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    Summary
    EudraCT Number:2016-003435-38
    Sponsor's Protocol Code Number:ACP-103-035
    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:2017-05-29
    Trial 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 number2016-003435-38
    A.3Full title of the trial
    A 52-Week, Open-Label, Extension Study of Pimavanserin for the Adjunctive Treatment of Schizophrenia
    Estudio abierto de extensión de 52 semanas de pimavanserina para el tratamiento complementario de la esquizofrenia
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A 52-Week Extension Study of Pimavanserin for the Treatment of Schizophrenia
    Un estudio de extensión de 52 semanas sobre el tratamienot de la esquizofrenia con pimavanserina
    A.4.1Sponsor's protocol code numberACP-103-035
    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 SponsorACADIA Pharmaceuticals Inc.
    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 supportACADIA Pharmaceuticals Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationACADIA Pharmaceuticals Inc.
    B.5.2Functional name of contact pointMichael Monahan
    B.5.3 Address:
    B.5.3.1Street Address3611 Valley Centre Drive, Suite 300
    B.5.3.2Town/ citySan Diego
    B.5.3.3Post codeCA 92130
    B.5.3.4CountryUnited States
    B.5.4Telephone number+34916307447
    B.5.6E-mailmmonahan@acadia-pharm.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 namePimavanserin
    D.3.2Product code ACP-103
    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 INNPimavanserina
    D.3.9.1CAS number 706782-28-7
    D.3.9.2Current sponsor codeACP-103
    D.3.9.3Other descriptive namePIMAVANSERINA TARTRATO
    D.3.9.4EV Substance CodeSUB128275
    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.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 namePimavanserin
    D.3.2Product code ACP-103
    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 INNPimavanserina
    D.3.9.1CAS number 706782-28-7
    D.3.9.2Current sponsor codeACP-103
    D.3.9.3Other descriptive namePIMAVANSERINA TARTRATO
    D.3.9.4EV Substance CodeSUB128275
    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.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 namePimavanserin
    D.3.2Product code ACP-103
    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 INNPimavanserina
    D.3.9.1CAS number 706782-28-7
    D.3.9.2Current sponsor codeACP-103
    D.3.9.3Other descriptive namePIMAVANSERINA TARTRATO
    D.3.9.4EV Substance CodeSUB128275
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number17
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Schizophrenia
    esquizofrenia
    E.1.1.1Medical condition in easily understood language
    Chronic, debilitating mental illness characterized by disturbances in
    thinking, emotional reaction, and behavior
    Enfermedad mental crónica debilitante caracterizada por alteraciones en el pensamiento, la reacción emocional y el comportamiento
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10039626
    E.1.2Term Schizophrenia
    E.1.2System Organ Class 10037175 - Psychiatric 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 evaluate the long-term safety and tolerability of pimavanserin after 52 weeks of adjunctive treatment in subjects with schizophrenia
    Evaluar la seguridad y la tolerabilidad a largo plazo de la pimavanserina después de 52 semanas de tratamiento complementario en pacientes con esquizofrenia
    E.2.2Secondary objectives of the trial
    Clinical global assessment of overall severity of symptoms
    Evaluación clínica global de la intensidad global de los síntomas
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Procedures:
    1.Able to understand and provide signed informed consent, and must be able to sign and date a request for medical records and/or subject privacy form, if applicable, according to local regulations
    2.Has a caregiver or some other identified responsible person (e.g., family member, social worker, caseworker, or nurse) considered reliable by the Investigator in providing support to the subject to help ensure compliance with study treatment, study visits, and protocol procedures and who is also able to provide input helpful for completing study rating scales
    3.Is completing the Week 6 visit in Study ACP-103-034 or -039 or the Week 26 visit in Study ACP-103-038 while continuing to take his/her assigned dose of blinded study drug and may, in the Investigator’s opinion, benefit from continued adjunctive treatment with pimavanserin to an antipsychotic
    Medical Status:
    4.If female, must be of non-childbearing potential (defined as either surgically sterilized or at least 1 year postmenopausal) or must agree to use two clinically acceptable methods of contraception (e.g., oral, intrauterine device [IUD], diaphragm plus spermicide, injectable, transdermal, or implantable contraception)
    •All female subjects must have a negative urine human chorionic gonadotropin (hCG) pregnancy test at Baseline and at Weeks 2, 6, 12, 20, 28, 36, 44, and 52
    5.Continue to be medically stable at enrollment, in the opinion of the Investigator
    Medications:
    6.Continues to take a stable dose of an antipsychotic within the dose range recommended according to the local Prescribing Information
    7.The main antipsychotic with which the subject is being treated must continue to be one of the antipsychotics listed below:
    •Aripiprazole
    •Aripiprazole long-acting injectables
    –Abilify Maintena
    –Aristada
    •Asenapine
    •Brexpiprazole
    •Cariprazine
    •Lurasidone
    •Olanzapine
    •Risperidone
    •Risperidone long-acting injection
    Procedimientos:
    1.Tiene que ser capaz de comprender y otorgar el consentimiento informado firmado, y tiene que ser capaz de firmar y fechar un formulario para su historia clínica y/o un formulario de confidencialidad del paciente, si procede, conforme a la normativa local
    2.Tiene un cuidador u otra persona responsable identificada (p. ej., un familiar, un trabajador social, una empleada del hogar o un asistente social) que el investigador considere fiable para brindar apoyo al paciente y garantizar el cumplimiento con el tratamiento del estudio, las visitas del estudio y los procedimientos del protocolo, y que también sea capaz de aportar información útil para cumplimentar las escalas de valoración del estudio
    3.Está completando la visita de la semana 6 del estudio ACP-103-034 o -039 o en la visita de la semana 26 del estudio ACP-103-038 mientras continúa tomando la dosis asignada del fármaco del estudio enmascarado y puede beneficiarse, en opinión del investigador, de continuar el tratamiento complementario con pimavanserina añadida a un antipsicótico
    Situación médica:
    4.Si es mujer, no tiene que tener capacidad de procrear (definida como esterilizada o al menos 1 año de posmenopausia) o tiene que aceptar utilizar dos métodos anticonceptivos clínicamente aceptables (p. ej., oral, dispositivo intrauterino [DIU], diafragma más espermicida o anticonceptivo inyectable, transdérmico o implantable)
    •Todas las mujeres tienen que tener un resultado negativo en la prueba de embarazo de gonadotropina coriónica humana (hCG) en orina en el momento inicial y en las semanas 2, 6, 12, 20, 28, 36, 44 y 52
    5.Continuar médicamente estable en la inscripción, en opinión del investigador
    Medicamentos:
    6.Continúa tomando una dosis estable de un antipsicótico en el intervalo de dosis recomendado conforme a la información de prescripción local
    7.El antipsicótico principal con el cual el paciente esté recibiendo tratamiento tiene que seguir siendo uno de los antipsicóticos indicados a continuación:
    •Aripiprazol
    •Aripiprazol inyectable de acción prolongada
    –Abilify Maintena
    –Aristada
    •Asenapina
    •Brexpiprazol
    •Cariprazina
    •Lurasidona
    •Olanzapina
    •Risperidona
    •Risperidona inyectable de acción prolongada
    E.4Principal exclusion criteria
    Procedures:
    1.Subject is judged by the Investigator or the Medical Monitor to be inappropriate for the study (e.g., significantly noncompliant in Studies ACP-103-034, -038, or -039)
    Medical Status:
    2. A urine drug screen (UDS) result at Baseline that indicates the presence of any tested prohibited substance of potential abuse, including marijuana (even if recreational or medicinal use is legal locally) except marijuana
    Subjects with a result indicating the presence of marijuana are permitted if they agree to abstain from marijuana use during the study and the medical monitor approves the subject's participation
    3.Is taking a medication or drug or other substance that is prohibited according to this protocol, including medications that prolong the QT interval, strong cytochrome P450 (CYP) 3A4 enzyme (CYP3A4) inhibitors and inducers
    4.Known family or personal history or symptoms of long QT syndrome
    5.Has a QRS interval <120 ms and QTcF > or = 460 ms OR
    has a QRS interval > or = 120 ms and QTcF > or = 480 ms at Baseline
    6.Has developed a serious and/or unstable psychiatric, neurologic, cardiovascular, respiratory, gastrointestinal, renal, hepatic, hematologic, or other medical disorder, including cancer or malignancies that, in the judgment of the Investigator, would jeopardize the safe participation of the subject in the study
    7.Is breastfeeding or lactating
    8.Has a significant sensitivity or allergic reaction to pimavanserin or its excipients
    9.Subject and/or caregiver has any condition that, in the opinion of the Investigator, would interfere with the ability to comply with study instructions, might confound the interpretation of the study results, or put the subject at undue risk
    10.Presence of any change in medical or treatment status which may increase the risk associated with taking study medication, would interfere with safety assessments, or would confound the interpretation of the study results, based on Investigator’s judgment
    Neuropsychiatric:
    11.Is at a significant risk of suicide, or is a danger to self or others, in the opinion of the Investigator
    12.Has a significant risk of violent behavior in the opinion of the Investigator
    Other:
    13.Is an employee of ACADIA, or has a family member who is an employee of ACADIA
    Procedimientos:
    1.El investigador o el monitor médico consideran que el paciente no es idóneo para el estudio (p. ej., incumplimiento significativo en los estudios ACP-103-034, -038, o 039)
    Situación médica:
    2.Un resultado de detección de drogas en orina (DDO) en el momento inicial que indique la presencia de cualquiera de las sustancias con potencial de abuso prohibidas analizadas, excepto la marihuana
    Se permite la participación de pacientes cuyo resultado indique la presencia de marihuana, si acceden a abstenerse de su consumo durante el estudio y el monitor médico aprueba su participación
    3.Está tomando un medicamento o fármaco u otra sustancia que están prohibidos conforme al protocolo, incluidos medicamentos que prolongan el intervalo QT y los inhibidores e inductores potentes de la enzima 3A4 del citocromo P450 (CYP) (CYP3A4)
    4.Tiene antecedentes familiares o personales o síntomas conocidos de síndrome de QT largo
    5.Tiene un intervalo QRS < 120 ms y QTcF > o = 460 ms O
    Tiene un intervalo QRS > o = 120 ms y QTcF > o = 480 ms en el momento inicial
    6.Ha desarrollado un problema médico grave y/o inestable de tipo psiquiátrico, neurológico, cardiovascular, respiratorio, gastrointestinal, renal, hepático, hematológico o de otro tipo, incluidos el cáncer o procesos malignos que, a criterio del investigador, pudieran poner en peligro la seguridad del paciente durante su participación en el estudio
    7.Está dando el pecho o lactando
    8.Tiene sensibilidad significativa o reacción alérgica a la pimavanserina o a sus excipientes
    9.El paciente y/o el cuidador tiene cualquier afección que, en opinión del investigador, pudiera interferir con la capacidad de cumplir las instrucciones del estudio, pudiera confundir la interpretación de los resultados del estudio o que suponga un riesgo indebido para el paciente
    10. Presencia de cualquier cambio en la situación médica o en el estado del tratamiento que pueda incrementar el riesgo asociado al medicamento del estudio, interferir con las evaluaciones de seguridad o confundir la interpretación de los resultados del estudio, según el criterio del investigador
    Neuropsiquiátrico:
    11.Hay un riesgo significativo de suicidio o hay peligro de lesiones a sí mismo o a otras personas, en opinión del investigador
    12.Tiene un riesgo significativo de conducta violenta, en opinión del investigador
    Otros:
    13.Es un empleado de ACADIA o tiene un familiar que es empleado de ACADIA
    E.5 End points
    E.5.1Primary end point(s)
    •Incidence and severity of adverse events (AEs), serious adverse events (SAEs), and withdrawals due to AEs
    •Vital sign measurements, weight, clinical laboratory assessments, physical examination findings, electrocardiogram (ECG) parameters, the Abnormal Involuntary Movement Scale (AIMS) score, the Barnes Akathisia Rating Scale (BARS) score, and the Simpson-Angus Extrapyramidal Side Effects Scale (SAS) score
    •Changes from Baseline in vital sign measurements, weight, clinical laboratory and ECG parameters, the AIMS score, the BARS score, and the SAS score
    •Suicidality: the incidence of subjects with suicidal ideation or suicidal behavior during the study as assessed by the Columbia-Suicide Severity Rating Scale (C SSRS)
    •Incidencia y seguridad de acontecimientos adversos (AA), acontecimientos adversos graves (AAG) y retiradas debidas a AA
    •Las mediciones de las constantes vitales, peso, evaluaciones del laboratorio clínico, los hallazgos de la exploración física, los parámetros del electrocardiograma (ECG), la escala de Movimientos involuntarios anómalos [Abnormal Involuntary Movement Scale, AIMS], la puntuación de la escala de valoración de la acatisia de Barnes (BARS) y la puntuación de la escala de Efectos secundarios extrapiramidales de Simpson-Angus (SAS)
    •Variaciones con respecto a los valores iniciales de las mediciones de las constantes vitales, peso, parámetros del laboratorio clínico y del ECG, puntuación AIMS, puntuación BARS y puntuación SAS
    •Tendencia suicida: incidencia de pacientes con ideación suicida o de conducta suicida durante el estudio evaluada mediante la escala de puntuación de la intensidad de la intención suicida de Columbia [Columbia-Suicide Severity Rating Scale, C-SSRS]
    E.5.1.1Timepoint(s) of evaluation of this end point
    Changes from Baseline
    Cambios desde la situación basal
    E.5.2Secondary end point(s)
    •Change from Baseline in the Clinical Global Impression – Severity scale (CGI-S)
    •Change from Baseline in the Clinical Global Impression of Schizophrenia Scale – Severity (CGI-SCH-S); (for subjects from Study ACP-103-038 only)
    •Variación con respecto al valor inicial de la Impresión clínica global – Escala de gravedad de la enfermedad (CGI-S)
    •Variación con respecto al valor inicial de la escala de impresión clínica global de la esquizofrenia – Escala de gravedad de la enfermedad (CGI-SCH-S) (solo en pacientes del estudio ACP-103-038)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Change from Baseline
    Cambios desde la situación basal
    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 No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability after 52 weeks of adjunctive treatment
    Tolerabilidad tras 52 semanas de tratamiento complementario
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 EEA40
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Bulgaria
    Canada
    Chile
    Czech Republic
    Germany
    Hungary
    Poland
    Russian Federation
    Serbia
    Slovakia
    Spain
    Ukraine
    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
    Última visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days0
    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: 550
    F.1.3Elderly (>=65 years) No
    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 state64
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 137
    F.4.2.2In the whole clinical trial 550
    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)
    At the end of participation in the trial, the study subjects will be returned to their previously standard of care
    Al final del estudio los pacientes volverán a su tratamiento estándar previo
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-06-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-06-22
    P. End of Trial
    P.End of Trial StatusOngoing
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