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    The EU Clinical Trials Register currently displays   43931   clinical trials with a EudraCT protocol, of which   7307   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2009-011779-65
    Sponsor's Protocol Code Number:ACA-SPAI-2008-20
    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:2010-04-14
    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 number2009-011779-65
    A.3Full title of the trial
    Comparación entre la administración de Levosimendan o placebo en la preparación de pacientes críticos que deben intervenirse de cirugía cardíaca.
    A.4.1Sponsor's protocol code numberACA-SPAI-2008-20
    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 SponsorFundació Privada Institut de Recerca de l?Hospital de la Santa Creu i Sant Pau
    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 RoleComparator
    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 Intravenous 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 µg/kg microgram(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.1
    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 placeboIntravenous 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
    Pacientes candidatos para cirugía cardíaca de revascularización coronaria por insuficiencia mitral isquémica, con o sin corrección de la válvula mitral por insuficiencia mitral isquémica.
    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
    El objetivo primario del presente estudio es comparar la mortalidad en el postoperatorio inmediato (hasta 30 días) y la mediata (60 y 90 días) en pacientes con FE ? 35% intervenidos de cirugía cardíaca no emergente que reciban levosimendan o placebo durante las 12 horas previas a una cirugía cardíaca de revascularización coronaria.
    E.2.2Secondary objectives of the trial
    - Requerimientos de fármacos inotrópicos o vasoactivos a dosis altas (hasta el alta hospitalaria o hasta los 30 días).
    - Valorar la mortalidad a medio y a largo plazo, es decir, a los 2, 3 y 6 meses, al año y a los 2 años.
    - Seguridad del tratamiento en cuanto a acontecimientos adversos.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Hombre o mujer de edad > 18 y < 85 años.
    2. FEVI &#8804; 35%
    3. Indicación de cirugía electiva de revascularización coronaria, con o sin reparación de la válvula mitral.
    4. Aceptación libre de participar en el ensayo, con consentimiento informado por escrito por parte del paciente.
    E.4Principal exclusion criteria
    1. Que el paciente no acepte el protocolo.
    2. Alergia (hipersensibilidad) al levosimendan o a alguno de sus componentes o a la riboflavina.
    3. Hipotensión grave o taquicardia severa antes de entrar en el estudio.
    4. Obstrucción mecánica significativa que afecte al llenado o al vaciado ventricular o a ambos.
    5. Historia de Torsade de Pointes.
    6. Requerimiento de fármacos inotrópicos o vasoactivos o cualquier tipo de asistencia mecánica durante las 48 horas previas a la intervención.
    7. Aparición de angor o Infarto agudo de Miocardio durante las 48 horas anteriores a la cirugía, o shock cardiogénico.
    8. Necesidad de una cirugía distinta a la planeada.
    9. Insuficiencia renal crónica o grave con necesidad de hemodiálisis o diálisis peritoneal ó valores de aclaramiento de creatinina por debajo de 30mL/min o presencia de síndrome nefrótico.
    10. Insuficiencia hepática con transaminasas 4 veces por encima del valor máximo normal.
    11. Que el paciente deba ser sometido a alguna cirugía programada concomitante, como por ejemplo de una válvula distinta de la mitral u otra cirugía.
    12. Cuando no sea posible realizar una visita de cribaje al menos durante las 24 horas previas a la cirugía.
    13. Diabetes Mellitus no controlada (glucosa en sangre > 24 mmol/L ó 432 mg/dL)
    14. Historia durante los 5 años previos de alguna patología que pudiera comprometer la vida del paciente, distinta de su enfermedad cardíaca.
    15. El paciente presenta en la actualidad abuso de alcohol o de sustancias tóxicas.
    16. Presencia de otra enfermedad médica o psiquiátrica que a opinión del investigador, haga que el candidato no sea elegible para el estudio.
    17. Mujeres con potencial de embarazo que no estén siguiendo un método contraceptivo eficaz.
    18. Participación en los 30 días previos en cualquier otro estudio ya sea con medicamentos experimentales o dispositivos.
    19. Índice de Masa Corporal (IMC) superior a 35.
    20. Administración de levosimendan en los últimos 30 días.
    E.5 End points
    E.5.1Primary end point(s)
    Mortalidad en el postoperatorio inmediato (hasta 30 días) y morbilidad grave, definida como la aparición de alguna de las siguientes alteraciones:

    • IAM de nueva aparición,
    • Insuficiencia cardíaca con necesidad de ventilación asistida, en el post-operatorio inmediato,
    • Necesidad de dobutamina, adrenalina o milrinona a dosis altas en el post-operatorio inmediato (dobutamina > 10 µg/Kg/min, adrenalina > 0,02 µg/kg/min, milrinona > 0,5 µg/Kg/min), o dos o más inotrópicos a cualquier dosis,
    • Insuficiencia Renal Aguda (IRA) con necesidad de furosemida en perfusión continua > 24 hrs o HFVV,
    • Ventilación Mecánica postoperatoria > 48 h,
    • Necesidad de Balón de Contrapulsación aórtico (IABP) o adrenalina o dobutamina o milrinona a dosis altas para separar al enfermo de la Circulación Extracorpórea (CEC),
    • Sepsis grave en el post-operatorio inmediato,
    • Accidente Vascular Cerebral (AVC).
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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 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 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 concerned14
    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 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
    Any early termination reason is defined, in addition of the death because for this trial the study medication is taken in a only visit, then in any case the end of the trial will be once is finished the follow up vists.
    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 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 2010-04-14. 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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state200
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 200
    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 Decision2010-06-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-11-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-11-06
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