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    The EU Clinical Trials Register currently displays   38963   clinical trials with a EudraCT protocol, of which   6398   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2009-010236-18
    Sponsor's Protocol Code Number:CSPP100A2368
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Restarted
    Date on which this record was first entered in the EudraCT database:2009-04-01
    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 number2009-010236-18
    A.3Full title of the trial
    Estudio multicéntrico, aleatorizado, doble ciego, de grupos paralelos, controlado con placebo para evaluar la eficacia y seguridad a 6 meses de la terapia de aliskiren, además de la terapia estándar, en la morbimortalidad cuando se inicia precozmente tras la hospitalización debido a insuficiencia cardíaca descompensada aguda.
    A.3.2Name or abbreviated title of the trial where available
    Astronaut
    A.4.1Sponsor's protocol code numberCSPP100A2368
    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 SponsorNovartis Farmacéutica 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 Information not present in EudraCT
    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 Film-coated 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 INNAliskiren
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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.IMP: 2
    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 Information not present in EudraCT
    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 Film-coated 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 INNAliskiren
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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 placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    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
    Insuficiencia Cardiaca aguda descompensada
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    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
    Comprobar si aliskiren, además de la terapia estándar, retrasa el tiempo hasta el primer acontecimiento de muerte cardiovascular o de rehospitalización debido a insuficiencia cardíaca, durante un período de 6 meses, en pacientes que presenten insuficiencia cardíaca descompensada aguda.
    E.2.2Secondary objectives of the trial
    Comprobar si aliskiren, además de la terapia estándar, retrasa el tiempo hasta el primer acontecimiento cardiovascular (que se define como muerte cardiovascular, hospitalización debido a IC, IM no fatal, accidente cerebrovascular no fatal, muerte súbita con reanimación) en pacientes hospitalizados debido a un acontecimiento de insuficiencia cardíaca aguda una vez estabilizados.
    Comprobar si aliskiren, además de la terapia estándar, reduce el tiempo hasta la mortalidad por todas las causas en pacientes hospitalizados debido a un acontecimiento de insuficiencia cardíaca aguda durante un período de 6 meses y hasta el final del estudio.
    Comprobar si aliskiren, además de la terapia estándar, reduce los niveles de BNP en pacientes hospitalizados debido a un acontecimiento de insuficiencia cardíaca aguda a 1 mes, 6 meses, 12 meses y al final del estudio.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Pacientes hospitalizados con un primer diagnóstico de empeoramiento de la insuficiencia cardíaca, ? 18 años de edad, hombres o mujeres.
    2. Pacientes con diagnóstico de insuficiencia cardíaca aguda que se manifiesta mediante síntomas (disnea o cansancio ? Clase III ? IV de la NYHA) y signos de sobrecarga de líquidos (es decir, distensión venosa yugular, edema o auscultación positiva de estertores o congestión pulmonar mediante radiografía de tórax) en el momento de la hospitalización.
    ? FEVI < 40% (medida durante los últimos 6 meses).
    ? Hospitalización debido a insuficiencia cardíaca descompensada aguda (ICDA) y que permanezcan ?estabilizados? durante al menos 6 horas (que se define como presión arterial sistólica (PAS) ? 110 mmHg tras un episodio descompensado agudo) y que no hayan recibido vasodilatadores i.v. (distintos a nitratos) y/o fármacos inotrópicos i.v. en cualquier momento desde la aparición de la ICDA hasta la aleatorización.
    3. Nivel elevado de BNP en la Visita 1 (BNP ? 400 pg/ml) (medido localmente)
    4. Pacientes con antecedentes de insuficiencia cardíaca crónica en terapia estándar, definidos como pacientes que precisen tratamiento para la IC durante al menos 30 días antes de la hospitalización actual, (Clase II ? IV de la NYHA)
    5. Consentimiento informado por escrito para participar en el estudio.
    6. Capacidad para cumplir todos los requisitos del estudio.
    E.4Principal exclusion criteria
    1. Pacientes que hayan requerido cualquier uso de vasodilatadores i.v. (salvo nitratos), y/o cualquier terapia inotrópica i.v. desde la aparición del empeoramiento de la IC hasta la aleatorización)
    2. Uso concomitante de IECA y ARA-II en la aleatorización
    3. Insuficiencia cardíaca derecha debido a enfermedad pulmonar
    4. Diagnóstico de miocardiopatía puerperal
    5. Infarto de miocardio o cirugía cardíaca, que incluya angioplastia coronaria transluminal percutánea (ACTP), en los últimos 3 meses.
    6. Pacientes con antecedentes de trasplante cardíaco o que están en lista de espera de trasplantes
    7. Angina de pecho inestable o arteriopatía coronaria que es probable que precisen de una derivación aortocoronaria (DAC) o angioplastia coronaria transluminal percutánea (ACTP) antes de la aleatorización.
    8. Arritmia ventricular sostenida con episodios de síncope en los últimos 3 meses que no esté tratada
    9. Presencia de estenosis mitral o regurgitación mitral hemodinámicamente significativas, excepto regurgitación mitral secundaria a dilatación ventricular izquierda
    10. Presencia de lesiones obstructivas hemodinámicamente significativas del tracto de salida del ventrículo izquierdo, incluida estenosis aórtica
    11. Presión arterial sistólica persistente < 110 mmHg
    12. Accidente cerebrovascular durante los últimos 3 meses
    13. Hepatopatía primaria que se considere que es potencialmente fatal
    14. Potasio sérico ? 5,0 mEql/L (5,0 mmol/L) en la Visita 2 (medido localmente)
    15. Hiponatremia grave < 130 mEq/l en la Visita 2 (medida localmente)
    16. Enfermedad renal o tasa de filtrado glomerular estimada (TFGe) < 40 ml/min/1,73m2 (medida según la fórmula MDRD) en la Visita 2 (medida localmente)
    E.5 End points
    E.5.1Primary end point(s)
    La variable de eficacia principal será el tiempo hasta el primer acontecimiento de muerte cardiovascular o rehospitalización debido a insuficiencia cardíaca en un período de 6 meses desde la aleatorización.
    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 Yes
    E.6.13.1Other scope of the trial description
    Ensayo de Morbilidad y Mortalidad
    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) 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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA482
    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
    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 months3
    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 months3
    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 state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 850
    F.4.2.2In the whole clinical trial 1782
    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 Decision2009-05-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-05-12
    P. End of Trial
    P.End of Trial StatusRestarted
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