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    Summary
    EudraCT Number:2010-023017-65
    Sponsor's Protocol Code Number:B1871019
    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:2012-03-14
    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 number2010-023017-65
    A.3Full title of the trial
    A Phase 2, multicenter, randomized, double-blind, placebo-controlled study of the safety, clinical activity and pharmacokinetics of bosutinib (PF 05208763) versus placebo in subjects with autosomal dominant polycystic kidney disease (ADPKD).
    Studio di Fase 2, multicentrico, randomizzato, in doppio cieco, controllato con placebo volto a valutare la sicurezza, l`™attivita' clinica e la farmacocinetica di bosutinib (PF-05208763) rispetto a placebo in soggetti affetti da malattia renale policistica autosomica dominante (ADPKD).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A multicenter, randomized, double-blind, placebo-controlled study of the safety, effectiveness and pharmacokinetics of bosutinib versus placebo in subjects with polycystic kidney disease
    Studio multicentrico, randomizzato, in doppio cieco, controllato con placebo volto a valutare la sicurezza, l'efficacia e la farmacocinetica di bosutinib rispetto a placebo in soggetti affetti da malattia renale policistica
    A.4.1Sponsor's protocol code numberB1871019
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01233869
    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 SponsorPFIZER 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 supportPfizer Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPfizer Inc.
    B.5.2Functional name of contact pointClinical Trials.gov Call Centre
    B.5.3 Address:
    B.5.3.1Street Address235 E 42nd Street
    B.5.3.2Town/ cityNew York
    B.5.3.3Post codeNY 10017
    B.5.3.4CountryUnited States
    B.5.4Telephone number001 800 7181021
    B.5.5Fax number001 303 7391119
    B.5.6E-mailClinicalTrials.govCallCentre@pfizer.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 nameBosutinib
    D.3.2Product code PF-05208763
    D.3.4Pharmaceutical form 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 INNBOSUTINIB
    D.3.9.1CAS number 380843-75-4
    D.3.9.2Current sponsor codePF-05208763
    D.3.9.3Other descriptive nameSKI-606
    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.3.11 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 placeboTablet
    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
    Autosomal Dominant Polycystic Kidney Disease (ADPKD)
    Malattia renale policistica autosomica dominante (ADPKD)
    E.1.1.1Medical condition in easily understood language
    Autosomal Dominant Polycystic Kidney Disease (ADPKD)
    Malattia renale policistica autosomica dominante (ADPKD)
    E.1.1.2Therapeutic area Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10036046
    E.1.2Term Polycystic kidney, autosomal dominant
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate that bosutinib reduces the rate of kidney enlargement in subjects with autosomal dominant polycystic kidney disease (ADPKD) entering the study with total kidney volume (TKV) ≥750 cc and eGFR ≥60 mL/min/1.73m2. To identify a safe and efficacious dose of bosutinib to be utilized for subsequent studies.
    Dimostrare che bosutinib riduce il tasso di aumento del volume del rene in pazienti affetti da malattia renale policistica autosomica dominante (ADPKD) arruolati nello studio con un volume totale del rene ≥750 cc ed eGFR ≥60 ml/min/1,73 m2. Individuare una dose di bosutinib sicura ed efficace da utilizzare per studi successivi.
    E.2.2Secondary objectives of the trial
    To evaluate the effect of treatment with bosutinib on renal function compared with placebo. To determine the time to first occurrence (or worsening) of clinical measures of disease activity. To evaluate the plasma PK of bosutinib. To evaluate the effect of treatment with bosutinib on subject-reported, disease specific quality of life compared with placebo. To demonstrate that a reduction in the rate of kidney enlargement is predictive of a reduction in decline in eGFR.
    Valutare l`effetto del trattamento con bosutinib sulla funzionalita' renale rispetto al placebo. Determinare il tempo alla prima manifestazione (o al peggioramento) delle misure cliniche di attivita' di malattia. Valutare la farmacocinetica plasmatica di bosutinib. Valutare l`effetto del trattamento con bosutinib sulla qualita' della vita correlata alla malattia, riferita dal paziente, rispetto al placebo. Dimostrare che una riduzione del tasso di aumento del volume del rene e' predittiva di una riduzione del declino dell`eGFR.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study: 1. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study. 2. Males and females, aged ≥18 years to 50 years at the time of consent. 3. Documented diagnosis of ADPKD by renal ultrasound cyst criteriabased on the Unified Criteria for Ultrasonographic Diagnosis of ADPKD. A family history of ADPKD is not required to support diagnosis by ultrasound criteria. Alternatively, the diagnosis of ADPKD may be based on PKD-1 or PKD-2 genotype findings as documented in the medical record 4. Total kidney volume ≥750 cc, as measured by centrally evaluated MRI. 5. Left ventricular ejection fraction by echocardiogram or MUGA ≥50% at screening. 6. All women of childbearing potential must have a negative pregnancy test result before administration of study drug. Because the effect of bosutinib on the efficacy of orally or transdermally administered contraceptives is unknown, women of childbearing potential must agree to use a medically acceptable nonhormonal method of contraception as described in the protocol for at least 14 days prior to the first dose of study medication and continue until 28 days after dosing. A woman of childbearing potential is one who is biologically capable of becoming pregnant. This includes women who are using contraceptives or those women whose sexual partners are either considered sterile or are using contraceptives. Any pregnancy that occurs in any female subject in the study must be reported if it occurs at any time during the active treatment phase of the study and for 4 weeks after the last dose of study drug. Any female who becomes pregnant during the active treatment phase must discontinue further therapy. 7. Men willing to use a medically acceptable method of contraception as described in the protocol throughout the active treatment phase of the study and for 4 weeks after the last dose of study drug. Any pregnancy that occurs in the female partner of a male subject in the study must be reported if it occurs at any time during the active treatment phase of the study or for 4 weeks after the last dose of study drug. 8. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
    1. Prova di documento di consenso informato firmato e datato personalmente, che indichi che il paziente (o un rappresentante legale) e' stato informato di tutti gli aspetti pertinenti dello studio. 2. Pazienti di entrambi i sessi, di eta' da ≥ 18 a 50 anni al momento del consenso. 3. Diagnosi di ADPKD documentata con ecografia renale cistica in base ai criteri unificati di diagnosi ecografica di ADPKD. Non e' richiesta un’anamnesi familiare di ADPKD per supportare la diagnosia dei criteri dell’ecografia. In alternativa, la diagnosi di ADPKD puo' essere basata sui risultati genotipi PKD-1 o PKD- 2 come documentato nella cartella clinica. 4. Volume totale del rene ≥ 750 cc, misurato con RM valutata a livello centrale. 5. Frazione di eiezione ventricolare sinistra, valutata con ecocardiogramma o MUGA, ≥50% allo screening. 6. Tutte le donne in eta' fertile devono presentare un risultato negativo del test di gravidanza prima della somministrazione del farmaco dello studio. Poiche' l`effetto di bosutinib sull`efficacia dei contraccettivi somministrati per via orale o transdermica non e' noto, le donne in eta' fertile devono accettare di usare un metodo di contraccezione non ormonale clinicamente accettabile come descritto nel protocollo per almeno 14 giorni prima della prima dose di farmaco dello studio e continuare per 28 giorni dopo la somministrazione. Una donna in eta' fertile e' una donna biologicamente in grado di iniziare una gravidanza. Sono incluse le donne che utilizzano contraccettivi o le donne i cui partner sessuali sono considerati sterili o utilizzano contraccettivi. L`eventuale gravidanza di una paziente durante la sperimentazione deve essere riferita se si verifica in qualsiasi momento durante la fase di trattamento attivo dello studio e nelle 4 settimane successive all`ultima dose del farmaco dello studio. Qualsiasi paziente che entri in stato di gravidanza durante la fase di trattamento attivo deve interrompere la terapia. 7. Uomini disposti a utilizzare un metodo di contraccezione clinicamente accettabile (ad es. preservativo con spermicida) per l`intera fase di trattamento attivo dello studio e per le 4 settimane successive all`ultima dose del farmaco dello studio. L`eventuale gravidanza di una partner di un paziente durante la sperimentazione deve essere riferita se si verifica in qualsiasi momento durante la fase di trattamento attivo dello studio o nelle 4 settimane successive all`ultima dose del farmaco dello studio. 8. Pazienti intenzionati a e in grado di rispettare le visite programmate, il piano di trattamento, le analisi di laboratorio e le altre procedure dello studio.
    E.4Principal exclusion criteria
    Subjects presenting with any of the following will not be included in the study: 1. Weight <40 kg or > 125 kg. 2. Women who are pregnant or breastfeeding or women who intend to become pregnant in the next six years. 3. Estimated glomerular filtration rate (eGFR) <60 mL/min/1.73m2 for primary treatment population. Subjects with moderate renal impairment (defined as 30 mL/min/1.73m2 ≤ eGFR ≤50mL/min/1.73m2) are excluded (from enrollment in an exploratory population) until results from a separate renal impairment PK study (study B1871020) demonstrate no substantial impact of renal impairment on bosutinib PK. Subjects with an eGFR<30 mL/min/1.73m2 will be excluded. 4. Abnormal urinalysis showing cellular casts. 5. Biopsy proven renal disease other than ADPKD. 6. Chronic back and/or flank pain requiring daily or near daily pain medication over the preceding month. 7. Documented renal vascular disease. 8. Documented systemic illness with renal involvement. 9. Creatine supplements within 3 months of the baseline visit. 10. Uncontrolled hypertension (defined as systolic blood pressure ≥140 or diastolic blood pressure ≥90 mm Hg). 11. Uncontrolled diabetes mellitus as evidenced by screening assessments and/or recent medical record.12. Medical history or diagnosis or immunodeficiency. 13. Autoimmune disease not in remission or requiring ongoing treatment with immunosuppressive medication. 14. Increased ALT and/or AST >2.5 x the upper limit of normal. 15. Total bilirubin >2 x the upper limit of normal (unless associated with Gilbert’s syndrome). 16. Grade 2 or higher abnormalities of serum sodium [sodium >150 or <130 mmol/l]. 17. Uncorrected hypomagnesemia or hypokalemia [serum magnesium or serum potassium < lower limit of normal]. 18. Grade 2 or higher elevation of serum potassium or serum magnesium [serum potassium >5.5 or serum magnesium >3.0 mg/dl (or >1.23 mmol/l)]. 19. Hemoglobin <9.0 gm/dl. 21. Platelet count,100.000/microlitre 21. Congenital absence of a kidney or prior surgical resection of a kidney for any reason. 22. Clinically significant or unstable cardiac disease (eg, unstable angina, recent myocardial infarction, clinically significant arrhythmia requiring treatment, uncontrolled congestive heart failure, etc). 23. Subjects with any pre-dose corrected QT interval (QTc) ≥450 msec based on any one of the machineread tracing using Fridericia’s formulae obtained at screening. Any decision to retest a subject must first be discussed with the Pfizer Medical Monitor. If a repeat QTc interval obtained pre-dose is ≥450 msec, the subject is excluded from enrollment. 24. History of prolonged QTc interval or additional risk factors for Torsade de Pointes (eg, heart failure, hypokalemia, family history of long QT syndrome). 25. Infection with hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV). 26. Past or present malignancy (with the exception of adequately treated, localized basal cell or squamous cell carcinoma of the skin). 27. Use of any investigational drug or investigational biologic compound within weeks prior to the screening visit or during the screening period. For the complete list of excl. crit. please see the protocol
    I pazienti che presentano una delle caratteristiche seguenti non saranno inclusi nello studio: 1. Peso &lt; 40 kg o &gt; 125 kg. 2. Donne in stato di gravidanza o che allattano al seno oppure che intendono ricercare una gravidanza nei prossimi due anni. 3. Velocita' di filtrazione glomerulare stimata (eGFR) &lt; 60 ml/min/1,73 m2 per la popolazione di trattamento primaria. I pazienti con compromissione moderata della funzionalita' renale (definita come 30ml/min/1,73 m2 ≤ eGFR ≤ 50ml/min/1,73m2) sono esclusi (dall`arruolamento in una popolazione esplorativa) fino a quando i risultati di uno studio farmacocinetico separato sulla compromissione della funzionalita' renale (studio B1871020) dimostrino l`assenza di un impatto sostanziale della compromissione della funzionalita' renale sulla farmacocinetica di bosutinib. I pazienti con una eGFR &lt; 30 ml/min/1,73 m2 saranno esclusi. 4. Analisi delle urine anormali che mostrino la presenza di cilindri. 5. Nefropatia comprovata da biopsia, diversa da ADPKD. 6. Dolore cronico alla schiena e/o ai fianchi, che abbia richiesto l`impiego quotidiano o quasi quotidiano di analgesici durante il mese precedente. 7. Malattia vascolare renale documentata. 8. Malattia sistemica documentata con interessamento renale. 9. Integratori di creatinina nei 3 mesi precedenti alla visita basale. 10. Ipertensione non controllata (definita come pressione arteriosa sistolica ≥ 140 o pressione arteriosa diastolica ≥ 90 mm Hg). 11. Diabete mellito non controllato come evidenziato dalle valutazioni di screening e/o dalle recenti cartelle cliniche. 12. Anamnesi medica o diagnosi o immunodeficienza. 13. Malattia autoimmune non in remissione o che richiede un trattamento continuo con farmaci immunosopressivi. 14.Aumento di ALT e/o AST &gt; 2,5 volte il limite superiore della norma. 15. Bilirubina totale &gt; 2 volte il limite superiore della norma (se non associata a sindrome di Gilbert). 16. Anormalita' del sodio sierico di grado 2 o superiore [sodio &gt;150 o &lt;130 mmol/l]. 17. Ipomagnesemia o ipokaliemia non corretta [magnesio sierico o potassio sierico &lt; limite inferiore della norma]. 18. Aumento di grado 2 o superiore del potassio sierico o del magnesio sierico [potassio sierico &gt; 5,5 o magnesio sierico &gt; 3,0 mg/dl (o &gt; 1,23 mmol/l)]. 19. Emoglobina &lt; 9,0 gm/dl. 20. Conteggio piastrine, 100.000/microlitro 21. Assenza congenita di un rene o resezione chirurgica precedente di un rene per qualsiasi motivo. 22. Cardiopatia clinicamente significativa o instabile (ad es. angina instabile, infarto miocardico recente, aritmia clinicamente significativa che necessita di trattamento, insufficienza cardiaca congestizia non controllata, ecc.). 23. Pazienti con qualsiasi intervallo QT corretto (QTc) pre-dose ≥ 450 msec in base a uno qualsiasi dei tracciati interpretati dalla macchina utilizzando la formula di Fridericia, ottenuti allo screening. Qualsiasi decisione di risottoporre un paziente all`esame deve essere discussa con il monitor medico di Pfizer. Se il nuovo intervallo QTc pre-dose e' ≥ 450 msec, il paziente e' escluso dall`arruolamento. 24. Anamnesi di intervallo QTc prolungato o altri fattori di rischio per torsione di punta (ad es. insufficienza cardiaca, ipokaliemia, anamnesi familiare di sindrome del QT lungo). 25. Infezione da virus dell`epatite B (HBV), da virus dell`epatite C (HVC) o da virus dell`immunodeficienza umana (HIV). 26. Tumore maligno in atto o pregresso (fatta eccezione per il carcinoma cutaneo basocellulare o squamocellulare localizzato, adeguatamente trattato). 27. Uso di qualsiasi farmaco sperimentale o composto biologico sperimentale nelle settimane precedenti alla visita di screening o durante il periodo di screening. Per la lista completa dei crit. di escl. si prega di far riferimento al protocollo
    E.5 End points
    E.5.1Primary end point(s)
    Annualized rate (%) of kidney enlargement relative to placebo. • Safety endpoints to include incidence of AEs and SAEs, changes in laboratory test results, including ECGs, and changes in vital signs.
    • Tasso annualizzato (%) di ingrossamento dei reni relativo al placebo. • Endpoint di sicurezza per includere l’incidenza di eventi avversi (EA) ed EA gravi, le variazioni nei risultati delle analisi di laboratorio, compresi ECG, e le variazioni dei segni vitali.
    E.5.1.1Timepoint(s) of evaluation of this end point
    25 Months & 71 Months
    25 mesi & 71 mesi
    E.5.2Secondary end point(s)
    The following clinical parameters to assess disease progression will be XML File Identifier: EG4/uSbRgg9D4614MyAo3+P9x5U= Page 13/23 evaluated: • Rate of decline of estimated Glomerular Filtration Rate (eGFR) relative to placebo. • Time to first occurrence or worsening of hypertension, defined as the need for increased dose of or need for additional anti hypertensive medication. • Time to first occurrence or worsening of back and/or flank pain. • Time to first occurrence of gross hematuria. • Time to first occurrence of proteinuria. • Onset of end stage renal disease requiring dialysis ≥56 days. • Renal function evaluations to include blood urea nitrogen and serum creatinine. • Pharmcokinetic parameters of bosutinib including Cmax, tmax, AUCtau, Cmin, Clearance, Vz/F, t1/2, and R. • Quality of Life measured by the Kidney Disease Quality of Life (KDQoL 36) questionnaire. • Cumulative decline in eGFR.
    Saranno presi in esame i seguenti parametri clinici per valutare la progressione della malattia: • Tasso di declino del tasso di filtrazione glomerulare (eGFR) stimato rispetto al placebo. • Tempo alla prima manifestazione o peggioramento di ipertensione, definito come la necessita' di un aumento della dose del farmaco antipertensivo o la necessita' di uno supplementare. • Tempo alla prima manifestazione o peggioramento di dolore alla schiena e/o fianco. • Tempo alla prima manifestazione di macroematuria. • Tempo alla prima manifestazione di proteinuria. • Insorgenza di malattia renale allo stadio terminale che necessita di dialisi ≥56 giorni. • Valutazioni della funzione renale per includere azoto ureico nel sangue e creatinina sierica. • Parametri farmacocinetici di bosutinib che includono Cmax, tmax, AUCtau, Cmin, Clearance, Vz/F, t1/2 e R. • Qualita' della vita misurata mediante il questionario Kidney Disease Quality of Life (KDQoL 36) relativo alla qualita' della vita nella nefropatia. • Declino cumulativo di eGFR.
    E.5.2.1Timepoint(s) of evaluation of this end point
    25 Months & 71 Months
    25 mesi & 71 mesi
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    - Stesso farmaco ad altro dosaggio
    - same IMP used at different dosage
    E.8.2.4Number of treatment arms in the trial3
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA70
    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
    Australia
    Canada
    Japan
    Korea, Democratic People's Republic of
    Switzerland
    Turkey
    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
    LVLS
    LVLS
    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 months77
    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 months85
    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: 275
    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 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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 275
    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)
    There are no plans at this point for treatment or care after the subject has ended his/her participation in the extended treatment phase.
    Al momento non ci sono programmi per il trattamento o l'assistenza dopo che il soggetto ha terminato la sua partecipazione alla fase di trattamento prolungato.
    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 Decision2011-10-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-06-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-09-09
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