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    Summary
    EudraCT Number:2004-003870-27
    Sponsor's Protocol Code Number:ENOSPROTOCOL
    National Competent Authority:Greece - EOF
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2012-09-20
    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 ConcernedGreece - EOF
    A.2EudraCT number2004-003870-27
    A.3Full title of the trial
    A prospective, collaborative, international, multicentre, randomised, parallel-group, single and outcome blinded, controlled, factorial trial to investigate the safety and efficacy of treatment with transdermal glyceryl trinitrate, a nitric oxide donor, and of continuing or stopping temporarily pre-stroke antihypertensive therapy, in patients with acute stroke
    Μία προοπτική, συνεργατική, διεθνής, πολυκεντρική, τυχαιοποιημένη, παράλληλων ομάδων, μονή τυφλή, τυφλή ως προς την έκβαση, ελεγχόμενη, παραγοντική μελέτη για να διαπιστώσει την ασφάλεια και αποτελεσματικότητα της θεραπείας με διαδερμική χορήγηση τρινιτρικής γλυκερίνης, ενός δότη οξειδίου του αζώτου, και της συνέχισης ή προσωρινής διακοπής της προ του εγκεφαλικού επεισοδίου αντι-υπερτασικής αγωγής σε ασθενείς με οξύ αγγειακό εγκεφαλικό επεισόδιο.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The Efficacy of Nitric Oxide in Stroke (ENOS) Trial
    Μελέτη της ασφάλειας και της αποτελεσματικότητας του μονοξειδίου του αζώτου σε ασθενείς με οξύ αγγειακό εγκεφαλικό επεισόδιο
    A.3.2Name or abbreviated title of the trial where available
    ENOS
    A.4.1Sponsor's protocol code numberENOSPROTOCOL
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN99414122
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00989716
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorUniversity of Nottingham, ResearchHead of research grants and contractsInnovation Services
    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 supportMedical Research Council
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDivision of Stroke Medicine, Nottingham University
    B.5.2Functional name of contact pointENOS International Coordinating Cen
    B.5.3 Address:
    B.5.3.1Street AddressClinical Science Building, Nottingham City Hospital Campus
    B.5.3.2Town/ cityNottingham
    B.5.3.3Post codeNG5 1PB
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+ 44 115 8231770
    B.5.5Fax number+ 44 115 8231771
    B.5.6E-mailenos@nottingham.ac.uk
    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 Yes
    D.2.1.2Country which granted the Marketing AuthorisationGreece
    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 nameGlyceryl trinitrate Transdermal
    D.3.4Pharmaceutical form Transdermal patch
    D.3.4.1Specific paediatric formulation No
    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 INNGlyceryl trinitrate Transdermal
    D.3.9.2Current sponsor code04001
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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
    Stroke
    Αγγειακό εγκεφαλικό επεισόδιο
    E.1.1.1Medical condition in easily understood language
    Stroke
    Αγγειακό εγκεφαλικό επεισόδιο
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    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
    Assess the balance of risk and benefit of lowering blood pressure with GTN immediately after ischaemic and haemorrhagic stroke.
    Εκτίμηση κινδύνων και οφέλους από τη μείωση της αρτηριακής πίεσης με νιτρώδη στην οξεία φάση του ισχαιμικού και αιμορραγικού αγγειακού εγκεφαλικού επεισοδίου.
    E.2.2Secondary objectives of the trial
    Assess whether pre-stroke antihypertensive therapy should be continued or stopped temporarily after stroke.
    Εκτίμηση της συνέχισης ή προσωρινής διακοπής της προ του αγγειακού εγκεφαλικού επεισοδίου αντι-υπερτασικής αγωγής.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    a) Adult (age > 18 years).
    b) Clinical stroke syndrome with limb weakness lasting at least 1 hour (i.e. not likely to be a
    transient ischaemic attack).
    c) Residual limb weakness at the time of enrolment (SSS Arm <6 and/or Leg <6, appendix C).
    d) Onset < 48 hours. If the time of onset is unknown, apply the time when the patient was last
    known to be well. [This timeframe covers the period of maximum uncertainty over altering
    blood pressure and should permit the vast majority of otherwise eligible patients to be
    recruited]
    e) Conscious (Glasgow Coma Scale > 8).
    f) Systolic blood pressure in range 140 mmHg to 220 mmHg inclusive on the basis of at least
    one of the three baseline pre-randomisation measures.
    g) Independent prior to stroke (pre-morbid modified Rankin Scale < 2).
    h) Meaningful consent, or assent from a relative or carer if the patient is unable to give
    meaningful consent (e.g. in cases of dysphasia, confusion, or reduced conscious level).
    α) Ενήλικες (≥ 18 ετών).
    β) Κλινικό αγγειακό εγκεφαλικό επεισόδιο με αδυναμία άκρων διάρκειας τουλάχιστον 1 ώρας (δηλαδή, όχι πιθανό παροδικό ισχαιμικό επεισόδιο).
    γ) Υπολειπόμενη αδυναμία άκρων κατά την ένταξη.
    δ) Ένταξη ≤ 48 ώρες από την έναρξη των συμπτωμάτων.
    ε) Glasgow Coma Scale > 8.
    στ) Συστολική ΑΠ από 140 mmHg έως 220 mmHg.
    ζ) mRankin ≤ 2 προ του οξέος αγγειακού εγκεφαλικού επεισοδίου.
    η) Ουσιαστική σύμφωνη γνώμη ή συγκατάθεση από συγγενή ή φροντιστή αν ο ασθενής δεν είναι σε θέση να δώσει ουσιαστική συγκατάθεση (π.χ. σε περιπτώσεις αφασίας, σύγχυσης ή μειωμένου επιπέδου συνείδησης).
    E.4Principal exclusion criteria
    a) Definite need for nitrate therapy: e.g. concurrent myocardial infarction, unstable angina, left
    ventricular failure. Patients admitted on nitrates for the management of stable angina may
    stop these for the 7 day trial treatment period.
    b) Contraindication to nitrate therapy: e.g. hypersensitivity to nitrates, dehydration,
    hypovolaemia, hypertrophic obstructive cardiomyopathy, aortic stenosis, cardiac
    tamponade, constrictive pericarditis, mitral stenosis, marked anaemia, closed-angle
    glaucoma, sildenafil (Viagra) or related drug, within 24 hours.
    c) Definite need for pre-stroke antihypertensive, anti-anginal or anti-heart failure medication:
    e.g. concurrent angina, heart failure.
    d) Definite need for new antihypertensive, anti-anginal or anti-heart failure medication during
    acute stroke: e.g. concurrent angina, heart failure, hypertensive encephalopathy, aortic
    dissection.
    e) Patients expected, on the basis of existing investigations, to require surgical intervention
    (e.g. clot evacuation, carotid endarterectomy) during the treatment or follow-up period.f) Known intracerebral pathology other than stroke, e.g. subarachnoid haemorrhage, brain
    tumour, cerebral abscess.
    g) Other serious condition which is likely to prevent outcome assessment at 90 days, e.g.
    advanced cancer.
    h) Previous enrolment in ENOS.
    i) Current involvement in another trial of an experimental drug. [Patients may be randomised
    into observational studies or non-drug trials.]
    j) Not available for follow-up, e.g. no fixed address, overseas visitor.
    k) Females of childbearing potential where pregnancy cannot be excluded by a negative
    pregnancy test, pregnancy, or breastfeeding.
    l) Need for new antihypertensive therapy to lower systolic blood pressure to achieve the
    enrolment range of 140-220mmHg
    m) New (not prescribed pre-stroke) antihypertensive medication commenced after stroke onset
    α) Σαφής ανάγκη για θεραπεία με νιτρώδη: π.χ. ταυτόχρονο έμφραγμα του μυοκαρδίου, ασταθής στηθάγχης, ανεπάρκεια αριστερής κοιλίας.
    β) Αντενδείξεις για θεραπεία με νιτρώδη: π. χ. υπερευαισθησία σε νιτρώδη, αφυδάτωση, υποογκαιμία, υπερτροφική αποφρακτική μυοκαρδιοπάθεια, στένωση αορτής, καρδιακός επιπωματισμός, περιοριστική περικαρδίτιδα, μιτροειδική στένωση, εκσεσημασμένη αναιμία, γλαύκωμα κλειστής γωνίας, σιλδεναφίλη (Viagra) ή σχετικά φάρμακα, εντός 24 ωρών.
    γ) Σαφής ανάγκη για συνέχιση ή έναρξη θεραπείας με αντι-υπερτασική αγωγή, αντιστηθαγχική αγωγή, φαρμακευτική αγωγή καρδιακής ανεπάρκειας: π.χ. στηθάγχη, καρδιακή ανεπάρκεια.
    δ) Ασθενείς που αναμένεται, βάσει της υπάρχουσας διερεύνησης, να χρειαστούν χειρουργική παρέμβαση (π.χ. αφαίρεση θρόμβου, καρωτιδική ενδαρτηρεκτομή) κατά τη διάρκεια της περιόδου θεραπείας ή παρακολούθησης
    ε). Ασθενείς με γνωστή ενδοεγκεφαλική παθολογία εκτός του αγγειακού εγκεφαλικού επεισοδίου π.χ. υπαραχνοειδής αιμορραγία, όγκος στον εγκέφαλο, εγκεφαλικό απόστημα.
    στ) Άλλη σοβαρή πάθηση που είναι πιθανόν να εμποδίσει την εκτίμηση των καταληκτικών σημείων στις 90 ημέρες π.χ. καρκίνος σε προχωρημένο στάδιο.
    ζ) Προηγούμενη συμμετοχή στην ENOS
    η) Παράλληλη συμμετοχή σε άλλη μελέτη πειραματικού φαρμάκου.
    θ) Ο ασθενής δεν είναι διαθέσιμος για μετέπειτα παρακολούθηση π.χ. μη σταθερή διεύθυνση, επισκέπτης από το εξωτερικό.
    ι) Γυναίκες με δυνατότητα τεκνοποίησης όπου η εγκυμοσύνη δεν μπορεί να αποκλειστεί με αρνητικό τεστ εγκυμοσύνης , εγκυμοσύνη ή θηλασμό.
    ια) Ανάγκη για νέα αντιυπερτασική θεραπεία για τη μείωση της συστολικής ΑΠς ώστε να επιτευχθεί το επιθυμητό εύρος συμμετοχής από 140 mmHg έως 220 mmHg
    ιβ) Νέα (μη συνταγογραφούμενα προ του ΑΕΕ) αντιυπερτασικά φάρμακα χορηγούμενα μετά την εκδήλωση του ΑΕΕ.
    E.5 End points
    E.5.1Primary end point(s)
    Combined death or dependency (modified Rankin Score >2)
    Το πρωτεύον καταληκτικό σημείο είναι ο συνδυασμός θανάτου ή εξάρτησης (τροποποιημένος δείκτης Raknin >2).
    E.5.1.1Timepoint(s) of evaluation of this end point
    90 days after stroke onset
    90 ημέρες μετά από την εμφάνιση του αγγειακού εγκεφαλικού επεισοδίου
    E.5.2Secondary end point(s)
    -----
    -----
    E.5.2.1Timepoint(s) of evaluation of this end point
    -----
    -----
    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 No
    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 Yes
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Εφαρμογή ή μη αυτοκόλλητου κάτω από τον επίδεσμο απόκρυψης
    Patch or no patch under gauze dressing
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Εφαρμογή ή μη αυτοκόλλητου κάτω από τον επίδεσμο απόκρυψης
    Εφαρμογή ή μη αυτοκόλλητου κάτω από τον επίδεσμο απόκρυψης
    E.8.2.4Number of treatment arms in the trial2
    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 EEA130
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Canada
    Egypt
    Hong Kong
    India
    Malaysia
    New Zealand
    Philippines
    Singapore
    Sri Lanka
    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
    LVLS
    Τελευταία επίσκεψη τελευταίου ασθενή
    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 months7
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years13
    E.8.9.2In all countries concerned by the trial months0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    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 No
    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 No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Patients with acute stroke and aphasic disorders
    Ασθενείς με οξύ αγγειακό εγκεφαλικό επεισόδιο και αφασικές διαταραχές.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state300
    F.4.2 For a multinational trial
    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)
    Treatment according to current international guidelines of the European Stroke Organization and the American Stroke Association
    Θα ακολουθηθεί η ενδεδειγμένη αντιμετώπιση σύμφωνα με τις διεθνείς τρέχουσες οδηγίες της European Stroke Organization και της American Stroke Association
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-11-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-10-16
    P. End of Trial
    P.End of Trial StatusOngoing
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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