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    Summary
    EudraCT Number:2018-000802-46
    Sponsor's Protocol Code Number:D169CC00001
    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:2018-07-17
    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 number2018-000802-46
    A.3Full title of the trial
    An International, Double-blind, Randomised, Placebo-Controlled Phase IIIb Study to Evaluate the Effect of Dapagliflozin on Reducing CV Death or Worsening Heart Failure in Patients with Heart Failure with Preserved Ejection Fraction (HFpEF).


    DELIVER - Dapagliflozin Evaluation to Improve the LIVEs of Patients with PReserved Ejection Fraction Heart Failure
    Ensayo fase III, internacional, doble ciego, aleatorizado y controlado con placebo, para evaluar el efecto de dapagliflozina en la reducción de la mortalidad cardiovascular o el empeoramiento de la insuficiencia cardiaca en pacientes con insuficiencia cardiaca con fracción de eyección preservada.

    DELIVER - Evaluación de dapagliflozina para mejorar las vidas de pacientes con insuficiencia cardiaca y fracción de eyección preservada.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to evaluate if dapagliflozin treatment is effective in patients with heart failure with preserved ejection fraction in reducing the risk of cardiovascular death and hospitalizations/urgent outpatient visits due to worsening heart failure.
    Estudio para evaluar si el tratamiento de dapagliflozina es efectivo en pacientes con insuficiencia cardíaca con fracción de eyección preservada en la reducción del riesgo de muerte y hospitalizaciones cardiovasculares/visitas urgentes ambulatorias debidas al empeoramiento de la insuficiencia cardíaca.
    A.3.2Name or abbreviated title of the trial where available
    DELIVER
    DELIVER
    A.4.1Sponsor's protocol code numberD169CC00001
    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 SponsorAstraZeneca AB
    B.1.3.4CountrySweden
    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 supportAstraZeneca AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstraZeneca Farmacéutica Spain, S.A.
    B.5.2Functional name of contact pointUnidad de Investigación Clínica
    B.5.3 Address:
    B.5.3.1Street AddressC/ Serrano Galvache, 56; Parque Norte, Edificio Álamo
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28033
    B.5.3.4CountrySpain
    B.5.4Telephone number0034900200444
    B.5.6E-mailinformation.center@astrazeneca.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 Forxiga
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca AB
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameDapagliflozin
    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 INNDAPAGLIFLOZIN PROPANEDIOL
    D.3.9.1CAS number 960404-48-2
    D.3.9.3Other descriptive nameDAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Heart Failure with Preserved Ejection Fraction (HFpEF)
    Insuficiencia cardiaca con fracción de eyección preservada (ICFE-P)
    E.1.1.1Medical condition in easily understood language
    Heart Failure with preserved pump function to eject blood flow
    Insuficiencia cardíaca con función de bombeo preservada para eyectar el flujo sanguíneo.
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine whether dapagliflozin is superior to placebo, when added to standard of care, in reducing the composite of CV death and HF events (hospitalisation for HF or urgent HF visit) in patients with HF and preserved systolic function.
    Determinar si la dapagliflozina es superior al placebo, cuando se añade al tratamiento habitual, en la reducción de la combinación de muerte de origen CV y episodios de IC (hospitalización por IC o visita urgente por IC) en pacientes con IC y función sistólica conservada.
    E.2.2Secondary objectives of the trial
    To determine whether dapagliflozin is superior to placebo in reducing the total number of recurrent HF hospitalisations and CV death.

    To determine whether dapagliflozin is superior to placebo in improving Patient Reported Outcomes measured by KCCQ.

    To determine whether dapagliflozin is superior to placebo in reducing the proportion of patients with worsened NYHA class.

    To determine whether dapagliflozin is superior to placebo in reducing all-cause mortality.
    Determinar si la dapagliflozina es superior al placebo en la reducción del número total de hospitalizaciones recurrentes por IC y muerte de origen CV.

    Determinar si la dapagliflozina es superior al placebo en la mejora de los resultados comunicados por los pacientes medidos mediante el cuestionario KCCQ.

    Determinar si la dapagliflozina es superior al placebo en la reducción de la proporción de pacientes con empeoramiento de la clase de la NYHA.

    Determinar si la dapagliflozina es superior al placebo en la reducción de la mortalidad global
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Provision of signed informed consent prior to any study specific procedures.

    2. Male or female patients age ≥40 years.

    3. Documented diagnosis of symptomatic heart failure (NYHA class II-IV) at enrolment, and a medical history of typical symptoms/signs of heart failure ≥6 weeks before enrolment with at least intermittent need for diuretic treatment.

    4. Left Ventricular Ejection Fraction (LVEF) >40% and evidence of structural heart disease (i.e. left ventricular hypertrophy or left atrial enlargement ) documented by the most recent echocardiogram, and/or cardiac MR within the last 12 months prior to enrolment. For patients with prior acute cardiac events or procedures that may reduce LVEF, e.g. as defined in exclusion criterion 6, qualifying cardiac imaging assessment at least 12 weeks following the procedure/event is required.

    5. NT-pro BNP ≥300 pg/ml at Visit 1 for patients without ongoing atrial fibrillation/flutter. If ongoing atrial fibrillation/flutter at Visit 1, NT-pro BNP must be ≥600 pg/mL.

    6. Patients may be ambulatory, or hospitalized; patients must be off intravenous heart failure therapy (including diuretics) for at least 12 hours prior to enrolment and 24 hours prior to randomisation.
    1. Disponer del consentimiento informado firmado antes de cualquier procedimiento específico del estudio.
    2. Pacientes hombres o mujeres de edad ≥40 años.
    3. Diagnóstico documentado de la insuficiencia cardíaca sintomática (clase II-IV de la escala NYHA) en el reclutamiento y una historia médica de los síntomas/signos típicos de la insuficiencia cardíaca ≥6 semanas antes del reclutamiento con al menos necesidad intermitente de tratamiento diurético.
    4. Fracción de eyección ventricular izquierda >40% y evidencia de enfermedad cardiaca estructural (es decir, hipertrofia ventricular izquierda o agrandamiento auricular izquierdo) documentada por un ecocardiograma reciente, y/o una resonancia magnética cardiaca en los últimos 12 meses anteriores al reclutamiento. Para pacientes con eventos o procedimientos cardiacos agudos anteriores que pueden reducir la fracción de eyección ventricular izquierda, p.ej. según se define en el criterio 6 de exclusión, se requiere una evaluación cualificada de la imagen cardiaca al menos 12 semanas después del procedimiento/evento.
    5. Pro-péptido natriurético tipo B ≥300 pg/ml en la Visita 1 para pacientes sin aleteo/fibrilación auricular en curso. Si el aleteo/fibrilación auricular está en curso en la Visita 1, el Pro-péptido natriurético tipo B de be ser ≥600 pg/ml.
    6. Los pacientes pueden ser ambulatorios u hospitalizados; los pacientes deben estar fuera de la terapia para la insuficiencia cardiaca intravenosa (incluyendo diuréticos) durante al menos 12 horas antes del reclutamiento y 24 horas antes de la aleatorización.
    E.4Principal exclusion criteria
    1. Receiving therapy with an SGLT2 inhibitor within 4 weeks prior to randomisation or previous intolerance to an SGLT2 inhibitor

    2. Type 1 diabetes mellitus (T1D)

    3. eGFR <25 mL/min/1.73 m2 (CKD-EPI formula) at Visit 1

    4. Systolic blood pressure (BP) <95 mmHg on 2 consecutive measurements at 5-minute intervals, at Visit 1 or at Visit 2

    5. Systolic BP≥160 mmHg if not on treatment with ≥3 blood pressure lowering medications or ≥180 mmHg irrespective of treatments, on 2 consecutive measurements at 5-minute intervals, at Visit 1 or at Visit 2.

    6. MI, unstable angina, coronary revascularization (percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG)), ablation of atrial flutter/fibrillation, valve repair/replacement within 12 weeks prior to enrolment. Before enrolment, these patients must have their qualifying echocardiography and/or cardiac MRI examination at least 12 weeks after the event.

    7. Planned coronary revascularization, ablation of atrial flutter/fibrillation and valve repair/replacement.

    8. Stroke or transient ischemic attack (TIA) within 12 weeks prior to enrolment

    9. Probable alternative or concomitant diagnoses which in the opinion of the investigator could account for the patient's HF symptoms and signs (e.g. anaemia, hypothyroidism)

    10. Body mass index >50 kg/m2

    11. Primary pulmonary hypertension, chronic pulmonary embolism, severe pulmonary disease including COPD (i.e., requiring home oxygen, chronic nebulizer therapy or chronic oral steroid therapy, or hospitalisation for exacerbation of COPD requiring ventilatory assist within 12 months prior to enrolment)

    12. Previous cardiac transplantation, or complex congenital heart disease. Planned cardiac resynchronisation therapy.

    13. HF due to any of the following: known infiltrative cardiomyopathy (e.g. amyloid, sarcoid, lymphoma, endomyocardial fibrosis), active myocarditis, constrictive pericarditis, cardiac tamponade, known genetic hypertrophic cardiomyopathy or obstructive hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy/dysplasia (ARVC/D), or uncorrected primary valvular disease

    14. A life expectancy of less than 2 years due to any non-cardiovascular condition, based on investigator's clinical judgement.

    15. Inability of the patient, in the opinion of the investigator, to understand and/or comply with study medications, procedures and/or follow-up OR any conditions that, in the opinion of the investigator, may render the patient unable to complete the study

    16. Active malignancy requiring treatment (with the exception of basal cell or squamous cell carcinomas of the skin).

    17. Acute or chronic liver disease with severe impairment of liver function (e.g., ascites, oesophageal varices, coagulopathy)

    18. Women of child-bearing potential (i.e. those who are not chemically or surgically sterilised or post-menopausal) not willing to use a medically accepted method of contraception considered reliable in the judgment of the investigator OR who have a positive pregnancy test at randomisation OR who are breast-feeding

    19. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca personnel and/or personnel at the study site)

    20. Previous randomisation in the present study

    21. Participation in another clinical study with an IP or device during the last month prior to enrolment
    1. Recibir terapia con un Inhibidor SGLT2 durante 4 semanas antes a la aleatorización o intolerancia previa a un inhibidor SGTL2.
    2. Diabetes Mellitus tipo 1 (DM1).
    3. eGFR <25 mL/min/1.73 m2 (fórmula CKD-EPI) en la visita 1.
    4. Presión sanguínea sistólica (PS) <95 mmHg en 2 mediciones consecutivas en intervalos de 5 minutos, en la vista 1 o en la visita 2.
    5. Presión sanguínea sistólica PS≥160 mmHg si no está en tratamiento con ≥3 medicamentos para bajar la presión sanguínea o ≥180 mmHg independientemente de los tratamientos, en 2 mediciones consecutivas en intervalos de 5 minutos, en la visita 1 o en la visita 2.
    6. Infarto de miocardio, angina inestable, revascularización coronaria (intervención coronaria percutánea (ICP) o injerto de bypass arterial coronario (CABG), ablación del aleteo/fibrilación auricular, reparación/reemplazo de la válvula durante las 12 semanas anteriores al reclutamiento. Antes del reclutamiento, estos pacientes deben tener su calificación ecocardiográfica y /o examen imagen cardíaca por resonancia magnética (IRM) al menos 12 semanas después del evento.
    7. Revascularización coronaria planificada, ablación de del aleteo/fibrilación auricular y reparación/reemplazo de la válvula.
    8. Ictus o ataque isquémico transitorio (AIT) durante las 12 semanas anteriores al reclutamiento.
    9. Diagnóstico probable alternativo o concomitante que a opinión del investigador podría explicar los síntomas y signos de la insuficiencia cardíaca del paciente (ej. anemia, hipotiroidismo).
    10. Índice de masa corporal >50 kg/m2.
    11. Hipertensión pulmonar primaria, embolismo pulmonar crónico, enfermedad pulmonar grave incluyendo EPOC (es decir, requerimiento de oxígeno, terapia crónica con nebulizador o terapia crónica con esteroides orales, u hospitalización por exacerbación de EPOC necesitando asistencia de ventilación durante los 12 meses anteriores al reclutamiento).
    12. Trasplante cardíaco previo, o cardiopatía congénita compleja. Terapia de resincronización cardíaca programada.
    13. Insuficiencia cardíaca debida a cualquiera de los siguientes: cardiomiopatía infiltrativa conocida (ej.: amiloide, sarcoidosis, linfoma, fibrosis endomiocárdica), miocarditis activa, pericarditis constrictiva, taponamiento cardíaco, cardiomiopatía hipertónica genética conocida o cardiomiopatía hipertónica obstructiva, cardiomiopatía ventricular derecha arritmogénica/dispalsia (MAVD/D), o enfermedad de la válvula primaria no corregida.
    14. Una esperanza de vida de menos de 2 años debido a cualquier condición no cardiovascular, basada en el juicio del investigador clínico.
    15. Incapacidad del paciente, a opinión del investigador, para entender y/o cumplir con las medicaciones del estudio, procedimientos y/o seguimiento o cualquier condición que, a opinión del investigador, pueda hacer que el paciente no pueda completar el estudio.
    16. Malignidad activa que requiere tratamiento (con excepción de las células basales o de carcinomas de células escamosas de la piel).
    17. Enfermedad hepática aguda o crónica con alteración grave de la función hepática (ej. Ascitis, varices esofágicas, coagulopatía).
    18. Mujeres en edad fértil (ej. Aquellas no esterilizadas quirúrgica o clínicamente o post-menopáusicas) que no estén dispuestas a utilizar un método de contracepción médicamente aceptado considerado fiable a juicio del investigador clínico o que tengan una test positivo de embarazo en la aleatorización o que estén en período de lactancia.
    19. Participación en la planificación y/o gestión del estudio (afecta a personal de AstraZeneca y/o personal del centro del estudio).
    20. Aleatorización previa en el presente estudio.
    21. Participación en otro ensayo clínico con un IP o dispositivo durante el último mes previo al reclutamiento.
    E.5 End points
    E.5.1Primary end point(s)
    Time to the first occurrence of any of the components of this composite:
    1. CV death
    2. Hospitalisation for HF
    3. Urgent HF visit (e.g., emergency department or outpatient visit)
    Tiempo transcurrido hasta el primer episodio de cualquiera de los componentes de esta variable compuesta:
    1. Muerte de origen CV
    2. Hospitalización por IC
    3. Visita urgente por IC (p. ej., visita ambulatoria o al Servicio de Urgencias)
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary endpoint will be evaluated up to approximately 33 months
    El endpoint primario será evaluado hasta 33 meses aproximadamente
    E.5.2Secondary end point(s)
    Total number of (first and recurrent) hospitalisations for HF and CV death.

    Change from baseline in the total symptom score (TSS) of the KCCQ at 8 months.

    Proportion of patients with worsened NYHA class from baseline to 8 months.

    Time to the occurrence of death from any cause.
    Número total de hospitalizaciones (primera y recurrentes) por IC y muerte de origen CV.

    Variación de la puntuación total de síntomas (TSS) del KCCQ desde el momento basal hasta los 8 meses.

    Proporción de pacientes con empeoramiento de la clase de la NYHA desde el momento basal hasta los 8 meses.

    Tiempo hasta la aparición de la muerte por cualquier causa.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Total number of hospitalizations for HF and CV Death, and time to death from any cause are predicted to be evaluated up to 33 months from randomization (the study is event driven).

    The KCCQ and the NYHA class endpoints will be evaulated at 8 months after randomization.
    Número total de hospitalizaciones por Insuficiencia cardíaca y muerte de origen cardiovascular, y tiempo hasta la muerte por cualquier causa predecible para ser evaluada hasta 33 meses desde la aleatorización (el estudio está conducido por el evento).

    Se evaluarán los endpoints KCCQ y la clase NYHA hasta los 8 meses tras la aleatorización.
    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 Yes
    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 Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned11
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA133
    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
    Belgium
    Brazil
    Bulgaria
    Canada
    China
    Czech Republic
    France
    Hungary
    Japan
    Mexico
    Netherlands
    Peru
    Poland
    Romania
    Russian Federation
    Saudi Arabia
    Spain
    Taiwan
    United States
    Vietnam
    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
    última visita del último paciente
    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 months9
    E.8.9.1In the Member State concerned days26
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial days26
    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: 2350
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2350
    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 state250
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1750
    F.4.2.2In the whole clinical trial 4700
    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 Decision2018-09-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-09-06
    P. End of Trial
    P.End of Trial StatusOngoing
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