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    The EU Clinical Trials Register currently displays   38185   clinical trials with a EudraCT protocol, of which   6272   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2009-011441-11
    Sponsor's Protocol Code Number:LAICA/09
    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:2009-06-26
    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 number2009-011441-11
    A.3Full title of the trial
    Estudio Randomizado Doble Ciego y Controlado con Placebo Para Evaluar la Eficacia y Seguridad de la Administración Intermitente y a Largo Plazo de Levosimendan en Pacientes con Insuficiencia Cardiaca Avanzada (Estudio LAICA).
    A.3.2Name or abbreviated title of the trial where available
    LAICA
    A.4.1Sponsor's protocol code numberLAICA/09
    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 SponsorDr. Francisco Marrero Rodríguez. Hospital Universitario de Canarias
    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 holderABBOTT LABORATORIES, S.A.
    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.3.1Product nameSimdax
    D.3.2Product code 64154
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    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
    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 placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Insuficiencia Cardiaca avanzada
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9
    E.1.2Level LLT
    E.1.2Classification code 10019282
    E.1.2Term Heart failure (NOS)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Objetivo Principal: evaluar la incidencia de admisión o ingreso por empeoramiento o descompensación de la IC en pacientes con IC avanzada, definida ésta como primera admisión a servicios de urgencia o ingreso hospitalario mayor de 12 horas debidos a un empeoramiento de los síntomas de IC.
    E.2.2Secondary objectives of the trial
    •Tiempo contabilizado como días transcurridos desde la randomización hasta la primera hospitalización por descompensación de insuficiencia cardiaca, definida ésta como admisión a servicios de urgencia o ingreso hospitalario mayor de 12 horas debidos a un empeoramiento de los síntomas de insuficiencia cardíaca.
    •Mortalidad por cualquier causa.
    •Eventos Cardiacos Mayores (Muerte Súbita, Isquemia Coronaria/Infarto de miocardio, Descompensación de IC y ACV).
    •Muerte súbita.
    •ACV.
    •Acontecimientos adversos graves.
    •Cambio en la escala NYHA antes y después del inicio del tratamiento 30 días, 6 y 12 meses.
    •Efectos sobre la activación neurohormonal e inflamatoria en la IC (niveles de NT-proBNP; citocinas, etc).
    •Identificar los factores asociados a una mejor supervivencia de los pacientes.
    •Calidad de vida.
    •Relación Costes- Efectividad del Tratamiento.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    a)Edad mayor de 18 años
    b)Síntomas severos de IC con disnea y/o astenia en reposo o a mínimos esfuerzos (Clase funcional III y IV de la NYHA)
    c)Episodios de retención de líquidos (congestión venosa sistémica o pulmonar, edemas periféricos) y/o de bajo gasto cardiaco en reposo (hipoperfusión periférica)
    d)Evidencias objetivas de disfunción cardíaca severa determinada por la presencia de al menos uno de los siguientes:
    –Fracción de eyección ventricular izquierda &#61603; 30%
    –Una alteración severa de la función cardíaca en la ecocardiografía doppler con un patrón de flujo transmitral pseudonormal o restrictivo.
    –Una presión de llenado ventricular izquierdo elevada (PCP > 16 mmHg y/o PAD media > 12 mmHg por cateterización de la arteria pulmonar)
    –Niveles de BNP o NT-ProBNP elevados en ausencia de causas no cardíacas para ello.
    e)Alteración severa de la capacidad funcional puesta de manifiesto por uno de los siguientes:
    –Incapacidad para el ejercicio
    –Una distancia <300 m o inferior en mujeres y/o pacientes &#61619;75 años en el test de caminar 6 minutos
    –Un test de consumo miocárdico de oxígeno < 12-14 ml/kg/min.
    f)Historia previa de &#61619; 1 hospitalización por IC en los 6 meses previos
    g)Presencia de todos los anteriores criterios a pesar de los intentos de optimizar el tratamiento incluyendo diuréticos, inhibidores del sistema renina-angiotensina-aldosterona y betabloqueantes, a menos que estos fármacos no fuesen tolerados o estuviesen contraindicados, así como el tratamiento de resincronización cardíaca cuando estuviera indicado.
    h)Que consientan participar en el estudio.
    E.4Principal exclusion criteria
    a)Alergia o hipersensibilidad a Levosimendan u otros componentes de Simdax®.
    b)Insuficiencia renal severa (aclaramiento de creatinina < 30 ml/min)
    c)Insuficiencia hepática severa.
    d)Historia de enfermedad autoinmune.
    e)Embarazo.
    f)Mujeres en edad fértil que no utilicen métodos anticonceptivos adecuados
    g)(hormonales, D.I.U., barrera + espermicida)
    h)Enfermedades cardíacas con obstrucciones significativas al llenado o vaciado ventricular.
    i)Hipotensión arterial grave (Presión Arterial Sistólica &#61603; 90 mmHg).
    j)Presencia de taquicardia >120 lpm o historia previa de Torsades de Pointes.
    k)Enfermedad concomitante severa con pronóstico disminuido a corto plazo.
    l)Incapacidad para dar consentimiento informado.
    m)Participación en otro estudio.
    E.5 End points
    E.5.1Primary end point(s)
    La variable principal del estudio es determinar la incidencia de admisión o ingreso por empeoramiento o descompensación de la IC en pacientes con IC avanzada. Se define ésta como admisión a servicios de urgencia o ingreso hospitalario mayor de 12 horas debidos a un empeoramiento de los síntomas y signos de IC.
    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 Yes
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    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.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 years4
    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 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 state213
    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 Decision2009-09-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-03-30
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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