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    Summary
    EudraCT Number:2015-000850-39
    Sponsor's Protocol Code Number:P141103
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-10-15
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2015-000850-39
    A.3Full title of the trial
    Assessment of Loading with the P2Y12 inhibitor Ticagrelor or clopidogrel to Halt ischemic Events in patients Undergoing elective coronary Stenting: the ALPHEUS study.
    Hodnocení účinku úvodní dávky nového inhibitoru P2Y12 (ticagreloru) ve srovnání s úvodní dávkou clopidogrelu na snížení výskytu ischemických příhod u pacientů podstupujících plánovanou koronární angioplastiku: studie ALPHEUS.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Assessment of Loading with the P2Y12 inhibitor Ticagrelor or clopidogrel to Halt ischemic Events in patients Undergoing elective coronary Stenting: the ALPHEUS study.
    Randomizovaná, otevřená studie zhodnocující podání inhibitoru P2Y12 ticagreloru nebo clopidogrelu ke zmírnění ischemických příhod u pacientů určených k zavedení koronárního stentu.
    A.3.2Name or abbreviated title of the trial where available
    ALPHEUS
    A.4.1Sponsor's protocol code numberP141103
    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 SponsorASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    B.1.3.4CountryFrance
    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 supportASTRAZENECA
    B.4.2CountryFrance
    B.4.1Name of organisation providing supportAPHP
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    B.5.2Functional name of contact pointDRCI
    B.5.3 Address:
    B.5.3.1Street AddressHôpital St Louis, 1 av. Claude Vellefaux
    B.5.3.2Town/ cityPARIS
    B.5.3.3Post code75010
    B.5.3.4CountryFrance
    B.5.4Telephone number0144841748
    B.5.5Fax number0144841701
    B.5.6E-mailpauline.cavelier@aphp.fr
    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 Brilique
    D.2.1.1.2Name of the Marketing Authorisation holderASTRA ZENECA
    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.3.1Product nameBrilique
    D.3.2Product code AZD6140
    D.3.4Pharmaceutical form 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 274693-27-5
    D.3.9.2Current sponsor codeAZD6140
    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.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 Trombex 75 mg potahované tablety
    D.2.1.1.2Name of the Marketing Authorisation holderZentiva, k. s.
    D.2.1.2Country which granted the Marketing AuthorisationCzech Republic
    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 nameclopidogrel 75 mg
    D.3.4Pharmaceutical form 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.3.9.2Current sponsor code120 202-66-6
    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
    PCI-related myocardial infarction (MI type 4) or injury (I) within 48 hours (or at hospital discharge if earlier than 48 hours) of elective PCI/stent
    E.1.1.1Medical condition in easily understood language
    PCI-related myocardial infarction (MI type 4) or injury (I) within 48 hours (or at hospital discharge if earlier than 48 hours) of elective PCI/stent
    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 PT
    E.1.2Classification code 10028596
    E.1.2Term Myocardial infarction
    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
    Primary Efficacy Objective
    The purpose of this study is to demonstrate the superiority of the new P2Y12 inhibitor ticagrelor over clopidogrel on PCI-related myocardial infarction (MI type 4) or major myocardial injury (I) within 48 hours (or at hospital discharge if earlier) of elective PCI/stent.

    Primary Safety Objective
    The primary safety objective is to compare the new P2Y12 inhibitor ticagrelor over clopidogrel on major bleeding events as assessed by the BARC criteria 19 (BARC type 3 or 5) at 48 hours (or discharge if it occurs earlier).
    Primární cíl
    - Prokázat superioritu ticagreloru oproti clopidogrelu v kontextu vzniku infarktu myokardu souvisejícího s PCI (typ 4) nebo závažným poškozením myokardu v průběhu 48 hodin (nebo při propuštění, pokud proběhne dříve) od provedení elektivní PCI/implantace stentu.

    Primární cíl
    - Porovnat bezpečnost ticagreloru a clopidogrelu v kontextu výskytu závažných krvácení dle BARC (typ 3 nebo 5) kritérií po 48 hodinách (nebo při propuštění, pokud proběhne dříve) od provedení elektivní PCI/implantace stentu.
    E.2.2Secondary objectives of the trial
    Secondary Efficacy Objectives are to demonstrate :
    - the superiority of the new P2Y12 inhibitor ticagrelor over clopidogrel on
    - myocardial infarction (MI) both at 48 hours (or at hospital discharge if earlier) and 30 days of elective PCI/stent.
    - death (any) or myocardial infarction (MI) both at 48 hours (or at hospital discharge if earlier) and 30 days of elective PCI/stent.
    - on death (any), MI/I, urgent revascularization or recurrent ischemia requiring catheterization at 48 hours and 30 days.
    - on PCI-related myocardial infarction (MI type 4) or any type of injury (major or minor) within 48 hours (or at hospital discharge if earlier) of elective PCI/stent.
    Secondary Safety Objectives are to assess the rates of :
    - major bleeding events as assessed by the BARC criteria19 (BARC type 3 or 5) at 30 days follow-up,
    - nuisance or minor bleeding (BARC type 1 or 2) at 48h and 30 day,
    - any bleeding (BARC 1, 2, 3, 4, 5) at 48h and 30 days,
    - stroke at 48h and 30 days.
    - Prokázat superioritu ticagreloru oproti clopidogrelu po 48 hodinách (nebo při propuštění, pokud proběhne dříve) a zároveň po 30 dnech od provedení elektivní PCI/implantace stentu v kontextu:
    > vzniku infarktu myokardu
    > úmrtí (jakákoliv příčina) a infarktu myokardu

    - Prokázat superioritu ticagreloru oproti clopidogrelu v kontextu vzniku infarktu myokardu (typ 4) souvisejícího s PCI nebo jakéhokoliv poškození myokardu v průběhu 48 hodin (nebo při propuštění, pokud proběhne dříve) od provedení elektivní PCI/implantace stentu.

    - Určit četnost:
    > příhod závažného krvácení dle BARC kritérií (typ 3 nebo 5) po 30 dnech.
    > obtíží nebo nezávažných krvácení dle BARC kritérií (typ 1 nebo 2) po 48 hodinách a po 30 dnech.
    > jakéhokoliv krvácení (BARC 1, 2, 3, 4, 5) po 48 hodinách a po 30 dnech.
    > cévní mozkové příhody po 48 hodinách a po 30 dnech
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Male or female ≥ 18 years of age
    - Having at least one high-risk feature (Age > 75, Renal insufficiency (Clearance below 60ml/min calculated with Cockcroft-Gault formula), Diabetes Mellitus, Overweight (BMI >30), History of ACS (in the past 12 months) including UA/NSTEMI and STEMI, LVEF < 40% and/or prior episode of heart failure, Multivessel disease (2 or 3 V), Multiple stents needed defined as i) more than one stent implanted in one vessel or ii) more than 2 stents in 2 or more vessels, or iii) total stent length envisioned > 30mm, Left main stenting, Bifurcation stenting (whatever the technique), ACC/AHA type B2 or C lesion , Stenting of venous or arterial coronary graft).
    - Undergoing non-emergent single or multiple sites/vessels PCI during the same procedure).
    - Negative troponin (hs-Tn preferably) or decreasing troponin in case of hs-Tn above the ULN and within the grey zone of the laboratory (or <3XULN if the grey zone is not defined) before enrolment according to local measurement, during hospitalization for coronary angiogram or PCI.
    -Informed consent obtained in writing at enrolment into the study
    - Muž nebo žena, věk ≥ 18 let
    - Splňuje alespoň jeden ukazatel vysokého rizika (Věk > 75; renální nedostatečnost (clearance pod 60 ml/min počítaná Cockcroft-Gaultovým vzorcem); diabetes mellitus; obezita (BMI > 30); historie ACS v posledních 12 měsících vč. UA/NSTEMI a STEMI; LVEF < 40% a/nebo předchozí epizoda srdečního selhání; postižení více tepen (2 nebo 3); potřeba více stentů definovaná jako: i) více než jeden stent implantovaný v jedné tepně, ii) více než 2 stenty ve 2 nebo více tepnách , iii) stent s délkou > 30 mm; stent levé tepny; stent bifurkace; ACC/AHA typu B2 nebo C léze; stent žilního nebo arteriálního koronárního štěpu)
    - Podstupuje non-emergentní PCI na jednom či více místech/tepnách během jedné procedury
    - Negativní troponin (hs-Tn přednostně) nebo klesající troponin v případě hs-Tn nad horní limit normálních hodnot (ULN) a v rámci šedé zóny laboratoře (nebo <3×ULN, pokud není šedá zóna definována) před zařazením na základě lokálních zvyklostí, během hospitalizace pro koronární angiogram nebo PCI
    - Podepsaný informovaný souhlas
    E.4Principal exclusion criteria
    Subjects presenting with any of the following will not be included in the study:
    - Women of child-bearing potential (ie, those who are not chemically or surgically sterilised or who are not post-menopause) who are not willing to use a medically accepted method of contraception that is considered reliable in the judgment of the investigator OR women who have a positive pregnancy test at randomisation OR women who are breast-feeding
    - Thrombolytic therapy within the previous 24 hours
    - Undergoing primary PCI for ongoing STEMI
    - Undergoing rescue PCI after failed thrombolysis
    - Any other elective PCI scheduled within the following 30 days after the index PCI
    - History of intracranial haemorrhage at any time.
    - Increased bleeding risk: intracranial tumor or aneurysm; recent trauma or major surgery (< 1 month) (including bypass surgery), active gastrointestinal, active bleeding
    - Uncontrolled arterial hypertension (defined as a systolic BP ≥ 180 mmHg and/or diastolic BP ≥ 100 mmHg)
    - Recent (<48 hours) or planned spinal/epidural anesthesia or puncture
    - Impaired haemostasis such as known International Normalized Ratio (INR) >1.5; past or present bleeding disorder (including congenital bleeding disorders such as von Willebrand's disease or hemophilia, acquired bleeding disorders, and unexplained clinically significant bleeding disorders), thrombocytopenia (platelet count <100,000/µL)
    - Known severe and moderated hepatic impairment
    - Treatment with oral anticoagulant therapy within 72 hours prior to inclusion or current need for oral anticoagulant therapy in the next month.
    - Use of abciximab within the previous 7 days or, tirofiban or eptifibatide within the past 12 hours of index PCI
    - Prohibited treatments (see section 8.3)
    - Inability to give informed consent or high likelihood of being unavailable for follow-up
    - Participation in another clinical research protocol with other investigational agents or devices within the previous 30 days, planned use of investigational drugs or devices, or previous enrolment in this trial (routine care authorized)
    - Known intolerance to clopidogrel or ticagrelor
    - Hypersensitivity to ticagrelor or its excipients
    - Hypersensitivity to clopidogrel or its excipients
    - Patient on prasugrel or ticagrelor before the procedure
    - Ženy ve fertilním věku bez adekvátní kontracepce, nebo ženy, které měly při randomizaci pozitivní těhotenský test, nebo kojící ženy
    - Trombolytická léčba během posledních 24 hodin
    - Podstupující primární PCI pro probíhající STEMI
    - Podstupující záchranou PCI po selhání trombolýzy
    - Indikace k další PCI během následujících 30 dnů po indexové PCI
    - Historie intrakraniální hemorhagie
    - Zvýšené riziko krvácení: intrakraniální tumor nebo aneurysma; nedávné trauma nebo operace (méně než 1 měsíc) (zahrnující bypass), aktivní gastrointestinální krvácení
    - Nekontrolovaná arteriální hypertenze (systolický krevní tlak ≥ 180 mmHg a/nebo diastolický krevní tlak ≥ 100 mmHg)
    - Nedávná (<48 hodin) nebo plánovaná spinální/epidurální anestezie nebo punkce
    - Porucha hemostázy jako INR >1,5; krvácivé stavy v minulosti nebo aktuálně (vč. kongenitálních krvácivých stavů jako je von Willebrandova choroba, hemofilie, získané krvácivé stavy a nezdůvodněné klinicky významné krvácivé stavy); trombocytopenie (počet destiček <100 000/µl)
    - Známé závažné nebo středně závažné poškození jater
    - Léčba orálními antikoagulancii během 72 hodin před zařazením do studie, nebo potřeba léčby orálními antikoagulancii během následujícího měsíce
    - Užití abciximabu v posledních 7 dnech, nebo užití tirofibanu nebo eptifibatidi v posledních 12 hodinách před indexovým PCI
    - Nedovolená léčba (prasugrel, cangrelor, simvastatin, lovastatin a inhibitory a aktivátory CYP3A4 v rameni ticagreloru)
    - Nemožnost udělení informovaného souhlasu nebo vysoká pravděpodobnost nemožnosti dalšího sledování
    - Účast v jiné klinické studii za použití jiných sledovaných přípravků nebo pomůcek v předchozích 30 dnech, plánované použití výzkumných léčivých přípravků nebo pomůcek, nebo předchozí zařazení do této studie
    - Známá intolerance clopidogrelu nebo ticagreloru
    - Přecitlivělost na ticagrelor nebo jeho excipienty
    - Přecitlivělost na clopidogrel nebo jeho excipienty
    - Léčba prasugrelem nebo ticagrelorem předcházející sledovanou událost
    E.5 End points
    E.5.1Primary end point(s)
    PCI-related myocardial infarction (MI type 4) or major myocardial injury (I) within 48 hours (or at hospital discharge if earlier) of elective PCI/stent. MI-4/I at 48 hours will include the following events (according to the third universal definition of MI)

    The primary safety endpoint including the rate of major bleeding events (BARC 3 or 5) will be evaluated from randomization to 48 hours of elective PCI/stent or hospital discharge if earlier.
    Bleeding will be defined by the BARC classification (type 1 to 5) although only types 3 and 5 will be considered as major bleeding and types 1 and 2 as minor/nuisance bleedings. We are not expecting any BARC bleeding type 4 by trial design.
    E.5.1.1Timepoint(s) of evaluation of this end point
    48h
    E.5.2Secondary end point(s)
    1/ Myocardial infarction (MI) both at 48 hours (hospital discharge if earlier) and 30 days of elective PCI/stent. MI will include the following events (according to the third universal definition of MI)
    2/ Death (any) or myocardial infarction (MI) both at 48 hours (hospital discharge if earlier) and 30 days of elective PCI/stent. MI will include the following events (according to the third universal definition of MI18)

    3/ Death (any), MI/I, urgent revascularization or recurrent ischemia requiring catheterization at 48 hours and 30 days.

    4/ PCI-related myocardial infarction (MI type 4) or any type of injury (I) (major or minor) within 48 hours (or at hospital discharge if earlier) of elective PCI/stent. MI-4/I will include the following events (according to the third universal definition of MI)


    The secondary safety endpoints will be evaluated from randomization to 48 hours of elective PCI/stent or hospital discharge if earlier and at 30 days and will includes:
    o the rate of major bleeding events (BARC 3 or 5) at 30 days
    o Nuisance or minor bleeding (BARC type 1 or 2)
    o Any bleeding (BARC 1, 2, 3, 4, 5)
    o Any stroke.
    E.5.2.1Timepoint(s) of evaluation of this end point
    48h and 30 days
    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 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 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 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA55
    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
    Members of the CEC are and will not be aware of the investigator's point of view. The CEC will assess all endpoints according to the definitions stated in the protocol. This will be a blinded evaluation. It is intended that the CEC meets to assess the clinical endpoints; several times during monitoring, after the finalization of the trial to assess the 48 hours followup. Clinical endpoint adjudication will be performed using blinded source data that are
    provided by CRAs to the CEC.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    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: 1900
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1900
    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 No
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state500
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1900
    F.4.2.2In the whole clinical trial 1900
    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
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-11-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-11-06
    P. End of Trial
    P.End of Trial StatusOngoing
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