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    Summary
    EudraCT Number:2016-002280-34
    Sponsor's Protocol Code Number:1245.121
    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:2018-02-16
    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 number2016-002280-34
    A.3Full title of the trial
    A phase III randomised, double-blind trial to evaluate efficacy and safety of once daily empagliflozin 10 mg compared to placebo, in patients with chronic Heart Failure with reduced Ejection Fraction (HFrEF).
    Ensayo en fase III, aleatorizado y doble ciego para evaluar la eficacia y la seguridad de una dosis diaria de 10 mg de empagliflozina en comparación con el placebo en pacientes con insuficiencia cardíaca crónica con fracción de eyección reducida (ICC-FER).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    EMPagliflozin outcomE tRial in patients with chrOnic heaRt failure EMPEROR-Reduced
    Ensayo sobre los resultados de la empagliflozina en pacientes con insuficiencia cardíaca crónica EMPEROR-PrReducida
    A.4.1Sponsor's protocol code number1245.121
    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 SponsorBoehringer Ingelheim International GmbH
    B.1.3.4CountryGermany
    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 supportBoehringer Ingelheim International GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBoehringer Ingelheim Pharma GmbH & Co. KG
    B.5.2Functional name of contact pointCT Disclosure & Data Transparency
    B.5.3 Address:
    B.5.3.1Street AddressBinger Strasse 173
    B.5.3.2Town/ cityIngelheim am Rhein
    B.5.3.3Post code55216
    B.5.3.4CountryGermany
    B.5.4Telephone number+1800243 0127
    B.5.5Fax number+1800821 7119
    B.5.6E-mailclintriage.rdg@boehringer-ingelheim.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 Jardiance
    D.2.1.1.2Name of the Marketing Authorisation holderBoehringer Ingelheim International GmbH
    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.3.4Pharmaceutical 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 INNEMPAGLIFLOZIN
    D.3.9.1CAS number 864070-44-0
    D.3.9.4EV Substance CodeSUB35915
    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 (HF) with reduced ejection fraction (EF).
    Insuficiencia cardíaca (IC) con fracción de eyección (FE) reducida.
    E.1.1.1Medical condition in easily understood language
    chronic (long-term) heart failure (HF)
    insuficiencia cardíaca (IC) crónica (a largo plazo)
    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 10008908
    E.1.2Term Chronic heart failure
    E.1.2System Organ Class 100000004849
    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 superiority of empagliflozin 10 mg versus placebo on top of guideline-directed medical therapy in patients with symptomatic, chronic HF and reduced ejection fraction (LVEF ≤ 40%).
    demostrar la superioridad de 10 mg de empagliflozina frente al placebo además del tratamiento médico indicado
    por las directrices en pacientes con IC crónica sintomática y fracción de eyección (FEVI ≤40 %).
    E.2.2Secondary objectives of the trial
    Not applicable
    No aplica
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Drug concentration measurements and Pharmacokinetics (PK) substudy:
    PK sampling will be done from a limited number of randomised patients (approx 1140) and at sites in pre-selected countries. Pre-dose blood samples will be collected at Visit 4 and between 22 to 26 h after the most recent drug intake, to determine plasma empagliflozin trough concentrations. These samples will serve to determine steady state trough concentrations of empagliflozin.
    Optional Biobanking sub-study requiring samples to be collected at Visit 2, 4 and 8 (plasma, serum, urine) and Visit 2 (DNA).
    Medición de la concentración del fármaco y sub-estudio farmacocinético (FC):
    Muestras de FC se tomarán a un número limitado de pacientes aleatorizados (aprox 1140) solo en centros en paises pre-seleccionados. Muestras sanguíneas pre-dosis serán tomadas en la visita 4 y entre las 22 y 26 horas posteriores a la
    toma más reciente de medicación, para determinar la concentración plasmática mínima de empagliflozina. Estas muestras servirán para determinar la concentración mínima en estado estable de empagliflozina.
    El sub-estudio opcional de biobanco requiere la toma de muestras en visita 2, 4 y 8 (plasma, suero, orina) y visita 2 (ADN).
    E.3Principal inclusion criteria
    - Patients with chronic HF diagnosed for at least 3 months before Visit 1 and currently in New York Heart Association (NYHA) HF class II-IV
    - Chronic HF with reduced EF defined as LVEF ≤ 40% per local reading (obtained under stable condition by echocardiography, radionuclide ventriculography, invasive angiography, MRI or CT). A historical LVEF may be used if it was measured within 6 months prior to visit 1 or the LVEF may be measured after study consent has been obtained. The LVEF must be documented in an official report prior to randomization.
    - In addition to LVEF ≤ 40%, patients must have at least one of the following evidence of HF:
    a) If EF ≥36% to ≤40%: Elevated NT-proBNP at Visit 1 ≥2500 pg/ml for patients without AF, OR ≥5000 pg/ml for patients with AF, analysed at the Central Laboratory,
    b) If EF ≥31% to ≤35%: Elevated NT-proBNP at Visit 1 ≥1000 pg/ml for patients without AF, OR ≥2000 pg/ml for patients with AF, analysed at the Central Laboratory,
    c) If EF≤30%: Elevated NT-proBNP at Visit 1 ≥600 pg/ml for patients without AF, OR ≥1200 pg/ml for patients with AF, analysed at the Central Laboratory
    d) For EF ≤ 40% and documented HHFc within 12 months prior to visit 1, elevated NT-proBNP at Visit 1 ≥ 600 pg/ml for patients without AF and ≥ 1200 pg/ml for patients with AF, analysed at the Central Laboratory.
    - Appropriate dose of medical therapy for HF (such as ACEi, ARB, β-blocker, oral diuretics, MRA, ARNI, ivabradine) consistent with prevailing local and international CV guidelines, stable for at least 1 week prior to Visit 1 and during screening period until Visit 2 with exception of diuretics stable for only one week prior to Visit 2 to control symptoms.

    - Appropriate use of medical devices such as cardioverter defibrillator (ICD) or a cardiac resynchronization therapy (CRT) consistent with prevailing local or international CV guidelines
    8. Body Mass Index < 45 kg/m2 at Visit 1.
    - Pacientes con IC crónica diagnosticada al menos 3 meses antes de la visita 1 y actualmente con IC de clase II-IV de la Asociación Cardiológica de Nueva York (New York Heart Association, NYHA).
    - IC crónica con FE reducida definida como FEVI ≤40 % por lectura local (obtenida en situación estable por ecocardiografía, ventriculografía con radionúclidos, angiografía invasiva, RM o TAC). Se pueden utilizar FEVI
    anteriores si se han medido en los 6 meses anteriores a la visita 1 o también puede medirse la FEVI tras obtener el consentimiento del estudio. Antes de la aleatorización, se dejará constancia de la FEVI en un informe oficial.
    - Además de la FEVI ≤40 %, los pacientes deben tener al menos uno de los
    siguientes signos de IC:
    *Si la FE es ≥36 y ≤40: extremo N del propéptido natriurético cerebral (NTproBNP) elevado en la visita 1 ≥2500 pg/ml en pacientes sin FA, O ≥5000 pg/ml en pacientes con FA, analizado en el laboratorio central.
    *Si la FE es ≥31 y ≤35: NT-proBNP elevado en la visita 1 ≥1000 pg/ml en pacientes sin FA, O ≥2000 pg/ml en pacientes con FA, analizado en el laboratorio central.

    *Si la FE es ≤30 %: NT-proBNP elevado en la visita 1 ≥600 pg/ml en pacientes sin FA, O ≥1200 pg/ml en pacientes con FA, analizado en el laboratorio central.
    *FE ≤40 % e HIC documentada en los 12 meses anteriores a la visita 1, y NT-proBNP elevado en la visita 1 con un valor ≥600 pg/ml en pacientes sin FA y ≥1200 pg/ml en pacientes con FA, analizado en el laboratorio central.
    -Dosis adecuada del tratamiento médico para la IC (IECA, BRA, betabloqueantes, diuréticos orales, AMC, INRA, ivabradina, etc.) y tratamiento con los productos adecuados conforme a las directrices CV actuales, estable al
    menos durante la semana anterior a la visita 1 (selección) y durante la fase de selección hasta la visita 2 (aleatorización), excepto los diuréticos, cuya dosis solo debe ser estable durante la semana anterior a la visita 2 para controlar los síntomas.
    U-so adecuado de productos sanitarios tales como un cardioversor-desfibrilador implantable (CDI) o tratamiento de resincronización cardíaca (TRC), conforme a las directrices CV actuales locales o internacionales (véase el criterio de
    exclusión n.º 29).
    -TFGe ≥20 ml/min/1,73 m2 en la visita 1.
    E.4Principal exclusion criteria
    1. Myocardial infarction (increase in cardiac enzymes in combination with symptoms of ischaemia or newly developed ischaemic ECG changes), coronary artery bypass graft surgery, or other major cardiovascular surgery, stroke or TIA in past 90 days prior to Visit 1
    2. Heart transplant recipient, or listed for heart transplant
    3. Currently implanted left ventricular assist device (LVAD)
    4. Cardiomyopathy based on infiltrative diseases (e.g. amyloidosis), accumulation diseases (e.g. haemochromatosis, Fabry disease), muscular dystrophies, cardiomyopathy with reversible causes (e.g. stress cardiomyopathy), hypertrophic obstructive cardiomyopathy or known pericardial constriction
    5. Any severe (obstructive or regurgitant) valvular heart disease, expected to lead to surgery during the trial in the investigator’s opinion
    6. Acute decompensated HF (exacerbation of chronic HF) requiring i.v. diuretics, i.v. inotropes, or i.v. vasodilators, or LVAD within 1 week from discharge to Visit 1 (Screening) and during screening period until Visit 2 (Randomisation).
    7. Atrial fibrillation or atrial flutter with a resting heart rate >110 bpm documented by ECG at Visit 2 (Randomisation)
    8. Untreated ventricular arrhythmia with syncope in patients without ICD documented within the 3 months prior to Visit 1
    9. Diagnosis of cardiomyopathy induced by chemotherapy or peripartum within the 12 months prior to Visit 1
    10. Symptomatic bradycardia or second or third degree heart block without a pacemaker after adjusting beta-blocker therapy, if appropriate
    1. Infarto de miocardio (aumento en las enzimas cardíacas en combinación con síntomas de isquemia o cambios recientemente desarrollados en el ECG isquémico), cirugía de revascularización coronaria u otra cirugía cardiovascular importante, accidente cerebrovascular o AIT en los 90 días anteriores a la visita 1.
    2. Receptor de trasplante de corazón o en espera para trasplante de corazón.
    3. Implantación de desfibrilador cardioversor implantable (DCI)
    4. Miocardiopatía según enfermedades infiltrantes (p. ej., amiloidosis), enfermedades de acumulación(p.ej hemocromatosis, Enfermedad de Fabry), distrofias musculares, cardiomiopatía con causas reversibles(p.ej cardiomiopatía por estres), cardiomiopatía obstructiva hipertrófica o constricción pericárdica conocida.
    5. Cualquier cardiopatía valvular grave (obstructiva o regurgitante) que el investigador considere que puede necesitar cirugía durante el ensayo.
    6. IC aguda descompensada (exacerbación de IC crónica) que requiera diuréticos intravenosos (i.v.), inotrópicos i.v. o
    vasodilatadores i.v., o un dispositivo de asistencia ventricular izquierda, en el intervalo de una semana desde el alta hasta la visita 1 y durante el período de selección hasta la visita 2 (aleatorización).
    7.Fibrilación auricular o aleteo auricular con una frecuencia cardíaca en reposo > 110 pulsaciones por minuto documentada por ECG en la Vista 2 (aleatorización).
    8. Arritmia ventricular no tratada con síncope en pacientes sin CDI documentada dentro de los 3 meses previos a la Visita 1
    9. Diagnóstico de miocardiopatía inducida por quimioterapia o periparto dentro de los 12 meses previos a la visita 1
    10. Bradicardia sintomática o bloqueo cardíaco de segundo o tercer grado sin marcapasos después de ajustar el tratamiento con bloqueadores beta, si corresponde
    E.5 End points
    E.5.1Primary end point(s)
    Time to first event of adjudicated CV death or adjudicated HHF in patients with Heart Failure with reduced Ejection Fraction (HFrEF).
    tiempo transcurrido hasta el primer acontecimiento de muerte CV adjudicada o HIC adjudicada en pacientes
    con ICC-FER.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Report time to event
    Al reporte del evento
    E.5.2Secondary end point(s)
    1. Occurrence of adjudicated HHF (first and recurrent),
    2. eGFR (CKD-EPI)cr slope of change from baseline

    Other secondary endpoints:
    - Time to first occurrence of chronic dialysis or renal transplant or sustained reduction of ≥40% eGFR (CKD-EPI) or
    a) sustained eGFR (CKD-EPI)cr <15 mL/min/1.73 m2 for patients with baseline eGFR ≥30 mL/min/1.73 m2
    b) sustained eGFR (CKD-EPI)cr <10 mL/min/1.73 m2 for patients with baseline eGFR <30 mL/min/1.73 m2
    Chronic dialysis is regarded as chronic if the frequency of dialysis is twice or more per week for at least 90 days.
    - Time to first adjudicated HHF
    - Time to adjudicated CV death
    - Time to all-cause mortality
    - Time to onset of DM (defined as HbA1c ≥6.5% or as diagnosed by the Investigator) in patients with pre- DM defined as no history of DM and no HbA1c ≥6.5 before treatment, and a pre-treatment HbA1c value of ≥ 5.7 and <6.5
    - Change from baseline in clinical summary score (HF symptoms and physical limitations domains) of the Kansas City Cardiomyopathy Questionnaire (KCCQ) at week 52
    - Occurrence of all-cause hospitalisation (first and recurrent)
    1. Incidencia de HIC adjudicada (primera y repetida).
    2. Cambio en la pendiente de la TFGe (colaboración epidemiológica de la insuficiencia renal crónica [Chronic Kidney Disease Epidemiology Collaboration, CKD-EPI])cr con respecto al inicio.

    Otros criterios de valoración secundarios son:
    -Tiempo hasta la primera aparición de diálisis crónica o trasplante renal o reducción
    sostenida de ≥40 % de TFGe (CKD-EPI)cr o
    a)TFGe (CKD-EPI)cr sostenida <15 ml/min/1,73 m2 en pacientes con TFGe
    inicial ≥30 ml/min/1,73 m2
    b)TFGe (CKD-EPI)cr sostenida <10 ml/min/1,73 m2 en pacientes con TFGe
    inicial <30 ml/min/1,73 m2.
    La diálisis crónica se considera crónica si la frecuencia de diálisis es dos veces o más por semana durante al menos 90 días.
    -Tiempo hasta la primera HIC adjudicada.
    -Tiempo hasta la muerte CV adjudicada
    -Tiempo hasta la mortalidad por cualquier causa
    -Tiempo hasta el inicio de la diabetes mellitus (DM) en pacientes con DM previa
    -Tiempo hasta la aparición de DM (definida como HbA1c ≥6.5% o diagnosticada por el Investigador) en pacientes con pre-DM definida como sin antecedentes de DM y sin HbA1c ≥6.5 antes del tratamiento, y un valor de HbA1c previo al tratamiento ≥ 5.7 y <6.5
    -Cambio desde el inicio en la puntuación clínica de resumen (dominios de síntomas de IC y de limitaciones físicas) del Cuestionario sobre la Miocardiopatía de Kansas City (Kansas City Cardiomyopathy Questionnaire, KCCQ) en la semana 52.
    -Incidencia de la hospitalización por cualquier causa (primera y repetida).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Report time to event
    Al reporte del evento
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    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 concerned12
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA152
    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
    Australia
    Brazil
    Canada
    China
    European Union
    India
    Japan
    Korea, Republic of
    Mexico
    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 years4
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months8
    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: 1425
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1425
    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 state31
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1114
    F.4.2.2In the whole clinical trial 2850
    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)
    The patient will continue treatment according to standard of care and prevailing guidelines.
    El paciente serguirá siendo tratado de acuerdo a la práctica clínica habitual y las guías actuales.
    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 Decision2018-04-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-04-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-05-28
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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