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    Summary
    EudraCT Number:2014-002275-28
    Sponsor's Protocol Code Number:1237.19
    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:2014-10-28
    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 number2014-002275-28
    A.3Full title of the trial
    A randomised, double-blind, active-controlled parallel group study to evaluate the effect of 52 weeks of once daily treatment of orally inhaled tiotropium + olodaterol fixed dose combination compared with tiotropium on Chronic Obstructive Pulmonary Disease (COPD) exacerbation in patients with severe to very severe COPD. [DYNAGITO]
    Studio randomizzato, in doppio cieco, controllato con farmaco attivo, a gruppi paralleli, volto a valutare l’efficacia di 52 settimane di trattamento una volta al giorno con l’associazione a dose fissa inalatoria per via orale di tiotropio + olodaterolo in confronto a tiotropio sulle riacutizzazioni della broncopneumopatia cronica ostruttiva (BPCO), in pazienti con BPCO da grave a molto grave
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparing the efficacy of tiotropium + olodaterol (5/5 µg) fixed dose combination (FDC) over tiotropium 5µg in reducing moderate to severe exacerbations in patients with severe to very severe Chronic Obstructive Pulmonary Disease.
    Confrontare l’efficacia di un trattamento una volta al giorno con l’associazione a dose fissa inalatoria per via orale di tiotropio + olodaterolo in confronto a tiotropio sulle riacutizzazioni della broncopneumopatia cronica ostruttiva (BPCO), in pazienti con BPCO da grave a molto grave
    A.3.2Name or abbreviated title of the trial where available
    DYNAGITO
    DYNAGITO
    A.4.1Sponsor's protocol code number1237.19
    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 SponsorBoehringer Ingelheim Italia S.p.A.
    B.1.3.4CountryItaly
    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 supportBoehringer Ingelheim Italia S.p.A.
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBoehringer Ingelheim Pharma GmbH & Co. KG
    B.5.2Functional name of contact pointQRPE PSC CT Information Disclosure
    B.5.3 Address:
    B.5.3.1Street AddressBinger Strasse 173
    B.5.3.2Town/ cityIngelheim am Rhein
    B.5.3.3Post code55216
    B.5.3.4CountryGermany
    B.5.4Telephone number+18002430127
    B.5.5Fax number+18008217119
    B.5.6E-mailclintriage.rdg@boehringer-ingelheim.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 nameTiotropium 2.5μg/Olodaterol 2.5μg
    D.3.4Pharmaceutical form Inhalation solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNtiotropium bromide
    D.3.9.1CAS number 186691-13-4
    D.3.9.3Other descriptive nameTIOTROPIUM
    D.3.9.4EV Substance CodeSUB25691
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNolodaterol
    D.3.9.1CAS number 868049-49-4
    D.3.9.3Other descriptive nameOLODATEROL
    D.3.9.4EV Substance CodeSUB36104
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(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 Yes
    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 Spiriva Respimat 2.5 microgram
    D.2.1.1.2Name of the Marketing Authorisation holderBoehringer Ingelheim International GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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.3.4Pharmaceutical form Inhalation solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNtiotropium bromide
    D.3.9.1CAS number 186691-13-4
    D.3.9.3Other descriptive nameTIOTROPIUM
    D.3.9.4EV Substance CodeSUB25691
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(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 Yes
    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
    chronic obstructive pulmonary disease
    pazienti con broncopneumopatia cronica ostruttiva (BPCO) da grave a molto grave
    E.1.1.1Medical condition in easily understood language
    Chronic Obstructive Pulmonary Disease
    N/A
    pazienti con broncopneumopatia cronica ostruttiva (BPCO)
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level LLT
    E.1.2Classification code 10010952
    E.1.2Term COPD
    E.1.2System Organ Class 100000004855
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the effect of Tiotropium + Olodaterol on COPD exacerbations
    L’obiettivo globale dello studio è valutare l’efficacia dell’associazione a dose fissa tiotropio + olodaterolo una volta al giorno in confronto a tiotropio 5 μg (entrambi erogati mediante inalatore Respimat®) sulle riacutizzazioni della BPCO da moderate a gravi, in pazienti con BPCO da grave a molto grave.
    E.2.2Secondary objectives of the trial
    To compare the effect of Tiotropium + Olodaterol on hospitalisation associated with exacerbations and survival
    valutare l’effetto dell’associazione a dose fissa tiotropio + olodaterolo una volta al giorno in confronto a tiotropio 5 μg (entrambi erogati mediante inalatore Respimat®) sull'ospedalizzazione associata alle riacutizzazioni della BPCO e la sopravvivenza.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Male or female patients, 40 years of age or older.
    - Diagnosis of COPD with a documented post-bronchodilator Forced expiratory volume in one second (FEV1)< 60% of predicted normal and a post-bronchodilator FEV1/FVC (Forced vital capacity) <70% at Visit 1
    - Documented history of at least one moderate to severe COPD exacerbation in the previous 12 months requiring treatment with systemic corticosteroids and/or antibiotics and/or related hospitalization.
    - Symptomatically stable as defined by: no evidence of COPD exacerbation requiring use of either antibiotics and/or steroids 4 weeks prior to visit 1 and no evidence of change in their usual COPD medication 4 weeks prior to visit 1.
    - Current or ex-smokers with a smoking history of more than 10 pack years.
    1.Tutti i pazienti devono firmare un consenso informato in accordo alle linee guida ICH-GCP prima della partecipazione allo studio, comprensivo di wash-out e restrizioni al trattamento.
    2.Pazienti di sesso maschile o femminile, di età uguale o superiore a 40 anni.
    3.Tutti i pazienti devono avere una diagnosi di BPCO e devono soddisfare i seguenti criteri spirometrici: ostruzione stabile delle vie aeree con un documentato FEV1 post-broncodilatatore < 60% del valore normale previsto (valore calcolato secondo i criteri definiti da European Coal and Steel Community), ed un FEV1/FVC post-broncodilatatore < 70% alla Visita 1 (vedi Appendice 10.5 per le equazioni del valore normale previsto ECSC).
    Possono essere usati dati spirometrici storici ottenuti negli ultimi 3 mesi presso il centro o presso un centro di riferimento, oppure possono essere condotte prove di funzionalità polmonare presso il centro sperimentale (vedi Appendice 10.5 per la documentazione spirometrica).
    4.Pazienti con una storia documentata (vedi sezione 8.3.1) di almeno una riacutizzazione della BPCO da moderata a grave nei 12 mesi precedenti, che abbia richiesto trattamento con corticosteroidi sistemici a/o antibiotici e/o ospedalizzazione correlata.
    5.Lo Sperimentatore dovrà inoltre accertare che il paziente sia sintomaticamente stabile, come definito da:
    nessuna evidenza di riacutizzazione della BPCO che richieda uso di antibiotici e/o steroidi nelle 4 settimane precedenti la Visita 1,
    nessuna evidenza di cambio dei farmaci abituali per la BPCO nelle 4 settimane precedenti la Visita 1.
    6.I pazienti devono essere fumatori o ex-fumatori con anamnesi di più di 10 pacchetti-anno (vedi Appendice 10.5 per il calcolo del numero di pacchetti-anno).
    7.I pazienti devono essere in grado di eseguire tutte le procedure dello studio a discrezione dello sperimentatore, compreso:
    Prove di funzionalità polmonare tecnicamente accettabili ed eleggibili (se eseguite presso il centro)
    Follow-up dello stato vitale in caso di interruzione fino alla data di uscita prevista (ovvero 52 settimane dalla prima assunzione del trattamento randomizzato + 21 giorni)
    Intervista sulle riacutizzazioni della BPCO ogni 6 settimane in caso di interruzione prematura fino alla data di uscita prevista (ovvero 52 settimane dalla prima assunzione del trattamento randomizzato + 21 giorni).
    8.I pazienti devono essere in grado di inalare farmaco in modo competente dall’inalatore Respimat® (Appendice 10.1) e da un inalatore dosato (MDI) a giudizio dello sperimentatore.
    E.4Principal exclusion criteria
    - Significant disease other than COPD.
    - Clinically relevant abnormal baseline haematology, blood chemistry, urinalysis or creatinine > x2 ULN will be excluded regardless of clinical condition
    - Current documented history of asthma. For patients with allergic rhinitis or atopy, source documentation is required to verify that the patient does not have asthma
    - A diagnosis of thyrotoxicosis
    - A history of myocardial infarction within 6 months of screening visit.
    - Life-threatening cardiac arrhythmia.
    - Known active tuberculosis.
    - Any malignancy unless free of disease for at least 5 years (patients with treated basal cell carcinoma or squamous cell skin cancers are allowed).
    - A history of cystic fibrosis.
    - Clinically relevant bronchiectasis.
    - Patients with severe emphysema requiring endobronchial interventions within 6 months prior to screening
    - A history of significant alcohol or drug abuse in the opinion of the investigator.
    - Patients who have undergone thoracotomy with pulmonary resection
    - Patients being treated with oral or patch ß-adrenergics.
    - Patients being treated with oral corticosteroid medication at unstable doses
    - Patients being treated with PDE4 inhibitors within 3 months of screening visit
    - Patients who have taken an investigational drug within one month or six half-lives
    - Pregnant or nursing women.
    - Women of childbearing potential not using a highly effective method of birth control.
    1.Pazienti con patologie significative diverse dalla BPCO; una patologia significativa è definita come una patologia che, a giudizio dello sperimentatore, possa:
    mettere il paziente a rischio in conseguenza della sua partecipazione allo studio
    influenzare i risultati dello studio
    ingenerare perplessità in merito alla capacità del paziente di prendere parte allo studio.
    2.Pazienti con, a giudizio dello sperimentatore, valori basali ematologici, ematochimici o urinari anomali in maniera clinicamente significativa, o creatinina > x2 ULN saranno esclusi indipendentemente dalla condizione clinica (una valutazione aggiuntiva di laboratorio non sarà effettuata in questi pazienti).
    3.Pazienti con anamnesi corrente documentata di asma. Per i pazienti con rinite allergica o atopia si richiede documentazione per accertare che il paziente non abbia asma.
    Pazienti con una qualsiasi delle seguenti condizioni:
    4.Diagnosi di tireotossicosi (per il noto profilo di effetti collaterali di classe dei β2-agonisti).
    5.Anamnesi di infarto del miocardio nei 6 mesi precedenti la visita di screening (Visita 1).
    6.Aritmia cardiaca tale da porre il paziente in pericolo di vita, a giudizio dello sperimentatore.
    7.Tubercolosi attiva nota.
    8.Qualsiasi neoplasia che non sia in remissione da almeno 5 anni (i pazienti con carcinoma basocellulare trattato o tumori della pelle a cellule squamose sono ammessi).
    9.Anamnesi di fibrosi cistica.
    10.Bronchiettasie clinicamente evidenti, a giudizio dello sperimentatore.
    11.Pazienti con enfisema grave che abbia richiesto intervento endobronchiale nei 6 mesi precedenti lo screening.
    12.Anamnesi di etilismo o tossicomania significativi, a giudizio dello sperimentatore.
    13.Pazienti che si siano sottoposti a toracotomia con resezione polmonare (i pazienti con anamnesi di toracotomia per altre ragioni devono essere valutati per il criterio di esclusione No. 1).
    14.Pazienti in trattamento con agonisti dei recettori β-adrenergici per via orale o transdermica.
    15.Pazienti in trattamento con corticosteroidi per via orale a dosi instabili (ovvero per meno di sei settimane alla stessa dose) o a dosi superiori all’equivalente di 10 mg di prednisone al giorno o 20 mg ogni due giorni.
    16.Pazienti in trattamento con inibitori della fosfodiesterasi-4 (come ad esempio roflumilast) entro 3 mesi dalla visita di screening non devono essere arruolati e gli inibitori della fosfodiesterasi-4 non devono essere sospesi ai fini del reclutamento nello studio.
    17.Pazienti che abbiano assunto un farmaco sperimentale entro un mese o sei emivite (il maggiore fra i due) o qualora la (sotto)classe del farmaco sperimentale sia elencata nel periodo di wash-out specificato nella tabella 4.2.2.1:1 prima della visita di screening (Visita 1).
    18.Pazienti con ipersensibilità nota ai farmaci β-adrenergici e/o anticolinergici, benzalconio cloruro (BAC), acido etilendiamminotetraacetico (EDTA) o a qualsiasi altro componente della soluzione per inalazione Respimat®.
    19.Donne in gravidanza o in allattamento.
    20.Donne potenzialmente fertili che non usino metodi anticoncezionali altamente efficaci*. Le donne verranno considerate potenzialmente fertili a meno che non siano state sterilizzate chirurgicamente mediante isterectomia o legamento bilaterale delle tube, o non siano in menopausa da almeno 2 anni.
    21.Pazienti che siano stati precedentemente randomizzati in questo studio o che stiano partecipando ad un altro studio.
    22.Pazienti che non siano in grado di rispettare le restrizioni farmacologiche polmonari prima della randomizzazione.
    * secondo ICH M3(R2): un metodo anticoncezionale altamente efficace è definito come un metodo che possieda un basso tasso di insuccesso (ovvero minore dell’ 1% annuo) quando usato coerentemente e correttamente
    E.5 End points
    E.5.1Primary end point(s)
    1: Primary endpoint: annualised rate of moderate to severe COPD exacerbation during the treatment period (within 1 day after the last drug administration date).


    L’endpoint primario è la frequenza annualizzata delle riacutizzazioni da moderate a gravi durante il periodo di trattamento (entro 1 giorno* dopo la data di ultima somministrazione di farmaco).
    E.5.1.1Timepoint(s) of evaluation of this end point
    1: 52 weeks + 1 day

    52 settimane + 1 giorno
    E.5.2Secondary end point(s)
    1: Key secondary endpoint: time to first moderate to severe COPD exacerbation during the treatment period (within 1 day after the last drug administration date).

    2: Time to all-cause mortality (within 1 day after the last drug administration date).

    3: Annualised rate of exacerbation leading to hospitalisation during the treatment period (within 1 day after the last drug administration date).

    4: Time to first COPD exacerbations leading to hospitalisation during the treatment period (within 1 day after the last drug administration date).
    L’endpoint secondario principale è il tempo alla prima riacutizzazione della BPCO da moderata a grave durante il periodo di trattamento (entro 1 giorno* dopo la data di ultima somministrazione di farmaco).

    Gli endpoints secondari sono:
    -frequenza annualizzata delle riacutizzazioni che conducono all’ospedalizzazione durante il periodo di trattamento (entro 1 giorno* dopo la data di ultima somministrazione di farmaco).
    -tempo alla prima riacutizzazione della BPCO che conduca all’ospedalizzazione durante il periodo di trattamento (entro 1 giorno* dopo la data di ultima somministrazione di farmaco).
    -tempo alla mortalità per tutte le cause (entro 1 giorno* dopo la data di ultima somministrazione di farmaco).
    E.5.2.1Timepoint(s) of evaluation of this end point
    1: 52 weeks + 1 day

    2: 52 weeks + 1 day

    3: 52 weeks + 1 day

    4: 52 weeks + 1 day
    Per tutti gli end-point: 52 settimane + 1 giorno
    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 Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned25
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA323
    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
    Australia
    Austria
    Belgium
    Brazil
    Bulgaria
    Canada
    Chile
    Colombia
    Croatia
    Czech Republic
    Denmark
    Ecuador
    Finland
    France
    Germany
    Greece
    Guatemala
    Hong Kong
    Hungary
    India
    Ireland
    Italy
    Japan
    Korea, Republic of
    Latvia
    Lebanon
    Lithuania
    Malaysia
    Mexico
    Montenegro
    Netherlands
    New Zealand
    Norway
    Philippines
    Poland
    Portugal
    Romania
    Russian Federation
    Serbia
    Singapore
    Slovakia
    Slovenia
    South Africa
    Spain
    Sweden
    Switzerland
    Taiwan
    Thailand
    Tunisia
    Turkey
    Ukraine
    United Kingdom
    United States
    Vietnam
    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 months1
    E.8.9.1In the Member State concerned days26
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days20
    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: 800
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 7000
    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 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 state160
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 3380
    F.4.2.2In the whole clinical trial 8200
    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
    G.4 Investigator Network to be involved in the Trial: 1
    G.4 Investigator Network to be involved in the Trial: 2
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-12-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-12-04
    P. End of Trial
    P.End of Trial StatusCompleted
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