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    Summary
    EudraCT Number:2009-018161-12
    Sponsor's Protocol Code Number:SPD503-315
    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:2011-12-28
    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 number2009-018161-12
    A.3Full title of the trial
    A phase 3, double-blind, placebo-controlled, multicentre, randomised-withdrawal, long-term maintenance of efficacy and safety study of extended-release Guanfacine Hydrochloride in children and adolescents aged 6-17 with Attention-deficit/Hyperactivity Disorder
    studio di Fase III, in doppio cieco, controllato verso placebo, multicentrico, randomizzato e di ritiro, sul mantenimento a lungo termine di sicurezza ed efficacia di guanfacina cloridrato a rilascio prolungato in bambini e adolescenti tra 6 e 17 anni con disordine di iperattivita'/deficit d'attenzione
    A.4.1Sponsor's protocol code numberSPD503-315
    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 SponsorShire Development Inc.
    B.1.3.4CountryUnited States
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 nameGuanfacina cloroidrato
    D.3.2Product code SPD503
    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 INNguanfacine hydrochloride
    D.3.9.1CAS number 29110-48-3
    D.3.9.2Current sponsor codeSPD503
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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.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 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 nameGuanfacina Cloroidrato
    D.3.2Product code SPD503
    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 INNguanfacine hydrochloride
    D.3.9.1CAS number 29110-48-3
    D.3.9.2Current sponsor codeSPD503
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number2
    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.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 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 nameGuanfacina cloroidrato
    D.3.2Product code SPD503
    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 INNguanfacine hydrochloride
    D.3.9.1CAS number 29110-48-3
    D.3.9.2Current sponsor codeSPD503
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number3
    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.IMP: 4
    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 nameGuanfacina cloroidrato
    D.3.2Product code SPD503
    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 INNguanfacine hydrochloride
    D.3.9.1CAS number 29110-48-3
    D.3.9.2Current sponsor codeSPD503
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number4
    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 placeboProlonged-release tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboProlonged-release tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 3
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboProlonged-release tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 4
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboProlonged-release tablet
    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
    ADHD
    ADHD
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10064104
    E.1.2Term ADHD
    E.1.2System Organ Class 10037175 - Psychiatric disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to evaluate the long-term maintenance of efficacy of SPD503 in children and adolescents (6-17 years) with attention-deficit/hyperactivity disorder (ADHD) who respond to an initial openlabel, short-term treatment with SPD503.
    L’obiettivo primario di questo studio e' quello di valutare il mantenimento a lungo termine dell’efficacia di SPD503 in bambini e adolescenti (6-17 anni) con disordine di iperattivita'/deficit d’attenzione (ADHD) che rispondono a un trattamento iniziale a breve termine in aperto con SPD503.
    E.2.2Secondary objectives of the trial
    1-To assess the long-term efficacy of SPD503 using the clinician-dministered Attention-deficit/Hyperactivity Disorder Rating Scale-IV (ADHD-RS-IV) total score.2-To assess the long-term efficacy of SPD503 using the clinician-administered Global Impressions- Severity of Illness Scale (CGI-S).3-To assess the efficacy of SPD503 using the clinician-administered Clinical Global Impressions-Improvement Scale (CGI-I).4-To evaluate efficacy on ADHD functional outcomes as measured by the Weiss Functional Impairment Rating Scale-Parent (WFIRS-P).5-To assess the impact of treatment on the perception of health state preferences using the Health Utilities Index-Mark 2 and Mark 3 (HUI-2/3).6-To evaluate the long-term safety of SPD503 based on treatment-emergent adverse events (TEAEs), specific evaluation of blood pressure and pulse, clinical laboratory tests, electrocardiogram (ECG) results, and results from the Columbia-Suicide Severity Rating Scale (C-SSRS).
    1-Valutare l’efficacia a lungo termine di SPD503 mediante il punteggio totale della ADHD-RS-IV somministrata dal medico.2-Valutare l’efficacia a lungo termine di SPD503 mediante la CGI-S somministrata dal medico.3-Valutare l’efficacia di SPD503 mediante la Clinical Global Impressions -improvement Scale (CGI-I)somministrata dal medico.4-Valutare l’efficacia in termini di esiti funzionali dell’ADHD misurati con la Weiss Functional Impairment Rating Scale-Parent (WFIRS-P).5-Valutare l’impatto del trattamento sulla percezione delle preferenze sullo stato di salute mediante Health Utilities Index - Mark 2 e Mark 3 (HUI-2/3).6-Valutare la sicurezza a lungo termine di SPD503 in base agli eventi avversi emersi durante il trattamento (TEAE), alla valutazione specifica di pressione arteriosa e polso, ai test clinici di laboratorio, ai risultati degli elettrocardiogrammi (ECG) e ai risultati della Columbia-Suicide Severity Rating Scale (C-SSRS).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female, aged 6-17 years at the time of consent/assent at Screening/Visit 1. 2. Subject meets Diagnostic and Statistical Manual of Mental Disorders, 4th ed.-Text Revision (DSM-IV-TR ) criteria for a primary diagnosis of ADHD, combined sub-type, hyperactive/impulsive sub-type, or inattentive sub-type based on a detailed psychiatric evaluation using the Kiddie Schedule for Affective Disorders and Schizophrenia-Present and Lifetime version (K-SADS-PL). 3. Subject has a minimum ADHD-RS-IV total score of 32 at Enrolment/Visit 2. 4. Subject has a minimum CGI-S score of 4 at Enrolment/Visit 2. 5. Subject is able to swallow intact tablets.
    1. Maschio o femmina di 6-17 anni di eta' al momento del consenso/assenso allo Screening/Visita 1. 2. Il soggetto deve soddisfare i criteri di Diagnostic and Statistical Manual of Mental Disorders, 4a ed. -Text Revision (DSM-IV-TR ) per una diagnosi primaria di ADHD, sottotipo combinato, sottotipo iperattivo/impulsivo o sottotipo disattento in base a una valutazione psichiatrica dettagliata mediante Kiddie Schedule for Affective Disorders and Schizophrenia-Present and Lifetime version (K-SADS-PL). 3. Punteggio totale ADHD-RS-IV minimo pari a 32 ad Arruolamento/Visita 2. 4. Punteggio CGI-S minimo pari a 4 ad Arruolamento/Visita 2. 5. Il soggetto deve essere in grado di inghiottire compresse intere.
    E.4Principal exclusion criteria
    1. Subject has a current, controlled (requiring a prohibited medication or behavioural modification program) or uncontrolled, co-morbid psychiatric diagnosis, except Oppositional Defiant Disorder (ODD), including any severe comorbid Axis II disorders or severe Axis I disorders such as Post Traumatic Stress Disorder, bipolar illness, psychosis, pervasive developmental disorder, obsessive-compulsive disorder, substance abuse disorder, or other symptomatic manifestations or lifetime history of bipolar illness, psychosis, or conduct disorder that, in the opinion of the Investigator, contraindicate SPD503 treatment or confound efficacy or safety assessments. 2. Subject has a known history or presence of structural cardiac abnormalities, serious heart rhythm abnormalities, syncope, cardiac conduction problems (e.g., clinically significant heart block), exercise-related cardiac events including syncope and pre-syncope, or clinically significant bradycardia. 3. Subject with orthostatic hypotension or a known history of controlled or uncontrolled hypertension. 4. Current use of any prohibited medication or other medications, including herbal supplements, that affect blood pressure (BP) or heart rate or that have central nervous system (CNS) effects or affect cognitive performance, such as sedating antihistamines and decongestant sympathomimetics (inhaled bronchodilators are permitted) or a history of chronic use of sedating medications (i.e., antihistamines) in violation of the protocol specified washout criteria at Enrolment/Visit 2. 5. Subject is significantly overweight based on Centre for Disease Control and Prevention Body Mass Index (BMI)-for-age gender specific charts. Significantly overweight is defined as a BMI >95th percentile. 6. Children aged 6-12 years with a body weight of <25.0kg or adolescents aged 13-17 years with a body weight of <34.0kg or >91.0kg at Screening/Visit 1. 7. Subject has a history of alcohol or other substance abuse or dependence, as defined by DSM-IV-TR (with the exception of nicotine) within the last 6 months. 8. Subject is currently considered a suicide risk in the opinion of the Investigator, has previously made a suicide attempt, or has a prior history of, or is currently demonstrating active suicidal ideation. Subjects with intermittent passive suicidal ideation are not necessarily excluded based on the assessment of the Investigator (see protocol for additional guidance). 9. History of failure to respond to an adequate trial of an α2-agonist for the treatment of ADHD (consisting of an appropriate dose and adequate duration of therapy in the opinion of the Investigator).
    1. Il soggetto presenta una diagnosi psichiatrica comorbile in atto, controllata (che necessita di un farmaco vietato o di un programma di modifica comportamentale) o incontrollata, a eccezione del disordine oppositivo provocatorio (ODD), tra cui disordini comorbili gravi dell’Asse II o disordini gravi dell’Asse I, come disordine da stress post-traumatico, malattia bipolare, psicosi, disordine pervasivo dello sviluppo,disordine ossessivo - compulsivo, disordine da abuso di sostanze o altre manifestazioni sintomatiche correnti o pregresse di malattia bipolare, psicosi o disordine della condotta che, in base al giudizio dello Sperimentatore, controindicano il trattamento con SPD503 o interferiscono con le valutazioni di efficacia o sicurezza. 2- Il soggetto ha una storia nota o presenza di anomalie cardiache strutturali, anomalie gravi del ritmo cardiaco, sincope, problemi di conduzione cardiaca (ad es. blocco cardiaco clinicamente significativo), eventi cardiaci correlati all’esercizio fisico, come sincope e pre-sincope, o bradicardia clinicamente significativa. 3- Soggetto con ipotensione ortostatica o storia nota di ipertensione controllata o incontrollata.4- Uso attuale di farmaci vietati o altri farmaci, compresi gli integratori erboristici, che influiscono sulla pressione arteriosa (BP) o la frequenza cardiaca, o che hanno effetti sul sistema nervoso centrale (SNC) o influiscono sulla performance cognitiva, come sedativi antistaminici e decongestionanti simpatico-mimetici (i broncodilatatori per inalazione sono ammessi) o storia di uso cronico di sedativi (antistaminici) in violazione dei criteri di wash-out specificato dal protocollo all’Arruolamento/Visita 2. 5- Soggetto in sovrappeso significativo in base all’indice di massa corporea (BMI) per eta' secondo le tabelle specifiche per sesso del Centre for Disease Control and Prevention. Il sovrappeso significativo e' definito come BMI &gt; 95° percentile. 6- Bambini di 6-12 anni con peso corporeo &lt; 25,0 kg o adolescenti di 13-17 anni con peso corporeo &lt; 34,0 kg o &gt; 91,0 kg allo Screening/Visita 1. 7- Il soggetto ha una storia di abuso o dipendenza da alcool o altre sostanze, secondo la definizione di DSM-IV-TR (a eccezione della nicotina), negli ultimi 6 mesi. 8- Il soggetto e' attualmente considerato a rischio di suicidio secondo il giudizio dello Sperimentatore, ha tentato il suicidio in precedenza o presenta una storia pregressa o corrente di ideazione suicidaria attiva. I soggetti con ideazione suicidaria passiva intermittente non sono necessariamente esclusi in base alla valutazione dello Sperimentatore (si veda il protocollo per ulteriori indicazioni). 9- Storia di mancata risposta a un trattamento adeguato dell’ADHD con un a2-agonista (basato su una dose appropriata e un’opportuna durata della terapia a giudizio dello Sperimentatore).
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy outcome for each subject is treatment failure during the double-blind randomisedwithdrawal phase (Phase 2), defined as a >/=50% increase (worsening) in ADHD RS-IV total score at 2 consecutive Phase 2 visits (Visits 14-23/ Early Termination) relative to Visit 13 and a >/=2 point increase in CGIS score relative to CGI-S at Visit 13 at the corresponding Phase 2 visits.
    L'esito primario di efficacia per ogni soggetto e' il fallimento della terapia durante il ritiro in doppio cieco randomizzato (fase 2), definito come un aumento > / = al 50% (peggioramento) nel total score del punteggio ADHD RS-IV per 2 visite consecutive di fase 2 (visita 14-23 / Early Termination) rispetto alla visita 13 e a un incremento > / = 2 nello score di CGI-S relativo al CGI-S della vista 13 e alla corrispondente visita di fase 2
    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 Yes
    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 Yes
    E.8.1.7.1Other trial design description
    fase di ottomizzazione/mantenimento dose in aperto, seguita da ritiro randomizzato
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned11
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    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
    la fine dello studio e' definita come visita di follow up per la sicurezza ( 7 giorni dopo l'ultima dose di farmaco, per l'utimo paziente)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months26
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months26
    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 Yes
    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) Yes
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2011-12-28. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    vista l'eta' della popolazione in studio, un consenso informato per adulti/genitori viene richiesto
    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 204
    F.4.2.2In the whole clinical trial 510
    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 Decision2010-11-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-11-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-07-09
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