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    Summary
    EudraCT Number:2013-001636-22
    Sponsor's Protocol Code Number:TROPICALACS
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-03-11
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2013-001636-22
    A.3Full title of the trial
    A prospective, randomized, parallel-group, open label, non-inferiority, multicenter trial of a 12 month vs. a short-term platelet function testing guided prasugrel therapy in acute coronary syndrome patients undergoing coronary stenting
    Wieloośrodkowe, prospektywne, randomizowane, równoległe, otwarte badanie równoważności 12-mięsiecznej oraz krótkiej, zależnej od funkcji płytek, terapii prasugrelem u pacjentów z ostrym zespołem wieńcowym poddanych leczeniu interwencyjnemu.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparison of a 12 month vs. a short-term therapy with prasugrel in patients with acute heart attack undergoing coronary stenting
    Porównanie dwunastomiesięcznego leczenia do krótkoterminowego leczenia prasugrelem pacjentów z atakiem serca poddanych leczeniu inwazyjnemu (stenty).
    A.4.1Sponsor's protocol code numberTROPICALACS
    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 SponsorHospital of the University of Munich, Grosshadern
    B.1.3.4CountryGermany
    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 supportRoche Diagnostics International AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospital of the University of Munich, Grosshadern
    B.5.2Functional name of contact pointI. Med. Klinik und Poliklinik
    B.5.3 Address:
    B.5.3.1Street AddressMarchioninistr. 15
    B.5.3.2Town/ cityMunich
    B.5.3.3Post code81377
    B.5.3.4CountryGermany
    B.5.4Telephone number+498970952371
    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.2.1.2Country which granted the Marketing AuthorisationGermany
    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 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 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 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 Efient
    D.2.1.1.2Name of the Marketing Authorisation holderEli Lilly Nederland BV
    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 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 INNPRASUGREL
    D.3.9.1CAS number 150322-43-3
    D.3.9.4EV Substance CodeSUB30236
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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: 3
    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 Efient
    D.2.1.1.2Name of the Marketing Authorisation holderEli Lilly Nederland BV
    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 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 INNPRASUGREL
    D.3.9.1CAS number 150322-43-3
    D.3.9.4EV Substance CodeSUB30236
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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
    Troponin positive acute coronary syndrome after successful percutaneous coronary intervention with an indication for a standard treatment of 12 month with prasugrel
    ostry zespół wieńcowy odpowiadający na leczenie troponinami po przezskórnej interwencji wieńcowej (PCI)ze wskazaniem do 12 miesięcznego leczenia prasugrelem
    E.1.1.1Medical condition in easily understood language
    Troponin positive acute heart attack after successful cardiac catheter treatment with an indication for a standard treatment of 12 month with prasugrel
    ostry atak serca odpowiadający na leczenie troponinami po przezskórnej interwencji wieńcowej (PCI)ze wskazaniem do 12 miesięcznego leczenia prasugrelem
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level PT
    E.1.2Classification code 10051592
    E.1.2Term Acute coronary syndrome
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    A Platelet function testing guided approach with a short-term (1 week) post hospital discharge prasugrel maintenance dose treatment and a switch-over to clopidogrel treatment in adequate responders to the drug is non-inferior to the currently recommended long-term (12 month) treatment with prasugrel in ACS patients undergoing PCI.
    Wykazanie, że strategia leczenia w zależności od wyników testów czynności płytek, obejmująca krótkoterminowe (przez 1 tydzień) leczenie prasugrelem, a następnie zastosowanie klopidogrelu u pacjentów z odpowiednią odpowiedzią na ten lek, jest nie gorsza niż standardowe 12-miesięczne leczenie prasugrelem u pacjentów z ACS leczonych przezskórną interwencją wieńcową (PCI)
    E.2.2Secondary objectives of the trial
    - Bleeding events with a grade >= 2 defined according to BARC criteria
    - Stent thrombosis (definite or probable) according to ARC (Academic Research Consortium) criteria
    - Incidence of urgent ischemia-driven revaccularization
    - Incidence of death from any cause
    - Pre-specified cost-effectiveness analysis on the economic impact of a platelet function testing guided tailored treatment for ACS patients
    - The individual ischemic components of the primary endpoint will be subject to the secondary endpoint analysis
    • Krwawienia stopnia ≥ 2 według kryteriów BARC
    • Zakrzepica w stencie (pewna lub prawdopodobna) według kryteriów Academic Research Consortium (ARC)
    •Pilna rewaskularyzacja spowodowana niedokrwieniem
    •Zgon z dowolnej przyczyny
    •Prospektywnie zaplanowana analiza efektywności kosztowej dotycząca ekonomicznych następstw leczenia w zależności od wyników testów czynności płytek u pacjentów z ACS
    •Poszczególne elementy składowe głównego punktu końcowego
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    1. TROPICAL-ACS Biomarker Substudy (included in Protocol V. 4.0, date 03. December 2013)
    - Identification of novel biomarkers that aid in personalized prediction of patients outcomes. Proteomic, metobolic, RNA expression, DNA polymorphism and methylation screening at genome-wide scale will be used
    - Extended platelet function testing with additional activators on day of randomization and day 14 to gain additional insights into correlation of platelet-function parameters and their predictive power
    - Combined analysis of biomarkers with platelet function testing to aid in the identification of novel prediction algorithms with potential impact on therapeutic approaches of ACS.

    2. Site specific Substudy Protocol for site Mainz and KUM (only valid for site Mainz and KUM V. 1.0, 24. Nov. 2013, Amendment 1 from 02. Apr. 2014, included as appendix 4 of the protocol V 5.0)
    - Substudy 1: The relationship between endothelial function and platelet activation
    -- Primary aim: To test whether the switch from prasugrel to clopidogrel, as compared to the continued administration of prasugrel, will result in a change in endothelial function, and whether there is a difference between responders and non-responders to clopidogrel.
    -- Endpoint of the substudy: Changes in Flow-mediated dilation (FMD) in response to the administration of clopidogrel or prasugrel on day 14 as compared to day 7.

    - Substudy 2: Effect of prasugrel versus clopidogrel on the thrombotic-inflammatory potential of platelets assessed by novel surrogate platelet function tests.
    -- Investigating the effect of prasugrel versus clopidogrel on the platelet proteomic profile and platelet-leukocyte interaction in terms of responsiveness to clopidogrel.
    -- Endpoint of the substudy: Changes in the platelet protein composition and platelet-leukocyte conjugate formation in response to the administration of clopidogrel or prasugrel on day 14 compared to day 7.

    Substudy 3: The hemostatic system as a modulator of acute coronary syndromes (ACS): Identification of genetic variants and their correlation with endothelial function, platelet activation and clinical outcome
    -- Identification of (novel) genetic variants in genes with crucial functional roles in the hemostatic system including endothelial function and platelet activation (by applying high-through-put sequencing strategies)
    -- Correlation with the primary endpoint of the main study: The primary end point of the study is a combined ischemic and bleeding end point, which is a composite endpoint consisting of death from cardiovascular cause (for a definition see appendix 2), myocardial infarction, nonfatal stroke and bleeding grade ≥2 defined according to BARC criteria (see main study protocol for details).
    -- Correlation with the following secondary endpoint of the main study:
    - Incidence of class ≥2 bleeding events at 12 months
    - Bleeding Academic Research Consortium (BARC)
    - Incidence of stent thrombosis (combined definite
    - defined according to Academic Research Consortium
    - Incidence of death from any cause at 12 months
    - Incidence of cardiovascular death at 12 months
    - Incidence of MI at 12 months
    - Incidence of nonfatal stroke at 12 months
    -- Correlation with angiographic outcomes.
    -- Correlation with endothelial and platelet function (see substudy 1 and 2)

    3. SPARTAN Substudy (included in protocol V 5.0 dated 02. Apr. 2014)
    - To determine if patients can be safely swtched from Prasugrel to Clopidogrel in LOF non carriers in the chrinic phase after ACS
    - To analyze the association of CYP2C19 alleles with on-treatment platelet reactivity (MEA ADP) under Prasugrel treatment
    - To test the feasibility and clinical application of rapid point of care genetic testing in the ACS setting
    - To evaluate the health economics if this approach

    - W połączeniu analiza biomarkerów TROPICAL-ACS Biomarker substudy (zawarte w protokole V. 4.0, data :03. grudnia 2013 r.)
    - Identyfikacja nowych biomarkerów, które pomagają w spersonalizowaniu przewidywanych
    wyników pacjentów. Będzie używany proteomiczna, metoboliczna, ekspresja RNA, wyszukanie polimorfizmu i metylacji DNA w skali całego genomu.
    – Rozszerzone badania funkcji płytek z dodatkowymi aktywatorami w dniu
    randomizacji i dniu 14, aby uzyskać dodatkowy wgląd w korelację parametrów funkcji płytek i ich moc predykcyjną z badania funkcji płytek krwi, aby pomóc w określeniu nowych algorytmów predyktywnych z potencjalnym wpływem na terapeutyczne podejścia z ACS.

    2. Substudy SPARTAN (zawarte w protokole v. 5 z dnia 02 kwietnia 2014)
    - Aby określić, czy pacjenci mogą bezpiecznie przejść z prasugrelu do
    Klopidogrel w LOF niebędących nosicielami w fazie przewlekłej po OZW
    - Analiza związku alleli CYP2C19 z reaktywnością płytek krwi (MEA ADP) w ramach leczenia prasugrelem
    - W celu zbadania możliwości zastosowania klinicznego i szybkiego nadzoru
    badaniem genetycznym w ustawieniu ACS
    - Do oceny ekonomiki zdrowia – takie podejście
    E.3Principal inclusion criteria
    - Patients with troponin positive ACS
    - Successful PCI (defined as a post PCI diameter stenosis <20% and TIMI flow >=2)
    - A planned treatment of prasugrel for 12 month after the procedure
    - Written informed consent
    1.Pacjenci z ACS z dodatnim wynikiem oznaczenia troponiny
    2.Udana PCI (zdefiniowana jako zwężenie naczynia po PCI o < 20% i przepływ TIMI ≥ 2)
    3.Planowany czas leczenia prasugrelem przez 12 miesięcy po zabiegu
    4. Pisemna świadoma zgoda na udział w badaniu
    E.4Principal exclusion criteria
    - Age < 18 years and > 80 years
    - Subjects with known contraindications to clopidogrel treatment, which are hypersensitivity to the drug substance or any component of the product and active pathological bleeding such as peptic ulcer or intracranial hemorrhage
    - Subjects with known contraindications to prasugrel treatment, which are hypersensitivity to the drug substance or any component of the product, active pathological bleeding such as peptic ulcer or intracranial hemorrhage and a history of prior transient ischemic attack (TIA) or stroke
    - Subjects with a history of a complicated or prolonged cardiogenic shock in the last two weeks prior to the beginning of this clinical trial. A complicated or prolonged cardiogenic shock is defined by a cardiogenic shock that required mechanical ventilation or the cardiovascular support with positive inotropic drugs (i.v. catecholamines) for ≥7 days.
    - Subjects requiring concomitant treatment with an anticoagulant agent (Vitamin-K antagonists or novel oral anticoagulants such as rivaroxaban, dabigatran or apixaban)
    - Indication for major surgery (per decision of the treating physician) for the planned duration of the study
    - Simultaneous participation in another clinical trial that involveds the administration of an investigational medicinal drug within 30 days prior to the beginning of this clinical trial
    - Known or persistent abuse of medication, drugs or alcohol
    - Current or planned pregnancy or nursing women, women 90 days after childbirth. Females of childbearing potential, who do not use and are not willing to use medically reliable methods of contraception for the entire study duration (such as oral, injectable, or implantable contraceptives, or intrauterine devices) unless they are surgically sterilized/hysterectomized or there are any other criteria considered sufficiently reliable by the investigator`s opinion
    - Evidence of significant active neuropsychiatric disease, in the investigator´s opinion
    1. Wiek < 18 lat lub > 80 lat
    2. Pacjenci ze znanymi przeciwwskazaniami do leczenia klopidogrelem: nadwrażliwość na substancję czynną lub dowolny składnik leku oraz aktywne patologiczne krwawienie, takie jak krwawienie z owrzodzenia trawiennego
    3. Pacjenci ze znanymi przeciwwskazaniami do leczenia prasugrelem: nadwrażliwość na substancję czynną lub dowolny składnik leku; aktywne patologiczne krwawienie, takie jak krwawienie z owrzodzenia trawiennego; oraz przebyty incydent przemijającego niedokrwienia ośrodkowego układu nerwowego (TIA) lub udar mózgu
    4. Pacjenci z wywiadami powikłanego lub długotrwałego wstrząsu kardiogennego w ciągu ostatnich dwóch tygodni przed planowanym włączeniem do badania klinicznego. Powikłany lub długotrwały wstrząs kardiogenny definiuje się jako wstrząs kardiogenny, który wymagał wentylacji mechanicznej lub wspomagania układu krążenia za pomocą leków o dodatnim działaniu inotropowym (katecholamin podawanych dożylnie) przez ≥ 7 dni
    5. Pacjenci wymagający jednoczesnego leczenia za pomocą leku przeciwzakrzepowego (antagonisty witaminy K lub nowego doustnego leku przeciwzakrzepowego, takiego jak riwaroksaban, dabigatran lub apiksaban)
    6. Wskazanie do poważnej operacji (na podstawie decyzji lekarza leczącego) w ciągu planowanego okresu trwania badania
    7. Jednoczesny udział w innym badaniu klinicznym, który wiązał się z podawaniem eksperymentalnego produktu medycznego w ciągu 30 dni przed planowanym włączeniem do badania klinicznego
    8. Znane lub utrzymujące się nadużywanie leków, narkotyków lub alkoholu
    9. Obecna lub planowana ciąża lub kobiety karmiące piersią, kobiety w ciągu 90 dni po urodzeniu dziecka. Kobiety w wieku rozrodczym, które nie stosują i nie chcą stosować medycznie wiarygodnych metod antykoncepcji przez cały planowany okres trwania badania (takich jak doustne, wstrzykiwane lub implantowane środki antykoncepcyjne albo wewnątrzmaciczne urządzenia do antykoncepcji), chyba że zostały wysterylizowane chirurgicznie/poddane histerektomii lub spełniają inne kryteria uznane przez badacza za wystarczająco wiarygodne w indywidualnych przypadkach
    10.Dowody istotnej aktywnej choroby neuropsychiatrycznej w opinii badacza
    E.5 End points
    E.5.1Primary end point(s)
    Combined ischemic and bleeding endpoint, which is a composite endpoint consisting of death from cardiovascular cause, myocardial infarction, stroke and bleeding grade >= 2 defined according to BARC (Bleeding Academic Research Consortium) criteria
    Łączna częstość występowania incydentów niedokrwiennych i krwotocznych, tj. złożony punkt końcowy obejmujący zgony z przyczyn sercowo-naczyniowych, zawały mięśnia sercowego, udary mózgu oraz krwawienia stopnia ≥ 2 według kryteriów Bleeding Academic Research Consortium (BARC)
    E.5.1.1Timepoint(s) of evaluation of this end point
    The time points of evaluation will be Follow up 30 days, 6 month and 12 month.
    Momenty ewaluacji Pierwszorzędowego Punktu Końcowego:
    30 dni, 6 miesięcy, 12 miesięcy
    E.5.2Secondary end point(s)
    - Bleeding events with a grade >= 2 defined according to BARC criteria
    - Stent thrombosis (definite or probable) according to ARC (Academic Research Consortium) criteria
    - Incidence of ischemia-driven revascularization
    - Incidence of death from any cause
    - Pre-specified cost-effectiveness analysis on the economic impact of a platelet function testing guided tailored treatment for ACS patients
    - The individual ischemic components of the primary endpoint will be subject to the secondary endpoint analysis
    -- Incidence of cardiovascular death at 12 month
    -- Incidence of MI at 12 month
    -- Incidence of nonfatal stroke at 12 month
    • Krwawienia stopnia ≥ 2 według kryteriów BARC
    • Zakrzepica w stencie (pewna lub prawdopodobna) według kryteriów Academic Research Consortium (ARC)
    •Pilna rewaskularyzacja spowodowana niedokrwieniem
    •Zgon z dowolnej przyczyny
    •Prospektywnie zaplanowana analiza efektywności kosztowej dotycząca ekonomicznych następstw leczenia w zależności od wyników testów czynności płytek u pacjentów z ACS
    •Poszczególne elementy składowe głównego punktu końcowego
    E.5.2.1Timepoint(s) of evaluation of this end point
    The time points of evaluation will be Follow up 30 days, 6 month and 12 month.
    Momenty ewaluacji Pierwszorzędowego Punktu Końcowego:
    30 dni, 6 miesięcy, 12 miesięcy
    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 Yes
    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 Yes
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 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 EEA28
    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
    Since this is a multi-center , multi-national trial with a high amount of clinical data the end of study is defined as data base lock.
    Ponieważ jest to wieloośrodkowe, wielonarodowe badanie o dużej ilości danych klinicznych koniec badania określa się jako zamkniecie bazy danych.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    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 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: 1500
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1100
    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 state400
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 2600
    F.4.2.2In the whole clinical trial 2600
    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
    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 Decision2015-06-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-02-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-05-15
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