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    The EU Clinical Trials Register currently displays   43925   clinical trials with a EudraCT protocol, of which   7306   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).

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    Summary
    EudraCT Number:2016-003036-20
    Sponsor's Protocol Code Number:1-2016
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-06-08
    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 number2016-003036-20
    A.3Full title of the trial
    A randomized trial of multifactorial primary prevention in high risk subjects candidate to a lung cancer early detection CT program
    Studio randomizzato di prevenzione primaria multifattoriale in soggetti ad alto rischio eleggibili a screening con TC torace
    Studio SMILE
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Prevention study for high risk subjects for age, sigarette smoking and inflammatory status candidate to a lung cancer early detection CT program
    Studio di prevenzione per soggetti considerati ad alto rischio per et¿, fumo di sigaretta e stato infiammatorio, candidati a un programma di diagnosi precoce del tumore polmonare con TAC torace
    A.3.2Name or abbreviated title of the trial where available
    SMILE
    SMILE
    A.4.1Sponsor's protocol code number1-2016
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN00000000
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00000000
    A.5.3WHO Universal Trial Reference Number (UTRN)U0000-0000-0000
    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 SponsorFONDAZIONE IRCCS "ISTITUTO NAZIONALE DEI TUMORI"
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportFondazione IRCCS Istituto Nazionale dei Tumori
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFondazione IRCCS Istituto Nazionale dei Tumori
    B.5.2Functional name of contact pointChirurgia Toracica Ricerca
    B.5.3 Address:
    B.5.3.1Street AddressVia G. Venezian 1
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20133
    B.5.3.4CountryItaly
    B.5.4Telephone number0223903759
    B.5.5Fax number0223903308
    B.5.6E-mailelena.bertocchi@istitutotumori.mi.it
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name CARDIOASPIRIN - 100 MG COMPRESSE GASTRORESISTENTI90 COMPRESSE
    D.2.1.1.2Name of the Marketing Authorisation holderBAYER S.P.A.
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameCardioaspirin
    D.3.2Product code 024840
    D.3.4Pharmaceutical form Gastro-resistant 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.3.8INN - Proposed INNACIDO ACETILSALICILICO
    D.3.9.2Current sponsor code03092200
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 Yes
    D.2.1.1.1Trade name Tabex
    D.2.1.1.2Name of the Marketing Authorisation holderSopharma Warszawa sp
    D.2.1.2Country which granted the Marketing AuthorisationPoland
    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 Capsule, hard
    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.3.8INN - Proposed INNCitisina
    D.3.9.1CAS number 485-35-8
    D.3.9.2Current sponsor code000000
    D.3.9.3Other descriptive nameCytisine
    D.3.9.4EV Substance CodeSUB31171
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    health subjects (multifactorial primary prevention)
    volontari sani (prevenzione primaria multifattoriale)
    E.1.1.1Medical condition in easily understood language
    health subjects (prevention)
    volontari sani (prevenzione)
    E.1.1.2Therapeutic area Diseases [C] - Symptoms and general pathology [C23]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10036654
    E.1.2Term Prevention
    E.1.2System Organ Class 100000004865
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main objective of the study is to evaluate the efficacy of multi-factor intervention in high risk subjects in terms of inflammatory inflammation. The primary endpoint is therefore the reduction in the percentage of subjects with high PCR (ie with PCR =2 mg / L).
    L¿obiettivo primario dello studio ¿ quello di valutare l¿efficacia dell¿intervento multi-fattoriale in soggetti ad alto rischio in termini di riduzione dello stato infiammatorio. L¿endpoint primario risulta pertanto la riduzione della percentuale di soggetti con PCR elevata (cio¿ con PCR =2 mg/L).
    E.2.2Secondary objectives of the trial
    ¿ Reduction in the proportion of smokers;
    ¿ Improving the efficacy and safety of Varenicline for smoking cessation, using an alternative way of administering the drug;
    ¿ Improvement of diet and physical activity;
    ¿ Improvement of anthropometric parameters in overweight / obese and underweight subjects;
    ¿ Improvement of metabolic values;
    ¿ Improving the quality of life;
    ¿ Reduction in the percentage of subjects with lung cancer;
    ¿ Reduction of total mortality;
    ¿ Evaluation of the relationship between inflammatory profile (PCR) plasma biomarkers and those related to the metabolic profile and microRNA profile
    ¿ Evaluation of the adherence, feasibility and tolerability of multi-factor prevention intervention
    ¿ Riduzione della percentuale di fumatori;
    ¿ Miglioramento dell¿efficacia e sicurezza della Vareniclina per la cessazione al fumo, utilizzando una modalit¿ alternativa di somministrazione del farmaco;
    ¿ Miglioramento della dieta e dell¿attivit¿ fisica;
    ¿ Miglioramento dei parametri antropometrici in soggetti sovrappesso/obesi e in quelli sottopeso;
    ¿ Miglioramento dei valori metabolici;
    ¿ Miglioramento della qualit¿ della vita;
    ¿ Riduzione della percentuale di soggetti con tumore del polmone;
    ¿ Riduzione della mortalit¿ totale;
    ¿ Valutazione della relazione tra biomarcatori plasmatici relativi al profilo infiammatorio (PCR) e quelli relativi al profilo metabolico e profilo microRNA.
    ¿ Valutazione dell'aderenza, fattibilit¿ e tollerabilit¿ dell'intervento multi-fattoriale di prevenzione
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Age between 55 and 75 years
    • Heavy smoker (=30 packages/year)
    • Eligibility to screening with annual chest CT
    • Availability and ability to use the Internet via PC, tablet or smartphone
    • Ability to understand the project to which you intend to participate
    • No tumors in the last 5 years
    • Signature of informed consent for enrollment in the study and for the processing of personal data
    • Età compresa tra 55 e 75 anni
    • Forte fumatore (=30 pacchetti/anno)
    • Eleggibilità a screening con TC torace annuale
    • Disponibilità e capacità di utilizzo di internet tramite PC, tablet o smartphone
    • Capacità di comprendere il progetto a cui si intende partecipare
    • Assenza di tumori da almeno 5 anni
    • Firma del consenso informato per l’arruolamento in studio e il trattamento dei dati personali
    E.4Principal exclusion criteria
    • Hypersensitivity to acetylsalicylic acid, salicylates or any of the excipients (excipients: cellulose powder, corn starch; coating: copolymers of methacrylic acid, sodium lauryl sulfate, polysorbate 80, talc, triethyl citrate)
    • Chronic treatment with cardioASA, or other anti-clotting or anti-coagulant drugs (for example: heparin, dicumarol)
    • Treatment with methotrexate
    • Existing Mastocytosis
    • History of asthma induced by the administration of salicylates or substances to similar activity, particularly non-steroidal anti-inflammatory drugs
    • Gastroduodenal ulcer
    • Hemorrhagic diathesis
    • Severe chronic pathology (eg: severe respiratory and / or renal and / or hepatic and / or cardiac insufficiency)
    • Severe kidney failure
    • Serious psychiatric problems
    • Previous treatment with Cytisine
    • Abuse of alcohol or other substances (even before)
    • Ipersensibilità all’acido acetilsalicilico, ai salicilati o a uno qualsiasi degli eccipienti (eccipienti: polvere di cellulosa, amido di mais; rivestimento: copolimeri dell’acido metacrilico, sodio laurilsolfato, polisorbato 80, talco, trietile citrato)
    • Trattamento cronico con cardioASA, o altri farmaci anti-aggreganti o anti-coagulanti (ad esempio: eparina, dicumarolici)
    • Trattamento con metotrexato
    • Mastocitosi preesistente
    • Anamnesi di asma indotta dalla somministrazione di salicilati o sostanze ad attività simile, in particolare i farmaci antinfiammatori non steroidei
    • Ulcera gastroduodenale
    • Diatesi emorragica
    • Patologia cronica severa (ad esempio: grave insufficienza respiratoria e/o renale e/o epatica e/o cardiaca)
    • Grave insufficienza renale
    • Gravi problemi psichiatrici
    • Precedente trattamento con Citisina
    • Abuso di alcool o altre sostanze (anche pregresso)
    E.5 End points
    E.5.1Primary end point(s)
    Reduction in the percentage of subjects with PCR =2 mg/L after one year of treatment in the interventional groups versus control group.
    Riduzione della percentuale di soggetti con PCR =2 mg/L dopo un anno di intervento nei gruppi di intervento rispetto al gruppo di controllo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 months
    12 mesi
    E.5.2Secondary end point(s)
    ¿ Reduction of the proportion of smokers after one year of follow-up in the intervention group on smoking cessation over the control group;; ¿ Greater adherence to the Mediterranean Diet, measured through specific indexes defined in scientific literature (such as the MDS), The inflammatory status group with respect to the control group;; ¿ Increased physical activity, quantified in terms of Metabolic Equivalence of the Task (MET) in the inflammatory response group compared to the control group;; ¿ Reduction of the various anthropometric parameters (IMC, waist circumference, waist circumference / waist ratio) and greater prevalence of weight-weight subjects in the inflammatory intervention group versus the control group;; ¿ Reduction of cardio-metabolic markers in the blood in the inflammatory group compared to the control group;; ¿ Better quality of life, quantified by SF-12 in intervention groups compared to control group;; ¿ Reduction of the incidence rate of lung cancer in the intervention group on smoking cessation with respect to the control group;; ¿ Reduction of the total mortality rate in the intervention groups compared to the control group;; ¿ Evaluation of the relationship between inflammatory profile (PCR) plasma biomarkers and cardio-metabolic profile and microRNA profile.; ¿ Reduction in percentage of smokers and adverse reactions after one year of follow-up in subjects treated with Cytisine with prolonged administration compared to standard drug administration;
    ¿ La riduzione della percentuale di fumatori dopo un anno di follow-up nel gruppo di intervento sulla cessazione dal fumo rispetto al gruppo di controllo;; ¿ Aumento dell¿aderenza alla dieta Mediterranea, misurata attraverso specifici indici definiti nella letteratura scientifica (come il Mediterranean Diet Score (MDS)) nel gruppo di intervento sullo stato infiammatorio rispetto al gruppo di controllo; ; ¿ Aumento dell'attivit¿ fisica, quantificata in termini di Equivalente Metabolico del Task (MET) nel gruppo di intervento infiammatorio rispetto al gruppo di controllo;; ¿ Riduzione dei vari parametri antropometrici (IMC, circonferenza vita, circonferenza vita / rapporto vita) e maggiore prevalenza di soggetti peso-peso nel gruppo di intervento infiammatorio rispetto al gruppo di controllo;; ¿ Riduzione dei marcatori cardio-metabolici nel flusso sanguigno nel gruppo di intervento infiammatorio rispetto al gruppo di controllo;; ¿ Una migliore qualit¿ della vita, quantificata da SF-12 nei gruppi di intervento rispetto al gruppo di controllo;; ¿ Riduzione del tasso di incidenza del cancro polmonare nel gruppo di intervento sulla cessazione del fumo rispetto al gruppo di controllo;; ¿ Riduzione del tasso di mortalit¿ totale nei gruppi di intervento rispetto al gruppo di controllo;; ¿ Valutazione della relazione tra biomarcatori plasmatici del profilo infiammatorio (PCR) e profilo cardio-metabolico e profilo microRNA.; ¿ La riduzione della percentuale di fumatori e di reazioni avverse, dopo un anno di follow-up, nei soggetti trattati con Citisina con una somministrazione prolungata rispetto alla somministrazione standard del farmaco;
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 and 24 months; 12 and 24 months; 12 and 24 months; 12 and 24 months; 12 and 24 months; 12 and 24 months; 12 and 24 months; 12 and 24 months; 12 and 24 months; 12 and 24 months
    12 e 24 mesi; 12 e 24 mesi; 12 e 24 mesi; 12 e 24 mesi; 12 e 24 mesi; 12 e 24 mesi; 12 e 24 mesi; 12 e 24 mesi; 12 e 24 mesi; 12 e 24 mesi
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety No
    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 Yes
    E.6.13.1Other scope of the trial description
    quality of life, factibility, reduction in risk factors
    qualit¿ di vita, fattibilit¿, riduzione delle condizioni di rischio (% fumatori attivi e soggetti con PCR >2)
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    A)Gruppo di intervento completo: CardioASA + programma dietetico e di attivit¿ fisica + Citisina;
    B)
    A) Complete intervention group: CardioASA + Dietary and physical activity program+Cytisine;
    B) Inter
    E.8.2.4Number of treatment arms in the trial4
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA1
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee 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
    The start date of the study is the date of enrollment of the first subject, and the end date is expected to be after 30 months.
    The end of the enrollment will be after 18 months from the beginning of the study. The follow-up will end after 12 months from the first visit of the last patient enrolled.
    This will guarantee for the 2000 recruited subjects a minimum follow-up of one year up to a maximum of two years.
    La data di inizio dello studio corrisponde alla data dell'arruolamento del primo soggetto, e la data di fine ¿ prevista dopo 30 mesi.
    La conclusione dell¿arruolamento ¿ prevista dopo 18 mesi dall¿inizio dello studio. Il follow up si concluder¿ dopo 12 mesi dalla prima visita dell¿ultimo paziente arruolato.
    Questo garantir¿ per i 2000 soggetti reclutati un follow-up minimo di un anno fino ad un massimo di due anni.
    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 months6
    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 months6
    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: 1350
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 650
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    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 state2000
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 2000
    F.4.2.2In the whole clinical trial 2000
    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)
    telephone follow up
    follow up telefonico
    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 Decision2017-10-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-07-20
    P. End of Trial
    P.End of Trial StatusOngoing
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