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    Summary
    EudraCT Number:2013-002288-25
    Sponsor's Protocol Code Number:BAY1021189/15829
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-09-24
    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 number2013-002288-25
    A.3Full title of the trial
    A randomized parallel-group, placebo-controlled, double-blind, multi-center dose finding phase II trial exploring the pharmacodynamic effects, safety and tolerability, and pharmacokinetics of four dose regimens of the oral sGC stimulator BAY 1021189 over 12 weeks in patients with worsening heart failure and preserved ejection fraction.
    Studio di Fase II, di dose finding, multicentrico, in doppio cieco, controllato con placebo, a gruppi paralleli, per valutare gli effetti farmacodinamici, la sicurezza, la tollerabilità e la farmacocinetica di quattro regimi posologici dello stimolatore orale di sGC BAY 1021189 per 12 settimane in pazienti con peggioramento dell’insufficienza cardiaca e con frazione di eiezione preservata (HFpEF)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to research BAY 1021189 in patients with worsening heart failure with preserved ejection fraction
    Studio di Fase IIb sulla sicurezza ed efficacia di quattro regimi posologici di BAY 1021189 in pazienti con HfpEF affetti da insufficienza cardiaca cronica in via di peggioramento (SOCRATES-PRESERVED)
    A.3.2Name or abbreviated title of the trial where available
    SOCRATES-PRESERVED
    SOCRATES-PRESERVED
    A.4.1Sponsor's protocol code numberBAY1021189/15829
    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 SponsorBayer HealthCare AG
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportBayer HealthCare AG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBayer HealthCare AG
    B.5.2Functional name of contact pointBayer Clinical Trials Contact
    B.5.3 Address:
    B.5.3.1Street AddressCTP Team/ RE:"EU CTR"/ Bayer Pharma AG
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post code13342
    B.5.3.4CountryGermany
    B.5.6E-mailclinical-trials-contact@bayerhealthcare.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 nameBAY 1021189 1.25 mg coated tablet
    D.3.2Product code BAY 1021189
    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.3.9.2Current sponsor codeBAY102189
    D.3.9.3Other descriptive nameBAY 1021189
    D.3.9.4EV Substance CodeSUB32031
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.25
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation 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 nameBAY 1021189 tablet 5 mg
    D.3.2Product code BAY 1021189
    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.3.9.2Current sponsor codeBAY 1021189
    D.3.9.3Other descriptive nameBAY 1021189
    D.3.9.4EV Substance CodeSUB32031
    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.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCoated 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
    Heart failure
    insufficienza cardiaca
    E.1.1.1Medical condition in easily understood language
    Heart failure
    insufficienza cardiaca
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level LLT
    E.1.2Classification code 10008908
    E.1.2Term Chronic heart failure
    E.1.2System Organ Class 100000004849
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To find the optimal dose of BAY 1021189 for Phase III that can be given in addition to standard diuretic and comorbidity treatment by characterizing the safety, tolerability, pharmacodynamic effects, and pharmacokinetics, and detecting a significant dose-response relationship in at least one of the two primary endpoints change in NT-proBNP and change of left atrial volume at 12 weeks in patients with worsening chronic heart failure with preserved ejection fraction.
    Individuare la dose ottimale dello stimolatore orale solubile della guanilato-ciclasi (sGC) BAY 1021189 per la Fase III che possa essere somministrato in aggiunta al trattamento diuretico standard e al trattamento delle patologie concomitanti, caratterizzandone la sicurezza, la tollerabilità, gli effetti farmacodinamici e la farmacocinetica, e per identificare un rapporto dose-risposta significativo in almeno uno dei due endpoint primari, cioè la variazione del N-terminal pro-brain natriuretic peptide (NT-proBNP) e la variazione del volume dell’atrio sinistro (LAV) a 12 settimane in pazienti con peggioramento dell’insufficienza cardiaca cronica con frazione di eiezione preservata (HFpEF)
    E.2.2Secondary objectives of the trial
    N/A
    N/A
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written informed consent signed before any study-specific procedure
    2. Ability to understand and follow study-related instructions
    3. Worsening chronic heart failure requiring hospitalization (or IV diuretic treatment for HF without hospitalization) with initiation of study treatment after clinical stabilization:

    Diagnostic methods:
    - History of chronic HF: NYHA class II-IV ≥30 days before hospitalization (or before IV diuretic treatment for HF without hospitalization)
    - Worsening HF at hospitalization (or at the time of IV diuretic treatment for HF without hospitalization)
    - NT-proBNP ≥300 or BNP ≥100 pg/mL in sinus rhythm, or NT-proBNP ≥600 or BNP ≥200 pg/mL in A. fib. in local routine labs, and
    - Symptoms and signs of congestion (clinical or radiographic signs in routine chest x-ray demonstrating pleural effusion, pulmonary congestion (redistribution, interstitial or alveolar edema), or cardiomegaly

    - Clinical stabilization defined by
    - no IV vasodilator for >24h and no IV diuretic for >12h before randomization and
    - SBP ≥110 and <160, DBP ≥40 and <100 mmHg, and resting HR ≥50 and <100 bpm at randomization

    - Diagnostic criteria of HFpEF by echocardiography at randomization
    - LVEF ≥45% and
    - Enlarged LA indicated by one of the following parameters: Left atrial volume (LAV) index ≥28 ml/m2, or LAV >58 mL in male and >52 mL in female patients, or LA area >20 cm2, or LA diameter >40 mm in male and >38 mm in female patients.

    4. Ability to understand and follow study-related instructions
    5. Men or confirmed postmenopausal women or women without childbearing potential based on surgical treatment such as bilateral tubal ligation, bilateral ovarectomy, or hysterectomy. Men enrolled in this study must agree to use adequate barrier birth control measures during the treatment period of the study.
    Insufficienza cardiaca cronica in via di peggioramento (WCHF) che richieda l’ospedalizzazione (o il trattamento diuretico endovenoso [IV] per l’insufficienza cardiaca senza ricovero in ospedale) con inizio del trattamento del farmaco in studio dopo stabilizzazione clinica
    1. Anamnesi di insufficienza cardiaca cronica di classe NYHA II-IV >30 giorni prima dell’ospedalizzazione
    2. Peggioramento dell’insufficienza cardiaca al momento dell’ospedalizzazione1
    a. N-terminal pro-brain natriuretic peptide (NT-proBNP) >300 o brai natriuretic peptide(BNP) >100 pg/mL in ritmo sinusale oppure NT-proBNP >600 o BNP >200 pg/mL in fibrillazione atriale dosati di routine presso illaboratorio locale , e
    b. Sintomi e segni di congestione (segni clinici o radiografici nelle radiografie del torace di routine che dimostrino un versamento pleurico, congestione polmonare o cardiomegalia)
    3. Stabilizzazione clinica definita come:
    a. nessun vasodilatatore e.v. per >24h e nessun diuretico e.v. per >12h prima della randomizzazione e
    b. Pressione arteriosa sistolica (SBP) >110 e <160, pressione arteriosa diastolica (DBP) >40 e <100 mmHg e frequenza cardiaca a riposo (HR) >50 e <100 battiti al minuto (bpm) alla randomizzazione
    4. Criteri ecografici diagnostici di HFpEF alla randomizzazione
    a. Frazione di eiezione del ventricolo sinistro (LVEF) >45% e
    b. Volume dell’atrio sinistro (LAV) >28 mL/m2 (o LAV >58 mL nei maschi / >52 mL nelle femmine, o area dell’atrio sinistro (LA) >20 cm2, o diametro dell’atrio sinistro >40 mm nei maschi e / >38 mm nelle femmine)
    1 o trattamento diuretico e.v. per insufficienza cardiaca senza ospedalizzazione
    E.4Principal exclusion criteria
    1. Legal lower age limitations for adults (country specific)
    2. IV inotropes at any time after hospitalization
    3. Cardiac comorbidity (any of the following):
    - Chronic atrial fibrillation: after enrollment of approximately 141 patients with chronic atrial fibrillation (30% of population), chronic atrial fibrillation will be considered an exclusion criterion
    - History of reduced ejection fraction (EF <45%)
    - Specific HF etiologies, including:
    - Hypertrophic cardiomyopathy with LV outflow tract obstruction; or
    - Pericardial disease, such as constrictive pericarditis; or
    - Infiltrative or inflammatory myocardial disease such as acute myocarditis, amyloidosis, sarcoidosis; or
    - Valvular heart disease: (severe aortic or mitral regurgitation, moderate or severe aortic stenosis, any mitral stenosis requiring surgical repair, active endocarditis)
    - Acute coronary syndrome, including unstable angina, NSTEMI or STEMI, or CABG within 60 days prior to randomization, or indication for PCI or CABG
    - Significant cardiac ischemia in a stress test within a year of enrollment without revascularization since
    - Requirement for nitrates as anti-anginal therapy in addition or alternatively to beta-blockers
    - Symptomatic carotid stenosis, or TIA or stroke within 30 days prior to randomization
    - Complex congenital heart disease
    4. Non-cardiac comorbidity, indicated by either of the following at the time of randomization
    - Glomerular filtration rate <30 ml/min/1.73 m2 calculated by Modification of Diet in Renal Disease [MDRD] formula
    - Hepatic insufficiency classified as Child-Pugh B or C
    - Morbid obesity with a BMI >40 kg/m²
    - Malignancy or other non-cardiac condition limiting life expectancy to <1 year, per physician judgment
    - Severe pulmonary disease with either requirement of continuous home oxygen or recent bronchial artery embolization for massive hemoptysis
    - Subjects with allergies, intolerance or hypersensitivity to investigational drug or any of the excipients
    - Medical condition or history thereof that in the opinion of the investigator would impair the ability to complete the planned study procedures
    5. Concomitant Treatment with a PDE5 inhibitor or sGC stimulator
    6. Participation in another clinical study or treatment with another investigational product ≤30 days prior to randomization
    Inotropi e.v. in qualsiasi momento dopo l’ospedalizzazione
    2. Cardiopatie concomitanti
    o Anamnesi di ridotta frazione di eiezione (EF <45%); oppure
    o Eziologie specifiche dell’insufficienza cardica, compresa la cardiomiopatia ipertrofica con ostruzione del deflusso del ventricolo sinistro (LV); patologia pericardica; patologia infiltrativa o infiammatoria del miocardio; valvulopatia con grave rigurgito aortico o mitralico, stenosi aortica moderata o severa, stenosi mitralica che richieda intervento chirurgico o endocardite in fase attiva; oppure
    o Sindrome coronarica acuta (ACS), compresa l’angina instabile, infarto miocardico senza sopra livellamento del tratto ST (NSTEMI) o infarto miocardico con sopra livellamento del tratto ST (STEMI) o bypass dell’arteria coronarica (CABG) entro 60 giorni precedenti la randomizzazione o indicazione all’angioplastica percutanea o al bypass (PCI o CABG); oppure
    o Ischemia cardiaca significativa alla prova da sforzo condotta entro 1 anno prima dell’arruolamento non seguita da rivascolarizzazione oppure
    o Necessità di trattamento con nitrati (qualsiasi somministrazione compresa la percutanea) come terapia anti-anginosa in aggiunta o in alternativa ai beta-bloccanti; oppure
    o Stenosi carotidea sintomatica o attacco ischemico transitorio (TIA) o ictus entro 30 giorni prima della randomizzazione; oppure
    o Cardiopatia congenita complessa
    3. Patologie concomitanti non-cardiache al momento della randomizzazione
    o Velocità di filtrazione glomerulare <30 mL/min/1,73 m2 calcolata mediante MDRD; oppure
    o Insufficienza epatica Child-Pugh B o C; oppure
    o Indice di massa corporea (BMI) >40 kg/m²; oppure
    o Neoplasia maligna o altra affezione non-cardiaca che limiti l’aspettativa di vita a <1 anno; oppure
    o Grave pneumopatia con necessità di ossigenoterapia continua a domicilio oppure recente embolizzazione dell’arteria bronchiale per emottisi massiva
    4. Partecipazione ad un altro studio clinico o trattamento con un altro prodotto sperimentale ≤30 giorni prima della randomizzazione
    E.5 End points
    E.5.1Primary end point(s)
    1. Change from baseline to week 12 in left atrial volume (LAV)
    2. Change from baseline to week 12 in log-transformed NT-proBNP
    E.5.1 End point primario (ripetere se necessario):
    I due endpoint primari sono
    • variazione del log NTproBNP alla settimana 12 rispetto al basale
    • variazione di LAV alla settimana 12 rispetto al basale
    Lo studio sarà positivo se l’analisi principale sarà significativa per almeno uno dei due endpoint primari.


    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 12 of treatment.
    settimana 12 di trattamento
    E.5.2Secondary end point(s)
    1. Changes in heart structure/function as measured by echocardiography
    2. Changes in biomarkers
    3. Changes to blood pressure & heart rate
    4. Changes in health-related quality of life
    5. Hospitalisations and death from cardiovascular causes
    6. Change in NYHA function class
    7. Incidence (new or recurrence) of atrial fibrillation
    8. Changes in background heart failure therapies
    9. Change in Composite Congestion Score
    1)Variazioni nella struttura/funzione cardiaca misurata tramite ecocardiografia
    2)Variazioni nei biomarcatori
    3)Variazioni di pressione/frequenza cardiaca
    4)Variazioni nella qualità della vita
    5)Ospedalizzazione e morte per cause cardiovascolari
    6)Variazione classe NYHA
    7) Incidenza di fibrillazione atriale
    8) Variazioni della terapia per insufficienza cardiaca
    9) Variazione del Composite Congestion Score

    E.5.2.1Timepoint(s) of evaluation of this end point
    1. From baseline to 12 weeks
    2. From baseline to 12 weeks
    3. From baseline to 12 weeks
    4. From baseline to 12 weeks
    5. From baseline to 16 weeks
    6. From baseline to 12 weeks
    7. From baseline to 16 weeks
    8. From baseline to 12 weeks
    9. From baseline to 12 weeks
    1. dal basale a 12 settimane
    2. dal basale a 12 settimane
    3. dal basale a 12 settimane
    4. dal basale a 12 settimane
    5. dal basale a 12 settimane
    6. dal basale a 12 settimane
    7. dal basale a 12 settimane
    8. dal basale a 12 settimane
    9. dal basale a 12 settimane
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial5
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA80
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Austria
    Belgium
    Canada
    China
    Czech Republic
    Denmark
    France
    Germany
    Hungary
    Israel
    Italy
    Japan
    Netherlands
    Poland
    Singapore
    Spain
    Sweden
    Switzerland
    Taiwan
    United States
    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 years1
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months8
    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: 94
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 376
    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 state29
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 350
    F.4.2.2In the whole clinical trial 470
    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
    NA
    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 Decision2013-09-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-10-15
    P. End of Trial
    P.End of Trial StatusCompleted
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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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