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    The EU Clinical Trials Register currently displays   35898   clinical trials with a EudraCT protocol, of which   5892   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2015-000962-76
    Sponsor's Protocol Code Number:17992
    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:2015-07-10
    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 number2015-000962-76
    A.3Full title of the trial
    Single-dose study testing a rivaroxaban dry powder formulation for oral suspension in children from 6 months to 12 years with previous thrombosis
    Ensayo de dosis única para evaluar la formulación de rivaroxaban en polvo seco para suspensión oral, en niños de 6 meses a 12 años con trombosis previa
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Single-dose study testing a rivaroxaban dry powder to be diluted into an oral suspension in children from 6 months to 12 years with previous blood clot
    Ensayo de dosis única para evaluar rivaroxaban en polvo seco para diluido en suspensión oral, en niños de 6 meses a 12 años con trombosis previa (formación de coágulos)
    A.3.2Name or abbreviated title of the trial where available
    Phase 1 dry powder
    NA
    A.4.1Sponsor's protocol code number17992
    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 SponsorBayer Health Care AG
    B.1.3.4CountryGermany
    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 supportBayer Health Care AG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBayer Health Care AG
    B.5.2Functional name of contact pointCTP Team/Ref:"EU CTR"/ Bayer Pharma
    B.5.3 Address:
    B.5.3.1Street Address.
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post code13342
    B.5.3.4CountryGermany
    B.5.4Telephone number0034.900102372
    B.5.6E-mailclinical-trials-contact@bayerhealthcare.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 namexarelto
    D.3.2Product code BAY59-7939
    D.3.4Pharmaceutical form Granules for oral suspension
    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 INNRIVAROXABAN
    D.3.9.1CAS number 366789-02-8
    D.3.9.2Current sponsor codeBAY59-7939
    D.3.9.4EV Substance CodeSUB29263
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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
    Thrombosis
    Trombosis
    E.1.1.1Medical condition in easily understood language
    Blood Clot
    Coagulación sanguínea
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10043607
    E.1.2Term Thrombosis
    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
    ? To characterize the pharmacokinetic profile of rivaroxaban administered as dry powder for suspension
    ? Determinar el perfil farmacocinético de Rivaroxaban administrado en forma de polvo seco para suspensión
    E.2.2Secondary objectives of the trial
    ?To document safety and tolerability in terms of AEs observed after administration of the rivaroxaban dry powder for suspension formulation
    ?Evaluar la seguridad y tolerabilidad en términos de Acontecimientos Adversos observados después de la administración de Rivaroxaban en polvo seco para suspensión
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Children with an age between 6 months and <12 years who
    have completed anticoagulant treatment at least 10 days prior
    to the planned study drug administration
    2. Normal prothrombin time (PT) and activated partial
    thromboplastin time (aPTT) within 10 days prior to planned
    study drug administration
    3. Written informed consent provided and, if applicable, child
    assent provided
    1.Niños de entre 6 meses y menos de 12 años que hayan finalizado el tratamiento anticoagulante al menos 10 días antes de la fecha prevista de administración del fármaco del estudio
    2.Tiempo de protrombina (TP) y tiempo de tromboplastina parcial activada (TTPa) normales en los 10 días previos a la fecha prevista de administración del fármaco del estudio
    3.Obtención del consentimiento informado y, si procede, del asentimiento del niño
    E.4Principal exclusion criteria
    1.Active bleeding or high risk for bleeding, contraindicating
    anticoagulant therapy
    2. Planned invasive procedures, including removal of central
    lines, within 24 hours before and after single dose intake
    3. An estimate glomerular filtration rate (eGFR)
    < 30 mL/min/1.73m2 calculated according to Cockcroft-Gault formula
    4. Hepatic disease which is associated either with: coagulopathy
    leading to a clinically relevant bleeding risk, or alanine aminotransferase (ALT) > 5x upper limit of normal (ULN), or total bilirubin > 2x ULN with direct bilirubin > 20% of the total
    5. Platelet count < 50 x 109/L
    6. Hypertension defined as systolic and/or diastolic blood pressure >95th percentile for age)
    7. Concomitant use of strong inhibitors of both CYP3A4 and P-glycoprotein, e.g., all human immunodeficiency virus protease inhibitors and the following azole-antimycotic agents: ketoconazole, itraconazole, voriconazole, and posaconazole, if used systemically (fluconazole is allowed)
    8. Concomitant use of strong inducers of CYP3A4, e.g., rifampicin, rifabutin, phenobarbital, phenytoin and carbamazepine
    9. Inability to cooperate with the study procedures
    10. Hypersensitivity to rivaroxaban
    11. Participation in a study with an investigational drug other than
    rivaroxaban or a medical device within 30 days prior to treatment
    1.Hemorragias activas o riesgo elevado de hemorragias que contraindique el tratamiento anticoagulante
    2.Procedimientos invasivos programados, incluidos la retirada de vías centrales en las 24 horas previas a la administración de la dosis única
    3.Filtración glomerular estimada (FGe) menor a 30 mL/min/1,73m2 calculada mediante la fórmula de Cockcroft-Gault
    4.Hepatopatía asociada a: coagulopatías que provocan un riesgo de hemorragia clínicamente relevante, o alanina aminotransferasa (ALT) mayor 5 × el límite superior de la normalidad (LSN), o bilirrubina total mayor 2 × LSN con bilirrubina directa mayor 20 % del total
    5.Cifra de plaquetas menor 50 × 109/L
    6.Hipertensión definida como una presión arterial sistólica o diastólica mayor al percentil 95 de edad
    7.Uso concomitante de inhibidores potentes de la isoenzima CYP3A4 y de la glucoproteína P, es decir, todos los inhibidores de la proteasa del virus de la inmunodeficiencia humana y los siguientes antimicóticos azólicos: ketoconazol, itraconazol, voriconazol y posaconazol, si se utilizan de forma sistémica (se permite el fluconazol)
    8.Uso concomitante de inductores potentes de la isoenzima CYP3A4, por ejemplo, rifampicina, rifabutina, fenobarbital, fenitoína y carbamazepina
    9.Incapacidad de colaborar con los procedimientos del estudio
    10.Hipersensibilidad a Rivaroxaban
    11.Participación en un estudio con un fármaco en investigación distinto a Rivaroxaban o con un producto sanitario en los 30 días previos al tratamiento
    E.5 End points
    E.5.1Primary end point(s)
    The primary variables for pharmacokinetics will be the standard pharmacokinetic (PK) parameters for exposure, area under the curve (AUC) and Cmax, derived via population PK approaches.
    Las variables principales para la farmacocinética serán los parámetros farmacocinéticos (FC) habituales para la exposición, el área bajo la curva (AUC) y la Cmáx, derivados mediante métodos de farmacocinética poblacional.
    E.5.1.1Timepoint(s) of evaluation of this end point
    After at least 6 children and end of study
    Después de que 6 niños finalicen el ensayo
    E.5.2Secondary end point(s)
    The principal safety outcome is the composite of major bleeding and clinically relevant non-major bleeding.
    La variable principal de seguridad es la combinación de hemorragias graves y hemorragias no graves clínicamente relevantes.
    E.5.2.1Timepoint(s) of evaluation of this end point
    After any incident, after 6 children and at the end of the trial
    Tras cualquier incidente, después de que 6 niñps finalicen el ensayo
    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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Pharmacokinetic
    E.7.2Therapeutic exploratory (Phase II) No
    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 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 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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
    Austria
    Belgium
    Canada
    Czech Republic
    Finland
    France
    Hungary
    Ireland
    Israel
    Italy
    Netherlands
    Spain
    Sweden
    United Kingdom
    United States
    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
    Última visita del último sujeto
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months9
    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: 24
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 8
    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 No
    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 No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    children age 6 months to 12 years
    Niños de 6 meses a 12 años de edad
    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 20
    F.4.2.2In the whole clinical trial 24
    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)
    As dictated by the physician
    Según las indicaciones de su médico
    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 Decision2015-08-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-07-30
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-05-22
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