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    The EU Clinical Trials Register currently displays   37212   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:2012-002896-32
    Sponsor's Protocol Code Number:D5136C00001
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:
    Date on which this record was first entered in the EudraCT database:2013-06-19
    Trial 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 ConcernedFrance - ANSM
    A.2EudraCT number2012-002896-32
    A.3Full title of the trial
    A multicenter, double-blind, placebo-controlled, pharmacokinetic, pharmacodynamic, safety and tolerability study in patients aged 12 to <18 years of age with a central venous catheter to support prediction of the age appropriate dose of ticagrelor with similar levels of inhibition of platelet aggregation to 90 mg bd in adults
    Une étude multicentrique, pharmacocinétique, pharmacodynamique, d’innocuité et de tolérabilité, menée en double aveugle et contrôlée par placebo sur des patients âgés de 12 à <18 ans portant un cathéter veineux central pour aider au calcul de la dose de ticagrelor correspondant à l’âge du patient, avec des niveaux similaires d’inhibition de l’agrégation plaquettaire, de l’ordre de 90 mg bd chez les adultes
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to determine how much ticagrelor needs to be given to children and adolescents with a central venous catheter.
    Une étude pour déterminer la dose de ticagrelor à administrer à des enfants et des adolescents portant un cathéter veineux central
    A.3.2Name or abbreviated title of the trial where available
    NA
    A.4.1Sponsor's protocol code numberD5136C00001
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/255/2012
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAstraZeneca AB
    B.1.3.4CountrySweden
    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 supportAstraZeneca AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstraZeneca
    B.5.2Functional name of contact pointInformation Center
    B.5.6E-mailinformation.center@astrazeneca.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 nameticagrelor 45 mg, tablets
    D.3.2Product code AZD6140
    D.3.4Pharmaceutical form Film-coated tablet
    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 INNTicagrelor
    D.3.9.1CAS number 274693-5
    D.3.9.2Current sponsor codeAZD6140
    D.3.9.3Other descriptive nameTICAGRELOR
    D.3.9.4EV Substance CodeSUB30898
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number45
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Thrombosis, thromboembolism
    E.1.1.1Medical condition in easily understood language
    Blod clot
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level PT
    E.1.2Classification code 10050661
    E.1.2Term Platelet aggregation inhibition
    E.1.2System Organ Class 10005329 - Blood and lymphatic system disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the pharmacodynamics of ticagrelor (45 mg bd), measured as the final extent of inhibition of platelet aggregation in paediatric patients aged from 12 to <18 years of age.
    E.2.2Secondary objectives of the trial
    To examine the pharmacokinetic profile of ticagrelor in paediatric patients 12 to <18 years of age.
    To evaluate the relationship between ticagrelor exposure and platelet aggregation inhibition.
    To assess the safety and tolerability of ticagrelor in patients aged 12 to <18 years of age with a central venous catheter by evaluation of adverse events, including bleeding events.
    To evaluate the relationship between inhibition of platelet aggregation and platelet reactivity index by determining the platelet reactivity index.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Written informed consent for study participation must be obtained prior to any study related procedures being performed and according to international guidelines and/or applicable EU guidelines
    Patients aged 12 to <18 years with a central venous catheter (CVC) with intended use for at least 5 days at
    time of randomisation.
    All post-menarche females are required to have a negative pregnancy test. Male and female patients are to adhere to appropriate contraceptive measures (if appropriate to the age of the child).
    E.4Principal exclusion criteria
    Sign or suspicion of extra-vascular bleeding in connection with placement of the CVC (>24 hours need to have elapsed since any sign or suspicion of ongoing bleeding, in order to allow randomisation of the patient).
    Patients who have an ongoing bleeding, risk of bleeding, previous intracranial haemorrhage, or platelet count <100,000 x 109/L.
    Surgery within 7 days unless judged to be a low risk for bleeding and at least 24 hours after surgery.
    Patients who are taking aspirin or other non-steroidal anti-inflammatory drugs within a week before randomisation and during the study period.
    Patients who are taking ADP receptor blockers (eg, clopidogrel, prasugrel,ticlopidine), dipyridamole, and cilostazol within a week before randomisation and during the study period.
    E.5 End points
    E.5.1Primary end point(s)
    Pharmacodynamics of ticagrelor:Final extent of inhibition of platelet aggregation(IPA). IPA will be assessed via light transmission aggregometry of platelet rich plasma with 3.2% sodium citrate as the anticoagulant and 20 umol/L of ADP as the agonist.
    E.5.1.1Timepoint(s) of evaluation of this end point
    On days 1 and 5 as well as after 2 day's follow-up
    E.5.2Secondary end point(s)
    #1) To examine the pharmacokinetic profile of ticagrelor by assessment of maximum concentration, time to maximum concentration, area under the plasma time concentration curve and accumulation ratio

    #2) To evaluate the relationship between ticagrelor exposure and platelet aggregation inhibition (IPA)

    #3) To assess the safety and tolerability ticagrelor by assessment of adverse events (AEs) including bleeding, laboratory values, physical examination, vital signs and ECG

    #4) To evaluate the relationship between inhibition of platelet aggregation (IPA) and platelet reactivity index (PRI). PRI will be determined by measurement of vasodilator-stimulated phosphoprotein phosphorylation (VASP-P)
    E.5.2.1Timepoint(s) of evaluation of this end point
    #1) On days 1 and 5

    #2) On days 1 and 5

    #3) AEs during the study, lab and vital signs at baseline, day 5 and 2 day's follow-up, phys exam at baseline and 2 days' follow-up, ECG at baseline, days 1 and 5, 2 day's follow-up

    #4) On days 1 and 5 as well as after 2 day's follow-up
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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 Yes
    E.8.2.3Other No
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA8
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    LSLV
    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: 18
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 18
    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 population aged 12 to less than 18 years of age with a condition requiring central venous catheter.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 18
    F.4.2.2In the whole clinical trial 18
    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)
    Standard of care
    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 Decision2013-01-25
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial Status
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