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    Summary
    EudraCT Number:2010-024249-59
    Sponsor's Protocol Code Number:ULA01
    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:2012-10-17
    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 number2010-024249-59
    A.3Full title of the trial
    Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial
    to Evaluate the Efficacy and Safety of Ularitide (Urodilatin) Intravenous
    Infusion in Patients Suffering from Acute Decompensated Heart Failure
    [TRUE-AHF]
    Sperimentazione di fase III, multicentrica, randomizzata, in doppio cieco, controllata con placebo, condotta per valutare l'efficacia e la sicurezza di Ularitide (Urodilatina) somministrato tramite infusione per via endovenosa in pazienti affetti da insufficienza cardiaca acuta scompensata [TRUE-AHF]
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Treatment of Acute Heart Failure
    Trattamento dell'insufficienza cardiaca acuta
    A.4.1Sponsor's protocol code numberULA01
    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 SponsorCARDIORENTIS LTD
    B.1.3.4CountrySwitzerland
    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 supportCardiorentis Ltd
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCardiorentis
    B.5.2Functional name of contact pointnd
    B.5.3 Address:
    B.5.3.1Street AddressGotthardstrasse 3
    B.5.3.2Town/ cityZug
    B.5.3.3Post code6304
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+41 41 511 00 72
    B.5.5Fax number+41 41 511 00 87
    B.5.6E-mailjholzmister@cardiorentis.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 nameUlaritide
    D.3.2Product code NA
    D.3.4Pharmaceutical form Powder for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNULARITIDE
    D.3.9.1CAS number 118812-69-4
    D.3.9.4EV Substance CodeSUB11377MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    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 placeboPowder for solution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Acute Decompensated Heart Failure
    Insufficienza cardiaca acuta scompensata
    E.1.1.1Medical condition in easily understood language
    Acute Heart Failure
    Insufficienza cardiaca acuta
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10064653
    E.1.2Term Acute decompensated 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 evaluate the effect of a continuous intravenous (IV) ularitide infusion on the clinical status of patients with ADHF.
    Valutare l’effetto di un’infusione continua di ularitide per via endovenosa (EV) sulle condizioni cliniche di pazienti affetti da ADHF.
    E.2.2Secondary objectives of the trial
    Not applicable
    Non applicabile
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    PHARMACOECONOMIC:
    Vers:1
    Date:2012/04/19
    Title:Pharmacoeconomic substudy in association with study ULA01
    Objectives:Determination of pharmacoeconomic aspects in treatment of ADHF

    PHARMACOKINETIC/PHARMACODYNAMIC:
    Vers:1
    Date:2012/04/19
    Title:Pharmacokinetic substudy in association with study ULA01
    Objectives:Determination of plasma pharmacokinetic parameters and population
    pharmacokinetic model
    FARMACOECONOMIA:
    Vers:1
    Data:2012/04/19
    Titolo:Sottostudio di farmacoeconomia in associazione con lo studio ULA01
    Obiettivi:Determinazione degli aspetti di farmacoeconomia nel trattamento di ADHF

    FARMACOCINETICA/FARMACODINAMICA:
    Vers:1
    Data:2012/04/19
    Titolo:Sottostudio di farmacocinetica in associazione con lo studio ULA01
    Obiettivi:Determinazione dei parametri farmacocinetici plasmatici e modello farmacocinetico di popolazione
    E.3Principal inclusion criteria
    1) Males and females aged 18 to 85 years.
    2) Unplanned hospitalization or emergency department visit for ADHF. Acute HF is defined as including all of the following: a) Dyspnea at rest in a recumbent sitting position (30 to 45 degrees), which has worsened within the past week. b) Radiological evidence of HF on a chest X-ray. c) BNP >500 pg/mL or NT-pro BNP >2000 pg/mL.
    3) Ability to start infusion of the study drug within 12 h after initial clinical assessment performed by a physician at the emergency room/hospital with symptoms of ADHF. 4) Ability to reliably carry out self-assessment of symptoms.
    5) Systolic blood pressure (SBP) ≥110 mmHg.
    6) Persisting dyspnea at rest despite standard background therapy for ADHF (as determined by the Investigator) which must include IV furosemide (or equivalent diuretic) at ≥40 mg (or its equivalent) at any time after start of emergency services (ambulance, emergency department, or hospital). At the time of randomization, the patient must still be symptomatic. In addition, the patient should not have received an IV bolus of a diuretic for at least 2 h prior to randomization, and the infusion rates of ongoing IV infusions must not have been increased or decreased for at least 2 h prior to randomization.
    7) Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (in accordance with national and local privacy regulations).
    1)Uomini e donne di età compresa tra 18 e 85 anni.
    2)Ricovero non programmato o visita al pronto soccorso a causa di ADHF. Si definisce insufficienza cardiaca acuta l’inclusione di tutti i seguenti criteri:
    a)Dispnea a riposo in posizione seduta supina(inclinazione da 30 a 45 gradi), peggiorata nell’arco dell’ultima settimana.
    b)Evidenza radiologica di HF su radiografia toracica.
    c)BNP &gt; 500 pg/ml o NT-pro BNP &gt; 2000 pg/ml.
    3)Capacità di iniziare l’infusione del farmaco in studio entro 12 ore dopo la valutazione clinica iniziale condotta da un medico presso il pronto soccorso/l’ospedale in presenza di sintomi di ADHF.
    4)Capacità di eseguire in maniera attendibile l’autovalutazione dei sintomi.
    5)Pressione arteriosa sistolica (PAS) ≥ 110 mmHg.
    6)Dispnea persistente a riposo nonostante terapia di base standard per l’ADHF (determinata dallo Sperimentatore) che deve includere furosemide (o un diuretico equivalente) per via EV a una dose di ≥ 40 mg (o rispettivo equivalente) in qualsiasi momento dopo l’avvio delle procedure di emergenza (ambulanza, pronto soccorso o ospedale). Al momento della randomizzazione, il/la paziente deve essere ancora sintomatico/a. Il/La paziente non deve inoltre aver ricevuto un bolo per via EV di un diuretico per almeno 2 ore prima della randomizzazione e la velocità di infusione delle infusioni per via EV in corso non deve essere stata incrementata o ridotta per almeno 2 ore prima della randomizzazione.
    7)Capacità di comprendere lo scopo e i rischi associati allo studio, fornire un consenso informato datato e firmato e l’autorizzazione all’utilizzo di informazioni sanitarie protette (in conformità alle normative nazionali e locali in materia di riservatezza).
    E.4Principal exclusion criteria
    1) Known active myocarditis, obstructive hypertrophic cardiomyopathy, congenital heart disease, restrictive cardiomyopathy, constrictive pericarditis, uncorrected clinically significant primary valvular disease.
    2) Treatment with dobutamine at a dose >5 μg/kg/min or use of drugs for support of BP at the time of randomization.
    3) Treatment with levosimendan, milrinone, or any other phosphodiesterase inhibitor within 7 days before randomization.
    4) Treatment with nesiritide within 30 days before randomization.
    5) Serum creatinine >2.5 mg/dL (220 μmol/L) at the time of screening.
    6) Planned coronary revascularization procedure (percutaneous coronary intervention or coronary artery bypass grafting) within 5 days of randomization.
    7) Clinical diagnosis of acute coronary syndrome meeting any 2 of the following 3 criteria: a) Prolonged chest pain at rest, or an accelerated pattern of angina; b) Electrocardiogram (ECG) changes indicative of ischemia or myocardial injury; c) Serum troponin >3 times upper limit of normal.
    8) Clinically suspected acute mechanical cause of ADHF (e.g., papillary muscular rupture). The diagnosis need not be confirmed by imaging or cardiac catheterization. 9) Anemia (hemoglobin <9 g/dL or a hematocrit <25%).
    10) Known vasculitis, active infective endocarditis, or suspected infections including pneumonia, acute hepatitis, systemic inflammatory response syndrome, or sepsis.
    11) Body temperature ≥38°C just prior to randomization.
    12) Acute or chronic respiratory disorder (e.g. severe chronic obstructive pulmonary disease) or primary pulmonary hypertension sufficient to cause dyspnea at rest, which may interfere with the ability to interpret dyspnea assessments or hemodynamic measurements.
    13) Terminal illness other than congestive heart failure with expected survival <180 days.
    14) Any previous exposure to ularitide.
    15) Known allergy to natriuretic peptides.
    16) Participation in an investigational clinical drug trial within 30 days prior to randomization.
    17) Current drug abuse or chronic alcoholism sufficient to impair participation and compliance to the study protocol.
    18)Women who are breast-feeding.
    19)Women of child-bearing potential without documentation of a negative urine pregnancy assay within 12 h prior to randomization.
    20) Any condition that, in the Investigator's opinion, makes the patient unsuitable for study participation.
    21) Legal incapacity or limited legal capacity.
    1)Miocardite attiva, cardiomiopatia ipertrofica ostruttiva, cardiopatia congenita, cardiomiopatia restrittiva, pericardite costrittiva, malattia delle valvole cardiache primaria clinicamente significativa e non corretta note.
    2)Trattamento con dobutamina a una dose pari a &gt; 5 μg/kg/min o assunzione di farmaci a sostegno della PA al momento della randomizzazione.
    3)Trattamento con levosimendan, milrinone o qualsiasi altro inibitore della fosfodiesterasi nei 7 giorni che precedono la randomizzazione.
    4)Trattamento con nesiritide nei 30 giorni che precedono la randomizzazione.
    5)Creatinina sierica pari a &gt; 2,5 mg/dl (220 μmol/l) in occasione dello screening.
    6)Procedura di rivascolarizzazione coronarica programmata (intervento percutaneo coronarico o innesto di bypass aorto-coronarico) entro 5 giorni dalla randomizzazione.
    7)Diagnosi clinica di sindrome coronarica acuta che soddisfi 2 dei seguenti 3 criteri:
    a)Dolore toracico prolungato a riposo o elementi caratteristici di angina accelerata.
    b)Alterazioni dell’elettrocardiogramma (ECG) indicative di ischemia o lesioni del miocardio.
    c)Troponina sierica &gt; 3 volte il limite superiore dell’intervallo normale.
    8)Sospetto clinico di causa meccanica acuta di ADHF (ad es. rottura del muscolo papillare). Non è necessario che la diagnosi sia confermata da diagnostica per immagini o cateterizzazione cardiaca.
    9)Anemia (emoglobina &lt; 9 g/dl o ematocrito &lt; 25%).
    10)Vasculite, endocardite infettiva attiva note o infezioni sospette comprese polmonite, epatite acuta, sindrome da risposta infiammatoria sistemica o sepsi.
    11)Temperatura corporea ≥ 38 °C appena prima della randomizzazione.
    12)Disturbo respiratorio acuto o cronico (ad es. grave broncopneumopatia cronica ostruttiva) o ipertensione polmonare primaria sufficiente a causare dispnea a riposo, che potrebbe interferire con la capacità di interpretare le valutazioni della dispnea o le misurazioni emodinamiche.
    13)Malattia terminale diversa dall’insufficienza cardiaca congestizia, con un periodo di sopravvivenza stimato pari a &lt; 180 giorni.
    14)Qualsiasi precedente esposizione a ularitide.
    15)Allergia nota ai peptidi natriuretici.
    16)Partecipazione a una sperimentazione clinica condotta su un farmaco sperimentale nei 30 giorni che precedono la randomizzazione.
    17)Attuale abuso di droghe o alcolismo cronico, sufficienti a compromettere la partecipazione e la conformità al protocollo dello studio.
    18)Donne in fase di allattamento al seno.
    19)Donne in età fertile senza documentazione di un test di gravidanza sulle urine negativo condotto nelle 12 ore che precedono la randomizzazione.
    20)Qualsiasi condizione che, a parere dello Sperimentatore, renda il/la paziente non idoneo/a alla partecipazione allo studio.
    21)Incapacità legale o capacità legale limitata.
    E.5 End points
    E.5.1Primary end point(s)
    Primary Efficacy Endpoint: Improvement in a hierarchical clinical composite comprised of elements associated with: patient global assessment using a 7-point scale of symptomatic improvement, lack of improvement, or worsening; persistent or worsening heart failure (HF) requiring an intervention (initiation or intensification of IV therapy, circulatory or ventilatory mechanical support, surgical intervention, ultrafiltration, hemofiltration or dialysis); and all-cause mortality. Assessment of the clinical composite will be performed at 6 hour (h), 24 h and 48 h after start of IV ularitide infusion. Patients will be classified as ''improved'' if the patients are moderately or markedly improved at all 3 time points (at 6 h, 24 h and 48 h) and do not fulfill criteria for ''worse'' during the first 48 hours following the start of the study drug infusion. Patients will be classified as ''worse'' if (during the 48 h) they die; experience worsening HF requiring a prespecified intervention at any time during the first 48 h; or experienced moderate or marked worsening of their global assessment at any of the 3 time points (at 6 h, 24 h or 48 h).
    Primary Safety Endpoints: All-cause mortality and cardiovascular rehospitalization at 30 days after start of study drug infusion.
    Endpoint primario di efficacia: Miglioramento in un composito clinico gerarchico costituito da elementi associati a: valutazione globale del paziente utilizzando una scala a 7 punti per la valutazione di miglioramento sintomatico, mancanza di miglioramento o peggioramento; insufficienza cardiaca (heart failure, HF) persistente o in peggioramento che richieda un intervento (inizio o intensificazione della terapia EV, supporto circolatorio o ventilatorio meccanico, intervento chirurgico, ultrafiltrazione, emofiltrazione o dialisi); mortalità di qualsiasi origine. La valutazione del composito clinico sarà condotta 6, 24 e 48 ore dopo l’inizio dell’infusione EV di ularitide.
    I pazienti saranno classificati come “migliorati” se evidenziano un miglioramento moderato o considerevole in occasione di ciascuno dei 3 momenti definiti (a 6, 24 e 48 ore) e non soddisfano i criteri di “peggioramento” durante le prime 48 che seguono l’inizio dell’infusione del farmaco dello studio. I pazienti saranno classificati come “peggiorati” in caso di decesso (durante le 48 ore), peggioramento dell’HF che richieda un intervento predefinito in qualsiasi momento durante le prime 48 ore, o peggioramento moderato o considerevole della valutazione globale in occasione di uno qualsiasi dei 3 momenti definiti (a 6, 24 o 48 ore).
    Endpoint primari di sicurezza:

    Mortalità di qualsiasi origine e nuovo ricovero cardiovascolare a 30 giorni dall’inizio dell’infusione del farmaco dello studio.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Primary Efficacy Endpoint: 3 time points (at 6 h, 24 h or 48 h). Primary Safety Endpoints: 30 days after start of study drug infusion
    Endpoint primario di efficacia: 3 momenti definiti (a 6, 24 e 48 ore). Endpoint primario di sicurezza: a 30 giorni dall’inizio dell’infusione del farmaco dello studio.
    E.5.2Secondary end point(s)
    • Changes of N-terminal pro brain natriuretic peptide (NT-pro BNP) at 48 h of treatment compared to baseline.
    • All-cause mortality and cardiovascular rehospitalization at Day 90 after start of study drug infusion.
    •Alterazioni del frammento N-terminale della pro-forma del peptide natriuretico cerebrale (N-terminal pro brain natriuretic peptide, NT-pro BNP) a 48 ore dal trattamento rispetto al basale.
    •Mortalità di qualsiasi origine e nuovo ricovero cardiovascolare al Giorno 90 dall’inizio dell’infusione del farmaco dello studio.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary Endpoints:
    • 48 h of treatment.
    • Day 90 after start of study drug infusion.
    Endpoint secondari:
    • 48 h di trattamento.
    • 90 giorni dopo l'inizio dell’infusione del farmaco dello studio.
    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 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 Yes
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA120
    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
    Argentina
    Brazil
    Canada
    Chile
    Colombia
    Switzerland
    Tunisia
    Turkey
    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 years0
    E.8.9.1In the Member State concerned months19
    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.1.1Number of subjects for this age range: 0
    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: 1058
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1058
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2012-10-17. Yes
    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 state70
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 930
    F.4.2.2In the whole clinical trial 2116
    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
    Nessuno
    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 Decision2012-10-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-09-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-12-18
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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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