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    Summary
    EudraCT Number:2014-000583-18
    Sponsor's Protocol Code Number:1160.108
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-07-14
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2014-000583-18
    A.3Full title of the trial
    Open label, single arm safety prospective cohort study of dabigatran etexilate for secondary prevention of venous thromboembolism in children from 0 to less than 18 years
    Studio prospettico, in aperto, con dabigatran etexilato, per la prevenzione secondaria della tromboembolia venosa in bambini dalla nascita fino ai 18 anni.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety of dabigatran etexilate in blood clot prevention in children
    Valutazione del profilo di sicurezza di dabigatran etexilato nella prevenzione dei coaguli sanguigni nei bambini.
    A.4.1Sponsor's protocol code number1160.108
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/007/2014
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorBoehringer Ingelheim Italia S.p.A.
    B.1.3.4CountryItaly
    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 supportBoehringer Ingelheim Italia S.p.A.
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBoehringer Ingelheim Pharma GmbH & Co. KG
    B.5.2Functional name of contact pointQRPE pSC CT Information Disclosure
    B.5.3 Address:
    B.5.3.1Street AddressBinger Strasse 173
    B.5.3.2Town/ cityIngelheim am Rhein
    B.5.3.3Post code55216
    B.5.3.4CountryGermany
    B.5.4Telephone number+18002430127
    B.5.5Fax number+18008217119
    B.5.6E-mailclintriage.rdg@boehringer-ingelheim.com
    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 namedabigatran etexilate, 50 mg
    D.3.2Product code BIBR 1048 MS
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation Yes
    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 INNDABIGATRAN ETEXILATE
    D.3.9.2Current sponsor codeBIBR 1048 MS
    D.3.9.4EV Substance CodeSUB20521
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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.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 Yes
    D.2.1.1.1Trade name Pradaxa
    D.2.1.1.2Name of the Marketing Authorisation holderBoehringer Ingelheim International GmbH
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 namedabigatran etexilate, 75 mg
    D.3.2Product code BIBR 1048 MS
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    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 INNDABIGATRAN ETEXILATE
    D.3.9.2Current sponsor codeBIBR 1048 MS
    D.3.9.4EV Substance CodeSUB20521
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    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.IMP: 3
    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.2.1.1.1Trade name Pradaxa
    D.2.1.1.2Name of the Marketing Authorisation holderBoehringer Ingelheim International GmbH
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 namedabigatran etexilate, 110 mg
    D.3.2Product code BIBR 1048 MS
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    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 INNDABIGATRAN ETEXILATE
    D.3.9.2Current sponsor codeBIBR 1048 MS
    D.3.9.4EV Substance CodeSUB20521
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number110
    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
    Secondary prevention of venous thromboembolism
    Prevenzione secondaria del tromboembolismo venoso
    E.1.1.1Medical condition in easily understood language
    Prevention of blood clots in the veins
    Prevenzione dei coaguli sanguigni nelle vene
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level LLT
    E.1.2Classification code 10049909
    E.1.2Term Venous thromboembolism prophylaxis
    E.1.2System Organ Class 100000004865
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the safety of dabigatran etexilate used for secondary prevention of venous thromboembolism in children from 0 to less than 18 years of age.
    valutare la sicurezza di dabigatran etexilato nella prevenzione secondaria della tromboembolia venosa (TEV) in età pediatrica.
    E.2.2Secondary objectives of the trial
    Not applicable
    non applicabile
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Male or female subjects 0 to less than 18 years of age at the time of informed consent / assent
    - Previously documented objective diagnosis of VTE, followed by completed course of initial VTE treatment (for at least 3 months) or completed study treatment (i.e. reached Visit 8) in the 1160.106 trial
    - Presence of an unresolved clinical risk factor requiring further anticoagulation for secondary VTE prevention (e.g. central venous line, underlying disease, thrombophilia, etc.)
    - Written informed consent form (ICF) provided by the patient's parent or legal guardian and assent provided by the patient (if applicable) at the time of ICF signature according to local regulations.
    1)Maschi o femmine da 0 a < 18 anni di età al momento della firma del consenso/assenso informato.
    2)Diagnosi oggettiva e documentata in precedenza di TEV, seguita da un ciclo completo di trattamento iniziale per TEV (almeno 3 mesi), o completamento del trattamento dello studio 1160.106 (cioè raggiungimento della Visita 8) fino alla Visita 1 di questo studio.
    3)Presenza di un fattore clinico di rischio non risolto che richieda un successivo trattamento anticoagulante per la prevenzione secondaria della TEV (es. linea venosa centrale, malattia concomitante, trombofilia, ecc..).
    4)Consenso informato scritto fornito dal genitore del paziente (o tutore legale) e assenso fornito dal paziente (se applicabile) al momento della firma del consenso informato, in accordo alle leggi locali.
    E.4Principal exclusion criteria
    - Conditions associated with an increased risk of bleeding
    - Renal dysfunction (eGFR < 80 mL/min/1.73m2 using the Schwartz formula) or requirement for dialysis
    - Active infective endocarditis
    - Subjects with a mechanical or a biological heart valve prosthesis
    - Hepatic disease: Active liver disease, including known hepatitis A, B or C or Persistent alanine aminotransferase (ALT) or aspartate transaminase (AST) or alkaline phosphatase (AP) > 2 × upper limit of normal (ULN) within 3 months of screening
    - Pregnant or breast feeding females. Females who have reached menarche and are not using an acceptable method of birth control, or do not plan to continue using this method throughout the study and / or do not agree to adhere to pregnancy testing required by this protocol
    - Anemia (hemoglobin < 80g/L) or thrombocytopenia (platelet count < 80 x 109/L) at screening. Transfusions during the screening period are allowed, provided that a satisfactory hemoglobin or platelet level is attained prior to visit 2
    - Patients who have taken restricted medication prior to first dose of study medication
    - Patients who have received an investigational drug in the past 30 days prior to screening, except patients who have completed the treatment period (up to Visit 8) in 1160.106 trial
    - Patients who are allergic/sensitive to any component of the study medication including solvent
    - Patients or parents/legal guardians considered unreliable to participate in the trial per investigator judgment or any condition which would present a safety hazard to the patient based on investigator judgment
    1)Condizioni associate ad un incremento del rischio di sanguinamento:
    a)Ogni precedente emorragia intracranica
    b)Chirurgia intracranica o intraspinale entro 6 mesi da visita 2 o qualsiasi altra chirurgia maggiore entro 4 settimane da visita 2. Le chirurgie maggiori possono includere un intervento invasivo su un organo del cranio, petto, addome, cavità pelvica o qualsiasi altra procedura considerata maggiore secondo il giudizio dello sperimentatore. In generale, nelle chirurgie maggiori, viene aperta una barriera mesenchimale (cavità pleurica, peritoneo, meningi). La rimozione di una linea venosa centrale non è considerata chirurgia maggiore.
    c)Qualsiasi procedura maggiore pianificata che possa esporre il paziente ad un aumentato rischio di sanguinamento, secondo il giudizio dello sperimentatore, nei 5 giorni precedenti l’inizio dell’assunzione del farmaco (V2).
    d)Storia di sanguinamento intracranico, intraoculare, spinale, retroperitoneale o intra-articolare atraumatico, tranne il caso in cui il fattore causa sia stato definitivamente trattato (es. con chirurgia).
    e)Emorragia gastrointestinale nel corso dell’ultimo anno prima dello screening a meno che la causa sia stata definitivamente eliminata (es. con chirurgia).
    f)Anamnesi di ulcera gastrointestinale.
    g)Anamnesi di disturbi emorragici o diatesi emorragica (es. malattia di Willebrand, emofilia di tipo A o B o altri disordini emorragici ereditari, storia di sanguinamento intrarticolare spontaneo, storia di sanguinamento prolungato dopo un intervento/chirurgia).
    h)Agenti fibrinolitici entro 48 ore dalla somministrazione di dabigatran (l’uso di attivatori del plasminogeno tissutale (t-PA), es. alteplase, o di altri agenti trombolitici per ristabilire la pervietà delle linee venose centrali è consentito se la dose utilizzata è priva di effetti sistemici rilevanti).
    i)Ipertensione non controllata nonostante la terapia antipertensiva (sistolica e/o diastolica al di sopra del limite superiore del valore di normalità per l’età e sostenute per oltre 24 ore).
    j)Qualsiasi altra malattia, condizione di salute o intervento che secondo il giudizio dello sperimentatore possa esporre il paziente ad un maggiore rischio di sanguinamento.
    2)Disfunzione renale (eGFR < 80mL/min/1.73m2 utilizzando la formula di Schwartz, consultare l’Appendice 10.1 del protocollo di studio) o necessità di dialisi.
    3)Endocardite infettiva attiva.
    4)Soggetti con una protesi valvolare cardiaca meccanica o biologica.
    5)Malattia epatica:
    a)Malattia epatica in fase attiva, inclusa l’epatite A, B o C o,
    b)Valori persistenti di ALT o AST o fosfatasi alcalina > 3 x limite superiore di normalità nei 3 mesi che precedono lo screening (V1).
    6)Femmine in gravidanza o in allattamento. Femmine che abbiano raggiunto il menarca e che non stiano utilizzando un metodo contraccettivo clinicamente accettato secondo le linee guida locali. I metodi anticoncezionali accettabili possono includere: dispositivo intrauterino (IUD), contraccettivi orali, impiantabili o iniettabili e cerotto estrogenico; metodo di doppia barriera (spermicida + diaframma); astinenza sessuale, a discrezione dello sperimentatore.
    7)Anemia (emoglobina < 80g/L) o trombocitopenia (conta piastrinica < 80 x 10**9/L). Le trasfusioni durante il periodo di screening sono permesse, purché vengano raggiunti dei livelli soddisfacenti di emoglobina o piastrine prima di visita 2.
    8)Pazienti che abbiano assunto trattamenti proibiti o soggetti a restrizioni (diversi da quelli utilizzati per il trattamento pianificato della TEV) prima della prima dose del farmaco in studio (V2). Per le restrizioni dello studio vedere la Sezione 4.2.2 del protocollo.
    9)Pazienti che abbiano ricevuto un farmaco sperimentale negli ultimi 30 giorni prima dello screening, tranne i pazienti che abbiano completato il periodo di trattamento (fino a Visita 8) nello studio 1160.106.
    10)Pazienti che siano allergici / sensibili a qualsiasi componente del farmaco in studio incluso il solvente.
    11)Pazienti o genitori/tutori legali che siano considerati a giudizio dello sperimentatore inaffidabili a partecipare nello studio o qualsiasi condizione che possa costituire un pericolo per la sicurezza del paziente, secondo il giudizio dello sperimentatore.
    E.5 End points
    E.5.1Primary end point(s)
    1: Recurrence of venous thromboembolism (VTE)

    2: Major and minor (including clinically relevant non-major (CRNM)) bleeding events

    3: Mortality overall and related to thrombotic or thromboembolic events
    1) Ricorrenza della TEV a 6 e 12 mesi
    2) Sanguinamenti maggiori e minori (incluso i sanguinamenti non-maggiori clinicamente rilevanti a 6 e 12 mesi).
    3) Mortalità totale e correlata a eventi trombotici o tromboembolici a 6 e 12 mesi.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1: 6 and 12 months

    2: 6 and 12 months

    3: 6 and 12 months
    1: mese 6 e 12
    2: mese 6 e 12
    3: mese 6 e 12
    E.5.2Secondary end point(s)
    1: Occurrence of post-thrombotic syndrome (PTS)

    2: Central measurement of aPTT (Activated partial thromboplastin time)

    3: Central measurement of ECT (Ecarin clotting time )

    4: Number of dabigatran etexilate dose adjustments during treatment period
    1) Occorrenza di Sindrome post-trombotica a 6 e 12 mesi.
    2) Valutazione farmacodinamica (misurazioni centralizzate di aPTT) a Visita 4.
    3) Valutazione farmacodinamica (misurazioni centralizzate di ECT) a Visita 4.
    4) Numero di aggiustamenti di dose di dabigatran durante la fase di trattamento.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1: 6 and 12 months

    2: after 3 weeks of treatment

    3: after 3 weeks of treatment

    4: 12 months
    1: mese 6 e 12
    2: dopo 3 settimane di trattamento
    3: dopo 3 settimane di trattamento
    4: mese 12
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy No
    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 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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    STUDIO DI COORTE PROSPETTICO
    prospective cohort study
    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.8.2.4Number of treatment arms in the trial1
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA32
    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
    Argentina
    Austria
    Belgium
    Brazil
    Bulgaria
    Canada
    Colombia
    Czech Republic
    Finland
    France
    Germany
    Greece
    Israel
    Italy
    Lithuania
    Mexico
    Norway
    Russian Federation
    Slovakia
    Spain
    Sweden
    Switzerland
    Taiwan
    Thailand
    Turkey
    Ukraine
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months10
    E.8.9.2In all countries concerned by the trial days26
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 100
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 10
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 30
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 60
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    paediatric patients
    pazienti pediatrici
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 49
    F.4.2.2In the whole clinical trial 100
    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)
    At the end of the study all patients need to discontinue dabigatran etexilate, or switch to standard of care, if there is continued need for anticoagulant treatment.
    Alla fine della sperimentazione tutti i pazienti dovranno interrompere il trattamento con Dabigatran Etexilato o passare al trattamento standard, se vi sia necessità di mantenere una terapia anticoagulante.
    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 Decision2014-09-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-07-30
    P. End of Trial
    P.End of Trial StatusCompleted
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