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    The EU Clinical Trials Register currently displays   43857   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:2009-013618-29
    Sponsor's Protocol Code Number:1160.89
    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:2011-11-21
    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 number2009-013618-29
    A.3Full title of the trial
    Open-label safety and tolerability of dabigatran etexilate mesilate given for 3 days at the end of standard anticoagulant therapy in successive groups of children aged 2 years to less than 12 years, and 1 year to less than 2 years.
    Estudio abierto de la seguridad y tolerabilidad de dabigatrán etexilato mesilato administrado durante 3 días al final del tratamiento anticoagulante estándar a grupos sucesivos de niños de 2 años a menos de 12 años y de 1 año a menos de 2 años.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety and tolerability of dabigatran etexilate solution in children 1 to < 12 years of age.
    Seguridad y tolerabilidad de dabigatrán etexilato solución en niños de 1 a < 12 años.
    A.4.1Sponsor's protocol code number1160.89
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/107/2010
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorBoehringer Ingelheim España, 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 supportBoehringer Ingelheim España, S.A.
    B.4.2CountrySpain
    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 number0018002430127
    B.5.5Fax number0018008217119
    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
    D.3.2Product code BIBR 1048 MS
    D.3.4Pharmaceutical form Oral solution
    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.3.9.1CAS number n.a.
    D.3.9.2Current sponsor codeBIBR1048MS
    D.3.9.3Other descriptive namen.a.
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.38
    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
    Venous Thrombotic Event
    Evento trombótico venoso
    E.1.1.1Medical condition in easily understood language
    Blood clots in the veins
    Coágulos de sangre en las venas.
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level LLT
    E.1.2Classification code 10066899
    E.1.2Term Venous thromboembolism
    E.1.2System Organ Class 10047065 - Vascular disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    This study is exploratory in nature and will investigate safety and tolerability of an oral liquid formulation of dabigatran etexilate in pediatric patients 1 to < 12 years old treated for primary VTE. The study will also provide preliminary pharmacokinetic and pharmacodynamic data for this age group.
    Este estudio es de naturaleza exploratoria e investigará la seguridad y tolerabilidad de una formulación líquida oral de dabigatrán etexilato en grupos sucesivos de pacientes pediátricos entre 2 y < 12 años de edad seguido de pacientes pediátricos de 1 a < 2 años de edad tratados por ETV. El estudio también proporcionará datos farmacocinéticos y farmacodinámicos preliminares para este grupo de edad.
    E.2.2Secondary objectives of the trial
    none
    ninguno
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Males or females 1 to < 12 years of age
    2) Objective diagnosis of VTE
    3) End of planned treatment course with low molecular weight heparin (LMWH) or oral anticoagulant (OAC) for VTE with INR and aPTT both within normal limits.
    4) Written informed consent provided by the patient's parent (or legal guardian) and assent provided by the patient (if applicable) at the time of ICF signature.
    1) Niños de ambos sexos entre 1 y < 12 años de edad.
    2) Diagnóstico objetivo de ETV.
    3) Final del período de tratamiento planeado con heparina de bajo peso molecular (HBPM) o anticoagulante oral (AO) para ETV, con INR y TTPa ambos dentro de los límites de normalidad.
    4) Consentimiento informado por escrito proporcionado por el progenitor (o tutor legal) del paciente y asentimiento del paciente (si procede) en el momento de la firma del FCI.
    E.4Principal exclusion criteria
    1) conditions associated with increased risk of bleeding
    2) severe renal dysfunction or requirement for dialysis
    3) active infective endocarditis
    4) hepatic disease
    5) anemia or thrombocytopenia
    6) use of prohibited or restricted drug within previous week
    7) pregnant females or females not using medically accepted contraceptive method
    8) received investigational drug within past 30 days
    9) unreliable patients or patients who have any condition that would not allow safe participation in study
    1) Patologías asociadas a un riesgo alto de hemorragia:
    2) Insuficiencia renal grave o necesidad de diálisis
    3) Endocarditis infecciosa activa
    4) Enfermedad hepática:
    5) Anemia o trombocitopenia.
    6) Pacientes que han tomado algún tratamiento prohibido/medicación restringida/tratamiento en la semana anterior
    7) Mujeres embarazadas o mujeres que no utilizan un método anticonceptivo aceptado médicamente..
    8) Pacientes que han recibido un fármaco en investigación en los últimos 30 días
    9) Pacientes considerados no aptos por el investigador en lo referente al seguimiento durante el estudio o el cumplimiento de la administración del fármaco del estudio, o que tienen cualquier enfermedad que, en opinión del investigador, no permitiría una participación segura en el estudio.
    E.5 End points
    E.5.1Primary end point(s)
    1) Incidence of all bleeding events,
    2) Incidence of all adverse events.
    3) Pharmacodynamic parameters: central and local measurement of TT
    4) Pharmacokinetic parameters: plasma concentrations of total and free dabigatran, BIBR 1048 BS, BIBR 951BS, and BIBR 1087 SE,
    1) Incidencia de todos los episodios hemorrágicos
    2) Incidencia de todos los acontecimientos adversos
    3) Parámetros farmacodinámicos: medición central y local de TT
    4) Parámetros farmacocinéticos: concentraciones plasmáticas de dabigatrán total y libre, BIBR 1048 BS, BIBR 951BS y BIBR 1087 SE.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Endpoints 1) & 2) measured during screening, treatment period and 30 day followup.
    Endpoints 3) & 4) measured during screening (baseline) and treatment period.
    Los criterios 1) y 2) se miden durante la selección, el periodo de tramiento y se realiza un seguimiento de 30 días.
    Los criterios 3) y 4) se miden durante la selección (periodo basal) y durante el periodo de tratamiento.
    E.5.2Secondary end point(s)
    1) Changes in laboratory and clinical parameters such as liver enzymes, ECG, and physical examination,
    2) Occurrences of clinical outcomes including recurrent thrombosis, post thrombotic syndrome (PTS), pulmonary emboli (PEs), and total and venous thrombolic event (VTE) related mortality,
    3)Global assessment of tolerability to study medication (including patient taste assessment),
    4) Pharmacodynamic parameters: local measurement of aPTT.
    1) Cambios en los parámetros de laboratorio y clínicos como enzimas hepáticas, ECG y exploración física
    2) Aparición de desenlaces clínicos como trombosis recurrente, síndrome postrombótico (SPT), embolia pulmonar (EP) y mortalidad total y relacionada con evento trombótico venoso (ETV)
    3) Evaluación global de la tolerabilidad de la medicación del estudio (incluida la evaluación del sabor por el paciente).
    4) Parámetros farmacodinámicos: medición local de TTPa.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Endpoints 1) to 3) measured during screening, treatment period and 30 day followup.
    Endpoint 4) measured during screening (baseline) and treatment period.
    Los criterios 1) al 3) se miden durante la selección, el tratamiento y durante un periodo de seguimiento de 30 días.
    El criterio 4) se mide durante la selección (periodo basal) y durante el periodo de tratamiento.
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA12
    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
    Austria
    Canada
    France
    Netherlands
    Switzerland
    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
    Sixteen patients who have completed the 30 day post treatment followup period.
    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 months1
    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 months1
    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 Yes
    F.1.1Number of subjects for this age range: 16
    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: 8
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 8
    F.1.1.6Adolescents (12-17 years) No
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2011-11-21. Yes
    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
    Parental/legal guardian consent and patient assent when applicable.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 12
    F.4.2.2In the whole clinical trial 16
    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)
    No.
    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 Decision2012-01-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-01-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-02-18
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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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