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    Summary
    EudraCT Number:2009-018161-12
    Sponsor's Protocol Code Number:SPD503-315
    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:2010-11-24
    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 number2009-018161-12
    A.3Full title of the trial
    A Phase 3, Double-blind, Placebo-controlled, Multicentre, Randomised withdrawal, Long-term Maintenance of Efficacy and Safety Study of Extended-release Guanfacine Hydrochloride in Children and Adolescents Aged 6-17 With Attention deficit/Hyperactivity Disorder Estudio de Fase 3, doble ciego, controlado con placebo, multicéntrico, de mantenimiento a largo plazo y retirada aleatorizada, de la eficacia y seguridad de Clorhidrato de Guanfacina de liberación prolongada en niños y adolescentes de 6 a 17 años con Trastorno por Déficit de Atención con Hiperactividad
    A.4.1Sponsor's protocol code numberSPD503-315
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorShire Development Inc
    B.1.3.4CountryUnited Kingdom
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 INTUNIV
    D.2.1.1.2Name of the Marketing Authorisation holderShire Development Inc
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameGuanfacine Hydrochloride
    D.3.2Product code SPD503
    D.3.4Pharmaceutical form Prolonged-release tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNGUANFACINE HYDROCHLORIDE
    D.3.9.1CAS number 29110-48-3
    D.3.9.2Current sponsor codeSPD503
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 Yes
    D.2.1.1.1Trade name INTUNIV
    D.2.1.1.2Name of the Marketing Authorisation holderShire Development Inc
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameGuanfacine Hydrochloride
    D.3.2Product code SPD503
    D.3.4Pharmaceutical form Prolonged-release tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNGUANFACINE HYDROCHLORIDE
    D.3.9.1CAS number 29110-48-3
    D.3.9.2Current sponsor codeSPD503
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 Yes
    D.2.1.1.1Trade name INTUNIV
    D.2.1.1.2Name of the Marketing Authorisation holderShire Development Inc
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameGuanfacine Hydrochloride
    D.3.2Product code SPD503
    D.3.4Pharmaceutical form Prolonged-release tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNGUANFACINE HYDROCHLORIDE
    D.3.9.1CAS number 29110-48-3
    D.3.9.2Current sponsor codeSPD503
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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: 4
    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 INTUNIV
    D.2.1.1.2Name of the Marketing Authorisation holderShire Development Inc
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameGuanfacine Hydrochloride
    D.3.2Product code SPD503
    D.3.4Pharmaceutical form Prolonged-release tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNGUANFACINE HYDROCHLORIDE
    D.3.9.1CAS number 29110-48-3
    D.3.9.2Current sponsor codeSPD503
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 placeboProlonged-release tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboProlonged-release tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 3
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboProlonged-release tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 4
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboProlonged-release 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
    Attention-Deficit/Hyperactive Disorder (ADHD)
    Trastorno por déficit de atención con hiperactividad
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10064104
    E.1.2Term ADHD
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10068451
    E.1.2Term ADHD, combined type
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10068452
    E.1.2Term ADHD, predominantly hyperactive-impulsive type
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10068453
    E.1.2Term ADHD, predominantly inattentive type
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    El análisis principal de la eficacia se realizará sobre las tasas de fracaso terapéutico durante la fase a doble ciego de retirada aleatorizada en la población del CAC aleatorizado mediante una prueba de Cochran-Mantel-Haenszel (CMH) estratificada por grupo de edad y por país. Los sujetos que abandonen el estudio por cualquier motivo durante la fase de retirada aleatorizada serán clasificados como fracaso terapéutico.
    La hipótesis nula sostiene que no existe diferencia en la tasa de fracaso terapéutico entre el SPD503 y el placebo, con una alternativa bilateral de una diferencia distinta de cero entre los grupos.
    E.2.2Secondary objectives of the trial
    1. Evaluar la eficacia a largo plazo del SPD503 a partir de la puntuación total de la Escala ADHD-RS-IV administrada por el facultativo.
    2. Evaluar la eficacia a largo plazo del SPD503 mediante la escala CGI-S o Clinical Global Impressions-Severity of Illness, cumplimentada por el facultativo.
    3. Evaluar la eficacia del SPD503 mediante la escala CGI-I o Clinical Global Impressions-Improvement, cumplimentada por el facultativo.
    4. Evaluar la eficacia sobre los resultados funcionales del TDAH mediante la Escala cumplimentada por los padres (WFIRS-P o Weiss Functional Impairment Rating Scale-Parent).
    5. Evaluar el impacto del tratamiento sobre la percepción del estado de salud a partir de las escalas HUI-2/3 o Health Utilities Index-Mark 2 and Mark 3.
    6. Evaluar la seguridad a largo plazo del SPD503 a partir de los acontecimientos adversos aparecidos durante el tratamiento (AAAT),determinación de la presión arterial y el pulso, análisis de laboratorio, ECGs y la Escala C-SSRS
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Sexo masculino o femenino, edad comprendida entre los 6 y los 17 años en el momento de prestar el consentimiento/asentimiento en la visita 1 o de selección.
    2. Criterios de diagnóstico primario de TDAH según el Manual diagnóstico y estadístico de los trastornos mentales, cuarta edición revisada (DSM-IV-TR) del tipo combinado, del tipo con predominio hiperactivo-impulsivo o del tipo con predominio del déficit de atención a partir de un examen psiquiátrico exhaustivo mediante la Kiddie-Escala para trastornos afectivos y esquizofrenia-presente y a lo largo de la vida (K SADS-PL o Kiddie Schedule for Affective Disorders and Schizophrenia Present and Lifetime).
    3. Puntuación mínima de 32 en la ADHD-RS-IV en la visita 2 o de inclusión.
    4. Puntuación mínima de 4 en la CGI-S en la visita 2 o de inclusión.
    5. Capacidad de deglutir comprimidos enteros.
    E.4Principal exclusion criteria
    1. Diagnóstico actual de un trastorno psiquiátrico controlado (para el que necesite un medicamento no permitido o programa de modificación de la conducta) o incontrolado excepto el trastorno negativista desafiante (TND) incluyendo cualquier trastorno concomitante grave del eje II o del eje I, como p. ej. el trastorno por estrés postraumático, los trastornos bipolares, las psicosis, los trastornos generalizados del desarrollo, el trastorno obsesivo-compulsivo, los trastornos por consumo de sustancias u otras manifestaciones sintomáticas o antecedentes personales de trastornos bipolares, psicosis o trastornos de la conducta que a juicio del investigador suponga una contraindicación para el tratamiento con SPD503 o dificulte las evaluaciones de eficacia o seguridad.
    2. Antecedentes o presencia de malformaciones cardíacas, arritmias graves, síncopes, alteraciones de la conducción cardíaca (p. ej. bloqueo cardíaco de relevancia clínica), episodios cardíacos relacionados con el ejercicio, como síncope o presíncope, o bradicardia de relevancia clínica.
    3. Hipotensión ortostática o antecedentes conocidos de hipertensión, controlada o no.
    4. Consumo actual de medicamentos no permitidos o productos farmacéuticos o fitoterapéuticos que alteren la presión arterial (PA) o la frecuencia cardíaca, que ejerzan efectos sobre el sistema nervioso central (SNC) o que afecten a la función cognitiva, como los antihistamínicos sedantes y los descongestionantes simpaticomiméticos (se permiten los broncodilatadores por vía inhalatoria), o antecedentes de consumo permanente de medicamentos con efectos sedantes (como antihistamínicos) que contravengan los criterios de lavado fijados por el protocolo para la visita 2/inclusión.
    5. Sobrepeso importante según los gráficos del índice de masa corporal por sexo y edad de los Centros para el Control y la Prevención de Enfermedades de los EEUU. Por sobrepeso importante se entiende un IMC > percentil 95.
    6. En el caso de los niños de 6-12 años, peso < 25,0 kg; en el caso de los adolescentes de 13-17, peso < 34,0 kg ó > 91,0 kg en la visita 1/selección.
    7. Antecedentes de alcoholismo, drogodependencia u otras toxicomanías en los últimos 6 meses (sin contar el tabaquismo), con arreglo a las definiciones del DSM-IV-TR.
    8. Riesgo actual de suicidio, según el investigador; antecedentes de intento de suicidio o antecedentes o presencia de ideas suicidas activas. No se excluirá necesariamente a los sujetos con ideas suicidas intermitentes de carácter pasivo, según la evaluación que haga el investigador (consúltese la orientación del protocolo).
    9. Antecedentes de ausencia de respuesta a la exposición a un agonista &#945;2 para el tratamiento del TDAH (consistente en un tratamiento con una dosis adecuada y una duración suficiente según determine el investigador).
    E.5 End points
    E.5.1Primary end point(s)
    El criterio principal de valoración para cada sujeto es el fracaso terapéutico durante la fase a doble ciego de retirada aleatorizada (fase 2), entendido como un aumento (empeoramiento) mayor o igual al 50% de la puntuación total de la ADHD-RS-IV en dos visitas consecutivas de la fase 2 (visitas 14 a 23/FP) respecto a la puntuación de la visita 13 y un aumento mayor o igual a 2 puntos en la CGI-S respecto a la visita 13 en las correspondientes visitas de la fase 2
    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 No
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 Yes
    E.8.1.7.1Other trial design description
    Open label dose optimisation/maintenance phase followed by randomised withdrawal.
    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.8.3 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    Se define final del ensayo con la visita de seguimiento de seguridad 7 días despues de la última dósis del medicamento en investigación del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days20
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days8
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    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) Yes
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.2Adults (18-64 years) No
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2010-11-24. Yes
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Debido a la edad de los pacientes del ensayo se ha generado un consentimiento para padres/tutores
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 204
    F.4.2.2In the whole clinical trial 510
    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)
    No se ha previsto ningun cuidado adicional para el paciente trás la finalización del estudio
    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 Decision2011-02-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-02-04
    P. End of Trial
    P.End of Trial StatusCompleted
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