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    Summary
    EudraCT Number:2012-003332-23
    Sponsor's Protocol Code Number:B1261007
    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:2013-01-29
    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 number2012-003332-23
    A.3Full title of the trial
    A phase 2, randomized, double-blind, placebo-controlled, parallel group, multi-center study to evaluate the efficacy and safety of once-daily administration of a chemokine CCR2/5 receptor antagonist (PF-04634817) in adults with Type 2 diabetes and overt nephropathy.
    Studio multicentrico di fase 2, randomizzato, in doppio cieco, controllato
    con placebo, a gruppi paralleli, per valutare l'efficacia e la sicurezza della
    somministrazione, una volta al giorno, di PF-04634817, un antagonista dei recettori CCR2/5 per le chemochine, in adulti affetti da diabete di tipo 2 e nefropatia conclamata
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase 2 multi-centre study to evaluate the efficacy and safety of a chemokine CCR2/5 receptor antagonist in adults with type 2 diabetes and overt nephropathy.
    Studio multicentrico di fase 2 per valutare l'efficacia e la sicurezza di un
    un antagonista dei recettori CCR2/5 per le chemochine, in adulti affetti da
    diabete di tipo 2 e nefropatia conclamata
    A.3.2Name or abbreviated title of the trial where available
    A phase 2 study of a chemokine CCR2/5 receptor antagonist in Type 2 diabetes with overt nephropathy
    Studio di fase 2 di un antagonista dei recettori CCR2/5 per le chemochine nel Diabete di Tipo 2
    A.4.1Sponsor's protocol code numberB1261007
    A.5.4Other Identifiers
    Name:IND/IDE numberNumber:107268
    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., 235 42nd Street, New York, NY 10017, USA
    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., 235 42nd Street, New York, NY 10017
    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 number+18007181021
    B.5.5Fax number+13037391119
    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 namePF-04634817-24 Drug Product
    D.3.2Product code PF-04634817-24
    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 INNNone available
    D.3.9.2Current sponsor codePF-04634817-24
    D.3.9.4EV Substance CodePF-04634817-24
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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
    Diabetic nephropathy
    Nefropatia diabetica
    E.1.1.1Medical condition in easily understood language
    Diabetic nephropathy
    Nefropatia diabetica
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10061835
    E.1.2Term Diabetic nephropathy
    E.1.2System Organ Class 10038359 - Renal and urinary 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 evaluate the efficacy of PF-04634817 compared to placebo in the reduction of
    albuminuria following 12 weeks of treatment in subjects with type 2 diabetes and overt nephropathy.
    Valutare l’efficacia di PF-04634817 rispetto a placebo nella riduzione dell'albuminuria dopo 12 settimane di trattamento in adulti affetti da diabete di tipo 2 e nefropatia conclamata
    E.2.2Secondary objectives of the trial
    To evaluate the safety and tolerability of PF-04634817 following 12 weeks of treatment.

    To evaluate the effect of PF-04634817 on renal function.

    To evaluate the pharmacodynamic profile of PF-04634817 following 12 weeks of treatment.

    To evaluate the pharmacokinetics of PF-04634817 in subjects with type 2 diabetes and overt nephropathy.
    Valutare la sicurezza e la tollerabilità di PF-04634817 dopo 12 settimane di trattamento.

    Valutare l'effetto di PF-04634817 sulla funzione renale.

    Valutare il profilo farmacodinamico di PF-04634817 dopo 12 settimane di trattamento.

    Valutare la farmacocinetica di PF-04634817 in soggetti con diabete di tipo 2 e nefropatia conclamata.
    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. Male or female subjects ≥18 years.

    2. Female subjects who are of non-child bearing potential (ie, meet at least one of the following criteria):
    - Have medically confirmed ovarian failure OR
    - Are medically confirmed to be postmenopausal (cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause) OR
    - Have undergone hysterectomy or bilateral oophorectomy.

    3. Clinical diagnosis of type 2 diabetes together with stages 3a or 3b CKD, based on an eGFR of 30-59 mL/min/1.73m2.

    4. Evidence of persistent, overt albuminuria; defined as a UACR ≥300 mg/g (≥33.9 mg/mmol) or UPCR ≥390 mg/g (44.1 mg/mmol), or equivalent, for 3 months or longer.

    5. Stable background therapy of RAAS inhibition (ie, an ACE inhibitor and/or an ARB, which may also include an aldosterone antagonist in double RAAS but not triple RAAS inhibitor therapy) for at least 3 months before screening and to be maintained for the duration of the study.

    6. Resting BP ≤165/105 mm Hg. Subjects with resting BP >135/85 but ≤165/105 must be being treated with at least one antihypertensive medication in addition to ACEi or ARB and have been on a stable dose(s) for at least 30 days.

    7. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.

    8. Willing and able to comply with scheduled visits, treatment plan, laboratory tests and other trial procedures.
    I soggetti devono soddisfare tutti i seguenti criteri di inclusione per essere arruolabili nello studio:

    1. Uomini o donne 18 anni.
    2. Le donne non potenzialmente fertili (che soddisfano, cioè, almeno uno dei criteri seguenti):
    • Siano affette da un'insufficienza ovarica clinicamente confermata o
    • Siano in menopausa clinicamente confermata (interruzione del ciclo mestruale regolare per almeno 12 mesi consecutivi senza altra causa patologica o fisiologica) o
    • Siano state sottoposte a isterectomia o ooforectomia bilaterale.
    3. Diagnosi clinica di diabete di tipo 2 con malattia renale cronica (MRC) allo stadio 3a o 3b, sulla base di un eGFR di 30 59 mL/min/1,73m2.
    4. Evidenza di albuminuria conclamata e persistente, definita come UACR ≥300 mg/g (≥33,9 mg/mmol) o UPCR ≥390 mg/g (44,1 mg/mmol), o equivalente, per almeno 3 mesi.
    5. Terapia di base stabile inibitoria del RASS (ad es., un ACE inibitore e/o un ARB, che potrebbe anche includere un antagonista dell'aldosterone nella terapia inibitoria del RAAS doppia ma non tripla) per almeno 3 mesi prima dello screening, da mantenersi per la durata dello studio.
    6. Pressione arteriosa a riposo ≤165/105 mm Hg. I soggetti con pressione arteriosa a riposo >135/85 ma ≤165/105 devono essere in trattamento con almeno un farmaco anti-ipertensivo oltre ad ACEi o ARB e aver assunto dosi stabili per almeno 30 giorni.
    7. Prova di un consenso informato personalmente firmato e datato indicante che il soggetto è stato informato di tutti gli aspetti pertinenti dello studio.
    8. Volontà e possibilità di rispettare le visite programmate, il piano di trattamento, le analisi di laboratorio e altre procedure del trial.




    E.4Principal exclusion criteria
    Subjects presenting with any of the following will not be included in the study:
    1. Subjects with CKD resulting from type 1 diabetes or non-diabetic CKD.

    2. Subjects who are diagnosed with autosomal dominant polycystic kidney disease (ADPCKD), severe peripheral vascular disease (PVD) or obstructive uropathy.

    3. Subjects who have had a kidney transplant, or who require renal replacement therapy, or are expected to require such therapy within 6 months.

    4. Subjects who have a history of proteinuria >8.5 g/day.

    5. Subjects who have serum albumin <2.0 g/dL (<20 g/L).

    6. Subjects with poorly controlled diabetes mellitus, defined as HbA1C >10.5%.

    7. Subjects on direct renin inhibitor therapy (aliskiren, Tekturna/Rasilez or Valturna).

    8. Subjects receiving or likely to receive during the study any moderate-strong inhibitors or inducers of cytochrome P450 3A4 eg, itraconazole, erythromycin, ketoconazole, protease inhibitors, verapamil or diltiazem (Appendix 1).

    9. Known history of human immunodeficiency (HIV) based on documented history with positive serological test, or positive HIV serological test at screening. (Note: a documented negative HIV test within 12 months of screening is acceptable and does not need to be repeated).

    10. Significant allergy or known intolerance to CCR2 or CCR5 inhibitors or any ingredient in the formulations.

    11. History of congestive heart failure (NYHA class III or IV) or unstable angina, or a history of myocardial infarction, stroke or transient ischemic attack in the previous 6 months.

    12. Any relevant, clinically-significant abnormalities on physical examination or clinically significant laboratory tests, including subjects with moderate liver function tests abnormalities >1.5 times the upper limit of normal.

    13. Family history of prolonged QT syndrome, or who themselves have a QTc >450 msec, a QRS >120 msec, or any clinically significant ischemic changes as assessed by the investigator by 12-lead supine ECG at screening. The ECG should be repeated two more times and the average of the three QTc or QRS values should be used to determine the subject’s eligibility. Preference is for QT to be corrected using Fridericia's correction, although Bazett's correction can also be used.

    14. Subjects currently experiencing any clinically significant or unstable medical condition that might limit their ability to complete the study, or to comply with the requirements of the protocol, including: dermatologic disease, hematological disease, pulmonary disease, hepatic disease, gastrointestinal disease, genitourinary disease, endocrine disease, neurological disease and psychiatric disease.

    15. Any malignancy not considered cured (except basal cell carcinoma and squamous cell carcinoma of the skin). A subject is considered cured if there has been no evidence of cancer recurrence in the previous 5 years.

    16. Blood donation in the previous 4 weeks, or stated intention to donate blood or blood products during the period of the study or within 1 month following completion of the study.

    17. Subjects who are investigational site staff members or relatives of those site staff members or subjects who are Pfizer employees directly involved in the conduct of the trial.

    18. Participation in other studies within the previous 60 days, or five times the plasma half-life (if known) of the investigational drug (whichever is longer) before the current study begins and/or during study participation.

    19. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.

    20. Pregnant females; breastfeeding females; females of childbearing potential; males not using highly effective contraception or not agreeing to continue highly effective contraception for at least 28 days after last dose of investigational product.
    Soggetti che presentino uno qualsiasi dei seguenti criteri non saranno inclusi nello studio:

    1. Soggetti con MRC derivante da diabete di tipo 1 o MRC non diabetica.
    2. Soggetti con diagnosi di malattia renale policistica autosomica dominante (ADPCKD), gravi malattie vascolari periferiche (MVP) o uropatia ostruttiva.
    3. Soggetti sottoposti a trapianto del rene o che necessitino di una terapia sostitutiva delle funzioni renali, o che si prevede avranno bisogno di tale terapia entro 6 mesi.
    4. Soggetti con storia clinica di proteinuria >8,5 g/die.
    5. Soggetti che presentino albumina sierica <2,0 g/dL (<20 g/L).
    6. Soggetti con diabete mellito insufficientemente controllato, definito come HbA1C >10,5%.
    7. Soggetti sottoposti a terapia inibitoria diretta della renina (aliskiren, Tekturna/Rasilez o Valturna).
    8. Soggetti che ricevono o hanno la probabilità di ricevere durante lo studio un inibitore o induttore moderato/forte del citocromo P450 3A4 ad es. itraconazole, eritromicina, ketoconazolo, inibitori della proteasi, verapamil o diltiazem (Appendice 1).
    9. Storia nota di immunodeficienza umana (HIV) in base all'anamnesi documentata con test sierologici positivi, o test sierologico positivo all'HIV allo screening. (Nota: un test documentato HIV negativo entro 12 mesi dallo screening è accettabile e non deve essere ripetuto).
    10. Allergia o intolleranza nota significativa agli inibitori di CCR2 o CCR5 o a qualsiasi principio attivo delle formulazioni.
    11. Storia di insufficienza cardiaca congestizia (NYHA classe III o IV) o angina instabile, o storia di infarto miocardico, ictus o attacco ischemico transitorio nei 6 mesi precedenti.
    12. Eventuali anomalie rilevanti clinicamente significative ed evidenziate all'esame obiettivo o da analisi di laboratorio clinicamente significative, tra cui soggetti con anomalie moderate nelle analisi sulla funzionalità epatica >1,5 volte il limite superiore del valore normale.
    13. Storia familiare della sindrome del QT lungo, o che abbiano loro stessi un QTc >450 msec, un QRS >120 msec, o qualunque variazione ischemica clinicamente significativa come valutato dallo sperimentatore con un ECG a 12 derivazioni in posizione supina allo screening. L'ECG deve essere ripetuto altre due volte e l'idoneità del soggetto deve essere determinata usando la media dei tre valori di QRS o QTc. A titolo preferenziale, il QT dovrebbe essere corretto usando la correzione di Fridericia, sebbene possa essere usata anche la correzione di Bazett.
    14. Soggetti che stanno attualmente vivendo una condizione medica clinicamente significativa o instabile, che potrebbe limitare la loro capacità di completare lo studio, o di soddisfare i requisiti del protocollo, tra cui: malattie dermatologiche, malattie ematologiche, malattie polmonari, malattie epatiche, malattie gastrointestinali, malattie genito-urinarie, malattie endocrine, malattie neurologiche e malattie psichiatriche.
    15. Qualsiasi tumore maligno non considerato guarito (ad eccezione del carcinoma basocellulare e del carcinoma a cellule squamose della pelle). Un soggetto è considerato guarito se non vi è stata alcuna evidenza di recidiva del tumore negli ultimi 5 anni.
    16. Donazione di sangue nelle 4 settimane precedenti o dichiarata intenzione di donare sangue o prodotti ematici durante il periodo di studio o entro 1 mese dopo il completamento dello studio.
    17. Soggetti membri del personale del centro di ricerca o parenti di tali membri del personale del centro o soggetti che siano dipendenti Pfizer direttamente coinvolti nella conduzione dello studio.
    18. Partecipazione in altri studi nei precedenti 60 giorni o cinque volte l'emivita plasmatica (se nota) del farmaco sperimentale (il periodo più lungo tra i due) prima dell'inizio effettivo dello studio e/o durante la partecipazione allo studio.
    19. Altra grave condizione medica o psichiatrica acuta o cronica o anomalia di laboratorio che potrebbe aumentare il rischio associato alla partecipazione allo studio o alla somministrazione del prodotto sperimentale o potrebbe interferire con l'interpretazione dei risultati dello studio e, a giudizio dello sperimentatore, renderebbe il soggetto inadatto all'ingresso in questo studio.
    20. Donne in gravidanza, donne in allattamento, donne potenzialmente fertili, uomini che non usano contraccettivi altamente efficaci o non accettano di continuare a utilizzare contraccettivi altamente efficaci per almeno 28 giorni dopo l'ultima dose del prodotto sperimentale.
    E.5 End points
    E.5.1Primary end point(s)
    Urinary albumin:creatinine ratio (UACR)
    Rapporto albumina-creatinina nelle urine (UACR)
    E.5.1.1Timepoint(s) of evaluation of this end point
    At Week 12
    alla Settimana 12
    E.5.2Secondary end point(s)
    Urinary albumin:creatinine ratio (UACR)

    Urinary protein:creatinine ratio (UPCR).

    Estimated glomerular filtration rate (eGFR) using the abbreviated (4 variable) Modification of Diet in Renal Disease (MDRD) formula.

    Estimated glomerular filtration rate (eGFR) using the eGFRcystatin formula.

    Serum creatinine.

    Serum cystatin C.

    Plasma glycosylated hemoglobin (HbA1c).

    An assessment of PF-04634817 exposure.
    Rapporto albumina/creatinina nelle urine (UACR)

    Rapporto proteine/creatinina (UPCR)

    Velocità di filtrazione glomerulare stimata (eGFR) utilizzandola formula abbreviata (4 variabili) Modifica della Dieta per Malattia renale (MDRD) .

    Velocità di filtrazione glomerulare stimata (eGFR) con la formula eGFR cistatina.

    Creatinina sierica.

    Cistatina C nel siero.

    Emoglobina glicosilata nel plasma (HbA1c).

    Una valutazione dell'esposizione a PF-04634817.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Urinary albumin:creatinine ratio (UACR) at Weeks 4, 8, 12 and 16.

    Urinary protein:creatinine ratio (UPCR) at Weeks 4, 8, 12 and 16.

    Estimated glomerular filtration rate (eGFR) using the abbreviated (4 variable) Modification of Diet in Renal Disease (MDRD) formula at Week 1 (Day 7), and Weeks 4, 8, 12 and 16.

    Estimated glomerular filtration rate (eGFR) using the eGFRcystatin formula at Weeks 12 and 16.

    Serum creatinine at Week 1 (Day 7), and Weeks 4, 8, 12 and 16.

    Serum cystatin C at Weeks 12 and 16.

    Plasma glycosylated hemoglobin (HbA1c) at Weeks 4, 8, 12 and 16.

    An assessment of PF-04634817 exposure at Weeks 0, 1, 4, 8 and 12.
    Rapporto albumina/creatinina nelle urine (UACR) alle settimane 4, 8, 12 e 16.


    Rapporto proteine/creatinina (UPCR) alle settimane 4, 8, 12 e 16.


    Velocità di filtrazione glomerulare stimata (eGFR) utilizzandola formula abbreviata (4 variabili) Modifica della Dieta per Malattia renale (MDRD) alla settimana 1 (Giorno 7), e settimane 4, 8, 12 e 16.


    Velocità di filtrazione glomerulare stimata (eGFR) con la formula eGFR cistatina alle settimane 12 e 16.

    Creatinina sierica alla Settimana 1 (Giorno 7), e settimane 4, 8, 12 e 16.

    Cistatina C nel siero alle settimane 12 e 16.

    Emoglobina glicosilata nel plasma (HbA1c) alle settimane 4, 8, 12 e 16.

    Una valutazione dell'esposizione a PF-04634817 alle settimane 0, 1, 4, 8 e 12.
    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 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 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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA32
    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
    Argentina
    Australia
    Brazil
    Canada
    Germany
    India
    Italy
    Korea, Republic of
    Peru
    Poland
    Romania
    Spain
    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 years1
    E.8.9.1In the Member State concerned months6
    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 months6
    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: 106
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 70
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state35
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 39
    F.4.2.2In the whole clinical trial 176
    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)
    As per standard of care.
    Secondo lo standard di cura
    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 Decision2013-03-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-02-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-09-22
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