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    Summary
    EudraCT Number:2009-017930-35
    Sponsor's Protocol Code Number:AB06002
    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:2012-03-29
    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 number2009-017930-35
    A.3Full title of the trial
    A prospective, multicenter, randomised, double-blind, placebocontrolled, 2-parallel group, phase 3 study to compare efficacy and safety of masitinib 6 mg/kg/day in combination with bortezomib and dexamethazone to placebo in combination with bortezomib and dexamethazone in the treatment of patients with relapsing multiple myeloma who received one previous therapy
    Studio di fase III prospettico, multicentrico, randomizzato, in doppio cieco, controllato con placebo, a 2 gruppi paralleli, per comparare l'efficacia e la sicurezza di masitinib 6 mg/kg/die in associazione con bortezomibe e desametasone rispetto a placebo in associazione con bortezomib e desametasone nel trattamento di pazienti con mieloma multiplo recidivante che hanno ricevuto una terapia precedente
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to compare masitinib in combination with bortezomib and dexamethasone to placebo in in combination with bortezomib and dexamethasone in the treatment of patients with relapsing multiple myeloma who have received one therapy in the past
    Uno studio per confrontare masitinib in combinazione con bortezomib e desametasone rispetto al placebo in combinazione con bortezomib e desametasone nel trattamento dei pazienti con mieloma multiplo recidivante che hanno ricevuto una terapia in passato
    A.3.2Name or abbreviated title of the trial where available
    not applicable
    non applicabile
    A.4.1Sponsor's protocol code numberAB06002
    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 SponsorAB SCIENCE
    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 supportAB Science
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAB Science
    B.5.2Functional name of contact pointClinical Project Manager
    B.5.3 Address:
    B.5.3.1Street Address3 avenue George V
    B.5.3.2Town/ cityParis
    B.5.3.3Post code75008
    B.5.3.4CountryFrance
    B.5.4Telephone number0033 0147207635
    B.5.5Fax number0033 0147202411
    B.5.6E-mailsophie.debuttet@ab-science.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 Yes
    D.2.5.1Orphan drug designation numberEU/3/05/286
    D.3 Description of the IMP
    D.3.1Product namemasitinib mesylate
    D.3.2Product code AB1010
    D.3.4Pharmaceutical form Film-coated 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 INNmasitinib
    D.3.9.1CAS number 790-299-79-5
    D.3.9.2Current sponsor codeAB1010
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeNA
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNmasitinib
    D.3.9.1CAS number 790-299-79-5
    D.3.9.2Current sponsor codeAB1010
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeNA
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 placeboFilm-coated 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
    relapsing multiple myeloma after one previous therapy
    mieloma multiplo recidivante dopo una precedente terapia
    E.1.1.1Medical condition in easily understood language
    relapsing multiple myeloma after one previous therapy
    mieloma multiplo recidivante dopo una precedente terapia
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10028228
    E.1.2Term Multiple myeloma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Objectives The objective is to compare the efficacy and safety of masitinib 6 mg/kg/day to placebo in the treatment of patients with relapsing multiple myeloma who have received one previous therapy. Patients will receive study treatment (masitinib/placebo) with the standard therapy: bortezomib (Velcade) and dexamethazone. Primary endpoint Overall Progression Free Survival (PFS) according to International Myeloma Working Group criteria 2009 (IMWG / revised Bladé criteria)
    L’obiettivo dello studio consiste nel comparare l’efficacia e la sicurezza di masitinib 6 mg/kg/die rispetto al placebo nel trattamento di pazienti con mieloma multiplo recidivante che sono stati sottoposti a una precedente terapia. I pazienti riceveranno il trattamento oggetto dello studio (masitinib/placebo) con la terapia standard: bortezomib (Velcade) e desametasone. Endpoint primario Sopravvivenza globale libera da progressione (PFS) in base ai criteri dell’International Myeloma Working Group 2009 (IMWG / criteri di Bladé rivisti).
    E.2.2Secondary objectives of the trial
    Secondary endpoints • Disease progression: - Overall Time to Progression (TTP) according to International Myeloma Working Group criteria 2009 (IMWG / revised Bladé criteria) - Time To Next Treatment (TTNT) • Survival: - Overall Survival (OS) • Response: - Best Response rate during study according to International Myeloma Working Group criteria 2009 (IMWG / revised Bladé criteria) • Quality of life assessment: - Quality of Life according to the EORTC QLQ-C30 questionnaire at week 12, 24, 36, 48, 64 and 72 - ECOG Performance Status at week 12, 24, 36, 48, 64 and 72 - Bone pain Verbal Rating Score (VRS) at week 12, 24, 36, 48, 64 and 72 - Analgesic (non-opioid) consumption at week 12, 24, 36, 48, 64 and 72 - Opioid consumption at week 12, 24, 36, 48, 64 and 72 • Safety assessments: - Safety profile using the NCI CTC v4.02 classification
    · Progressione della malattia: - Tempo totale alla progressione (TTP) in base ai criteri dell’International Myeloma Working Group 2009 - Tempo al trattamento successivo (TTNT) · Sopravvivenza: - Sopravvivenza totale (OS) · Risposta: - Miglior tasso di risposta durante lo studio in base ai criteri dell’International Myeloma Working Group 2009 · Valutazione della qualità della vita: - Qualità della vita in base al Questionario EORTC QLQ-C30 alla settimana 12, 24, 36, 48, 64 e 72 - Performance Status ECOG alla settimana 12, 24, 36, 48, 64 e 72 - Score di valutazione verbale del dolore osseo (VRS) alla settimana 12, 24, 36, 48, 64 e 72 - Consumo di analgesici (non oppioidi) alla settimana 12, 24, 36, 48, 64 e 72 - Consumo di oppioidi alla settimana 12, 24, 36, 48, 64 e 72 · Valutazione della sicurezza: - Profilo di sicurezza utilizzando la classificazione NCI CTC v4.02
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patient with confirmed multiple myeloma requiring systemic therapy. All three criteria must be met: • Clonal bone marrow plasma cells > 10% • Presence of serum and/or urinary monoclonal protein • Evidence of end-organ damage that can be attributed to the underlying plasma cell proliferative disorder, specifically: o Hypercalcemia: serum calcium > 11.5 mg/100 ml or o Renal insufficiency: serum creatinine > 173 μmol/l o Anemia: normochromic, normocytic with a hemoglobin value of > 2g/100 ml below the lower limit of normal or a hemoglobin value < 10g/100 ml o Bone lesions: lytic lesions, severe osteopenia or pathologic fractures 2. Patient with multiple myeloma relapsing according to the International uniform response criteria for multiple myeloma (IMWG 2009/ revised Bladé criteria) (defined in Table 1) to one previous line of treatment (defined in Table 2). Patients previously treated, with Bortezomib, for multiple myeloma can be included if and only if : o they have shown minimal, partial or complete response to this treatment o they have not been refractory to this treatment (to be considered as bortezomib refractory patient, any patient who didn’t show any response to previous bortezomib treatment or whose disease progressed during or within 60 days of bortezomib treatment) 3. Patient candidate for receiving the standard therapy (bortezomib and dexamethazone) 4. Patient with measurable progressive disease defined by at least one of the following two measurements: • Serum M-protein 1 g/dL • Urine M-protein ³ 200 mg/24h 5. Patient with ECOG 2 6. Patient with adequate organ function • Absolute neutrophil count (ANC) 1.5 giga/L • Platelets (PTL) 75 x 109/L • AST/ALT 2.5 ULN • Creatinin clearance > 30 mL/min • Bilirubin 1.5 ULN • Albumin 1 x LLN • Urea 2 x ULN • Albuminuria 300 mg/day 7. Patient with life expectancy > 6 months 8. Man or non-pregnant non-lactating woman, age >18 years and weight > 40 Kg and BMI > 18 kg/m² 9. Man and woman of childbearing potential, (entering the study after a menstrual period and who have a negative pregnancy test) must agree to use two methods (one for the patient and one for the partner) of medically acceptable forms of contraception during the study and for 3 months after the last treatment intake. 10. Patient able and willing to comply with study procedures as per protocol 11. Patient able to understand, sign, and date the written informed consent form at screening visit prior to any protocol-specific procedures
    1. Pazienti con mieloma multiplo accertato che necessitano di una terapia sistemica. Devono essere soddisfatti tutti e tre i criteri: · Plasmacellule midollari clonali &gt; 10% · Presenza di proteina monoclonale sierica e/o urinaria · Evidenza di danno d’organo terminale che può essere attribuito al disordine proliferativo in oggetto delle plasmacellule, in particolare: o Ipercalcemia: calcio sierico &gt; 11.5 mg/100 ml oppure o Insufficienza renale: creatinina sierica &gt; 173 μmol/l o Anemia: normocromica, normocitica con un valore di &gt; 2g/100 ml sotto il limite inferiore di normalità o un valore di emoglobina &lt; 10g/100 ml o Lesioni ossee: lesioni litiche, osteopenia severa o fratture patologiche 2. I pazienti con mieloma multiplo recidivante in base ai criteri di risposta uniformi internazionali per il mieloma multiplo (IMWG 2009/ criteri di Bladé rivisti) (definiti nella Tabella 1) a una precedente linea di trattamento (definito nella Tabella 2). Pazienti trattati in precedenza con Bortezomib per il mieloma multiplo possono essere inclusi se e solo se: oHanno evidenziato una risposta minima, parziale o completa a questo trattamento oNon si sono rivelati refrattari a questo trattamento (va considerato come paziente refrattario al bortezomib un qualsiasi paziente che non ha evidenziato alcuna risposta a un precedente trattamento con bortezomib o la cui malattia è progredita durante o entro 60 giorni il trattamento con bortezomib) 3. Pazienti candidati a ricevere la terapia standard (bortezomib e desametasone) 4. Pazienti con malattia progressiva misurabile definita da almeno due delle seguenti misurazioni: · Proteina M sierica ≥ 1 g/dl · Proteina M urinaria ³ 200 mg/24 ore 5. Pazienti con ECOG ≤ 2 6. Pazienti con funzionalità d’organo adeguata · Conta assoluta dei neutrofili (ANC) ≥ 1.5 giga/L · Piastrine (PTL) ≥ 75 x 109/L · AST/ALT ≤ 2.5 ULN · Clearance della creatinina &gt; 30 mL/min · Bilirubina ≤ 1.5 ULN · Albumina ≥ 1 x LLN · Urea ≤ 2 x ULN · Albuminuria ≤ 300 mg/die 7. Pazienti con aspettativa di vita &gt; 6 mesi 8. Uomini o donne non in gravidanza o che non allattano, di età &gt;18 anni e peso &gt; 40 Kg e BMI &gt; 18 kg/m² 9. Uomini e donne potenzialmente fertili (che sono state incluse nello studio dopo il ciclo mestruale e che hanno un test di gravidanza negativo) devono acconsentire all’uso di due metodi (uno per il paziente e uno per il partner) di forme di contraccezione medicalmente accettabili durante lo studio e per i 3 mesi successivi alla somministrazione dell’ultima dose del trattamento. 10. Pazienti in grado e desiderosi di attenersi alle procedure dello studio come da protocollo 11. Pazienti in grado di comprendere, firmare e datare il modulo di consenso informato fornito alla visita di screening che precede qualsiasi procedura protocollo-specifica
    E.4Principal exclusion criteria
    1. Patient with peripheral neuropathy Grade >2 2. Patient with hypersensitivity to bortezomib, boron or dexamethazone 3. Patient whose disease progressed during or within 60 days of bortezomib treatment or of any other Multiple Myeloma therapy 4. Patient who received bortezomib within 6 months of randomisation to this study 5. Past discontinuation of bortezomib due to associated grade 3 or higher adverse event 6. Patient with contra-indication to high dose of steroids (including ongoing active infection, use of live vaccines, virosis such as hepatitis, herpes, varicella, herpes zoster) 7. Patient with acute diffuse infiltrative pulmonary and pericardial disease 8. Patient treated for a cancer other than multiple myeloma within five years before enrolment, with the exception of basal cell carcinoma and cervical cancer in situ 9. Patient with central nervous system (CNS) metastasis or with history of CNS metastasis 10. Patient with one of the following cardiac conditions: • Patient with recent cardiac history (within 6 months) of: - Acute coronary syndrome - Acute heart failure (class III or IV of the NYHA classification) - Significant ventricular arrhythmia (persistent ventricular tachycardia, ventricular fibrillation, resuscitated sudden death) • Patient with cardiac failure class III or IV of the NYHA classification • Patient with severe conduction disorders which are not prevented by permanent pacing (atrio-ventricular block 2 and 3, sino-atrial block) • Syncope without known aetiology within 3 months • Uncontrolled severe hypertension, according to the judgment of the investigator, or symptomatic hypertension 11. Patient with history of poor compliance or history of drug/alcohol abuse, or excessive alcohol beverage consumption that would interfere with the ability to comply with the study protocol, or current or past psychiatric disease that might interfere with the ability to comply with the study protocol or give informed consent Previous treatments 12. High dose of corticosteroids and/or local irradiation should be stopped at least 2 weeks prior to Baseline 13. Administration of any other treatment for multiple myeloma should be stopped at least 4 weeks prior to Baseline. Patients who received bortezomib within 6 months prior to Baseline are excluded 14. Treatment with any investigational agent should be stopped at least 4 weeks prior to Baseline 15. Patient eligible for bone-marrow transplantation as second line therapy
    1. Pazienti con neuropatia periferica di Grado &gt;2 2. Pazienti con ipersensibilità a bortezomib, boro o desametasone 3. Pazienti la cui malattia è progredita durante o nel giro di 60 giorni il trattamento con bortezomib o con qualunque altra terapia per il Mieloma Multiplo 4. Pazienti che hanno ricevuto bortezomib nei 6 mesi precedenti la randomizzazione per questo studio 5. Interruzione in passato di bortezomib a causa di reazioni avverse di grado 3 o superiori 6. Pazienti nei quali sono controindicate dosi elevate di steroidi (inclusi infezioni attive in corso, uso di vaccini vivi, virosi quali epatite, herpes, varicella, herpes zoster) 7. Pazienti con patologia diffusa infiltrativa acuta polmonare e pericardica 8. Pazienti trattati per un tumore diverso dal mieloma multiplo nei cinque anni precedenti l’inclusione nello studio, con l’eccezione del carcinoma basocellulare e del cancro della cervice in situ 9. Pazienti con metastasi del sistema nervoso centrale (SNC) o con anamnesi di metastasi del SNC 10. Pazienti che presentano una delle seguenti condizioni cardiache: o Pazienti con recente (entro 6 mesi) storia clinica cardiaca di: - Sindrome coronarica acuta - Insufficienza cardiaca acuta (di classe III o IV secondo la classificazione NYHA) - Aritmia ventricolare significativa (tachicardia ventricolare persistente, fibrillazione ventricolare, rianimazione dopo decesso) o Pazienti con insufficienza cardiaca acuta di classe III o IV secondo la classificazione NYHA o Pazienti con disordini severi di conduzione che non sono stati prevenuti con pacemaker permanente (blocco atrio-ventricolare di classe 2 o 3, blocco seno atriale) o Sincope senza eziologia nota entro 3 mesi o Ipertensione severa non controllata, in accordo al giudizio dello sperimentatore, e ipertensione sintomatica 11. Pazienti con storia di scarsa compliance o storia di abuso di droga/alcool, o eccessivo consumo di bevande alcoliche che potrebbero interferire con la capacità di aderire al protocollo dello studio, o patologie psichiatriche attuali o pregresse che possono interferire con la capacità di aderire al protocollo dello studio o di rilasciare il consenso informato Trattamenti precedenti 12. Dosi elevate di corticosteroidi e/o radioterapia locale devono essere interrotti almeno 2 settimane prima del Baseline 13. La somministrazione di un qualunque altro trattamento per il mieloma multiplo deve essere interrotto almeno 4 settimane prima del Baseline. I pazienti che hanno ricevuto bortezomib nei 6 mesi precedenti il Baseline devono essere esclusi dal protocollo 14. Il trattamento con qualunque farmaco sperimentale va interrotto almeno 4 settimane prima del Baseline 15. Pazienti eligibili a trapianto di midollo osseo come trattamento di seconda linea
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint Overall Progression Free Survival (PFS) according to International Myeloma Working Group criteria 2009 (IMWG / revised Bladé criteria).
    Sopravvivenza globale libera da progressione (PFS) in base ai criteri dell’International Myeloma Working Group 2009 (IMWG / criteri di Bladé rivisti).
    E.5.1.1Timepoint(s) of evaluation of this end point
    date of documented progression or death during the study
    data di progressione documentata o decesso durante lo studio
    E.5.2Secondary end point(s)
    Secondary endpoints • Disease progression: - Overall Time to Progression (TTP) according to International Myeloma Working Group criteria 2009 (IMWG / revised Bladé criteria) - Time To Next Treatment (TTNT) • Survival: - Overall Survival (OS) • Response: - Best Response rate during study according to International Myeloma Working Group criteria 2009 (IMWG / revised Bladé criteria) • Quality of life assessment: - Quality of Life according to the EORTC QLQ-C30 questionnaire at week 12, 24, 36, 48, 64 and 72 - ECOG Performance Status at week 12, 24, 36, 48, 64 and 72 - Bone pain Verbal Rating Score (VRS) at week 12, 24, 36, 48, 64 and 72 - Analgesic (non-opioid) consumption at week 12, 24, 36, 48, 64 and 72 - Opioid consumption at week 12, 24, 36, 48, 64 and 72 • Safety assessments: - Safety profile using the NCI CTC v4.02 classification
    · Progressione della malattia: - Tempo totale alla progressione (TTP) in base ai criteri dell’International Myeloma Working Group 2009 - Tempo al trattamento successivo (TTNT) · Sopravvivenza: - Sopravvivenza totale (OS) · Risposta: - Miglior tasso di risposta durante lo studio in base ai criteri dell’International Myeloma Working Group 2009 · Valutazione della qualità della vita: - Qualità della vita in base al Questionario EORTC QLQ-C30 alla settimana 12, 24, 36, 48, 64 e 72 - Performance Status ECOG alla settimana 12, 24, 36, 48, 64 e 72 - Score di valutazione verbale del dolore osseo (VRS) alla settimana 12, 24, 36, 48, 64 e 72 - Consumo di analgesici (non oppioidi) alla settimana 12, 24, 36, 48, 64 e 72 - Consumo di oppioidi alla settimana 12, 24, 36, 48, 64 e 72 · Valutazione della sicurezza: - Profilo di sicurezza utilizzando la classificazione NCI CTC v4.02
    E.5.2.1Timepoint(s) of evaluation of this end point
    TTP: date of documeted progression; TTNT: date of initiation of a new line of treatment due to progression; OS: documented death; QOL: see paragraph above
    TTP: data di progressione documentata; TTNT: data dell'inizio di una nuova linea di trattamento a causa della progressione; OS: decesso documentato; QOL: vedere quanto riportato sopra
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA60
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Korea, Democratic People's Republic of
    United States
    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
    week 72 of the last patient
    settimana 72 dell'ultimo paziente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    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.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 250
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 state16
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 225
    F.4.2.2In the whole clinical trial 300
    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)
    non applicable
    non applicabile
    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 Decision2011-10-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-09-23
    P. End of Trial
    P.End of Trial StatusOngoing
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