrollar fármacos más seguros y eficaces y/o para garantizar que los participantes reciban la dosis correcta del fármaco adecuados en el momento preciso.
    E.3Principal inclusion criteria
    1. Chest radiograph or computed tomography scan of the thorax (within 5 years of Screening/Visit 1 and after the onset of chronic cough) not demonstrating any abnormality considered to be significantly contributing to the chronic cough or any other clinically significant lung disease in the opinion of the principal investigator or the sub-investigator.
    2. Have chronic cough for ≥1 year and a diagnosis of refractory chronic cough or unexplained chronic cough.
    3. Have a score of ≥40 mm on the Cough Severity VAS at both the Screening and Baseline visits.
    4. Women and men at least 18 years of age at the time of informed consent.
    5. A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
    a.) Not a woman of childbearing potential (WOCBP)
    OR
    b.) A WOCBP who agrees to follow the contraceptive guidance from the time of signing the informed consent through at least 14 days after the last dose of study treatment.
    6. The participant (or legally acceptable representative if applicable) provides written informed consent for the study. The participant may also provide consent for Future Biomedical Research. However, the participant may participate in the study without participating in Future Biomedical Research.
    7. The participant is willing and able to comply with all aspects of the protocol, including demonstrating an ability to follow study procedures (including use of the digital cough recording device and completion of the Cough Severity VAS, CSD, LCQ, and other protocol questionnaires) to the satisfaction of the investigator/qualified designee prior to randomization.
    1. Radiografía de tórax o tomografía computarizada de tórax (en los 5 años previos a la selección/visita 1 y después del comienzo de la tos crónica) que no demuestre ninguna anomalía que se considere que contribuye de manera significativa a la tos crónica o cualquier otra enfermedad pulmonar clínicamente importante en opinión del investigador principal o el subinvestigador.
    2. Tener tos crónica durante 1 año y un diagnóstico de tos crónica resistente o tos crónica sin explicación.
    3. Tener una puntuación ≥ 40 mm en la EAV de la intensidad de la tos en las visitas de selección y basal.
    4. Varones y mujeres de al menos 18 años de edad en el momento de firmar el consentimiento informado.
    5. Las mujeres podrán participar en el estudio si no están embarazadas (véase el Apéndice 5, Normas anticonceptivas y prueba de embarazo), no están amamantando y cumplen al menos una de las condiciones siguientes:
    a.) No ser una mujer en edad fértil (MEF) según se define en el Apéndice 5.
    O
    b.) Es una MEF que se compromete a seguir las normas relativas a métodos anticonceptivos indicadas en el Apéndice 5 durante el período de tratamiento y hasta, como mínimo, 14 días después de la última dosis del tratamiento del estudio.
    6. El participante (o su representante legal cuando proceda) otorga su consentimiento informado por escrito para el estudio. El participante también podrá otorgar su consentimiento para la futura investigación biomédica. No obstante, podrá participar en el estudio sin necesidad de hacerlo en la futura investigación biomédica.
    7. El paciente está dispuesto a cumplir todos los aspectos del protocolo y es capaz de hacerlo, incluida la demostración de su capacidad para someterse a los procedimientos del estudio (incluidos el uso del dispositivo digital de registro de la tos [VitaloJAK™] y la cumplimentación de la EAV de intensidad de la tos, el CSD, el LCQ y otros cuestionarios del protocolo) a satisfacción del investigador/persona cualificada designada antes de la aleatorización.
    E.4Principal exclusion criteria
    1. Current smoker.
    2. Individuals who have given up smoking within 12 months of Screening/Visit 1.
    3. Former smokers with a pack/year history greater than 20 pack-years.
    4. Forced expiratory volume in 1 second (FEV1)/ forced vital capacity (FVC) ratio <60% (spirometry performed within the past year is acceptable if the investigator confirms that spirometry was done during a period where the participant was clinically stable, eg, not during an upper respiratory infection).
    5. History of upper or lower respiratory tract infection or recent clinically significant change in pulmonary status within 4 weeks of Screening/Visit 1.
    6. History of chronic bronchitis, defined as a cough that produces a clinically significant amount of sputum (greater than approximately 1 tablespoon of phlegm) that occurs every day for at least 3 months in a row, with those periods occurring at least 2 years in a row.
    7. Individuals who are currently taking an angiotensin converting enzyme inhibitor or have taken an angiotensin converting enzyme inhibitor within 3 months of Screening/Visit 1.
    8. Estimated glomerular filtration rate (eGFR) <50 mL/min/1.73 m2 (using the Chronic Kidney Disease Epidemiology Collaboration [CKD EPI] formula at Screening.
    9. Has a history of malignancy ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.
    10. Is, at the time of signing informed consent, a user of recreational or illicit drugs or has had a recent history (within the last year) of drug or alcohol abuse or dependence.
    11. Screening systolic blood pressure >160 mm Hg or a diastolic blood pressure >90 mm Hg.
    12. History of cutaneous adverse drug reaction to sulfonamides with or without systemic symptoms or history of anaphylaxis to sulfonamides.
    13. Has a known allergy/sensitivity or contraindication to MK-7264 or its excipients.
    14. Has donated or lost ≥1 unit of blood (approximately 300 mL) within 8 weeks prior to the first dose of MK-7264.
    15. A WOCBP who has a positive urine pregnancy test at Visit 1. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
    16. Requiring treatment with a therapy that does not adhere to the guidance parameters specified in the Protocol.
    17. Has previously received MK-7264.
    18. Is currently participating in or has participated in an interventional clinical study with an investigational compound or device within 30 days of participating in this current study.
    19. Significantly abnormal laboratory tests at Screening.
    20. Has a history or current evidence of any condition, therapy, lab abnormality, or other circumstance that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results, and in the judgment of the investigator or Sponsor, would make the participant inappropriate for entry into this study.
    21 Is or has an immediate family member (eg, spouse, parent/legal guardian, sibling or child) who is investigational site or sponsor staff directly involved with this trial.
    1. Fumador activo.
    2. Personas que hayan dejado de fumar en los 12 meses previos a la selección/visita 1.
    3. Antiguos fumadores con un consumo de paquetes-año superior a 20 paquetes-año.
    4. Cociente volumen espiratorio máximo en el primer segundo (FEV1)/capacidad vital forzada (FVC) < 60 % (se admite una espirometría realizada en el último año si el investigador confirma que la espirometría se hizo durante un periodo en que el participante estaba clínicamente estable, por ejemplo, no durante una infección respiratoria alta).
    5. Antecedentes de infección de las vías respiratorias superiores o inferiores o alteración reciente clínicamente significativa de la situación pulmonar en las 4 semanas previas a la selección/visita 1.
    6. Antecedentes de bronquitis crónica, definida como una tos que produce una cantidad de esputo clínicamente significativa (mayor que aproximadamente 15 ml de flema) que se manifiesta cada día al menos 3 meses seguidos, con periodos que tienen lugar al menos 2 años seguidos.
    7. Personas que estén tomando actualmente un inhibidor de la enzima convertidora de la angiotensina o lo hayan tomado en los 3 meses previos a la selección/visita 1.
    8. Filtración glomerular estimada (FGe) < 50 ml/min/1,73 m2 (utilizando la fórmula de la Chronic Kidney Disease Epidemiology Collaboration [CKD EPI] [http://mdrd.com/]) en la selección/visita 1.
    9. Antecedentes de una neoplasia maligna en los ≤ 5 años previos a la firma del consentimiento informado, excepto carcinoma basocelular o espinocelular de la piel debidamente tratado o cáncer de cuello uterino in situ.
    10. Ser, en el momento de firmar el consentimiento informado, consumidor de drogas o tener antecedentes recientes (en el último año) de alcoholismo o toxicomanía.
    11. Presión arterial sistólica > 160 mm Hg o presión arterial diastólica > 90 mm Hg en la selección.
    12. Antecedentes de reacción adversa cutánea a sulfamidas con o sin síntomas generales o antecedentes de anafilaxia a sulfamidas.
    13. Alergia/sensibilidad o contraindicación conocida a MK-7264 o sus excipientes.
    14. Donación o pérdida de 1 unidad de sangre (alrededor de 300 ml) en las 8 semanas previas a la primera dosis de MK-7264.
    15. MEF que tenga un resultado positivo en una prueba de embarazo en orina en la visita 1. Cuando el resultado de la prueba en orina sea positivo o no pueda confirmarse que es negativo, será necesario hacer una prueba de embarazo en suero.
    16. Necesidad de tratamiento que no cumpla los parámetros orientativos especificados en la sección 7.7 – Tratamiento concomitante.
    17. Haber recibido previamente MK-7264.
    18. Estar participando actualmente o haber participado en un ensayo clínico intervencionista con un fármaco o dispositivo experimental en los 30 días previos a la participación en el presente estudio.
    19. Pruebas analíticas significativamente anormales en la selección.
    20. Antecedentes o indicios actuales de cualquier trastorno, tratamiento, anomalía analítica u otra circunstancia que pueda aumentar el riesgo asociado a la participación en el estudio o a la administración del producto en investigación o que pueda interferir en la interpretación de los resultados del estudio y, en opinión del investigador o el promotor, podría motivar que el paciente no fuera apto para incorporarse a este ensayo.
    21. El paciente o un familiar directo (por ejemplo, cónyuge, padre/madre o tutor legal, hermano o hijo) forman parte del personal del centro de investigación o del promotor implicado directamente en este ensayo.
    E.5 End points
    E.5.1Primary end point(s)
    - 24-hour coughs per hour at Week 12
    - Number of participants experiencing an AE
    - Number of participants discontinuing study treatment due to an AE
    -Tos por hora durante 24 horas en la semana 12
    -Número de participantes que experimenten un acontecimiento adverso (AA)
    -Número de participantes que suspendan el tratamiento del estudio por un AA
    E.5.1.1Timepoint(s) of evaluation of this end point
    - Week 12 (Efficacy)
    - Throughout study (Safety)
    -Semana 12 (Eficacia)
    -Durante todo el estudio (Seguridad)
    E.5.2Secondary end point(s)
    - Awake coughs per hour at Week 12
    - Proportion of participants with a ≥30% reduction from baseline in 24-hour coughs per hour at Week 12
    - Proportion of participants with a ≥1.3-point reduction from baseline in mean weekly Cough Severity Diary (CSD) total score at Week 12
    - Proportion of participants with a ≥2.7-point reduction from baseline in mean weekly CSD total score at Week 12
    - Proportion of participants with a ≥30 mm reduction from baseline in Cough Severity Visual Analog Scale (VAS) score at Week 12
    - Proportion of participants with a ≥1.3-point increase from baseline in Leicester Cough Questionnaire (LCQ) total score at Week 12
    -Tos por hora estando despierto en la semana 12
    -Porcentaje de participantes con una disminución ≥ 30 % de la tos por hora durante 24 horas entre el momento basal y la semana 12
    -Porcentaje de participantes con una disminución ≥ 1,3 puntos de la puntuación total semanal media del Diario de intensidad de la tos (CSD) entre el momento basal y la semana 12
    -Porcentaje de participantes con una disminución ≥ 2,7 puntos de la puntuación total semanal media del CSD entre el momento basal y la semana 12
    -Porcentaje de participantes con una disminución ≥ 30 mm de la puntuación en la escala analógica visual (EAV) de la intensidad de la tos entre el momento basal y la semana 12
    -Porcentaje de participantes con un aumento ≥ 1,3-puntos de la puntuación total del Cuestionario de la tos de Leicester (LCQ) entre el momento basal y la semana 12
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 12
    Semana 12
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    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 trial3
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA48
    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
    Argentina
    Canada
    Czech Republic
    Denmark
    France
    Hungary
    Ireland
    Israel
    Japan
    Korea, Republic of
    Poland
    Spain
    Taiwan
    Turkey
    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
    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 months7
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months7
    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: 480
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 240
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 427
    F.4.2.2In the whole clinical trial 720
    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
    Ninguno
    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 Decision2018-07-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-04-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-08-17
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