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    Summary
    EudraCT Number:2015-005438-24
    Sponsor's Protocol Code Number:1346.23
    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:2016-07-15
    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 number2015-005438-24
    A.3Full title of the trial
    A multi-centre, double-blind, parallel-group, randomised controlled study to investigate efficacy and safety of orally administered BI 425809 during a 12-week treatment period compared to placebo in patients with cognitive impairment due to Alzheimer's Disease.
    Estudio multicéntrico, doble ciego, aleatorizado y controlado de grupos paralelos para investigar la eficacia y seguridad de BI 425809, administrado oralmente durante un periodo de tratamiento de 12 semanas, comparado con placebo en pacientes con deterioro cognitivo debido a enfermedad de Alzheimer.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    BI 425809 in patients with cognitive impairment due to Alzheimer's Disease.
    BI 425809 en pacientes con deterioro cognitivo debido a enfermedad de Alzheimer.
    A.4.1Sponsor's protocol code number1346.23
    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 España, S.A.
    B.1.3.4CountrySpain
    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 España, S.A.
    B.4.2CountrySpain
    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 pointQRPE PSC CT Information Disclosure
    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+34934045100
    B.5.5Fax number+34934045580
    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 No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameBI 425809/5 mg
    D.3.2Product code BI 425809
    D.3.4Pharmaceutical form 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 INNnot available
    D.3.9.2Current sponsor codeBI 425809
    D.3.9.3Other descriptive nameBI 425809
    D.3.9.4EV Substance CodeSUB130377
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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.3.1Product nameBI 425809/25 mg
    D.3.2Product code BI 425809
    D.3.4Pharmaceutical form 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 INNnot available
    D.3.9.2Current sponsor codeBI 425809
    D.3.9.3Other descriptive nameBI 425809
    D.3.9.4EV Substance CodeSUB130377
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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: 3
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameBI 425809/1 mg
    D.3.2Product code BI 425809
    D.3.4Pharmaceutical form 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 INNnot available
    D.3.9.2Current sponsor codeBI 425809
    D.3.9.3Other descriptive nameBI 425809
    D.3.9.4EV Substance CodeSUB130377
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 placeboTablet
    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 placeboTablet
    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
    Cognitive impairment due to Alzheimer's Disease
    Patients with diagnosis of mild-to moderate Alzheimer's dementia according to teh recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease.
    Deterioro cognitivo debido a enfermedad de Alzheimer
    Pacientes con diagnóstico de demencia por Alzheimer de leve a moderada, según las recomendaciones de los grupos de trabajo en guías de diagnóstico para la enfermedad de Alzheimer del National Institute on Aging-Alzheimer's Association.
    E.1.1.1Medical condition in easily understood language
    Cognitive impairment due to Alzheimer's Disease
    Deterioro cognitivo debido a enfermedad de Alzheimer
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10012271
    E.1.2Term Dementia Alzheimer's type
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10001896
    E.1.2Term Alzheimer's disease
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess safety, tolerability and efficacy of different doses of BI 425809 compared to placebo in treatment of cognitive impairment due to Alzheimer's Disease
    Evaluar la seguridad, tolerabilídad y eficacia de diferentes dosis de BI 425809 en comparación con placebo en el tratamiento del deterioro cognitivo debido a la enfermedad de Alzheimer
    E.2.2Secondary objectives of the trial
    Not applicable
    No aplica
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients with early signs of dementia of Alzheimer Type
    - Male and female patients with an age of at least 55 years
    -MMSE 15-26
    - All patients must sign and date an Informed Consent Form personally
    - Concomitant use of AChEIs is allowed but not required. Patients who are currently taking AChEIs are eligible as long as they have been using a stable dose for at least 3 months prior to screening and no change is foreseen for the duration of the study. This dose must be consistent with the product label in the concerned country. Patients who are not currently taking AChEIs but have taken them in the past are also eligible if AChEIs were stopped at least 3 months prior to screening.

    - Patients must have at least 6 years of formal education and fluency in the test language as verbally confirmed by the patient and documented by the study investigator.
    - Patients must have a reliable study partner (per investigator judgement, for instance a family member, partner etc., guardian or, if applicable, a legal representative)
    - Pacientes con síntomas tempranos de demencia de tipo Alzheimer
    - Pacientes varones o mujeres mayores de 55 años de edad
    - MMSE 15-26
    - Todos los pacientes deben firmar y fechar personalmente un formulario de consentimiento informado
    - El uso concomitante de inhibidores de acetilcolinesterasas (IACEs) está permitido pero no es un requerimiento. Los pacientes que estén tomando actualmente IACEs son idóneos siempre y cuando hayan estado utilizando una dosis estable durante por lo menos 3 meses antes de la selección y no esté previsto ningún cambio durante el estudio. Esta dosis debe ser coherente con la información del producto en el país en cuestión. Los pacientes que no estén tomando en la actualidad IACEs pero que los hayan tomado en el pasado también son idóneos si los IACEs se suspendieron al menos 3 meses antes de la selección.
    - Los pacientes deben tener un mínimo de 6 años de nivel educativo formal y fluidez en el idioma de las pruebas, lo que el paciente deberá confirmar verbalmente y documentado por el investigador del estudio.
    - Los pacientes deben tener un cuidador del estudio fiable (según el criterio del investigador, por ejemplo, un miembro de su familia, pareja, etc., un tutor o, si procede, un representante legal).
    E.4Principal exclusion criteria
    - Dementia secondary to disorders other than Alzheimer's Disease Dementia. Lewy body dementia or vascular or multi-infarct dementia as primary diagnosis is excluded.
    - Any central nervous system disease other than AD which according to the investigator may be associated with worsening of cognition. Patients with epileptic seizure in last 2 years should be excluded.
    - A disease or condition which in the opinion of the investigator are likely to interfere with trial testing procedures or put the patient at risk when participating in this trial.
    - Any documented active or suspected malignancy or history of malignancy with need of concomitant treatment that interfere with the investigational product.
    - Patients with life expectancy of less than 2 years are also excluded.
    - Any other clinical condition that, in the opinion of the investigator, would jeopardize patient safety while participating in this clinical trial.
    - Severe renal impairment defined as a GFR < 30 mL/min/1.73 m2 in the screening central lab report.
    - Haemoglobin less than 120 g/L (12g/dL) in men or 115g/L (11.5g/dL) in women in the screening lab report.
    - Clinically significant uncompensated hearing loss in the judgment of the investigator. Use of hearing aids is allowed.
    - Any suicidal behaviour in the past 2 years (i.e. actual attempt, interrupted attempt, aborted attempt, or preparatory acts or behaviour).
    - Any suicidal ideation of type 4 or 5 in the C-SSRS in the past 3 months (i.e. active suicidal thought with intent but without specific plan, or active suicidal thought with plan and intent).
    - Known history of HIV infection.
    - Significant history of drug dependence or abuse (including alcohol, as defined in Diagnostic and Statistical Manual of Mental Disorders [DSM-V] or in the opinion of the investigator) within the last two years.
    - Previous participation in investigational drug studies of dementia of Alzheimer's Type within three months prior to screening. Having received active treatment in any other study targeting disease modification of AD like Aß immunization and tau therapies. Previous participation in studies with non-prescription medications, vitamins other nutritional formulations or non-pharmacological treatments is allowed.
    - Treatment with restricted medication.
    - Planned elective surgery requiring general anaesthesia, or hospitalisation for more than 1 day (requiring an overnight stay) during the study period.
    - For females: Women who are of child bearing potential. Women not of potential are defined as: Women who are postmenopausal (12 months with no menses without an alternative medical cause) or who are permanently sterilized (e.g. hysterectomy, bilateral oophorectomy or bilateral salpingectomy). For males: Men who are able to father a child, unwilling to be abstinent or to use an adequate form of effective contraception for the duration of study participation and for at least 28 days after treatment has ended.
    - Indication of liver disease, defined by serum levels of either ALT (SGPT), AST (SGOT), or alkaline phosphatase above 3 x upper limit of normal (ULN) as determined during screening.
    - Demencia secunadaria a cualquier desorden distinto a una demencia de tipo Alzheimer. Demencia de cuerpo de Lewy o demencia vascular o por multi-infarto como diagnóstico primario están excluidas.
    - Cualquier enfermedad del sistema nervioso central distinta a la enfermedad de Alzheimer, que según el investigador pueda estar asociada com un empeoramiento de la cognición. Pacientes con convulsiones epilépticas en los últimos 2 años deben ser excluidos.
    - Enfermedad o condición que en opinión del investigador pueda interferir con los procedimientos de test del ensayo o que pueda poner al paciente en riesgo cuando participe en este ensayo.
    - Cualquier malignidad activa o sospechada documentada o historia de malignidad con necesitada de tratamiento concomitante que interfiera con el medicamento en investigación.
    - Pacientes con esperanza de vida de menos de 2 años también está excluidos.
    - Cualquier otra condicón clínica que, en opinión del investigador, pudiera comprometer la seguridad del paciente durante la participación en este ensayo clínico.
    - Disfunción renal severa definida como TFG<30 mL/min/1.73 m2 en el informe del laboratorio central para el screening.
    - Hemoglobina inferior a 120 g/L (12g/dL) en hombres o 115g/L (11.5g/dL) en mujeres en el informe del laboratorio central para el screening.
    - Pérdida de audición descompensada clínicamente significativa, según el criterio del investigador. Se permite el uso de los audífonos.
    - Cualquier comportamiento suicida en los últimos 2 años (incluye intento real, intento interrumpido, intento abortado, o actos o comportamiento preparatorios ).
    - Cualquier idea de suicidio del tipo 4 o 5 en la C-SSRS en los últimos 3 meses ( pensamiento suicida activo con intención pero sin plan específico, o pensamiento suicida activo con plan e intención).
    - Historial conocido de infección por VIH.
    - Historia significativa de depndencia o abuso de drogas (incluyendo alcohol, como se define en el manual diagnóstico y estadístico de desórdenes mentales [DSM-V] o en opinión del investigador) en los últimos dos años.
    -P articipación previa en estudios de fármacos en investigación para la demencia de tipo Alzheimer 3 meses antes de la selección. Haber recibido tratamiento activo en cualquier otro estudio cuyo objetivo fuese la modificación de la enfermedad de Alzheimer como la inmunización Aß o terapias tau. La participación previa en estudios con medicamentos de no-prescripción, vitaminas u otras fórmulas nutritivas, o tratamientos no farmacológicos está permitida.
    - Tratamiento con medicación restringida.
    - Cirugía electiva planeada que requiera anestesia general, u hospitalización de más de 1 dia (que requiera estancia por la noche) durante el periodo del estudio.
    - Para mujeres: Mujeres que pueden quedarse embarazadas. Las mujeres sin potencial de quedarse embarazadas se definen como: mujeres post-menopáusicas (12 meses sin menstruación sin otra causa médica alternativa) o que están esterilizadas permanentemente (histerectomia, ooforectomia bilateral o salpinguectomía bilateral). Para hombres: hombres que son capaces de concebir un hijo, reticentes a la abstinencia o al uso de una foma adecuada de anticoncepción efectiva para la duración de la participación en el estudio y al menos 28 dias después del final del tratamiento.
    - Indicación de enfermedad hepática, definida por los niveles en suero de ALT (SGPT), AST (SGOT), fosfatasa alcalina por encima de 3 veces el límite superior normal (ULN) determinadas durente el screening.
    E.5 End points
    E.5.1Primary end point(s)
    1: The change from baseline in ADAS-Cog11 (Alzheimer's Disease Assessment Scale - cognitive subscale 11 item) total score after 12 weeks of treatment
    1: Cambio respecto al periodo basal en la puntuación total de la subescala cognitiva de la Escala de evaluación de la enfermedad de Alzheimer (Alzheimer's Disease Assessment Scale-cognitive subscale, ADAS-cog11) después de 12 semanas de tratamiento
    E.5.1.1Timepoint(s) of evaluation of this end point
    1: 12 weeks
    1: 12 semanas
    E.5.2Secondary end point(s)
    1: Change from baseline in the ADCS-ADL (Alzheimer's Disease Cooperative Study/Activities of Daily Living) score after 12 weeks of treatment
    2: CIBIC+ (Clinician's Interview-Based Impression of Change) score after 12 weeks of treatment
    1: Cambio respecto al periodo basal en la puntuación total de la escala CDR-SB (suma de casillas de la Escala de valoración clínica de la demencia) después de 12 semanas de tratamiento
    2: Puntuación de la impressión de cambio del clínico basada en la entrevista
    E.5.2.1Timepoint(s) of evaluation of this end point
    1: 12 weeks

    2: 12 weeks
    1: 12 semanas

    2: 12 semanas
    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 Yes
    E.6.10Pharmacogenetic No
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 Yes
    E.8.1.7.1Other trial design description
    Doble enmascaramiento
    Double Dummy
    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 trial5
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA60
    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
    Austria
    Canada
    Finland
    France
    Germany
    Greece
    Hungary
    Italy
    Japan
    Norway
    Spain
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee No
    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 days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months7
    E.8.9.2In all countries concerned by the trial days15
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    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: 293
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 292
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 672
    F.4.2.2In the whole clinical trial 950
    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)
    After termination of the study teh patient should be switched to teh standard treatment according to local practices.
    Desoués de finalizar el estudio, el paciente debe ser cambiado al tratamiento estándar según las prácticas locales.
    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 Decision2018-04-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-02-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-10-11
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