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    The EU Clinical Trials Register currently displays   43857   clinical trials with a EudraCT protocol, of which   7284   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:2008-000622-40
    Sponsor's Protocol Code Number:12402A
    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:2008-11-24
    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 number2008-000622-40
    A.3Full title of the trial
    Estudio fase III, aleatorizado, doble ciego, de grupos paralelos controlado con placebo, para evaluar la eficacia y seguridad de desmoteplasa en el tratamiento del infarto cerebral isquémico agudo
    A.3.2Name or abbreviated title of the trial where available
    DIAS-3
    A.4.1Sponsor's protocol code number12402A
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberN/A
    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 SponsorH. Lundbeck A/S
    B.1.3.4CountryDenmark
    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 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 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.3.1Product namedesmoteplase
    D.3.2Product code Lu-AE03329
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous bolus use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNdesmoteplasa
    D.3.9.1CAS number 145137-38-8
    D.3.9.2Current sponsor codeLu-AE03329
    D.3.9.3Other descriptive nameActivador del plasminógeno alpha 1, rDSPAα1, ZK 152 387 recombinante de la saliva de Desmodus
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number9
    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) Yes
    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 Yes
    D.3.11.13.1Other medicinal product typeProteína terapéutica recombinante
    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 placeboPowder for solution for injection
    D.8.4Route of administration of the placeboIntravenous bolus use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Infarto cerebral isquémico agudo en las 3 - 9 horas después del inicio de los síntomas
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10055221
    E.1.2Term Ischemic stroke
    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 de 90 µg/kg de desmoteplasa versus placebo en la mejoría clínica de los sujetos con infarto cerebral isquémico agudo a los 90 días
    E.2.2Secondary objectives of the trial
    • Evaluar la eficacia de 90 µg/kg de desmoteplasa versus placebo en la mejoría clínica en los sujetos con infarto cerebral agudo isquémico en el Día 7/alta hospitalaria y en el Día 30
    • Evaluar la eficacia de 90 µg/kg desmoteplasa versus placebo en la mejoría clínica en el Día 90 en el subgrupo de sujetos con una lesión central basal con un volumen < 25 cc
    • Evaluar la recanalización asociada con la administración 90 µg/kg de desmoteplasa versus placebo en el subgrupo de sujetos con una angiografía de seguimiento a las 12-24 horas
    • Evaluar la seguridad y tolerabilidad de desmoteplasa
    • Evaluar la mortalidad en los grupos de tratamiento
    • Evaluar la incidencia de hemorragias intracraneales sintomáticas (sICH)
    • Evaluar la inmunogenicidad de desmoteplasa
    • Evaluar la farmacocinética/farmacodinámica de desmoteplasa
    • Evaluar el impacto del tratamiento en la calidad de vida de los sujetos
    • Evaluar el impacto del tratamiento en la utilización de recursos asistenciales
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Diagnóstico clínico de infarto cerebral isquémico agudo
    • Obtención del consentimiento informado de acuerdo con los procedimientos aprobados por el comité ético responsable de la aprobación del ensayo en el centro
    • El sujeto es hombre o mujer con edades comprendidas entre los 18-85 años (ambos extremos incluidos)
    • El tratamiento del sujeto debe iniciarse entre las 3-9 horas después del inicio de los síntomas del infarto cerebral. Si la hora precisa del comienzo de los síntomas no está clara entonces se considerará como inicio de los síntomas la hora en la que se sabe que el sujeto se encontró bien por última vez. Se deberán tomar todas las medidas necesarias para que el tratamiento con alteplasa dentro de las 3 primeras horas tras el inicio de los síntomas no se retrase en aquellos sujetos para los que esté indicada alteplasa
    • Sujetos con una puntuación entre 4-24 (extremos incluidos) en el NIHSS con signos clínicos de infarto hemisférico (por ejemplo hemiparesia)
    • El sujeto presenta oclusión o estenosis de grado alto valorada por RM o CTA en las arterias cerebrales proximales que se corresponda con el déficit clínico agudo. Los vasos de elección son la arteria cerebral media (MCA) M1, MCA M2, arteria cerebral anterior (ACA) o arteria cerebral posterior (PCA)
    • El sujeto debería recibir IMP en los 60 minutos tras habérsele completado el diagnóstico de selección por imagen
    E.4Principal exclusion criteria
    • El sujeto tiene una puntuación en la mRS previa al infarto cerebral > 1 indicativa de incapacidad previa
    • Sujetos que hayan recibido previamente desmoteplasa
    • Si el sujeto presenta signos de infarto extensivo temprano en la imagen por MR o TC en cualquier área afectada, es decir un núcleo del tejido isquémico que afecta a >1/3 del territorio MCA o a >1/2 de los territorios ACA o PCA
    • Sujetos que presenten evidencia mediante técnicas de imagen de una ICH o SAH (independientemente de la antigüedad de la hemorragia); malformaciones AV; aneurismas cerebrales; o neoplasia cerebral (meningiomas y microsangrados fortuitos per se no son criterios de exclusión. Un aneurisma intracraneal fortuito no trombosado, de tamaño pequeño (< 5 mm), y sin sangrado visible, no constituye un criterio de exclusión)
    • Sujetos con una oclusión de la arteria carótida interna en el lado de la lesión infartada
    • Sujetos tratados con heparina en las últimas 48 horas y con un tiempo parcial de tromboplastina alargado superior al límite superior de los rangos normales del laboratorio local. Dosis bajas preventivas de heparina de bajo peso molecular (LMWH) (por ejemplo para la profilaxis de la trombosis venosa profunda (DVT)) no descalifica al sujeto para el estudio
    • Sujetos que tomen actualmente anticoagulantes orales y presenten un tiempo de protrombina alargado (INR>1.6)
    • Sujetos tratados en las últimas 72 horas con inhibidores de la glicoproteina IIb - IIIa. El uso de un único inhibidor oral plaquetario (dosis bajas de clopidogrel 75 mg o dosis bajas de aspirina ≤325 mg) o bien la combinación de dosis bajas de aspirina (50 mg) y dipiridamol (400 mg) están permitidos antes de la inclusión del sujeto en el ensayo
    • El sujeto ha sido tratado con inhibidores del factor Xa en las últimas 72 horas
    • El sujeto ha sido tratado con un agente trombolítico en las últimas 72 horas
    E.5 End points
    E.5.1Primary end point(s)
    Mejoría clínica de los sujetos con infarto cerebral isquémico agudo a los 90 días definida por una puntuación en la mRS de 0-2
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Inmunogenicidad
    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.8.3 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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA45
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    N/A
    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 months3
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months3
    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 2008-11-24. 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 Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Estos sujetos pueden ser incluidos por persona vinculada a ellos por razones familiares/de hecho. Si esta persona no estuviera disponible, entonces el médico que trata al sujeto y otro médico independiente al estudio podrán incluirle.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state45
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 225
    F.4.2.2In the whole clinical trial 320
    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)
    N/A
    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 Decision2009-02-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-01-16
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-07-07
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