Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43851   clinical trials with a EudraCT protocol, of which   7283   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2016-003440-36
    Sponsor's Protocol Code Number:I8D-MC-AZFD
    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:2021-06-04
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2016-003440-36
    A.3Full title of the trial
    A Randomized, Double-Blind, Delayed-Start Study of LY3314814 (AZD3293) in Early Alzheimer’s Disease Dementia (Extension of Study AZES, The AMARANTH Study)
    Studio randomizzato in doppio cieco ad inizio ritardato di LY3314814 (AZD3293) nel trattamento della demenza di Alzheimer in fase precoce di malattia (estensione dello studio AZES, studio AMARANTH)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of LY3314814 in early Alzheimer's disease dementia
    Studio di LY3314814 nella demenza di Alzheimer in fase precoce di malattia
    A.3.2Name or abbreviated title of the trial where available
    A study of LY3314814 in early Alzheimer's disease dementia
    Studio di LY3314814 nella demenza di Alzheimer in fase precoce di malattia
    A.4.1Sponsor's protocol code numberI8D-MC-AZFD
    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 SponsorELI LILLY COMPANY
    B.1.3.4CountryUnited States
    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 supportEli Lilly and Company
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEli Lilly
    B.5.2Functional name of contact pointClinical Trial Registry Office
    B.5.3 Address:
    B.5.3.1Street AddressLilly Corporate Center, DC 1526
    B.5.3.2Town/ cityIndianapolis
    B.5.3.3Post code46285
    B.5.3.4CountryUnited States
    B.5.4Telephone number0554257386
    B.5.5Fax number0554257348
    B.5.6E-mailEU_Lilly_Clinical_Trials@lilly.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 No
    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 nameLY3314814
    D.3.2Product code LY3314814
    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.3.9.2Current sponsor codeLY3314814
    D.3.9.4EV Substance CodeSUB181816
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 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 No
    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 nameLY3314814
    D.3.2Product code LY3314814
    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.3.9.2Current sponsor codeLY3314814
    D.3.9.4EV Substance CodeSUB181816
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Early Alzheimer's Disease (mild cognitive impairment due to AD (ie, prodromal AD) and mild dementia of the Alzheimer's type)
    Alzheimer in fase precoce di malattia (lieve deterioramento cognitivo dovuto all’AD [ossia,
    fase prodromica dell’AD] e demenza lieve dovuta all’Alzheimer)
    E.1.1.1Medical condition in easily understood language
    Early Alzheimer's Disease
    Alzheimer in fase precoce di malattia
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10012271
    E.1.2Term Dementia Alzheimer's type
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate disease modification as outlined in Liu-Seifert (2015). This will be accomplished by testing the three delayed-start hypotheses in both doses of LY3314814 across Study AZES and up to Week 26 (Visit 7) of Study AZFD.
    Valutare la modifica della malattia come indicato in Liu-Seifert (2015). La valutazione sarà effettuata testando le tre ipotesi di inizio ritardato per entrambe le dosi di LY3314814 nello studio AZES e fino alla settimana 26 (visita 7) dello studio AZFD
    E.2.2Secondary objectives of the trial
    1. To evaluate the disease modification of both
    doses of LY3314814 on functional and cognitive outcomes across Study AZES and up to Week 26 (Visit 7) of Study AZFD using the primary analysis methodology.
    2. The delayed start analyses as outlined above will also be examined through Week 104 (Visit 15) for cognitive and functional outcomes.
    3. Collect information in order to further
    characterize the safety and tolerability of
    LY3314814 in patients with early AD
    dementia (at the time of entry into Study
    AZES)
    1. Valutare la modifica della malattia con entrambe le dosi di LY3314814 in termini di outcome funzionali e cognitivi nello studio AZES e fino alla settimana 26 (visita 7) dello studio AZFD utilizzando la metodologia dell’analisi primaria.
    2. L'analisi dell’inizio ritardato, come descritta sopra, sarà inoltre effettuata durante la settimana 104 (visita 15) in termini di outcome cognitivi e funzionali.
    3. Raccogliere informazioni al fine di caratterizzare ulteriormente la sicurezza e la tollerabilità di LY3314814 nei pazienti con demenza dovuta ad AD in fase precoce (al momento dell’ingresso nello studio AZES)
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives

    Pharmacogenetics
    Version: 3.1; 1.1
    Date: 12/07/2017
    Title: -Protocol Addendum I8D-MC-AZFD(3)
    Genetics v 16 Nov 2016
    - Protocol Addendum I8D-MC-AZFD(1.1) - FDG PET Imaging biomarker, v 12-Jul-2017
    - Protocol Addendum I8D-MC-AZFD (2.1) - Flortaucipir F 18 (18F-AV-
    1451) Tau PET Imaging Biomarker, v 12-Jul-2017.
    Objectives: - being conducted to collect and store whole
    blood
    deoxyribonucleic acid (DNA) and ribonucleic acid (RNA) samples for
    future investigation of
    variable response to LY3314814 and genetic variants thought to play a
    role in Alzheimer's
    disease (AD) and neurodegeneration.
    - The objectives are to evaluate the effect of LY3314814 on
    brain metabolic rates using FDG
    PET and to evaluate change from baseline (in Study AZES) in brain
    metabolism as measured by FDG PET.
    - The objective is to
    evaluate change from baseline (in Study AZES) in tau as measured by
    flortaucipir F 18 PET.

    Other types of substudies
    Specify title, date and version of each substudy with relative objectives: - To evaluate the effect of LY3314814 on brain amyloid burden using
    positron emission tomography (PET) in the longitudinal PET sub-study
    (included in the main protocol).
    - Protocol Addendum I8D-MC-AZFD(1) - FDG PET Imaging biomarker, v
    16 Nov 2016. The objectives are to evaluate the effect of LY3314814 on
    brain metabolic rates using FDG
    PET and to evaluate change from baseline (in Study AZES) in brain
    metabolism as measured by FDG PET.
    - Protocol Addendum I8D-MC-AZFD (2) - Flortaucipir F 18 (18F-AV-1451)
    Tau PET Imaging Biomarker, v 16 Nov 2016. The objective is to evaluate
    change from baseline (in Study AZES) in tau as measured by flortaucipir
    F 18 PET.
    -Protocol Addendum I8D-MC-AZFD(3)
    Genetics v 16 Nov 2016: being conducted to collect and store whole
    blood
    deoxyribonucleic acid (DNA) and ribonucleic acid (RNA) samples for
    future investigation of
    variable response to LY3314814 and genetic variants thought to play a
    role in Alzheimer's
    disease (AD) and neurodegeneration.

    Farmacogenetica
    Versione: 3.1; 1.1
    Data: 12/07/2017
    Titolo: - Addendum al protocollo I8D-MC-AZFD (3.1) Genetica v 12 Jul 2017
    - Protocol Addendum I8D-MC-AZFD(1.1) - FDG PET Imaging biomarker, v 12-Jul-2017
    - Protocol Addendum I8D-MC-AZFD (2.1) - Flortaucipir F 18 (18F-AV-
    1451) Tau PET Imaging Biomarker, v 12-Jul-2017 (Non applicabile per Italia)
    Obiettivi: - condotto per prelevare e conservare campioni di acido desossiribonucleico (DNA) e acido ribonucleico (RNA) da sangue intero per future ricerche sulla risposta variabile a LY3314814 e sulle varianti genetiche che si ritiene abbiano un ruolo nella malattia di Alzheimer (AD) e nella neurodegenerazione.
    - Valutare l'effetto di LY3314814 sul metabolismo cerebrale come misurato da FDG PET
    - Valutare le modifiche di Tau dal baseline (Studio AZES) misurata tramite flortaucipir F 18 PET (Non applicabile per Italia)

    Altre tipologie di sottostudi
    specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: - Valutare gli effetti di LY3314814 sull’accumulo di amiloide a livello cerebrale mediante tomografia a emissione di positroni (PET) nel sottostudio longitudinale sulla PET (incluso nel protocollo principale).
    – Addendum al protocollo I8D-MC-AZFD (1) - Biomarcatore imaging per FDG-PET, v 16 Nov 2016. Gli obiettivi sono valutare gli effetti di LY3314814 sui tassi metabolici cerebrali utilizzando la FDG-PET e valutare la variazione rispetto al basale (nello studio AZES) del metabolismo cerebrale misurato tramite FDG-PET.
    – Addendum al protocollo I8D-MC-AZFD (2) - Biomarcatore imaging per PET flortaucipir F 18 (18F-AV-1451) specifico per tau, v 16 Nov 2016. L’obiettivo è valutare la variazione rispetto al basale (nello studio AZES) della tau, misurata tramite PET con flortaucipir F 18.
    - Addendum al protocollo I8D-MC-AZFD (3) Genetica v 16 Nov 2016: condotto per prelevare e conservare campioni di acido desossiribonucleico (DNA) e acido ribonucleico (RNA) da sangue intero per future ricerche sulla risposta variabile a LY3314814 e sulle varianti genetiche che si ritiene abbiano un ruolo nella malattia di Alzheimer (AD) e nella neurodegenerazione.
    E.3Principal inclusion criteria
    Participants previously enrolled in AMARANTH (NCT02245737) who meet eligibility criteria for delayed start I8D-MC-AZFD
    Partecipanti precedentemente arruolati nello studio AMARANTH (NCT02245737) che soddisfano i criteri di eleggibilità per lo studio I8D-MC-AZFD a inizio ritardato
    E.4Principal exclusion criteria
    Participants who participate in AMARANTH (NCT02245737) who develop new conditions precluding them from enrolling into I8D-MC-AZFD.
    Partecipanti allo studio AMARANTH (NCT02245737) che sviluppano nuove condizioni che ne precludono l’arruolamento nello studio I8D-MC-AZFD.
    E.5 End points
    E.5.1Primary end point(s)
    1. Delayed start analysis on the ADAS-Cog13
    1. Analisi di inizio ritardato su ADAS-Cog13
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Visit 5, 7 and at early discontinuation
    1. Visite 5, 7 e interruzione anticipate
    E.5.2Secondary end point(s)
    1. Delayed start analysis on the ADCS-iADL 2. Delayed start analysis on the FAQ 3. Delayed start analysis on the iADRS 4. Delayed start analysis on the MMSE 5. Delayed start analysis on the ADAS-Cog13 Standard safety assessments: 6. Spontaneously reported AEs 7. Clinical laboratory tests 8. Vital signs 9. Body weight 10. 12-lead ECGs 11. Physical examinations including neurological examinations • Additional safety assessments: 12. Eye examinations 13. Skin examinations 14. Serial MRI 15. Columbia-Suicide Severity Rating Scale (C-SSRS)
    1. Analisi di inizio ritardato su ADAS-iADL 2. Analisi di inizio ritardato su FAQ 3. Analisi di inizio ritardato su iADRS 4. Analisi di inizio ritardato su MMSE 5. Analisi di inizio ritardato su ADAS-Cog13 Valutazioni standard di sicurezza: 6. EA riferiti spontaneamente 7. Test clinici di laboratorio 8. Segni vitali 9. Peso corporeo 10. ECG a 12 derivazioni 11. Esami obiettivi, incluse valutazioni neurologiche • Ulteriori valutazioni di sicurezza: 12. Esami oculistici 13. Esami della cute 14. Immagini RM seriate 15. Scala Columbia-Suicide Severity Rating (C-SSRS)
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. V. 7, 11, 13, 15 & early discontinuation 2. V. 7, 11, 13, 15 & early discontinuation 3. V. 7, 11, 13, 15 & early discontinuation 4. V. 5, 7, 11, 13, 15 & early discontinuation 5. V. 5, 7, 11, 13, 15 & early discontinuation 6, As observed 7. V. 3, 4, 5, 7, 9, 11,12, 13, 14, 15 & early discontinuation 8. V2, 3, 4, 5, 6, 7, 9, 10, 11,12, 13, 14, 15 & early discontinuation 9 V. 5, 7, 11, 15 & early discontinuation 10. V. 2, 3, 5, 7, 9, 11, 13, 15 & early discontinuation 11. V. 3, 5, 7, 9, 11, 12, 13, 14, 15 & early discontinuation 12. V. 11, 15 & early discontinuation 13. V. 5, 11, 15 & early discontinuation 14. V. 11, 15 & early discontinuation 15. V. 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15 & early discontinuation and follow-up
    1. Visite 7, 11, 13, 15 e interruzione anticipata 2. Visite 7, 11, 13, 15 e interruzione anticipata 3. Visite 7, 11, 13, 15 e interruzione anticipata 4. Visite 5, 7, 11, 13, 15 e interruzione anticipata 5. Visite 5, 7, 11, 13, 15 e interruzione anticipata 6. Secondo osservazione 7. Visite 3, 4, 5, 7, 9, 11,12, 13, 14, 15 e interruzione anticipata 8. Visite 2, 3, 4, 5, 6, 7, 9, 10, 11,12, 13, 14, 15 e interruzione anticipata 9. Visite 5, 7, 11, 15 e interruzione anticipata 10. Visite 2, 3, 5, 7, 9, 11, 13, 15 e interruzione anticipata 11. Visite 3, 5, 7, 9, 11, 12, 13, 14, 15 e interruzione anticipata 12. Visite 11, 15 e interruzione anticipata 13. Visite 5, 11, 15 e interruzione anticipata 14. Visite 11,15 e interruzione anticipata 15. Visite 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety 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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    LY3314814 either 20 mg or 50 mg
    LY3314814 either 20 mg or 50 mg
    E.8.2.4Number of treatment arms in the trial4
    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 concerned14
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA113
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Canada
    Japan
    Korea, Republic of
    United States
    Belgium
    France
    Germany
    Hungary
    Italy
    Poland
    Romania
    Spain
    United Kingdom
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    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
    E.8.9.2In all countries concerned by the trial months4
    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: 285
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1115
    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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Represented by their legal representative
    Rappresentati dal loro rappresentante legale
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state128
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 594
    F.4.2.2In the whole clinical trial 1400
    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)
    As defined in the protocol
    Come definito nel protocollo
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-02-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-01-31
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Fri Apr 19 22:22:03 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA