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    Summary
    EudraCT Number:2014-001989-97
    Sponsor's Protocol Code Number:1403/MU
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2014-06-13
    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 ConcernedAustria - BASG
    A.2EudraCT number2014-001989-97
    A.3Full title of the trial
    Clinical study to investigate the efficiency of vascular occlusion prevention by ticagrelor after stent implantation in patients with peripheral artery disease (PAD) and high platelet reactivity during treatment with clopidogrel
    Klinische Studie zur Überprüfung der Effizienz einer Gefäßverschlussprävention durch Ticagrelor nach Stentimplantationen bei Patienten mit peripherer arterieller Verschlusskrankheit (PAVK) und hoher Plättchenreaktivität unter Behandlung mit Clopidogrel
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical study to investigate whether in patients with peripheral artery disease, after implantation of a stent and showing high platelet reactivity during treatment with clopidogrel, treatment with ticagrelor is able to prevent effectively vascular occlusion
    Klinische Studie zur Überprüfung, ob bei Patienten mit peripherer arterieller Verschlusskrankheit, denen ein Stent eingesetzt wurde und die unter Behandlung mit Clopidogrel eine hohe Reaktivität der Blutplättchen aufweisen, eine Behandlung mit Ticagrelor einem Gefäßverschluss wirksam vorbeugen kann
    A.3.2Name or abbreviated title of the trial where available
    PAVK-TAH-Studie
    A.4.1Sponsor's protocol code number1403/MU
    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 SponsorOA Doz. Dr. Thomas Müller c/o B&S Zentrallabor Konventhospital Barmherzige Brüder Linz
    B.1.3.4CountryAustria
    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 supportKonventhospital Barmherzige Brüder Linz
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOö. Patientenvertretung
    B.5.2Functional name of contact pointOö. Patientenvertretung
    B.5.3 Address:
    B.5.3.1Street AddressBahnhofplatz 1
    B.5.3.2Town/ cityLinz
    B.5.3.3Post code4021
    B.5.3.4CountryAustria
    B.5.4Telephone number004373277201421
    B.5.6E-mailppv.post@ooe.gv.at
    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 Yes
    D.2.1.1.1Trade name Plavix 75mg
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi Clir SNC 54, rue La Boétie F-75008 Paris – Frankreich
    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.3.4Pharmaceutical 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 INNCLOPIDOGREL
    D.3.9.3Other descriptive nameCLOPIDOGREL
    D.3.9.4EV Substance CodeSUB13395MIG
    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 Brilique 90mg
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca AB, S-151 85, Södertälje, Schweden
    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.3.4Pharmaceutical 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 INNTICAGRELOR
    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 number90
    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
    peripheral artery disease (PAD)
    periphere arterielle Verschlusskrankheit (PAVK)
    E.1.1.1Medical condition in easily understood language
    peripheral artery disease (PAD)
    periphere arterielle Verschlusskrankheit (PAVK)
    E.1.1.2Therapeutic area Not possible to specify
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Comparison of the effects of ticagrelor intake and the effects of clopidogrel intake on the time to occurrence of in-stent restenosis> 50%
    Vergleich der Auswirkungen einer Ticagrelor-Einnahme mit den Auswirkungen einer Clopidogrel-Einnahme
    auf das Intervall bis zum Auftreten einer In-Stent Restenose >50%
    E.2.2Secondary objectives of the trial
    Comparison of the effects of ticagrelor intake and the effects of clopidogrel intake on the time to occurrence of myocardial infarction (STEMI or NSTEMI), acute ischemic stroke or death
    Vergleich der Auswirkungen einer Ticagrelor-Einnahme mit den Auswirkungen einer Clopidogrel-Einnahme
    auf das Intervall bis zum Auftreten eines der Ereignisse Herzinfarkt (i.e. STEMI oder NSTEMI), akuter ischämischer Schlaganfall oder Exitus
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.) written consent to participate after previous sufficient written and oral information (informed consent)
    2.) arteriosclerotic PAD (Fontaine stages II – IV or Rutherford stages 1 – 6)
    3.) implantation of a bare-metal stent into the Arteria femoralis superficialis of at least one leg one day ago (first intervention at this vessel)
    4.) Proper intake of Plavix ® since stent implantation (including routine intake of one Plavix ® film-coated tablet à 75mg clopidogrel in the morning immediately before inclusion in the clinical trial)
    5.) suspected availability within the one-year period of the study participation (out-patient care)
    6.) suspected discharge from the hospital within a week after stent implantation
    7.) caucasian appearance
    1.) Schriftliche Dokumentation der Einwilligung zur Prüfungsteilnahme nach
    vorhergehender ausreichender schriftlicher und mündlicher Information
    2.) Arteriosklerotische PAVK Stadium II bis IV nach Fontaine (bzw. Rutherford Kategorien 1-6)
    3.) Implantation eines unbeschichteten Metallstents (bare-metal stent / BMS) in die Arteria femoralis superficialis (zumindest) eines Beins vor einem Tag im Sinne eines Ersteingriffes an diesem Gefäß
    4.) Ordnungsgemäße Einnahme von Plavix® seit der Stentimplantation (incl. routinemäßige Einnahme einer Plavix®-Filmtablette à 75mg Clopidogrel am Morgen unmittelbar vor der – Entscheidung über die – Aufnahme in die klinische Prüfung)
    5.) Voraussichtliche Verfügbarkeit innerhalb des einjährigen Zeitraums der Prüfungsteilnahme (ambulante Betreuung)
    6.) Voraussichtliche Entlassung aus dem Krankenhaus innerhalb von einer Woche nach der Stentimplantation
    7.) Kaukasisches Erscheinungsbild
    E.4Principal exclusion criteria
    1.) non-completion of the 18th year of life
    2.) detention (for a court or administrative order), accommodation (in accordance with the Placement Act) or (already performed or initiated) appointment of a custodian
    3.) incapability
    4.) military service
    5.) pregnancy and non-exclusion of pregnancy (women of childbearing potential)
    6.) risk of pregnancy occurrence during the test participation
    7.) lactation
    8.) (with the exception of taking ASS up to 150 mg daily) intake of other TAH than clopidogrel since stent implantation
    9.) (with the exception of maintaining a long-term therapy with ASS up to 150 mg daily) foreseeable need for intake of further TAH within the one-year period of study participation
    10.) contraindication for Plavix ® or Brilique ® administration
    a. hypersensitivity to any component of Plavix ® or Brilique ®
    b. acute pathological bleeding e.g. at peptic ulcer or intracranial bleeding
    c. intracranial hemorrhage in history
    d. moderate to severe hepatic impairment
    e. use of CYP3A4 inhibitors (e.g. ketoconazole, clarithromycin, nefazodone, ritonavir and atazanavir)
    11.) bypass surgery and / or stent implantation into the affected vessel in history
    12.) intake of anticoagulants (vitamin K antagonists or new direct oral anticoagulants such as dabigatran, rivaroxaban or apixaban) in the last week
    13.) suspected demand of taking anticoagulants (vitamin K antagonists or new direct oral anticoagulants such as dabigatran, rivaroxaban, apixaban or) within the one-year period of study participation
    14.) myocardial infarction (STEMI or NSTEMI) or acute ischemic stroke in the last 30 days
    15.) acute or non-arteriosclerotic PAOD (e.g. arterial thrombotic or embolic event, thromboangiitis obliterans, vasculitis, congenital or metabolic vascular disease, etc.)
    16.) malignant neoplasm (status post or existing)
    17.) platelets <100 G/L
    18.) hematocrit <30% or> 52%
    19.) uremia or glomerular filtration rate <30ml/min/1. 73m ²
    20.) liver cirrhosis or bilirubin> 2mg/dl or GPT and / or GOT> 1.5 of the upper reference value
    21.) simultaneous participation in another clinical study with insurance coverage
    1.) Nichtvollendung des 18. Lebensjahres
    2.) Anhaltung (auf gerichtliche oder behördliche Anordnung), Unterbringung (gemäß Unterbringungsgesetz) oder (bereits erfolgte oder eingeleitete) Bestellung eines Sachwalters
    3.) Nicht-Geschäftsfähigkeit
    4.) Präsenzdienst
    5.) Schwangerschaft und Nichtausschluss einer Schwangerschaft (bei gebärfähigen Frauen)
    6.) Risiko des Eintretens einer Schwangerschaft während der Prüfungsteilnahme (bei Frauen Nichtvorliegen von zumindest einem der folgenden Kriterien: Eintritt der Menopause vor mehr als 2 Jahren, postmenopausale Sterilisation, chirurgische Sterilisation, Zusage für eine Kontrazeption während der Studienintegration mit Hormonen, Spirale oder Diaphragma/Kondom+Spermizid)
    7.) Stillperiode
    8.) (Mit Ausnahme einer Einnahme von Azetylsalizylsäure bis zu 150 mg täglich) Einnahme von anderen TAH als Clopidogrel seit der Stentimplantation
    9.) (Mit Ausnahme der Beibehaltung einer Langzeittherapie mit Azetylsalizylsäure bis zu 150 mg täglich) absehbarer Bedarf einer Einnahme von weiteren TAH (über die Prüfpräparateinnahme hinaus) innerhalb des einjährigen Zeitraums der Prüfungsteilnahme
    10.) Kontraindikation für eine Plavix® oder eine Brilique®-Verabreichung (– vgl. SmPCs zu Plavix® und Brilique® im Prüfplananhang)
    a) Überempfindlichkeit gegenüber einem Bestandteil von Plavix® oder Brilique®
    b) Akute pathologische Blutung, wie bei Magen-Darm-Geschwüren oder intrakraniellen Blutungen
    c) Intrakranielle Blutungen in der Anamnese
    d) Mäßige bis schwere Leberfunktionsstörungen
    e) Einnahme von CYP3A4-Inhibitoren (z. B. Ketoconazol, Clarithromycin, Nefazodon, Ritonavir und Atazanavir)
    11.) Vorbefund einer Bypass-Operation und/oder einer Stenteinbringung in das betroffene Gefäß
    12.) Einnahme von Antikoagulantien (Vitamin-K-Antagonisten oder neue direkte orale Antikoagulantien wie Dabigatran, Rivaroxaban oder Apixaban) in der letzten Woche
    13.) Absehbarer Bedarf einer Einnahme von Antikoagulantien (Vitamin-K-Antagonisten oder neue direkte orale Antikoagulantien wie Dabigatran, Rivaroxaban oder Apixaban) innerhalb des einjährigen Zeitraums der Prüfungsteilnahme
    14.) Herzinfarkt (i.e. STEMI oder NSTEMI) oder akuter ischämischer Schlaganfall in den letzten 30 Tagen
    15.) Akute oder nichtatherosklerotische PAVK (z.B. arteriell thrombotisches oder embolisches Ereignis, Thromboangiitis obliterans, Vaskulitis, kongenitale oder metabolische Gefäßerkrankung etc.)
    16.) Maligne Neoplasie (Status post oder rezent/existent)
    17.) Thrombozyten < 100G/l
    18.) Hämatokrit < 30% oder > 52%
    19.) Urämie oder Glomeruläre Filtrationsrate < 30ml/min/1,73m²
    20.) Leberzirrhose oder Bilirubin > 2mg/dl oder GPT und/oder GOT >1,5 des oberen Referenzwertes
    21.) Zeitgleiche Teilnahme an einer anderen klinischen Studie mit Versicherungsschutz
    E.5 End points
    E.5.1Primary end point(s)
    (1) time from stent implantation to in-stent restenosis to> 50% [days]
    (2) time from stent implantation to myocardial infarction (STEMI or NSTEMI), acute ischemic stroke and/or death [days]
    (1) Intervall Stentimplantation bis In-Stent Restenose >50% [Tage]
    (2) Intervall Stentimplantation bis Herzinfarkt (i.e. STEMI oder NSTEMI) und/oder akuter ischämischer Schlaganfall und/oder Exitus [Tage]
    E.5.1.1Timepoint(s) of evaluation of this end point
    E1 until occurrence of the event
    E1 = examination immediately after patient enrollment
    U1 bis Aufreten des Ereignisses
    U1 = Untersuchung unmittelbar nach Patienteneinschluss
    E.5.2Secondary end point(s)
    • myocardial infarction (STEMI or NSTEMI), acute ischemic stroke and/or death between E1 and incl. E3
    • myocardial infarction (STEMI or NSTEMI), acute ischemic stroke and/or death between E1 and incl. E2
    • in-stent restenosis > 50% [yes/no] between E1 and incl. E3
    • in-stent restenosis > 50% [yes/no] between E1 and incl. E2
    • myocardial infarction (STEMI or NSTEMI) [yes/no] between E1 and incl. E3
    • myocardial infarction (STEMI or NSTEMI) [yes/no] between E1 and incl. E2
    • STEMI [yes/no] between E1 and incl. E3
    • STEMI [yes/no] between E1 and incl. E2
    • NSTEMI [yes/no] between E1 and incl. E3
    • NSTEMI [yes/no] between E1 and incl. E2
    • acute ischemic stroke [yes/no] between E1 and incl. E3
    • acute ischemic stroke [yes/no] between E1 and incl. E2
    • death [yes/no] between E1 and incl. E3
    • death [yes/no] between E1 and incl. E2
    E1 = examination immediately after patient enrollment
    E2 = examination after ½ year
    E3 = examination after 1 year (termination of patient’s study participation)
    • Herzinfarkt (i.e. STEMI oder NSTEMI) und/oder akuter ischämischer Schlaganfall und/oder Exitus [ja/nein] zwischen U1 und incl. U3
    • Herzinfarkt (i.e. STEMI oder NSTEMI) und/oder akuter ischämischer Schlaganfall und/oder Exitus [ja/nein] zwischen U1 und incl. U2
    • In-Stent Restenose >50% [ja/nein] zwischen U1 und incl. U3
    • In-Stent Restenose >50% [ja/nein] zwischen U1 und incl. U2
    • Herzinfarkt (i.e. STEMI oder NSTEMI [ja/nein] zwischen U1 und incl. U3
    • Herzinfarkt (i.e. STEMI oder NSTEMI [ja/nein] zwischen U1 und incl. U2
    • STEMI [ja/nein] zwischen U1 und incl. U3
    • STEMI [ja/nein] zwischen U1 und incl. U2
    • NSTEMI [ja/nein] zwischen U1 und incl. U3
    • NSTEMI [ja/nein] zwischen U1 und incl. U2
    • Akuter ischämischer Schlaganfall [ja/nein] zwischen U1 und incl. U3
    • Akuter ischämischer Schlaganfall [ja/nein] zwischen U1 und incl. U2
    • Exitus [ja/nein] zwischen U1 und incl. U3
    • Exitus [ja/nein] zwischen U1 und incl. U2
    U1 = Untersuchung unmittelbar nach Patienteneinschluss
    U2 = Untersuchung nach ½ Jahr
    U3 = Untersuchung nach 1 Jahr (Beendigung der Patiententeilnahme)
    E.5.2.1Timepoint(s) of evaluation of this end point
    E2 and E3
    E2 = examination after ½ year
    E3 = examination after 1 year (termination of patient’s study participation)
    U2 und U3
    U2 = Untersuchung nach ½ Jahr
    U3 = Untersuchung nach 1 Jahr (Beendigung der Patiententeilnahme)
    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 Yes
    E.6.4Safety No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) Yes
    E.8.2.2Placebo No
    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 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
    last patient out
    last patient out
    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 months42
    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: 200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 300
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state500
    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)
    not different from the expected normal treatment of that condition
    nicht unterschiedlich von der üblichen Behandlung in der gegebenen Situation
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-07-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-06-20
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2018-04-30
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