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    Summary
    EudraCT Number:2009-017827-24
    Sponsor's Protocol Code Number:LEVOPED1
    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:2009-12-07
    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 number2009-017827-24
    A.3Full title of the trial
    Eficacia y seguridad del levosimendan en el fallo cardiaco agudo grave en niños críticos
    A.4.1Sponsor's protocol code numberLEVOPED1
    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 SponsorJosé Luis Vázquez Martínez
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    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 SIMDAX 2,5 mg/ml concentrado para solución para perfusión
    D.2.1.1.2Name of the Marketing Authorisation holderORION CORPORATION
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 Information not present in EudraCT
    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 INNLEVOSIMENDAN
    D.3.9.1CAS number 141505-33-1
    D.3.9.3Other descriptive nameLEVOSIMENDAN
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Fallo cardiaco agudo grave en niños
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9
    E.1.2Level LLT
    E.1.2Classification code 10000803
    E.1.2Term Acute heart failure
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluar la eficacia del levosimendan en el tratamiento del fallo cardiaco agudo grave en niños críticos comparando la proporción de pacientes con mejoría hemodinámica a las 24 horas y 48 horas entre el grupo que recibió levosimendan como tratamiento de rescate (tratamiento experimental) frente al que recibió únicamente tratamiento inotrópico convencional (tratamiento control)
    E.2.2Secondary objectives of the trial
    1) comparar la mejoría del gasto cardiaco inducida por levosimendan en el tratamiento del FCA grave en niños críticos respecto al tratamiento inotrópico convencional a las 24 y 48h
    2) comparar la mejoría del perfil neurohormonal (evaluada como una reducción del BNP) inducido por levosimendan en el tratamiento del FCA grave en niños respecto al tratamiento inotrópico convencional a las 24 y 48h
    3) comparar el tiempo de estancia en UCIP y los días de ventilación mecánica a los 30 días
    4) valorar la seguridad del uso del levosimendan en el FCA grave en niños críticos a los 30 días
    5) supervivencia a los 30 días
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ·Pacientes, que tras haber recibido información sobre el diseño, los fines del estudio, los posibles riesgos que de él pueden derivarse y de que en cualquier momento pueden denegar su colaboración, otorguen por escrito su consentimiento para participar en el estudio
    ·Entender el propósito del estudio y estar disponibles para realizar los procedimientos escritos en el protocolo
    ·Cualquier niño de 1 día de vida a 18 años de edad, ingresado en UCIP por fallo cardiaco agudo grave de cualquier
    ·Definimos FCA grave como la persistencia del FCA pese al uso de tratamiento inotrópico convencional, con presencia de hipotensión arterial (TA media <35 mmHg en neonatos, <45 mmHg en lactantes y <55 mmHg en niños), oliguria (diuresis menor de 0,5 ml/kg/h), mala perfusión periférica (tiempo de relleno capilar superior a 2 segundos o gradiente térmico central-periférico mayor de 3ºC) y disfunción ventricular (fracción de eyección < 30%) con alguno de los siguientes datos:
    lactacidemia > 2 mMol/L
    SatO2 en sangre venosa mixta < 60% en acianóticos ó < 50% en cianóticos
    gasto cardiaco < 3,3 L/min/m2
    E.4Principal exclusion criteria
    Todos aquellos pacientes que
    ·manifiesten su deseo de no participar en el protocolo
    ·presenten de miocardiopatía hipertrófica o restrictiva
    ·presenten estenosis aórtica
    ·presenten alergia conocida a cualquier fármaco utilizado en el estudio
    ·en los que no se pueda prescribir la medicación del estudio por estar contraindicada según ficha técnica, o a criterio del médico responsable del enfermo
    ·se encuentren embarazadas
    E.5 End points
    E.5.1Primary end point(s)
    La eficacia se define como el porcentaje de pacientes con mejoría hemodinámica a las 24 y 48 horas de iniciado el tratamiento, considerada esta como la normalización de tensión arterial media (TA media > 35 mmHg en neonatos, > 45 mmHg en lactantes y > 55 mmHg en niños), de la perfusión periférica (tiempo de relleno capilar < 2 segundos o gradiente térmico central-periférico < 3ºC) y de la diuresis (> 0,5 ml/kg/hora) asociada a un
    ·descenso del 50% de la lactacidemia, o
    ·descenso del 15% del tratamiento convencional (medido por el score inotrópico, ver más adelante), o
    ·incremento del 15% de SatO2 en sangre venosa mixta, o
    ·incremento del 15% de la fracción de eyección.
    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) 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) 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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    tratamiento inotrópico convencional
    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 concerned21
    E.8.5The trial involves multiple Member States No
    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 Information not present in EudraCT
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    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 months0
    E.8.9.1In the Member State concerned days0
    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) Yes
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    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 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 Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Menores incapaces en situación de urgencia
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state106
    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 Decision2010-03-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-03-10
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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