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    Summary
    EudraCT Number:2015-000993-37
    Sponsor's Protocol Code Number:UNIPD001
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2021-09-27
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2015-000993-37
    A.3Full title of the trial
    Downstream versus Upstream strategy for the administration of P2Y12 receptor Blockers In non ST elevated acUte coronary Syndromes with initial invasive indication
    Downstream versus Upstream strategy for the administration of P2Y12 receptor Blockers In non ST elevated acUte coronary Syndromes with initial invasive indication
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Downstream versus Upstream strategy for the administration of two antiplatelets in non ST elevated coronary syndrome with initial invasive indication
    Confronto tra strategie "a valle" e "a monte" nella somministrazione di due antiaggreganti in sindrome coronarica acuta senza sopraslivellamento del tratto ST con un'indicazione invasiva iniziale
    A.3.2Name or abbreviated title of the trial where available
    DUBIUS
    DUBIUS
    A.4.1Sponsor's protocol code numberUNIPD001
    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 SponsorAZIENDA OSPEDALIERA DI PADOVA
    B.1.3.4CountryItaly
    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 supportAzienda Ospedaliera di Padova
    B.4.2CountryItaly
    B.4.1Name of organisation providing supportSoc Italiana Cardiologia Interventistica SICI-GISE
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAzienda Ospedaliera di Padova
    B.5.2Functional name of contact pointUOC Cardiologia
    B.5.3 Address:
    B.5.3.1Street AddressVia Giustiniani, 1
    B.5.3.2Town/ cityPadova
    B.5.3.3Post code35128
    B.5.3.4CountryItaly
    B.5.4Telephone number0498211844
    B.5.5Fax number0498212309
    B.5.6E-mailgiuseppe.tarantini.1@gmail.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name BRILIQUE - 90 MG - COMPRESSE RIVESTITE CON FILM - USO ORALE - BLISTER(PVC/PVDC/ALU) 56 COMPRESSE (CONF. CALENDARIZZATA)
    D.2.1.1.2Name of the Marketing Authorisation holderASTRAZENECA AB
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 - 5MG - COMPRESSA RIVESTITA CON FILM - USO ORALE BLISTER (ALL) 28 COMPRESSE
    D.2.1.1.2Name of the Marketing Authorisation holderELI LILLY NEDERLAND BV
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameEfient
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.11 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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 - 10MG - COMPRESSA RIVESTITA CON FILM - USO ORALE BLISTER (ALL) 28 COMPRESSE
    D.2.1.1.2Name of the Marketing Authorisation holderELI LILLY NEDERLAND BV
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameefient
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.11 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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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: 4
    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 EPSOCLAR - 25.000 U.I./5 ML SOLUZIONE PER INFUSIONE 10 FIALE 5 ML
    D.2.1.1.2Name of the Marketing Authorisation holderHOSPIRA ITALIA S.R.L.
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameEpsoclar 5000
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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: 5
    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 ANGIOX - 10 FIALE DA 250 MG
    D.2.1.1.2Name of the Marketing Authorisation holderTHE MEDICINES COMPANY UK LTD
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameAngiox
    D.3.4Pharmaceutical form Powder and solvent for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    Patients with non ST elevated acute coronary syndrome (unstable angina, non ST elevated myocardial infarction), with an onset of symptoms during the previous 72 hours with initial invasive indication
    Pazienti con sindrome coronarica acuta senza sopraslivellamento del tratto ST (angina instabile, infarto miocardico senza sopraslivellamento del tratto ST), con comparsa dei sintomi nelle 72 ore precedenti e per i quali viene scelta una strategia invasiva iniziale
    E.1.1.1Medical condition in easily understood language
    Non ST elevated myocardial infarction or unstable angina
    Infarto miocardico senza sopraslivellamento del tratto ST o angina instabile
    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 10051592
    E.1.2Term Acute coronary syndrome
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10071111
    E.1.2Term Non ST segment elevation 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
    Determine the net clinical benefit of downstream strategy for the administration of newer antiplatelet agents (prasugrel or ticagrelor) versus the upstream strategy (only ticagrelor) in patients with NSTEACS invasive initial indication.
    Determine the net clinical benefit of prasugrel compared with administration of ticagrelor, within the group of the PCI arm downstream strategy.
    Stabilire il beneficio clinico netto della strategia downstream per la somministrazione dei più recenti agenti antipiastrinici (prasugrel o ticagrelor) versus la strategia upstream (solo ticagrelor) in pazienti NSTEACS con indicazione invasiva iniziale.
    Stabilire il beneficio clinico netto del prasugrel rispetto alla somministrazione del ticagrelor, all'interno del gruppo PCI del braccio strategia downstream.
    E.2.2Secondary objectives of the trial
    Determine the net clinical benefit of unfractionated heparin compared to bivalirudin within the entire group PCI.
    Stabilire il beneficio clinico netto dell’eparina non frazionata rispetto alla bivalirudina all'interno dell’intero gruppo PCI.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients with acute coronary syndromes non ST-segment elevation (NSTEACS) with onset of symptoms during the previous 24 hours and for which the initial invasive strategy is chosen. The subject is able to verbally confirm the understanding of the risks and benefits and provides informed consent signed.
    Paziente con sindrome coronarica acuta senza sopraslivellamente del tratto ST (NSTEACS) con comparsa dei sintomi durante le 24 ore precedenti e per i quali viene scelta una strategia invasiva iniziale. Il soggetto è in grado di confermare verbalmente la comprensione dei rischi e dei benefici e fornisce il consenso informato firmato.
    E.4Principal exclusion criteria
    Platelet count <100,000 cells / mm³ or> 700,000 cells / mm³, or white blood cell count (WBC) <3,000 cells / mm³ seven days before the procedure.
    Previous hemorrhagic or ischemic stroke, transient ischemic attack (TIA), or subarachnoid hemorrhage. Receiving a GP IIb / IIIa inhibitor
    Conteggio piastrinico <100.000 cellule / mm³ o > 700.000 cellule / mm³, o conteggio globuli bianchi (WBC) <3.000 cellule / mm³ 7 giorni prima della procedura.
    Precedenti emorragici o di ictus ischemico, attacco ischemico transitorio (TIA), o emorragia subaracnoidea. Ricevono un inibitore della GP IIb / IIIa
    E.5 End points
    E.5.1Primary end point(s)
    Incidence at 30 days and 12 months of NACE (Net Adverse Cardiac Events), defined as a composite of: death from vascular causes (death from cardiovascular causes or cerebrovascular causes and any death without another known cause), non fatal MI, or non fatal stroke, BARC type 3, 4 and 5 bleeding.
    Incidenza a 30 giorni di NACE (eventi avversi cardiaci netti) definiti come un composito di: morte per cause vascolari (morte per cause cardiovascolari o cerebrovascolari e ogni morte senza un'altra causa nota), IM non fatale, ictus non fatale, sanguinamento BARC tipo 3, 4 e 5.
    E.5.1.1Timepoint(s) of evaluation of this end point
    30 days and 12 months
    30 giorni e 12 mesi
    E.5.2Secondary end point(s)
    Misura singola e combinata di morte per cause vascolari, infarto miocardico, ictus, TIA, grave ischemia recidivante, ischemia ricorrente, o altri eventi trombotici arteriosi. ; morte per qualsiasi causa.; Qualsiasi trombosi dello stent in base ai criteri di ARC.
    ; Rivascolarizzazione del vaso target (TVR).; Rivascolarizzazione della lesione target (TLR); NACE (eventi avversi cardiaci netti) che si sono verificati nel periodo tra il ricovero e la rivascolarizzazione coronarica definita come un composito di: morte per cause vascolari (morte per cause cardiovascolari o cerebrovascolari cause e ogni morte senza un'altra causa nota), non fatale, o non ictus fatale, sanguinamento BARC tipo 2, 3, 4 e 5.
    ; Compliance alla terapia antiaggregante. ; Sanguinamento BARC tipo 2, 3, 4 e 5.; Sanguinamenti secondo classificaizone TIMI maggiori.
    E.5.2.1Timepoint(s) of evaluation of this end point
    30 giorni e 12 mesi; 30 giorni e 12 mesi; 30 giorni e 12 mesi; 30 giorni e 12 mesi; 30 giorni e 12 mesi; 30 giorni e 12 mesi; 30 giorni e 12 mesi; 30 giorni e 12 mesi; 30 giorni e 12 mesi
    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 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) 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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA48
    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 Information not present in EudraCT
    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
    LVLS
    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 months0
    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 months0
    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: 500
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2020
    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 Yes
    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 state2520
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 2520
    F.4.2.2In the whole clinical trial 2520
    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)
    At the end of the trial subjects will receive additional drug treatments or diagnostic investigations according to the treating physician
    Al termine della sperimentazione i soggetti verranno sottoposti ad ulteriori trattamenti farmacologici o approfondimenti diagnostici secondo giudizio del medico curante
    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 Decision2015-09-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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