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    Summary
    EudraCT Number:2012-002619-24
    Sponsor's Protocol Code Number:A1481316
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2012-11-29
    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 number2012-002619-24
    A.3Full title of the trial
    A MULTI-CENTRE, RANDOMIZED, PLACEBO-CONTROLLED,
    DOUBLE-BLIND, TWO-ARMED, PARALLEL GROUP STUDY TO EVALUATE
    EFFICACY AND SAFETY OF IV SILDENAFIL IN THE TREATMENT OF NEONATES WITH PERSISTENT PULMONARY HYPERTENSION OF THE
    NEWBORN (PPHN) OR HYPOXIC RESPIRATORY FAILURE AND AT RISK FOR PPHN, WITH A LONG TERM FOLLOW-UP INVESTIGATION OF DEVELOPMENTAL PROGRESS 12 AND 24 MONTHS AFTER COMPLETION OF STUDY TREATMENT
    ESTUDIO MULTICÉNTRICO, ALEATORIZADO, CONTROLADO CON PLACEBO, EN DOBLE CIEGO, DE DOS GRUPOS PARALELOS, PARA EVALUAR LA EFICACIA Y LA SEGURIDAD DEL SILDENAFILO IV EN EL TRATAMIENTO DE NEONATOS CON HIPERTENSIÓN PULMONAR PERSISTENTE DEL RECIÉN NACIDO (HPPRN) O INSUFICIENCIA RESPIRATORIA HIPÓXICA Y EN RIESGO DE HPPRN, CON UN SEGUIMIENTO A LARGO PLAZO PARA INVESTIGACIÓN DE LA EVOLUCIÓN DE SU DESARROLLO 12 Y 24 MESES DESPUÉS DE LA FINALIZACIÓN DEL TRATAMIENTO DEL ESTUDIO
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A trial to evaluate the effectiveness and safety of intravenous Sildenafil in the treatment of neonates with persistent pulmonary hypertension of the newborn or hypoxic respiratory failure and risk for PPHN
    -Los objetivos principales de este estudio son evaluar la eficacia y la seguridad del sildenafilo IV cuando se añade a iNO para el tratamiento de neonatos con HPPRN o IRH y con riesgo de HPPRN.
    A.4.1Sponsor's protocol code numberA1481316
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/158/2012
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorPfizer Inc., 235 East 42nd Street, New York, NY 10017
    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 supportPfizer Inc., 235 East 42nd Street, New York, NY 10017
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPfizer Inc
    B.5.2Functional name of contact pointClinical Trials.gov Call Center
    B.5.3 Address:
    B.5.3.1Street Address235 E 42nd Street
    B.5.3.2Town/ cityNew York
    B.5.3.3Post codeNY 10017
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1 800 7181021
    B.5.5Fax number+1 303 7391119
    B.5.6E-mailClinicalTrials.gov_Inquiries@pfizer.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 Revatio
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Ltd
    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 Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSILDENAFIL
    D.3.9.1CAS number 171599-83-0
    D.3.9.2Current sponsor codeUK-92,480
    D.3.9.3Other descriptive nameSILDENAFIL CITRATE
    D.3.9.4EV Substance CodeSUB04386MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.8
    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 placeboSolution for injection
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Persistent pulmonary hypertension of the newborn
    Hipertensión pulmonar persistente del recién nacido
    E.1.1.1Medical condition in easily understood language
    Persistent pulmonary hypertension of the newborn
    Hipertensión pulmonar persistente del recién nacido
    E.1.1.2Therapeutic area Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10053592
    E.1.2Term Newborn persistent pulmonary hypertension
    E.1.2System Organ Class 100000004850
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objectives of this study are to evaluate the efficacy and safety of IV sildenafil when added to iNO for the treatment of neonates with PPHN or hypoxic respiratory failure and at risk for PPHN.
    El objetivo principal de este estudio es evaluar la eficacia y la seguridad del sildenafilo IV cuando se añade a iNO para el tratamiento de neonatos con HPPRN o IRH y con riesgo de HPPRN.
    E.2.2Secondary objectives of the trial
    ?To monitor the developmental progress of patients with PPHN treated with IV sildenafil or placebo, at 12 and 24 months after the end of study treatment.
    ? Pharmacokinetics (PK): To further characterize the PK of sildenafil and UK-103,320 in neonates with PPHN or HRF and at risk of developing PPHN.
    -Monitorizar la evolución del desarrollo de los pacientes con HPPRN tratados con sildenafilo IV o placebo, 12 y 24 meses después del final del tratamiento del estudio.
    -Farmacocinética (Fc): Caracterizar mejor los parámetros farmacocinéticos del sildenafilo y de UK-103,320 en los neonatos con HPPRN o IRH y con riesgo de presentar HPPRN.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subject eligibility should be reviewed and documented by an appropriately qualified member of the investigator?s study team before subjects are included in the study.

    Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:
    1. PPHN or hypoxic respiratory failure (HRF) at risk for PPHN associated with:
    ? Idiopathic PPHN;
    ? Meconium aspiration syndrome;
    ? Sepsis; or
    ? Pneumonia.
    2. ?72 hours of age and ?34 weeks of gestation at screening.
    3. OI >15 and <60, calculated using two blood gases taken at least 30 minutes apart prior to randomization and start of study drug infusion.
    4. Concurrent treatment with iNO at 10-20 ppm on ?50% oxygen.
    5. Screening echocardiogram, within 24 hours of study start, to confirm presence of pulmonary hypertension for continued participation in the trial.
    6. Screening cranial ultrasound, within 24 hours of study start, to eliminate patients with clinically significant intracranial bleeds per investigator judgment.
    7. Evidence of a personally signed and dated informed consent document indicating that the subject?s legal representative has been informed of all pertinent aspects of the study; and
    8. Subjects whose legal representative is willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
    La elegibilidad de los sujetos deberá revisarla y confirmarla un miembro debidamente cualificado del equipo del estudio del investigador antes de la inclusión de los sujetos en el estudio.

    Los sujetos deberán cumplir todos los siguientes criterios de inclusión para ser elegibles para su inclusión en el estudio:
    1.HPPRN o insuficiencia respiratoria hipóxica (IRH) con riesgo de HPPRN asociada a:
    -HPPRN idiopática,
    -Síndrome de aspiración meconial,
    -Septicemia, o
    -Neumonía.
    2.? 72 horas de vida y ? 34 semanas de gestación en el momento de la selección.
    3.IO > 15 y < 60, calculado mediante gasometría utilizando dos muestras obtenidas con al menos 30 minutos de diferencia antes de la aleatorización y el inicio de la infusión del fármaco del estudio.
    4.Tratamiento concomitante con iNO a 10 - 20 ppm con oxígeno al ? 50%.
    5.Ecocardiograma en la selección, en las 24 horas anteriores al inicio del estudio, para confirmar la presencia de hipertensión pulmonar, obligatoria para que el paciente continúe en el estudio.
    6.Ecografía craneal en la selección, en las 24 horas anteriores al inicio del estudio, para descartar a los pacientes con hemorragia intracraneal clínicamente significativa según el criterio del investigador.
    7.Existencia de un documento de consentimiento informado, firmado y fechado, que indique que el representante legal del sujeto ha sido informado de todos los aspectos pertinentes del estudio.
    8.Sujetos cuyo representante legal esté dispuesto a cumplir las visitas programadas, el plan de tratamiento, las pruebas analíticas y demás procedimientos del estudio, y pueda hacerlo.
    E.4Principal exclusion criteria
    Subjects presenting with any of the following will not be included in the study:
    1. Prior or immediate need for ECMO or CPR.
    2. Expected duration of mechanical ventilation of less than 48 hours.
    3. Life-threatening or lethal congenital anomaly.
    4. Profound hypoxemia: PaO2 <30 mm Hg on any arterial blood gas drawn within 30 minutes of starting study drug infusion.
    5. Severe hypotension at baseline (mean arterial pressure (MAP) <30 mmHg) not responsive to medical management, or shock any time during screening.
    6. Significant congenital heart disease or defect exclusive of inter-atrial communication or patent ductus arteriosus.
    7. Large left to right intracardiac or ductal shunting (diagnosed from echocardiogram within 24 hours of admission).
    8. Large clinically significant intracranial bleed (diagnosed from cranial ultrasound within 24 hours of admission).
    9. Lung hypoplasia syndromes diagnosed on the basis of prolonged oligohydramnios or hydrops faetalis.
    10. Congenital diaphragmatic hernia.
    11. Clinically significant active seizures, as per clinical judgment of the investigator.
    12. Apgar score of <3 at 5 minutes after birth.
    13. Bleeding diathesis, as per clinical judgment of the investigator.
    14. Receipt of any prohibited concurrent medication/therapy at any time prior to screening:
    ? Potent cytochrome P450 3A4 inhibitors (eg, erythromycin, ketoconazole, itraconazole, and protease inhibitors), erythromycin ophthalmic ointment is allowed;
    ? Ritonavir or nicorandil;
    ? Endothelin antagonists (eg, Tracleer (RTM)/bosentan, Letairis(RTM)/ambristan, etc);
    ? PDE5 inhibitors (eg, sildenafil, tadalafil, vardenafil), IV or per orogastric tube;
    ? Nitrates or nitric oxide donors, except iNO (A subject is eligible if nitroprusside was used only if it was discontinued at least 2 hours prior to study drug infusion; iNO may be used per protocol);
    ? Vasodilators (eg, alpha blockers, magnesium sulfate as infusion, calcium channel blockers, other PDE inhibitors, prostacyclins, etc) at study entry (Excludes milrinone, which is allowed during the study as concurrent therapy) at study entry; or
    ? Supplemental arginine administered for the purpose of improving NO-dependent vasodilation (Maintenance quantities in total parental nutrition (TPN) are allowed).
    15. Known hereditary degenerative retinal disorders, such as retinitis pigmentosa.
    16. Symptoms of drug- or alcohol-related withdrawal.
    17. In the opinion of the investigator, a subject inappropriate for the study for any reason.
    18. Other acute or severe medical conditions, or marked laboratory abnormalities that may increase the risk associated with study participation or investigational product administration, or may interfere with the interpretation of study results and, in the
    judgment of the investigator, would make the subject inappropriate for entry into this study.
    19. Participation in any other experimental studies involving other drug or non-interventional therapies before the current study begins and/or during study participation.
    Subjects who are relatives of investigational site staff members or Pfizer employees directly involved in the conduct of the trial.
    No se incluirá en el estudio a los sujetos en alguna de las circunstancias siguientes:
    1.Necesidad anterior o inmediata de ECMO o RCP.
    2.Duración prevista de la ventilación mecánica inferior a 48 horas.
    3.Anomalía congénita mortal o potencialmente mortal.
    4.Hipoxemia profunda: PaO2 <30mm Hg en una gasometría arterial realizada en los 30 minutos anteriores al inicio de la infusión del fármaco del estudio.
    5.Hipotensión severa en el periodo basal (presión arterial media [PAM] < 30 mm Hg) que no responde a tratamiento farmacológico, o insuficiencia cardiocirculatoria aguda en cualquier momento durante la selección.
    6.Cardiopatía congénita significativa, defecto exclusivo de la comunicación interauricular o conducto arterioso permeable.
    7.Gran cortocircuito intracardíaco o ductal izquierda-derecha (diagnosticado mediante ecocardiograma en las 24 horas siguientes al ingreso del paciente).
    8.Hemorragia intracraneal abundante y clínicamente significativa (diagnosticada mediante ecografía craneal en las 24 horas siguientes al ingreso del paciente).
    9.Síndromes de hipoplasia pulmonar diagnosticados a partir de oligohidramnios o hidropesía fetal prolongados.
    10.Hernia diafragmática congénita.
    11.Crisis epilépticas activas clínicamente significativas, según el criterio clínico del investigador.
    12.Puntuación < 3 en la prueba de Apgar a los 5 minutos de vida.
    13.Diátesis hemorrágicas, según el criterio clínico del investigador.
    14.Administración de algún tratamiento/medicamento concomitante prohibido en cualquier momento anterior a la selección:
    -Se permite el uso de inhibidores potentes de la isoenzima 3A4 del citocromo P450 (p. ej., eritromicina, ketoconazol, itraconazol e inhibidores de la proteasa), eritromicina en pomada oftálmica;
    -Ritonavir o nicorandil;
    -Antagonistas de las endotelina (p. ej. Tracleer ®/bosentán, Letairis®/ambristán, etc.);
    -Inhibidores de la PDE5 (p. ej., sildenafilo, tadalafilo, vardenafilo), IV o por sonda orogástrica;
    -Nitratos o donadores de óxido nítrico, salvo iNO (un sujeto es elegible sólo si se administró nitroprúsido y se interrumpió al menos dos horas antes de la infusión del fármaco del estudio; nO puede utilizarse por protocolo);
    -vasodilatadores (p. ej., alfabloqueantes, sulfato de magnesio en infusión, antagonistas del calcio, otros inhibidores de la PDE, prostaciclinas, etc.) en el momento de la admisión en el estudio (se excluye milrinona, que se permite durante el estudio como tratamiento concomitante) en el momento de la admisión en el estudio; o
    -Arginina complementaria, administrada para mejorar la vasodilatación dependiente de NO (se permiten cantidades de mantenimiento en la nutrición parenteral total [NPT]).
    15. Trastornos retinianos hereditarios conocidos, como retinosis pigmentaria.
    16. Síntomas de abstinencia por retirada de alcohol o drogas.
    17.Sujeto no apto para el estudio, en opinión del investigador, por cualquier motivo.
    18.Otros procesos médicos agudos o severos, o anomalías analíticas marcadas que pueden aumentar el riesgo asociado a la participación en el estudio o a la administración del producto en investigación, o que pueden interferir en la interpretación de los resultados del estudio y, en opinión del investigador, harían que el sujeto no fuera apto para su admisión en este estudio.
    19.Participación en cualquier otro estudio experimental con tratamientos farmacológicos o no intervencionistas antes del inicio del estudio actual y/o durante la participación en el mismo.
    Familiares de los miembros del personal del centro investigador o empleados de Pfizer que intervengan directamente en la realización del ensayo.
    E.5 End points
    E.5.1Primary end point(s)
    Assessed at Day 14 or hospital discharge, whichever occurs first:
    ? Time on iNO treatment after initiation of IV study drug for subjects without treatment failure;
    ? Treatment failure rate, defined as need for additional treatment targeting PPHN, need for ECMO, or death during the study.
    Evaluado el Día 14 o al recibir el alta hospitalaria, lo que suceda en primer lugar:
    - Tiempo en tratamiento con iNO después del inicio de la administración IV del fármaco del estudio en los sujetos sin fracaso terapéutico;
    -Tasa de fracaso terapéutico, definido como la necesidad de tratamiento adicional para la HPPRN, necesidad de ECMO o muerte durante el estudio
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 14 or hospital discharge
    Día 14 o recibir el alta hospitalaria
    E.5.2Secondary end point(s)
    Assessed at Day 14 or hospital discharge, whichever occurs first:
    ? Time to final weaning of mechanical ventilation for PPHN;
    ? Time from initiation of study drug to treatment failure (additional drug treatment targeting PPHN, ECMO, or death); each component will also be evaluated separately;
    ? Proportion of subjects with individual components of treatment failure (needing additional treatment targeting PPHN, needing ECMO, or who die);
    ? Change in OI at 6, 12, and 24 hours from baseline;
    ? Change in differential saturation (pre- and post-ductal) at 6, 12, and 24 hours from baseline;
    ? Change in P/F ratio at 6, 12, and 24 hours from baseline;
    ? Sildenafil and UK-103,320 plasma concentrations and the corresponding PK parameters obtained from a population PK analysis; and
    ? Safety parameters: Incidence and severity of adverse events and abnormal laboratory parameters.
    Evaluado el Día 14 o al recibir el alta hospitalaria, lo que suceda en primer lugar:
    -Ttiempo hasta la retirada definitiva de la ventilación mecánica para la HPPRN;
    -Ttiempo desde el inicio del fármaco del estudio hasta el fracaso terapéutico; cada componente también se evaluará por separado;
    -Cambio en el IO a las 6, 12 y 24 horas con respecto al basal;
    -Cambio en la saturación diferencial (preductal y posductal) a las 6, 12 y 24 horas con respecto al basal;
    -Cambio en la relación P/F a las 6, 12 y 24 horas con respecto al basal;
    -Concentraciones plasmáticas de sildenafilo y UK-103,320, y los parámetros farmacocinéticos correspondientes, obtenidos en un análisis farmacocinético poblacional; y
    -Parámetros de seguridad: incidencia e intensidad de los acontecimientos adversos y parámetros analíticos anómalos.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 14 or hospital discharge
    Día 14 o recibir el alta hospitalaria
    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 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 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA23
    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
    Belgium
    Canada
    Finland
    France
    Germany
    Italy
    Netherlands
    Norway
    Spain
    Sweden
    Switzerland
    United Kingdom
    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
    As per Protocol
    Según el protocolo
    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 months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months6
    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 Yes
    F.1.1Number of subjects for this age range: 64
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Yes
    F.1.1.2.1Number of subjects for this age range: 4
    F.1.1.3Newborns (0-27 days) Yes
    F.1.1.3.1Number of subjects for this age range: 60
    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) 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 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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Minors
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 48
    F.4.2.2In the whole clinical trial 64
    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)
    Post Trial Treatment is Standard Care.
    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 Decision2013-01-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-01-14
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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