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    Summary
    EudraCT Number:2017-005068-16
    Sponsor's Protocol Code Number:221181
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-01-02
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2017-005068-16
    A.3Full title of the trial
    Measurement of Acetylsalicylic acid Concentration and Effect - MACE
    Måling af Acetylsalicylsyres Koncentration og Effekt - MAKE
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Measurement of Aspirin Concentration and Effect - MACE
    A.4.1Sponsor's protocol code number221181
    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 Hospital of Aarhus
    B.1.3.4CountryDenmark
    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 supportUniversity Hospital of Aarhus
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Hospital of Aarhus
    B.5.2Functional name of contact pointDepartment of Clinical Biochemistry
    B.5.3 Address:
    B.5.3.1Street AddressPalle Juul-Jensens Boulevard 99
    B.5.3.2Town/ cityAarhus N
    B.5.3.3Post code8200
    B.5.3.4CountryDenmark
    B.5.4Telephone number+4578455252
    B.5.6E-mailbiokemi@auh.rm.dk
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 Hjertemagnyl®
    D.2.1.1.2Name of the Marketing Authorisation holderTakeda Pharma A/S
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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.3.4Pharmaceutical form 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 INNACETYLSALICYLIC ACID
    D.3.9.3Other descriptive nameAspirin
    D.3.9.4EV Substance CodeSUB12730MIG
    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: 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 Hjertealbyl®
    D.2.1.1.2Name of the Marketing Authorisation holderActavis Group PTC ehf.
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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.3.4Pharmaceutical form 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 INNACETYLSALICYLIC ACID
    D.3.9.3Other descriptive nameAspirin
    D.3.9.4EV Substance CodeSUB12730MIG
    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.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
    Healthy volunteers

    (Prophylaxis of arterial thrombosis)
    Raske frivillige

    (Profylakse af arterielle tromber)
    E.1.1.1Medical condition in easily understood language
    Healthy volunteers

    (Prevention of cardiovascular disease)
    Raske frivillige

    (Forebyggelse af hjertekar-sygdom )
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level SOC
    E.1.2Classification code 10022891
    E.1.2Term Investigations
    E.1.2System Organ Class 10022891 - Investigations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Investigate the correlation between acetylsalicylic acid and salicylic acid pharmacokinetics and the platelet inhibition determined by the following parameters:
    Parameters for assesing acetylsalicylic acid and salicylic acid pharmacokinetics:
    - Maximal concentration
    - Areal under the concentration curve
    - Time above a certain concentration
    - Time for maximal concentration
    Parameters to assess the platelet inhibition:
    - Platelet inhibition at the time of maximal acetylsalicylic acid and salicylic acid concentrations
    - Maximal platelet inhibition
    - Areal under the effect curve
    - Platelet inhibition 24 hours after acetylsalicylic acid intake (through effect)
    - Time for maximal platelet inhibition.
    Undersøge korrelationen mellem acetylsalicylsyres og salicylats farmakokinetik og trombocythæmning bedømt på følgende parametre:
    Parametre til vurdering af acetylsalicylsyres og salicylats farmakokinetik:
    - Maksimale koncentration
    - Arealet under koncentrationskurven
    - Tid over en given koncentration
    - Tidspunkt for maksimale koncentration
    Parametre til vurdering af trombocythæmning:
    - Trombocythæmning til tidspunktet for maksimale acetylsalicylsyre og salicylat koncentrationer
    - Maksimale trombocythæmning
    - Arealet under effektkurven
    - Trombocythæmning 24 timer efter acetylsalicylsyre indtag (daleffekt)
    - Tidspunkt for maksimal trombocythæmning.
    E.2.2Secondary objectives of the trial
    Determine if treatment with enteric coated acetylsalicylic acid (Hjertealbyl®) and non enteric coated acetylsalicylic acid (Hjertemagnyl®) result in the same degree of platelet inhibition, and determine if assessment of treatment effect must be made at different times dependent on formulation.
    Afklare om behandling med entero- og non-enterocoated acetylsalicylsyre (henholdsvis Hjertealbyl® og Hjertemagnyl®) medfører samme grad af trombocythæmning, samt om vurdering af behandlingseffekt skal foretages på forskellige tidspunkter afhængigt af formulering.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. ≥18 years.
    2. Capable of giving informed consent.
    3. For women of childbearing potential: Use of safe contraception through the entire study period.
    1. ≥18 år.
    2. I stand til at give informeret samtykke.
    3. For kvinder i fertil alder: anvendelse af sikker prævention i hele forsøgsperioden.
    E.4Principal exclusion criteria
    1. Established or assumed intolerans towards acetylsalicylic acid
    2. Medical history of heart, liver or kidney disease
    3. Medical history of haemophilia
    4. Intake of medicine that affects the platelets or the turnover of platelets (e.g. NSAID) within the last week before study enrollment.
    5. Antithrombotic treatment.
    6. Current or previous medical history of gastrointestinal bleeding.
    7. Thrombocytopenia (<150 x 109/l).
    8. Pregnancy or current wish to achieve pregnancy.
    1. Kendt eller formodet overfølsomhed overfor acetylsalicylsyre.
    2. Kendt hjerte, lever- eller nyresygdom.
    3. Kendt blødersygdom.
    4. Indtag af medicin, der kan påvirke trombocytterne eller omsætningen af disse (f.eks. NSAID) indenfor den sidste uge før deltagelse.
    5. Antitrombotisk behandling.
    6. Aktuelt eller tidligere tilfælde af gastrointestinal blødning.
    7. Trombocytopeni (<150 x 109/l).
    8. Graviditet eller aktuelt forsøg på at opnå graviditet.
    E.5 End points
    E.5.1Primary end point(s)
    - Maximal acetylsalicylic acid concentration.
    - Platelet inhibition at the time of maximal acetylsalicylic acid concentration.
    - Maksimale acetylsalicylsyre koncentration
    - Trombocythæmning til tidspunktet for maksimale acetylsalicylsyre koncentration.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary end points will be evaluated after the collection of all data. No interim analyses will be performed.

    Blood for measurement of the primary end points will be collected at day 7 and day 8 after intake of the 7 th. dose of acetylsalicylic acid, where we will perform serial measurements of acetylsalicylic acid concentrations and platelet aggregation.

    As this is a randomised cross-over study, the primary endpoints will be evaluated both after intake of non enteric coated acetylsalicylic acid (Hjertemagnyl®) and enteric coated acetylsalicylic acid (Hjertealbyl®).
    De primære endepunkter vil blive evalueret efter indsamling af alle data. Der udføres ikke interim analyser.

    Blod til måling af de primære endepunkter indsamles på dag 7 og dag 8 efter indtag af 7. dosis acetylsalicylsyre, hvor vi udfører serielle målinger af acetylsalicylsyre koncentrationer samt trombocyt aggregation.

    Da dette er et randomiseret cross-over studie, bliver de primære endepunkter evalueret både efter indtag af non enterocoated acetylsalicylsyre (Hjertemagnyl®) og enterocoated acetylsalicylsyre (Hjertealbyl®)

    E.5.2Secondary end point(s)
    - Maximal salicylic acid concentration.
    - The area under the concentrationcurves for acetylsalicylic acid and salicylic acid
    - Time above a certain concentration of acetylsalicylic acid and salicylic acid.
    - The time for maximal concentrations of acetylsalicylic acid and salicylic acid.
    - Platelet inhibition at the time of maximal salicylic acid concentration.
    - Maximal platelet inhibition
    - The area under the effect curve
    - Platelet inhibition 24 hours after acetylsalicylic acid intake (through effect)
    - Time for maximal platelet inhibition.
    - Platelet count and other platelet-, erytrocyte- and leukocytederived Sysmex® parameters (heamatological parameters)
    - Maksimale salicylat koncentration efter indtag
    - Arealet under acetylsalicylsyres og salicylats koncentrationskurver
    - Tid over en given acetylsalicylsyre og salicylat koncentration.
    - Tidspunktet for maksimale acetylsalicylsyre og salicylat koncentrationer.
    - Trombocythæmning til tidspunktet for maksimale salicylat koncentration.
    - Maksimale trombocythæmning
    - Areal under effektkurven
    - Trombocythæmning 24 timer efter acetylsalicylsyre indtag (daleffekt)
    - Tidspunkt for maksimal trombocythæmning.
    - Trombocyttal og øvrige trombocyt-, erytrocyt- og leukocytderiverede Sysmex® parametre (hæmatologiske parametre)
    E.5.2.1Timepoint(s) of evaluation of this end point
    The secondary end points will be evaluated after the collection of all data. No interim analyses will be performed.

    Blood for measurement of the secondary endpoints will be collected at day 7 after intake of the 7 th. dose of acetylsalicylic acid, where we will perform serial measurements of acetylsalicylic acid concentrations and platelet aggregation.

    As this is a randomised cross-over study, the secondary endpoints will be evaluated both after intake of non enteric coated acetylsalicylic acid (Hjertemagnyl®) and enteric coated acetylsalicylic acid (Hjertealbyl®).
    De sekundære endepunkter vil blive evalueret efter indsamling af alle data. Der udføres ikke interim analyser.

    Blod til måling af de sekundære endepunkter indsamles på dag 7 efter indtag af 7. dosis acetylsalicylsyre, hvor vi udfører serielle målinger af acetylsalicylsyre koncentrationer samt trombocyt aggregation.

    Da dette er et randomiseret cross-over studie, bliver de sdekundære endpoints evalueret både efter indtag af non enterocoated acetylsalicylsyre (Hjertemagnyl®) og enterocoated acetylsalicylsyre (Hjertealbyl®)
    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 No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence Yes
    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 Yes
    E.8.1.2Open No
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    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 No
    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.
    Sidste forsøgspersons sidste besøg.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    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.1.2.1Number of subjects for this age range: 20
    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 Yes
    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 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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    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)
    None
    Ingen
    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 Decision2018-02-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-01-23
    P. End of Trial
    P.End of Trial StatusOngoing
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