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    Summary
    EudraCT Number:2015-003149-24
    Sponsor's Protocol Code Number:Ranolazine¿AOUPi/001
    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:2021-01-27
    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 number2015-003149-24
    A.3Full title of the trial
    Ranolazine in patients with post systolic thickening due to stable effort angina: a phase II, randomized, open-label, standard therapy controlled, parallel group study assessing the effects on left ventricular function, exercise capacity and symptomatic status
    Ranolazina in pazienti con ispessimento post-sistolico secondario ad angina stabile: studio di fase II randomizzato, in aperto, controllato verso terapia standard, a gruppi paralleli, per la valutazione dell¿efficacia del farmaco sulla funzione ventricolare sinistra, la capacit¿ di esercizio e lo stato sintomatologico
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effect of Ranolazine in patients with impaired left ventricular function due to their stable angina for the presence of an abnormal ventricular contractile status that is maintained in the post-systolic
    Effetto della Ranolazina in pazienti con funzione ventricolare sinistra compromessa a causa della loro angina stabile per la presenza di un anomalo stato contrattile ventricolare che si mantiene nella fase post-sistolica
    A.3.2Name or abbreviated title of the trial where available
    Ranolazine - AOUPi/001
    Ranolazine - AOUPi/001
    A.4.1Sponsor's protocol code numberRanolazine¿AOUPi/001
    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 SponsorAZIENDA OSPEDALIERO-UNIVERSITARIA PISANA
    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 supportMenarini Internatinal Operations Luxemburg S.A.
    B.4.2CountryLuxembourg
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAZIENDA OSPEDALIERO-UNIVERSITARIA PISANA
    B.5.2Functional name of contact pointU.O. CARDIO - ANGIOLOGIA
    B.5.3 Address:
    B.5.3.1Street AddressVIA PARADISA, 2 - CISANELLO
    B.5.3.2Town/ cityPISA
    B.5.3.3Post code56100
    B.5.3.4CountryItaly
    B.5.4Telephone number050-995315
    B.5.5Fax number050-995316
    B.5.6E-mailvitantonio.dibello@med.unipi.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 RANEXA - 375 MG-COMPRESSA A RILASCIO PROLUNGATO-USO ORALE-BLISTER(PVC/PVDC/ALLUMINIO) 30 COMPRESSE
    D.2.1.1.2Name of the Marketing Authorisation holderMENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.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 nameRANEXA
    D.3.4Pharmaceutical form Prolonged-release 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 INNRANOLAZINA
    D.3.9.1CAS number 95635-55-5
    D.3.9.2Current sponsor codeNON DISPONIBILE
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number375
    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 RANEXA - 500 MG-COMPRESSA A RILASCIO PROLUNGATO-USO ORALE-BLISTER(PVC/PVDC/ALLUMINIO) 30 COMPRESSE
    D.2.1.1.2Name of the Marketing Authorisation holderMENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.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 nameRANEXA
    D.3.4Pharmaceutical form Prolonged-release 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 INNRANOLAZINA
    D.3.9.1CAS number 95635-55-5
    D.3.9.2Current sponsor codeNON DISPONIBILE
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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: 3
    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 RANEXA - 750 MG-COMPRESSA A RILASCIO PROLUNGATO-USO ORALE-BLISTER(PVC/PVDC/ALLUMINIO) 30 COMPRESSE
    D.2.1.1.2Name of the Marketing Authorisation holderMENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.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 nameRANEXA
    D.3.4Pharmaceutical form Prolonged-release 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 INNRANOLAZINA
    D.3.9.1CAS number 95635-55-5
    D.3.9.2Current sponsor codeNON DISPONIBILE
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number750
    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
    Stable angina with normal ejection fraction
    Angina stabile con frazione di eiezione nella norma
    E.1.1.1Medical condition in easily understood language
    Stable angina
    Angina stabile
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10002383
    E.1.2Term Angina pectoris
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Demonstrate the efficacy of ranolazine in reducing segmentary post systolic thickening due to myocardial ischemia - allowing the synchronisation of the impaired myocardial segments - using strain imaging (SI) derived from 2-dimensional speckle-tracking echocardiography in patients with stable effort angina.
    Dimostrare l¿efficacia della ranolazina nel ridurre l¿inspessimento segmentario post sistolico secondario a ischemia miocardica, permettendo cos¿ la sincronizzazione dei segmenti miocardici compromessi ¿ mediante la strain imaging (SI) derivata dalla ecocardiografia speckle tracking a 2 dimensioni in pazienti affetti da angina stabile
    E.2.2Secondary objectives of the trial
    Demonstrate the efficacy of ranolazine on exercise capacity in patients affected by stable effort angina using the supine bicycle exercise test and the symptomatic status. The assessment of safety by evaluation of adverse events, laboratory findings, the rest standard 12-lead ECG, and physical examination will also be considered as secondary study objectives.
    Dimostrare l¿efficacia di ranolazina sulla capacit¿ di esercizio in pazienti affetti da angina stabile mediante l¿utilizzo del test di esercizio con la bicicletta in posizione supina e la rilevazione dello stato sintomatico. Verr¿ inoltre studiata nella stessa popolazione la safety di ranolazina.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Male and female gender (females of childbearing potential must be using adequate contraceptive precautions such as implants, injectables, combined oral contraceptives, intrauterine devices, sexual abstinence or vasectomised partner);
    • Females of childbearing potential or within two years from the menopause must have a negative urine pregnancy test;
    • Patients which diagnosis of stable effort chronic angina based on clinical symptoms (angina; ischemic equivalents) or ischemia tests (stress ECG/stress-exercise echocardiography/Miocardial perfusion scintigraphy) independently from baseline antianginal therapy.
    • Patients aged = 18 years;
    • Patients with normal LV ejection fraction (EF) without LV wall motion abnormalities detected by standard echocardiography or if abnormalities are present, the post systolic thickening must be present in a different, non-contiguous segment;
    • Patients with post systolic thickening independently from baseline antianginal therapy, defined as the presence of SI = 50%, 5 min. during and/or after the supine bicycle speckle tracking echo stress (speckle tracking) test performed by using the standard Bruce protocol;
    • Presence of sinus rhythm;
    • Written informed consent prior to enrolment into the study.
    • Uomini e Donne (le donne in età fertile dovranno precauzionalmente fare uso di adeguate metodiche contraccettive);
    • Le donne in età fertile o entro due anni dalla presumibile data della menopausa dovranno avere un test urinario di gravidanza negativo;
    • Pazienti con diagnosi clinica di angina stabile (angina; equivalenti ischemici) o mediante test ischemici (ECG da stress/Ecocardiografia da stress/scintigrafia perfusionale miocardica) indipendente dalla terapia antianginosa di base;
    • Pazienti di età = 18 anni;
    • Pazienti con Frazione di Eiezione ventricolare sinistra normale (EF) senza anomalie della motilità della ventricolare sinistra diagnosticata mediante ecocardiografia standard o, in caso di presenza di dette anomalie, presenza di inspessimento post sistolico in un segmento differente non contiguo;
    • Pazienti con inspessimento post sistolico indipendente dalla terapia antiangionosa di base, definite come presenza di un SI = 50%, 5 min. durante e/o dopo il test di ecco stress mediante bicicletta supina speckle tracking eseguito secondo il protocollo standard di Bruce;
    • Presenza di ritmo sinusale;
    • Consenso informato scritto prima dell’ingresso nello studio.
    E.4Principal exclusion criteria
    • Females of childbearing potential not using adequate contraceptive precautions;
    • Presence of unstable angina, left main trunk disease, previous myocardial infarction, previous cardiac surgery, artificial pacemaker, non-sinus rhythm, significant valvular heart disease;
    • Presence of congestive heart failure;
    • Presence of Chronic Obstructive Airways Disease;
    • Concomitant administration of potent CYP3A4 inhibitors (e.g. itraconazole, ketoconazole, voriconazol, posaconazol, HIV protease inhibitors, clarithromycin, telithromycin, nefazodone). Grapefruit juice is also a potent CYP3A4 inhibitor.
    • Concomitant administration of Class Ia (e.g. quinidine) or Class III (e.g. dofetilide, sotalol) antiarrhythmics other than amiodarone.
    • Any clinically relevant haematological or biochemical abnormality on routine screening, according to Investigator’s judgment;
    • Severe concurrent pathology, including terminal illness (cancer, AIDS, etc.);
    • Severe renal impairment defined as GFR < 29 mL/min; creatinine level > 2.5 mg/dL; BUN >60 mg/dL;
    • Moderate or severe hepatic impairment or hepatic insufficiency defined as SGOT or SGPT > 2 times greater than normal upper limit or total serum bilirubin > 1.5 times greater than normal upper limit;
    • Dementia, psychosis, alcoholism (>350 g ethanol/week) or chronic abuse of medicines, drugs or psychoactive substances;
    • Females who are pregnant or lactating;
    • Conditions which in the Investigator’s opinion may interfere with the study’s execution or due to which the patient should not participate for safety reasons;
    • Risk of low patient cooperation;
    • Inability or unwillingness to issue the informed consent;
    • Inability to perform an exercise stress test.
    • Donne in età fertile che non fanno uso di adeguate precauzioni contraccettive;
    • Presenza di angina instabile, left main trunk disease, pregresso infarto del miocardio, pregresso intervento chirurgico cardiaco, presenza di pacemaker artificiale, ritmo non sinusale, malattia valvolare cardiaca significativa;
    • Presenza di scompenso cardiaco congestizio;
    • Presenza di Broncopneumopatia Cronica Ostruttiva;
    • Somministrazione concomitante di potenti inibitori del citocromo CYP3A4 (es. itraconazole, ketoconazole, voriconazol, posaconazol, HIV protease inhibitors, clarithromycin, telithromycin, nefazodone). Anche il succo di pompelmo è un potente inibitore del citocromo CYP3A4;
    • Somministrazione concomitante di antiaritmici di Classe Ia )es. chinidina) o di Classe III (es. dofetilide, sotalolo) diversi dall’amiodarone;
    • Qualunque anormalità ematologica o biochimica clinicamente rilevante, presente nei test di screening, secondo il giudizio dello sperimentatore;
    • Patologia concomitante di grado severo, incluse le malattie in stadio terminale (Cnacro, AIDS….);
    • Insufficienza renale di grado severo definita come GFR < 29 mL/min; creatininemia > 2.5 mg/dL; BUN >60 mg/dL;
    • Alterazione della funzionalità epatica di grado moderato o severo, o insufficienza epatica definite come presenza di valori di GOT o GPT > 2 volte la norma o bilirubina totale > 1.5 oltre la norma;
    • Demenza, psicosi, alcolismo (>350 g etanolo/settimana) o abuso cronico di medicine, sostanze stupefacenti o psicostimolanti;
    • Donne in gravidanza o allattamento;
    • Condizioni che a giudizio dello Sperimentatore possono interferire con l’esecuzione dello studio o per le quali, per motivi di safety i pazienti non possono parteciparvi;
    • Pazienti a rischio di scarsa collaborazione;
    • Incapacità o riluttanza a firmare il consenso informato;
    • Incapacità ad eseguire un test da stress.
    E.5 End points
    E.5.1Primary end point(s)
    Evaluation of SI in patients with stable effort angina after 2 months and 3 weeks of treatment with ranolazine + standard therapy (ST) or standard therapy (ST) alone using the 2-dimensional speckle-tracking echocardiography.
    Valutazione della SI in pazienti con angina stabile dopo 2 mesi di trattamento e tre settimane con ranolazina + ST o ST mediante l’utilizzo ecocardiografia speckle tracking a 2 dimensioni.
    E.5.1.1Timepoint(s) of evaluation of this end point
    2 MONTHS AND 3 WEEKS
    2 MESI E 3 SETTIMANE
    E.5.2Secondary end point(s)
    The change in Exercise capacity after 2 months and 3 weeks of treatment with ranolazine 375/500/750 mg /bid + ST or ST alone in the two study groups; The change in Symptomatic Status Evaluation using the Seattle Angina Questionnaire, after 2 months and 3 weeks of treatment with ranolazine 375/500/750 mg /bid + ST or ST alone in the two study groups; The change in Symptomatic Status Evaluation using the Seattle Angina Questionnaire, after 1 month of treatment with ranolazine 375/500/750 mg /bid + ST or ranolazine 500 mg/bid + ST in the two study groups from visit 7 to visit 8 (end study visit).; The change in SI, after 1 month of treatment with ranolazine 375/500/750 mg /bid + ST or ranolazine 500 mg/bid + ST in the two study groups from visit 7 to visit 8 (end study visit).; The change in Exercise capacity, after 1 month of treatment with ranolazine 375/500/750 mg /bid + ST or ranolazine 500 mg/bid + ST in the two study groups from visit 7 to visit 8 (end study visit).
    Il cambiamento nella capacit¿ di esercizio dopo 2 mesi e 3 settimane di trattamento con ranolazina 375/500/750 mg / bid + ST o solo ST nei due gruppi di studio; La variazione del Symptomatic Status Evaluation utilizzando il Seattle Angina Questionnaire, dopo 2 mesi e 3 settimane di trattamento con ranolazina 375/500/750 mg / bid + ST o solo ST nei due gruppi di studio; La variazione di Symptomatic Status Evaluation utilizzando il Seattle Angina Questionnaire, dopo 1 mese di trattamento con ranolazina 375/500/750 mg / bid + ST o ranolazina 500 mg / bid + ST nei due gruppi di studio dalla visita 7 alla visita 8 (fine visita di studio).; Il cambiamento di SI, dopo 1 mese di trattamento con ranolazina 375/500/750 mg / bid + ST o ranolazina 500 mg / bid + ST nei due gruppi di studio dalla visita 7 alla visita 8 (visita di studio fine).; Il cambiamento nella capacit¿ di esercizio, dopo 1 mese di trattamento con ranolazina 375/500/750 mg / bid + ST o ranolazina 500 mg / bid + ST nei due gruppi di studio da visita 7 alla visita 8 (visita di studio finale).
    E.5.2.1Timepoint(s) of evaluation of this end point
    2 MONTHS and 3 WEEKS; 2 MONTHS AND 3 WEEKS; 1 MONTH; 1 MONTH; 1 MONTH
    2 MESI e 3 SETTIMANE; 2 MESI E 3 SETTIMANE; 1 MESE; 1 MESE; 1 MESE
    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 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) 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
    Terapia standard
    Standard therapy
    E.8.2.4Number of treatment arms in the trial2
    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 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 years1
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days21
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial days21
    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: 14
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 14
    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 state28
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 28
    F.4.2.2In the whole clinical trial 28
    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)
    Patients will continue with the assistance programs that would perform regardless of the participation in the study.
    I pazienti proseguiranno con i programmi assistenziali che effettuerebbero indipendentemente dalla partecipazione allo studio.
    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 Decision2016-01-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-09-24
    P. End of Trial
    P.End of Trial StatusOngoing
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