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    EudraCT Number:2013-001358-81
    Sponsor's Protocol Code Number:CTPX01
    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:2014-02-18
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2013-001358-81
    A.3Full title of the trial
    "First-in-human clinical trial, double blind, randomized with placebo, open for the six first patients (dose ranging), to evaluate the safety and efficacy of intracoronary infusion of allogeneic human cardiac stem cells (CSCs) in patients with Acute Myocardial Infarction and Left Ventricular Dysfunction." - CAREMI
    "Primer ensayo clínico en humanos, doble ciego, aleatorizado con placebo, abierto para los seis primeros pacientes (escalado de dosis), para evaluar la seguridad y eficacia de la infusion intracoronaria de células madre cardíacas (CMC) humanas alogénicas en pacientes con Infarto Agudo de Miocardio y Disfunción Ventricular Izquierda" - CAREMI
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    First-in-human clinical trial using human cardiac stem cells obtained from a donor for Acute Myocardial Infarction treatment. Patients will receive either cells or placebo by intracoronary infusion to evaluate the safety and efficacy of this treatment.
    Primer ensayo clínico en humanos utilizando células madre cardíacas humanas obtenidas de un donante para el tratamiento del Infarto Agudo de Miocardio. Los pacientes recibirán o células o placebo por infusión intracoronaria para evaluar la seguridad y eficacia de este tratamiento.
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberCTPX01
    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 SponsorCoretherapix S.L.U.
    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 supportCoretherapix S.L.U.
    B.4.1Name of organisation providing supportEuropean Commision - Seventh Framework Programme (FP7)
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCoretherapix
    B.5.2Functional name of contact pointClinical Trial Information Desk
    B.5.3 Address:
    B.5.3.1Street AddressSantiago Grisolia 2
    B.5.3.2Town/ cityTres Cantos
    B.5.3.3Post code28760
    B.5.4Telephone number34918063089
    B.5.5Fax number34918063090
    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.3.2Product code AlloCSC-01
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntracoronary use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNA
    D.3.9.3Other descriptive nameCardioblastos troncales adultos alogénicos humanos cardíacos expandidos // Human allogeneic adult stem cells extracted from heart tissue an in vitro expanded
    D.3.9.4EV Substance CodeSUB126475
    D.3.10 Strength
    D.3.10.1Concentration unit million organisms million organisms
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number35
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    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) Yes
    D. cell therapy medicinal product Yes
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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 infusion
    D.8.4Route of administration of the placeboIntracoronary use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Acute Myocardial Infarction (AMI):
    "First STEMI submitted to elective primary PCI with successful revascularization (TIMI ? 2), but intermediate-high risk of HF development (infarct size by MRI>25%"
    Infarto Agudo de Miocardio
    E.1.1.1Medical condition in easily understood language
    Heart Attack
    Infarto de Corazón
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    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 objective consists in the evaluation of the safety of the treatment:
    - In the dose escalation phase the principal objective is to evaluate the safety and feasibility of the procedure (MRI and administration method) that is not part of the routine care of a heart attack, and confirm that the target dose can be administered intracoronary in a safe way.
    The following will be assessed:
    o Deaths from any cause within 30 days
    o Adverse Events (AEs) of any nature observed from magnetic resonance imaging (MRI) of patient inclusion to up to 7 days after treatment administration.

    - In the randomization phase, the Major Adverse Cardiac Events (MACE) will be assessed for the first 30 days of treatment administration, defined as death from any cause, new myocardial infarction, hospitalization for failure heart, ventricular tachycardia (VT), ventricular fibrillation (VF) and stroke.
    Este objetivo consiste en evaluar la seguridad del tratamiento:
    ? En la fase de escalado de dosis el objetivo principal es evaluar la seguridad y viabilidad del procedimiento (pruebas de imagen y método de administración) que no forma parte del cuidado rutinario de un infarto así como confirmar que la dosis objetivo se puede administrar de forma segura por vía intracoronaria
    Se evaluarán:
    -Fallecimientos por cualquier causa dentro de los primeros 30 días
    -Acontecimientos Adversos (AA) de cualquier naturaleza observados desde la realización de la Resonancia Magnética de inclusión hasta 7 días tra la administración del tratamiento
    ?En la fase de aleatorización se evaluarán los AA Cardiacos Principales (MACE) durante los primeros 30 días desde la administración del tratamiento definidos como fallecimiento por cualquier causa, nuevo infarto agudo de miocardio, hospitalización por insuficiencia cardiaca, taquicardia ventricular, fibrilación ventricular y accidentes cerebrovasculares
    E.2.2Secondary objectives of the trial
    MACE in the first 6 months and at 12 months. Death from any cause. Death from cardiovascular cause. General monitoring of all serious adverse events from any cause.
    Evolution of infarct (morphology): % change in MRI at 6 and 12 months after treatment administration vs. screening MRI and 1 month MRI. Compare CSC versus placebo. Evolution of edema: % change in MRI at 1 month after treatment administration vs screening MRI. Evolution of the biomechanical parameters by MRI: % changes of MRI at 6 and 12 months of administration of the treatment vs screening MRI and 1 month MRI. Compare CSC vs placebo.
    CLINICAL PARAMETERS OF ANALYSIS: ProBNP curve (one day prior to 2nd hemodynamic assessment, 6 months, 12 months). CRP (one day prior to 2nd hemodynamic assessment, at discharge, 1 month). 6 minute walking test at discharge, 6 and 12 months. NYHA at discharge, 6 and 12 months. MLHFQ at discharge, 6 and 12 months. Hospital admission for HF. CCV mortality.
    SEGUIMIENTO DE SEGURIDAD: MACE en 6 primeros meses y a los 12 meses. Muerte por cualquier causa durante el ensayo. Muerte por causa cardiovascular. Supervisión general de todos los eventos adversos graves por cualquier causa.
    EFICACIA: Evolución del infarto (morfología):% de cambio en la RM a 6 y 12 meses tras la administración de tratamiento vs el screening por RM y al mes. Comparar CMC vs placebo. Evolución de edema:% de cambio en la RM a 1 mes tras la administración del tratamiento vs MRI del screening. Evolución de los parámetros biomecánicos por RM:% cambios de la RM a los 6 y 12 meses tras la administración del tratamiento vs MRI de screening y MRI al mes.
    PARÁMETROS CLÍNICOS: curva proBNP (1día antes del segundo cateterismo, a los 6 y 12 meses). CRP (1día antes del segundo cateterismo, al alta hospitalaria y al mes). Prueba de esfuerzo de 6 minutos al alta, 6 y 12 meses. NYHA al alta, 6 y 12 meses. MLHFQ al alta, 6 y 12 meses. Ingreso hospitalario por IC. Mortalidad CCV.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Adult patients ? 18 years of age and ? 80 years.
    2. Patients presenting a ST-segment-elevation in the acute myocardial infarction (STEMI) according to the universally accepted definition founded in the STEMI management guide of the European Society of Cardiology
    3. Killip ? 2 on admission
    4. Successful primary percutaneous coronary intervention (PCI) (Thrombolysis In Myocardial Infarction [TIMI] = 3) during the first 12h after infarct symptoms
    5. Bare-metal stent at primary PCI
    6. Ejection Fraction (EF) ?45% analyzed by echocardiography at day 2 after primary PCI
    7. Ejection Fraction (EF) ?45% analyzed by magnetic resonance imaging (MRI). This MRI will be done between day 3 and day 7 after infarction.
    8. Patients with an infarct size in left ventricle (LV) ?25% tested in the first MRI will be included.
    9. The affected coronary artery must be adequate for cells infusion by catheterization.
    10. The presence of microvascular obstruction at inclusion MRI is permitted
    11. The patient is stable and in adequate clinical condition to undergo the administration of the cell medicine through a second catheterization, between 4-7 days after the first PCI.
    1. Pacientes adultos ? 18 años de edad y ? 80 años.
    2. Pacientes que presenten un infarto agudo de miocardio con elevación del segmento ST de acuerdo a la definición aceptada universalmente a través de la guía de la Sociedad Europea de Cardiología.
    3. Killip ? 2 al ingreso en el hospital.
    4. Intervención Percutánea Coronaria primaria exitosa (Thrombolysis In Myocardial Infarction? ? TIMI = 3) en las primeras 12 horas tras los síntomas del infarto.
    5. Stent metálico no medicalizado en la PCI primaria.
    6. Fracción de Eyección (?Ejection Fraction? - EF) ?45% analizado mediante ecocardiografía en el día 2 tras la PCI primaria.
    7. EF ?45% mediante RM. Esta RM se realizará entre el día 3 y el día 7 tras el infarto.
    8. Se incluirán pacientes con un tamaño de infarto ?25% del ventrículo izquierdo cuantificado mediante RM.
    9. La arteria coronaria afectada debe ser adecuada para realizar la infusión de las células mediante cateterismo.
    10. Se permite la presencia de obstrucción microvascular en la RM de inclusión.
    11. El paciente se encuentra estable y en condiciones clínicas adecuadas para someterse al tratamiento de administración del medicamento celular a través de un segundo cateterismo entre 4-7 días tras la PCI primaria.
    E.4Principal exclusion criteria
    1. Participation in another clinical trial in the last 30 days
    2. Has previously received cell or gene therapy
    3. Women who are pregnant or breastfeeding
    4. Mental disease or psychological condition that impedes the subject from understanding the nature of the protocol and granting his/her consent
    5. Previous Q-wave infarction
    6. Valve disease, relapsing pericarditis, history of cardiac tamponade, cardiomyopathies
    7. Involvement of coronary trunk
    8. Severe stenotic lesion (>90%) in a coronary vessel with size >2.75mm, shown in the first PCI and non revascularizable during primary PCI
    9. Admission for prior HF or EF<45 or NYHA > 2 before STEMI
    10. Killip >2 on admission
    11. History of sustained VT or VF at any point since hospital admission
    12. Sustained VT that does not revert with treatment or requires >6 hours to be controlled in the 48 hours prior to the product administration procedure
    13. Complete Auriculo Ventricular blockade on arrival to the Emergency Room (previously unknown), or acute branch block during hospitalization
    14. History of cardioembolic disease
    15. Platelets <100,000 and/or Hb<8.5g/dL
    16. Acute or chronic renal failure with creatinine ?2.5 or creatinine clearance ?50 mL/min
    17. Infection with systemic involvement (fever or documented Systemic Inflammatory Response Syndrome) current and/or in the month prior to AMI
    18. History of bleeding in the 3 months prior to screening in any location due to uncontrolled coagulopathy
    19. Cancer disease, except that eradicated at least 5 years before inclusion, and without receiving radiotherapy on chest. It is permitted coetaneous non-melanoma neoplasms completely eliminated (at any time) and that do not require subsequent chemotherapy or radiotherapy on chest.
    20. Child's C stage chronic liver disease
    21. Stroke in the previous 12 months
    22. Baseline respiratory failure and/or requires oxygen at home
    23. Advanced dementia according to the Barthel index
    24. History of autoimmune disease and/or positive autoantibodies at least double titer of the normal ranges
    25. Patients with Hepatitis B virus (HBV), Hepatitis C virus (HCV), Human Immunodeficiency virus (HIV) or asymptomatic carriers (positive without clinical disease) except positive for HBV by vaccination
    26. Uncontrolled hypertension at screening despite treatment (systolic blood pressure [BP] ? 180 and/or diastolic BP ? 110)
    27. Very poorly controlled diabetes (Hb1Ac ?8.5 g/dL) or with serious target organ lesion (peripheral vascular disease requiring revascularization or non revascularizable, CRF with creatinine clearance ?50 mL/min, stroke in the previous 12 months, severe non-revascularizable coronary disease)
    28. Primary or acquired immune deficiency or immunosuppressant treatment (including treatments with immunosuppressants in the previous three months or with systemic corticosteroids in the previous month or foreseeable need for those treatments during the course of the study).
    29. Very poorly controlled hypercholesterolemia (total cholesterol ?250 mg/dL despite treatment)
    30. Active smoking greater than or equal to 40 cigarettes/day
    31. Recreational drug use that would hamper heart or cardiovascular function, at least once in the past 6 months
    32. Weekly alcohol consumption over 80 g per kg
    33. Women of childbearing potential who do not agree to use contraceptives during the study period and up to 6 months afterwards
    34. Life expectancy of less than 2 years for any reason.
    35. Previous or current blood transfusion or allogeneic transplant
    36. Allergy to Amynoglicoside antibiotics
    37. Contraindications preventing the use of Magnetic Resonance Imaging.
    1. Participación en otro ensayo clínico en los últimos 30 días
    2. Ha recibido previamente terapia celular o génica
    3. Mujeres embarazadas o lactantes
    4. Enfermedad mental o condición psicológica que impide al sujeto comprender la naturaleza del protocolo y otorgar su consentimiento
    5. Infarto previo con onda Q
    6. Valvulopatías, pericarditis recidivante, historia de taponamiento cardiaco, miocardiopatías
    7. Afectación del tronco coronario
    8. Lesión estenótica severa (>90%) en un vaso coronario evidenciada en la primera PCI y no revascularizable durante la PCI primaria
    9. Ingresos por IC previa o FE < 45 o NYHA > 2 antes de STEMI
    10. Killip > 2 al ingreso hospitalario
    11. Historia de la TV o FV sostenida en cualquier momento desde el ingreso hospitalario
    12. TV sostenida que no revierte con el tratamiento o precisa para su control > 6 horas en las 48 horas previas al procedimiento de administración del medicamento celular
    13. Bloqueo Aurículo-Ventricular completo a la llegada a urgencias (hasta ahora desconocido) o bloqueo agudo de rama durante la hospitalización
    14. Historia de enfermedad cardioembólica
    15. Plaquetas < 100000 y / o Hb < 8.5g/dL
    16. Insuficiencia renal aguda o crónica con creatinina ? 2,5 o aclaramiento de creatinina ? 50 ml / min
    17. Infección con afectación sistémica (fiebre o Síndrome de Respuesta Inflamatoria Sistémica documentado) actual y / o en el mes previo al infarto agudo de miocardio
    18. Historia de sangrado en los 3 meses previos al screening en cualquier localización por coagulopatía no controlada
    19. Enfermedad neoplásica, excepto la erradicada al menos 5 años antes de la inclusión y que no haya recibido radioterapia sobre el tórax. Se exceptúan las neoplasias cutáneas tipo no melanoma eliminadas por completo (en cualquier momento) y que no precisaron tratamiento con quimioterapia posterior o radioterapia en el tórax
    20. Hepatopatía crónica estadio C de Child
    21. Accidente cerebro-vascular ?ACVA- en los 12 meses previos
    22. Insuficiencia respiratoria de base y / o con requerimientos de oxígeno en domicilio
    23. Demencia avanzada según el índice de Barthel
    24. Historia de la enfermedad autoinmune y / o autoanticuerpos positivos al menos a un título doble a los rangos normales
    25. Pacientes con hepatitis B (VHB) , hepatitis C (VHC), virus de la inmunodeficiencia humana (VIH) o portadores asintomáticos (positivos sin enfermedad clínica) excepto positivos a VHB por vacunación
    26. Hipertensión no controlada en el screening a pesar de tratamiento (presión arterial sistólica [TA] ? 180 y / o diastólica TA ? 110 )
    27. Diabetes con muy mal control metabólico (Hb1Ac ? 8,5 g / dl) o con lesión grave de órgano diana (enfermedad vascular periférica que precisa revascularización o no revascularizable, IRC con aclaramiento de creatinina ? 50 ml / min, ACVA en los 6 meses previos, enfermedad coronaria severa no revascularizable)
    28. Inmunodeficiencia primaria o adquirida o tratamiento con inmunosupresores (incluyendo tratamientos con inmunosupresores desde los tres meses previos o con corticoides sistémicos en el mes previo o previsión de necesidad de estos tratamientos durante el tiempo que dure el estudio)
    29. Hipercolesterolemia con muy mal control (colesterol total ? 250 mg / dL a pesar de tratamiento)
    30. Tabaquismo activo mayor o igual a 40 cigarrillos / día
    31. Uso recreativo de drogas que dañarían el corazón o la función cardiovascular, al menos una vez en los últimos 6 meses
    32. Consumo semanal de alcohol de más de 80 g por kg
    33. Mujeres en edad fértil que no estén de acuerdo en usar anticonceptivos durante el período de estudio y hasta 6 meses después
    34. Expectativa de vida de menos de 2 años por cualquier causa.
    35. Transfusión de sangre previa o actual o trasplante alogénico
    36. Alergia a los antibióticos del grupo de los aminoglucósidos
    37. Contraindicaciones que impidan el uso de la Resonancia Magnética por Imágenes.
    E.5 End points
    E.5.1Primary end point(s)
    Primary Endpoints: Safety variables
    - Any AE
    - MACE
    - Global mortality
    - Cardiovascular mortality
    Daily assessment of safety will be performed during the hospitalization phase; monthly evaluations will be performed during the first 6-months of follow-up and then quarterly assessments thereafter until the 12 months of the clinical trial.
    Dose-escalation phase: For the first 6 patients who comprise the dose-escalation phase of this protocol, the primary evaluation will be safety from the screening MRI performed and during the first week after administration of the therapy (AE and global mortality from any cause). Secondary evaluations will be identical to those at the randomized phase.
    Variables de Seguridad:
    - Cualquier AA
    - MACE
    - Mortalidad global.
    - Mortalidad cardiovascular.
    Se realizará una evaluación diaria de la seguridad durante la fase de hospitalización. Se realizarán evaluaciones mensuales de seguimiento durante los primeros 6 meses y a partir de entonces trimestrales hasta los 12 meses del ensayo clínico.
    Fase de escalado de dosis: La evaluación primaria para los 6 primeros pacientes incluidos en la fase de escalado de dosis será la seguridad desde la realización de la RM de screening y durante la primera semana tras la administración del tratamiento (AA y mortalidad global por cualquier causa). Las evaluaciones secundarias serán similares a las de la fase de aleatorización.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Daily assessment of safety will be performed during the hospitalization phase; monthly evaluations will be performed during the first 6-months of follow-up and then quarterly assessments thereafter until the 12 months of the clinical trial.
    Se realizará una evaluación diaria de la seguridad durante la fase de hospitalización. Se realizarán evaluaciones mensuales de seguimiento durante los primeros 6 meses y a partir de entonces trimestrales hasta los 12 meses del ensayo clínico.
    E.5.2Secondary end point(s)
    Efficacy Variables:
    1. Evolution of infarct size comparing the percentage of change with respect to the LV. The analysis will be performed by MRI at 6 and 12 months after treatment administration versus screening MRI and 1 month MRI.
    2. Evolution of edema: comparing the percentage of change at 1 month after treatment administration versus edema at the moment of the screening. The analysis will be by MRI.
    3. Evolution of the biomechanical parameters comparing the percentage of changes at 6 and 12 months after administration of the treatment versus the ones at the moment of the screening or at month 1 after the administration. The analysis will be by MRI.
    All analysis will be performed by comparing the population treated with CSCs versus the one treated with placebo.

    Clinical Parameters:
    1. BNP curve. Comparing the BNP levels one day prior to the PCI of administration and 6 and 12 months after treatment.
    2. CRP: comparing the CRP levels one day prior to the PCI of administration, at hospital discharge, and 1 month after treatment
    3. 6 minute walking test at hospital discharge and 6 and 12 months after treatment
    4. NYHA classification at hospital discharge and 6 and 12 months after treatment
    5. MLHFQ at hospital discharge and 6 and 12 months after treatment
    6. Hospital admission for HF during the 12 months of the clinical trial will be registered.
    7. Follow-up of all the cases of cardiovascular mortality during the whole clinical trial.
    All analysis will be performed by comparing the population treated with CSCs versus the one treated with placebo.
    Variables de Eficacia:
    1. Evolución del tamaño del infarto: comparando el cambio porcentual de la zona infartada con respecto al tamaño total del VI. El análisis se hará mediante RM a los 6 y 12 meses tras la administración del tratamiento frente a la RM del screening y la RM a 1 mes.
    2. Evolución de los parámetros biomecánicoscomparando su cambio porcentual en las RM a los 6 y 12 meses tras la administración del tratamiento, frente a la RM en el momento de la inclusión y a 1 mes tras la administración del tratamiento.
    3. Evolución del edema: comparando su cambio porcentual en la RM tras la administración del tratamiento frente a la RM de screening.

    Todos los análisis se realizarán comparando la población tratada con CSC frente a la tratada con placebo.

    Parámetros clínicos:
    1. Curva BNP. Se compararán los niveles de BNP un día antes del cateterismo de administración y a los 6 y 12 meses tras la administración del tratamiento.
    2. Proteína C-reactiva (PCR).Se compararán los niveles de PCR un día antes del cateterismo de administración, al alta hospitalaria y 1 mes tras la administración del tratamiento.
    3. Prueba de esfuerzo (?6 minute walking test?) se realizará esta prueba al alta hospitalaria y a los 6 y 12 meses tras la administración del tratamiento.
    4. Clasificación en la escala funcional de la NYHA al alta hospitalaria y a los 6 y 12 meses tras la administración el tratamiento.
    5. Se realizará el MLHFQ al alta hospitalaria y a los 6 y 12 meses tras la administración el tratamiento.
    6. Se registrarán los ingresos hospitalarios por IC durante el ensayo clínico.
    7. Se hará un seguimiento de los casos de mortalidad cardiovascular durante todo el ensayo clínico.

    Todos los análisis se realizarán comparando la población tratada con CSC frente a la tratada con placebo.
    E.5.2.1Timepoint(s) of evaluation of this end point
    First month and 6 and 12 months.
    Al mes y a los 6 y 12 meses.
    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 No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans Yes
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E. 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 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 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA4
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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 (Last Visit of the Last Subject)
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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 state41
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 55
    F.4.2.2In the whole clinical trial 55
    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)
    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 Decision2014-04-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-04-04
    P. End of Trial
    P.End of Trial StatusCompleted
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