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    Summary
    EudraCT Number:2012-003487-48
    Sponsor's Protocol Code Number:F373280CA201
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-05-24
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2012-003487-48
    A.3Full title of the trial
    Efficacy and safety study of F373280 for maintenance of sinus rhythm after electrical cardioversion in patients with persistent Atrial Fibrillation and Chronic Heart Failure.
    Studio di Efficacia e sicurezza di F373280 per il mantenimento del ritmo sinusale dopo cardioversione elettrica in pazienti con Fibrillazione Atriale persistente e Insufficienza Cardiaca Cronica.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and safety study of F373280 for maintenance of sinus rhythm after electrical cardioversion in patients with persistent Atrial Fibrillation and Chronic Heart Failure.
    Studio di Efficacia e sicurezza di F373280 per il mantenimento del ritmo sinusale dopo cardioversione elettrica in pazienti con Fibrillazione Atriale persistente e Insufficienza Cardiaca Cronica
    A.3.2Name or abbreviated title of the trial where available
    NA
    NA
    A.4.1Sponsor's protocol code numberF373280CA201
    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 SponsorPierre Fabre Medicament
    B.1.3.4CountryFrance
    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 supportPierre Fabre Medicament
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInstitut de Recherche Pierre Fabre - Centre R&D Pierre Fabre
    B.5.2Functional name of contact pointMarlène Guiraud
    B.5.3 Address:
    B.5.3.1Street AddressInstitute de recherche Pierre Fabre- Centre de R&D Pierre Fabre - BP 13562 - 3 Avenue Hubert Curien
    B.5.3.2Town/ cityToulouse Cédex 1
    B.5.3.3Post code31035
    B.5.3.4CountryFrance
    B.5.4Telephone number+33(0)534506348
    B.5.5Fax number+33(0)534506592
    B.5.6E-mailmarlene.guiraud@pierre-fabre.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 namePanthenyl Ester of DHA
    D.3.2Product code F373280
    D.3.4Pharmaceutical form Capsule, soft
    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 INNPanthenyl Ester of DHA
    D.3.9.2Current sponsor codeF373280
    D.3.9.3Other descriptive nameDOCOSAHEXAENOIC ACID PANTHENYL ESTER
    D.3.9.4EV Substance CodeSUB33358
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(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 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 placeboCapsule, soft
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    F373280 is a new therapy based on DHA delivery (pro-drug) developed for the maintenance of sinus rhythm after electrical cardioversion in persistent Atrial Fibrillation (AF) patients with chronic hearth failure. The results of pharmacological studies performed in animals evidenced that DHA reduces the duration of Atrial Fibrillation (AF) induced by burst pacing.
    F373280 è una nuova terapia basata dul rilascio di DHA sviluppata per il mantenimento del ritmo sinusale dopo cardioversione elettrica in pazienti con fibrillazione atriale persistente e scompenso cardiaco cronico.
    I risultati degli studi farmacologici effettuati in animali hanno evidenziato che DHA riduce la durata della fibrillazione atriale indotta da burst pacing.
    E.1.1.1Medical condition in easily understood language
    F373280 is a new therapy based on DHA delivery developed for the maintenance of sinus rhythm after electrical cardioversion in persistent Atrial Fibrillation (AF) patients with chronic hearth failure
    F373280 è una nuova terapia basata sul rilascio di DHA per il mantenimento del ritmo sinusale dopo cardioversione elettrica in pz con fibrillazione atriale persistente e scompenso cardiaco cronico
    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 PT
    E.1.2Classification code 10061024
    E.1.2Term Cardiac disorder
    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
    Primary:
    Efficacy of F373280 on the maintenance of sinus rhythm after electrical cardioversion in persistent Atrial Fibrillation patients with chronic hearth failure.
    Primario:
    Efficacia di F373280 per il mantenimento del ritmo sinusale dopo cardioversione elettrica in pazienti con fibrillazione atriale persistente e scompenso cardiaco cronico.
    E.2.2Secondary objectives of the trial
    Secondary:
    - Efficacy of F373280 on the efficency of direct electrical cardioversion
    - Effect of F373280 on echocardiographic paramenters
    - Safety and tolerability of F373280
    Secondari:
    - Efficacia di F373280 sull'efficienza della cardioversione elettrica diretta
    - Effetto di F373280 sui paramentri ecocardiografici
    - Sicurezza e tollerabilotà di F373280
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Men or women aged more than 18 years (inclusive),
    2. Patients with persistent AF between 7 days and 6 months duration for whom electrical cardioversion is warranted.
    3. History of first documented persistent AF less than 1 year
    4. History of ischemic or non ischemic heart failure
    5. NYHA class I or II chronic heart failure at selection and at inclusion
    6. Reduced left ventricular ejection fraction between 30% and 45% inclusive (using the two-dimensional echocardiography biplane Simpson’s rule) ) at selection and at inclusion
    7. On appropriate, stable medical treatments for heart failure, including a diuretic and/or angiotensin-converting enzyme, and/or angiotensin-receptor blocker and/or mineralocorticoid receptor (MR) antagonists, and/or betablockers
    8. Left atrial area  40 cm² ) at selection and at inclusion
    9. Patients treated or having to be treated by anti-vitamin K
    10. For female patient of child-bearing potential :
    • in all the countries except Italy:
    - use of an effective method of contraception (hormonal contraception or intra-uterine device) assessed by the investigator, for at least 2 months before the selection in the study, and agreement to go on using it during the whole duration of the study and up to 1 month after the last dose of the study treatment
    - documented as surgically sterilized

    • in Italy only:
    - absolute abstention from sexual intercourse during the whole duration of the study and for a month after the end of the study or
    - use of double barrier contraception method (use of effective medical contraception method) from at least 2 months before the start of the study to the entire duration of the study and for a month after the end of the study or
    - documented as surgically sterilized

    11. For female patient of child-bearing potential: negative urine pregnancy test at inclusion
    12. For male with a child-bearing potential partner (In Italy only):
    - Absolute abstention from sexual intercourse during the whole duration of the study and for a month after the end of the study or
    - use of double barrier contraception method (use of condom for male and effective contraception method for the partner) from the entire duration of the study to a month after the end of the study.
    13. Having signed his/her written informed consent,
    14. Affiliated to a social security system, or is beneficiary (if applicable in the national regulation)
    1. Pazienti di entrambi i sessi di età uguale o superiore a 18 anni;
    2. Pazienti con FA persistente di durata compresa tra 7 giorni e 6 mesi che necessitano di cardioversione elettrica;
    3. Storia di primo episodio documentato di FA persistente non antecedente ad un anno;
    4. Storia di insufficienza cardiaca ischemica o non ischemica;
    5. Insufficienza cardiaca cronica di classe NYHA I o II al momento dello screening e dell’ arruolamento;
    6. Frazione di eiezione ventricolare sinistra ridotta tra il 30% and 45% (misurata con ecocardiografia bidimensionale con il metodo di Simpson biplano) al momento dello screening e dell’arruolamento;
    7. Terapia medica stabile e appropriata per l’insufficienza cardiaca, fra cui uso di diuretici e/o di enzimi di conversione dell’angiotensina e/o di antagonisti dei recettori dell’ angiotensina e/o di antagonisti del recettore dei mineralcorticoidi (MR), e/o di betabloccanti;
    8. Superficie atriale sinistra ≤ 40 cm² al momento della screening e dell’arruolamento;
    9. Pazienti in trattamento o trattati in precedenza con antagonisti della vitamina K;
    10. Per le pazienti di sesso femminile in età fertile:
    in tutti i Paesi ad eccezione dell’Italia:
    • uso di un metodo contraccettivo efficace (contraccezione ormonale o dispositivo intrauterino) valutato dallo sperimentatore, per almeno 2 mesi prima della arruolamento nello lo studio, e consenso all’uso dello stesso per l’intera durata dello studio e fino a un mese dopo l’assunzione dell’ultima dose di trattamento sperimentale;
    • sterilizzazione chirurgica documentata

    solo in Italia:
    • assoluta astensione dai rapporti sessuali per tutta la durata dello studio e per almeno un mese dopo la fine dello studio, o
    • utilizzo dei metodi contraccettivi di doppia barriera (metodo medico di contraccezione efficace) per un periodo di almeno 2 mesi prima dell’inizio dello studio, per tutta la durata dello studio e per un mese dopo la fine dello studio, o
    • sterilizzazione chirurgica documentata

    11. Per le pazienti di sesso femminile in età fertile: test di gravidanza sulle urine negativo al momento dell’inclusione;
    12. Per gli uomini con una partner in età fertile (solo per l’Italia):
    • assoluta astensione dai rapporti sessuali per tutta la durata dello studio e per almeno un mese dopo la fine dello studio, o
    • utilizzo dei metodi contraccettivi di doppia barriera (uso del profilattico per l’uomo e un metodo di contraccezione efficace per la partner) per tutta la durata dello studio e per almeno un mese dopo la fine dello studio.
    13. I soggetti dovranno aver firmato il Modulo di consenso informato;
    14. I soggetti dovranno essere iscritti o beneficiari di un sistema nazionale di previdenza sociale (se applicabile ai sensi della legislazione nazionale).
    E.4Principal exclusion criteria
    1. History of first documented episode of persistent AF more than 1 year
    2. More than two successful cardioversions (electrical or pharmacological) in the last 6 months
    3. Secondary Atrial Fibrillation due to alcohol or severe valvular heart disease (grade III to IV)
    4. NYHA class III or IV heart failure at selection or at inclusion
    5. Thyroid disease uncontrolled by treatment: TSH ± T4L ± T3L to be checked in case of treatment for thyroid disease
    6. Myocardial infarction or unstable angina or presence of unstable ischemic coronaropathy assessed by coronarography or cardiac stress test (Echo stress, exercice stress test, nuclear or MR perfusion evaluation methods) within 6 months before selection
    7. Severe chronic kidney disease (creatinine  25 mg/L or estimated glomerular filtration rate < 30 mL/min) at selection
    8. Bradycardia (HR  50 bpm)
    9. Hyperkalemia or hypokalemia (K>5.5 mEq/L or K < 3.5 mEq/L) at selection
    10. Cardiac surgery within 3 months before selection or planned during the study duration
    11. Previously ineffective pharmacological or electrical cardioversion
    12. Concomitant treatment with any anti-arrhythmic drug (within 7 days prior to selection), except stable dose of digoxin, betablockers, calcium-blockers
    13. Previous treatment with oral amiodarone within 12 months prior to inclusion
    14. Previous treatment with intravenous amiodarone within 6 months prior to inclusion
    15. Patient requiring a cardiac resynchronization therapy (CRT) or having undergone CRT implantation within the last 6 months
    16. Treatment with any Polyunsaturated Fatty Acid (PUFA) within the last 3 months
    17. Dietary supplement with ω3 or ω6 according to investigator’s judgement
    18. Having undergone any form of ablation therapy for AF
    19. Patient treated with other anticoagulant treatment than antivitamin K: thrombin inhibitor such as Dabigatran or treated with antiaggregant P2Y12 inhibitors such as Clopidogrel or Prasugrel
    20. Patient liable not to comply with protocol instructions and/or with treatment, in the investigator’s opinion
    21. Patient having taken part in a clinical trial in the preceding 2 months or taking part in a trial at the time of selection
    22. Patient linguistically or mentally unable to understand the nature, objectives and possible consequences of the trial, or refusing to patient himself/herself to its constraints
    23. Patient family member or work associate (secretary, nurse, technician,..) of the Investigator
    24. Patient having forfeited his / her freedom by administrative or legal award or being under guardianship
    25. Breastfeeding female patient
    Primo episodio documentato di FA risalente a più di un anno;
    2. Più di due cardioversioni riuscite (elettriche o farmacologiche) nel corso degli ultimi 6 mesi;
    3. Fibrillazione Atriale Secondaria dovuta ad alcolismo o a valvulopatia grave (grado III o IV);
    4. Insufficienza cardiaca di classe NYHA III o IV al momento dello screening o dell’arruolamento;
    5. Patologia tiroidea non controllata farmacologicamente: in caso di terapia dovranno essere controllati i valori di TSH ± T4L ± T3L;
    6. Infarto del miocardio o angina instabile o presenza di coronaropatia ischemica instabile valutata con coronarografia o test da sforzo (Ecostress, test ergometrico, metodi di valutazione della perfusione con scintigrafia o risonanza magnetica) nei 6 mesi precedenti lo screening;
    7. Insufficienza renale grave (creatinina ≥25 mg/L o clearance della creatinina < 30 mL/min) al momento dello screening;
    8. Bradicardia (frequenza cardiaca ≤ 50 bpm);
    9. Iperpotassiemia o ipopotassiemia (K>5.5 mEq/L o K < 3.5 mEq/L) al momento dello screening;
    10. Interventi di cardiochirurgia nei tre mesi precedenti lo screening, o previsti durante lo svolgimento dello studio.
    11. Pregressa cardioversione farmacologica o elettrica inefficace;
    12. Terapia concomitante con farmaci antiaritmici (nei 7 giorni precedenti lo screening) ad eccezione di dosaggi stabili di digoxina, betabloccanti, calcioantagonisti;
    13. Pregresso trattamento con amiodarone per os nei 12 mesi precedenti l’arruolamento;
    14. Pregresso trattamento con amiodarone ev nei 6 mesi precedenti l’arruolamento;
    15. Pazienti che necessitano di risincronizzazione cardiaca (CRT), o dispositivo CRT impiantato negli ultimi 6 mesi;
    16. Pazienti in trattamento con Acidi Grassi Polinsaturi (PUFA) negli ultimi 3 mesi;
    17. Pazienti in trattamento con integratori alimentari contenenti omega 3 o omega 6 a giudizio dello sperimentatore;
    18. Pregresse terapie ablative di qualsiasi tipo per FA;
    19. Pazienti trattati con altri farmaci anticoagulanti oltre agli antagonisti della vitamina K: inibitori della trombina come Dabigatran, o trattati con inibitori del P2Y12 come Clopidogrel o Prasugrel.
    20. Pazienti che a giudizio dello sperimentatore potrebbero non ottemperare alle procedure del protocollo e/o al trattamento;
    21. Pazienti che abbiano partecipato a un trial clinico nei 2 mesi precedenti o che stiano prendendo parte a un trial al momento dello screening;
    22. Pazienti che per problemi linguistici o mentali non siano in grado di comprendere la natura, gli obiettivi e le possibili conseguenze del trial, o che rifiutino di sottoporsi ai vincoli che esso pone;
    23. Pazienti che siano familiari o colleghi di lavoro (segretari, infermieri, tecnici) dello sperimentatore;
    24. Pazienti che siano stati privati della propria libertà a seguito di provvedimenti amministrativi o legali o che siano sotto tutela giudiziaria;
    25. Donne in allattamento
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy
    Efficacia
    E.5.1.1Timepoint(s) of evaluation of this end point
    Time to first atrial fibrillation recurrence defined by the first episode of atrial fibrillation lasting for at least 10 minutes.
    Tempo intercorso fino alla prima recidiva di fibrillazione atriale definita dal primo episodio di FA della durata di almeno 10 minuti.
    E.5.2Secondary end point(s)
    Safety
    Sicurezza
    E.5.2.1Timepoint(s) of evaluation of this end point
    Adverse Events
    Vital Signs
    Physical Examination
    Standard 12-lead ECG
    Haematology
    Biochemistry
    Coagulation parameters
    Eventi Avversi
    Segni vitali
    Esame obiettivo
    ECG standard a 12 derivazioni
    Esami ematologici
    Esami biochimici
    Parametri della coagulazione
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA45
    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 No
    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
    LVLP
    LVLP
    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 months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months3
    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: 122
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 152
    F.4.2.2In the whole clinical trial 152
    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 Decision2013-05-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-03-05
    P. End of Trial
    P.End of Trial StatusCompleted
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