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    The EU Clinical Trials Register currently displays   43861   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:2009-010615-32
    Sponsor's Protocol Code Number:PM1111810
    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:2010-02-18
    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 number2009-010615-32
    A.3Full title of the trial
    Estudio randomizado, doble ciego, controlado con placebo, para evaluar la seguridad del tratamiento durante 12 semanas con GW856553 y sus efectos en los marcadores inflamatorios, tamaño del infarto y función cardiaca de pacientes con infarto de miocardio sin elevación del segmento ST
    A.3.2Name or abbreviated title of the trial where available
    SOLSTICE: Study Of LoSmapimod Treatment on Inflammation and InfarCt SizE
    A.4.1Sponsor's protocol code numberPM1111810
    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 SponsorGlaxoSmithKline, S.A.
    B.1.3.4CountrySpain
    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 nameGW856553
    D.3.2Product code GW856553
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLosmapimod
    D.3.9.2Current sponsor codeGW856553
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number7.5
    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 placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Sujetos con infarto de miocardio sin elevación del segmento ST
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10064347
    E.1.2Term Non ST segment elevation myocardial infarction
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1. Valorar la seguridad de GW856553 en sujetos con IMSEST.
    2. Valorar los efectos de GW856553 sobre los biomarcadores de inflamación en sujetos con IMSEST durante las 12 semanas de tratamiento.
    3. Valorar los efectos de GW856553 en el tamaño del infarto y la función cardíaca durante el período en torno al infarto y en las 12 semanas de tratamiento siguientes.
    E.2.2Secondary objectives of the trial
    Se valorarán diferentes objetivos exploratorios, incluyendo flujo/presión coronaria, farmacocinética/farmacodinamia y calidad de vida.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Hay dos sub-estudios; There are two sub-studies; un subestudio de resonancia magnética cardiaca y un subestudio de flujo y presión coronarios. Ambos se describen en el protocolo, por lo que no tienen versión y fecha diferentes.
    El propósito del subestudio de resonancia magnética cardiaca es determinar el tamaño del infarto de miocardio mediante resonancia magnética.
    La justificación para el subestudio de flujo y presión coronarios es que la reserva de flujo coronario y la reserva fraccional de flujo son buenos predictores de tasas de eventos coronarios.
    E.3Principal inclusion criteria
    1. Sujetos con IMSEST, definido como:
    ? síntomas (p. ej., dolor torácico, disnea) compatibles con síndrome coronario agudo de al menos 10 minutos de duración; los más recientes deben haber ocurrido en las 24 horas previas a la presentación,
    ? sin elevación del segmento ST persistente en el ECG de 12 derivaciones al ingreso y
    ? con troponina (T o I) por encima del límite superior normal (LSN) del centro local en las 12 horas siguientes a la presentación.
    2. Sujetos que puedan aleatorizarse en las 18 horas siguientes a la presentación.
    3. Sujetos en quienes sea probable una ICP en las 2 a 48 horas siguientes a la aleatorización [los que no se sometan a ICP no se retirarán del estudio].
    4. Sujetos de ambos sexos de 45 a 81 años de edad.
    5. Una mujer será elegible para participar si:
    ? No está en edad fértil; se entiende por tales a las mujeres premenopáusicas con ligadura de trompas o histerectomía documentada, o a las posmenopáusicas, definidas como 12 meses de amenorrea espontánea [en los casos dudosos será confirmatoria una muestra de sangre con valores simultáneos de folitropina (FSH) > 40 MIU/ml y de estradiol < 40 pg/ml (< 140 pmol/l)], o
    ? Está en edad fértil y acepta usar uno de los métodos anticonceptivos enumerados en la sección 8.1 durante la totalidad de la administración y hasta la primera visita de seguimiento (~2 semanas después de la última dosis).
    6. Prueba de embarazo en orina o suero negativa (sólo en mujeres en edad fértil).
    7. Los varones deberán comprometerse a utilizar uno de los métodos anticonceptivos enumerados en la sección 0. Este criterio deberá seguirse desde el momento de la primera dosis de la medicación del estudio hasta la primera visita de seguimiento (~2 semanas después de la última dosis).
    8. QTcB o QTcF menores o iguales de 530 ms.
    9. Es capaz de dar su consentimiento informado por escrito, que implica el cumplimiento de los requisitos y las limitaciones enumeradas en el impreso de consentimiento.
    E.4Principal exclusion criteria
    1. Antecedentes de insuficiencia cardíaca grave, definida como clase III o IV de la NYHA, o sujetos con disfunción grave del VI [fracción de eyección (FE) < 30 %], con independencia del estado sintomático.
    2. Sospecha de disección aórtica.
    3. Estenosis aórtica grave u otra valvulopatía grave.
    4. Proceso amenazante de la vida conocido en curso distinto de enfermedad vascular (p. ej., enfermedad crónica grave de las vías aéreas) que pueda impedir que un sujeto complete el estudio.
    5. Sujetos con artritis reumatoide, trastornos del tejido conjuntivo y otros procesos que se sabe que están asociados con inflamación crónica o aguda activa (p. ej., enfermedad intestinal inflamatoria, osteomielitis, neumonía, etc.).
    6. Antecedentes de miopatía o rabdomiólisis.
    7. Antecedentes actuales o crónicos de hepatopatía, anomalías hepáticas o biliares conocidas (a excepción del síndrome de Gilbert o cálculos biliares asintomáticos).
    8. Positividad conocida para la hepatitis B o C.
    9. Uso actual o previsto de esteroides (orales, inhalados o IV).
    10. Uso actual o previsto de sustratos de BCRP con un índice terapéutico estrecho (p. ej., daunorubicina, doxorubicina, topotecán, mitoxantrona); véase la sección 0.
    11. Antecedentes de enfermedad maligna distinta de cáncer de piel distinto del melanoma.
    12. Abuso conocido de alcohol, fármacos o drogas en los últimos 6 meses.
    13. Exposición previa a GW856553.
    14. Uso de otro producto en investigación en los 30 días o 5 semividas (el plazo más largo) anteriores a la primera dosis del PI en el estudio actual.
    15. Cualquier otro sujeto a quien el investigador no considere apto para el estudio (p. ej., por motivos médicos, anomalías analíticas, previsión de incumplimiento de la medicación del estudio).
    16. Falta de disposición o incapacidad para seguir los procedimientos expuestos en el protocolo.
    E.5 End points
    E.5.1Primary end point(s)
    - Criterios de valoración de seguridad:
    Se hará una evaluación de la seguridad valorando todos los acontecimientos adversos, los acontecimientos cardiovasculares adversos mayores (ACAM) definidos en la sección 0, los análisis de laboratorio de seguridad (incluidos los valores de la función hepática), las constantes vitales y los parámetros del ECG de 12 derivaciones.
    - Criterios de valoración inflamatorios:
    PCRas en la semana 12

    - Criterios de valoración del tamaño de infarto de miocardio y la función cardiaca
    AUC de TnIc durante 72 horas tras la aleatorización o hasta el alta hospitalaria (lo que antes ocurra)
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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) 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 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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA35
    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
    Según se recoge en la sección 10.4 del protocolo:

    No habrá tratamiento con GW856553 después del final del estudio. Los sujetos incluidos en este estudio ya estarán recibiendo la asistencia habitual adecuada, que se continuará al final del estudio (a criterio del médico local del sujeto).
    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 months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial 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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 400
    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)
    ver sección 10.4 del protocolo
    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 Decision2010-04-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-04-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-03-06
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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