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    The EU Clinical Trials Register currently displays   37211   clinical trials with a EudraCT protocol, of which   6120   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:2004-003870-27
    Sponsor's Protocol Code Number:RA2363
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2008-07-17
    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 number2004-003870-27
    A.3Full title of the trial
    ENOS: Efficacy of Nitric Oxide in Stroke. Estudio ENOS: Eficacia del óxido nítrico en el ictus
    A.3.2Name or abbreviated title of the trial where available
    ENOS
    A.4.1Sponsor's protocol code numberRA2363
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN99414122
    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 SponsorUniversity of Nottingham
    B.1.3.4CountryUnited Kingdom
    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 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.3.1Product namenitroglicerina
    D.3.4Pharmaceutical form Medicated plaster
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPTransdermal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNITROGLICERINA
    D.3.9.1CAS number 55-63-0
    D.3.9.3Other descriptive nameNITROGLICERINA
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Hipertensión en el ictus agudo
    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
    Evaluar el balance riesgo-beneficio de la reducción de la presión arterial con nitroglicerina (GTN) inmediatamente tras el ictus isquémico o hemorrágico
    E.2.2Secondary objectives of the trial
    Evaluar si el tratamiento hipotensor previo debería ser continuado o interrumpido temporalmente tras el ictus.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    a) Adultos (edad > 18 años).
    b) Síndrome de ictus clínico con debilidad en miembros que dure al menos una hora (es decir, que no se trate de un ataque isquémico transitorio).
    c) Debilidad en miembros (SNSS brazo <6 y/o pierna <6).
    d) Inicio < 48 horas. Si no se conoce el momento del inicio, se deberá usar la última hora conocida en la que el paciente se encontró bien. Este límite temporal permitirá incluir a la mayoría de pacientes seleccionables de otro modo y cubre el período de máxima incertidumbre relativo a la alteración de la tensión arterial.
    e) Consciente (escala de Glasgow > 8).
    f) No dependiente antes del ictus (escala de Rankin pre-mórbida < 2).
    g) Consentimiento coherente, o asentimiento por parte de un pariente o cuidador si el paciente no es capaz de proporcionarlo (por ejemplo, en casos de disfasia, confusión o nivel de consciencia reducido).
    E.4Principal exclusion criteria
    a) Necesidad firme de terapia con trinitrato: por ejemplo, infarto concurrente de miocardio, angina inestable, fallo en el ventrículo izquierdo. Los pacientes ingresados que sigan una terapia con nitratos para el tratamiento de la angina estable podrán detener la misma durante el período de 7 días de tratamiento del ensayo.
    b) Contraindicaciones a la terapia con nitrato: por ejemplo, hipersensibilidad a los nitratos, deshidratación, hipovolemia, cardiomiopatía obstructiva hipertrófica, estenosis aórtica, taponamiento cardíaco, pericarditis constrictiva, estenosis mitral, anemia marcada, glaucoma de ángulo cerrado, sildenafil (Viagra) en un plazo de 24 horas.
    c) Necesidad firme de medicación anterior antihipertensiva o antianginosa: por ejemplo, angina concurrente o fallo en el ventrículo izquierdo.
    d) Necesidad firme de terapia antihipertensiva durante el ictus agudo: por ejemplo, encefalopatía hipertensiva concurrente o disección de aorta.
    e) Tensión arterial sistólica < 140 mmHg o > 220 mmHg.
    f) Pacientes que es probable que necesiten una intervención quirúrgica, según las investigaciones actuales (por ejemplo, evacuación de coágulos, endarterectomía carotídea) durante el tratamiento o seguimiento del paciente.
    g) Patología intracerebral conocida aparte del ictus, por ejemplo, hemorragia subaracnoidea, tumor cerebral, absceso cerebral.
    h) Otra afección grave que pueda impedir la valoración tras 3 meses, como por ejemplo, un cáncer avanzado.
    i) Participación previa en ENOS o participación actual en otro ensayo relacionado con una intervención farmacológica experimental.
    j) Pacientes a los que no se pueda realizar un seguimiento, como por ejemplo, los que carecen de un domicilio fijo, o los visitantes extranjeros.
    k) Mujeres en edad fértil, embarazo o lactancia.
    E.5 End points
    E.5.1Primary end point(s)
    Escala de Rankin modificada a los 90 días
    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 No
    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) 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 Yes
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA100
    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
    ENOS es un ensayo clínico en pacientes agudos y la duración del seguimiento del paciente es de 90 días. El final del ensayo será cuando el último paciente incluido alcance la visita de seguimiento de los 90 días
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months0
    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 No
    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
    muchos pacientes con ictus agudo son incapaces de otorgar su consentimiento debido a la naturaleza de su enfermedad
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state500
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 3000
    F.4.2.2In the whole clinical trial 5000
    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)
    En este ensayo, el fármaco en investigación se emplea para tratar la hipertensión en la fase aguda del ictus hasta un máximo de 7 días. La medicación antihipertensiva habitual se comienza después de 7 días y continua hasta que el paciente ha completado el periodo de seguimiento
    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 Decision2008-10-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-07-17
    P. End of Trial
    P.End of Trial StatusOngoing
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