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    Summary
    EudraCT Number:2011-005722-21
    Sponsor's Protocol Code Number:D4280C00004
    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:2012-06-18
    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 number2011-005722-21
    A.3Full title of the trial
    A Phase III, Randomized, Multicenter, Double-Blind, Double Dummy, Parallel Group, Comparative Study to Determine the Efficacy, Safety, and Tolerability of Ceftazidime-Avibactam (CAZ-AVI, formerly CAZ104) Versus Doripenem Followed by Appropriate Oral Therapy in the Treatment of Complicated Urinary Tract Infections, Including Acute Pyelonephritis, With a Gram Negative Pathogen in Hospitalized Adults.
    Studio comparativo di fase III, randomizzato, multicentrico, in doppio cieco, doppio mascheramento, a gruppi paralleli, progettato per determinare l'efficacia, la sicurezza e la tollerabilita' di ceftazidima avibactam (CAZ-AVI, gia' CAZ104) rispetto a doripenem seguito da appropriata terapia orale nel trattamento delle infezioni complicate delle vie urinarie, tra cui pielonefrite acuta, con agente patogeno gram-negativo, in adulti ospedalizzati.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Compare Ceftazidime-Avibactam vs Doripenem Followed by Oral Therapy for hospitalized adults with complicated UTIs
    Confronto nell'uso di Ceftazidime-Avibactam in confronto con doripenem e terapia orale in pazienti adulti ospedalizzati per infezioni urinarie complicate.
    A.4.1Sponsor's protocol code numberD4280C00004
    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 SponsorASTRAZENECA AB
    B.1.3.4CountrySweden
    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 supportAstraZeneca AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstraZeneca
    B.5.2Functional name of contact pointInformation Centre
    B.5.3 Address:
    B.5.3.1Street Address-
    B.5.3.2Town/ city-
    B.5.3.3Post code-
    B.5.3.4CountryUnited States
    B.5.4Telephone number-
    B.5.5Fax number-
    B.5.6E-mailinformation.center@astrazeneca.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 nameceftazidime avibactam
    D.3.2Product code CAZ-AVI
    D.3.4Pharmaceutical form Powder for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCEFTAZIDIME PENTAHYDRATE
    D.3.9.1CAS number 78439-06-2
    D.3.9.4EV Substance CodeSUB01134MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2000
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNavibactam
    D.3.9.1CAS number 1192491-61-4
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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 RoleComparator
    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 Yes
    D.2.1.1.1Trade name Doribax
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag International NV
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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.3.4Pharmaceutical form Powder for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDORIPENEM
    D.3.9.1CAS number 148016-81-3
    D.3.9.4EV Substance CodeSUB22196
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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 Yes
    D.2.1.1.1Trade name Ciproxin
    D.2.1.1.2Name of the Marketing Authorisation holderBayer plc, Bayer Schering Pharma
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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.3.4Pharmaceutical 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 INNciprofloxacina
    D.3.9.1CAS number 85721-33-1
    D.3.9.4EV Substance CodeSUB07470MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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 Yes
    D.2.1.1.1Trade name Septrin Forte
    D.2.1.1.2Name of the Marketing Authorisation holderAspen Pharma Trading Limited
    D.2.1.2Country which granted the Marketing AuthorisationIreland
    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.3.4Pharmaceutical 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 INNSulfametoxazolo
    D.3.9.1CAS number 723-46-6
    D.3.9.4EV Substance CodeSUB10711MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number800
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 738-70-5
    D.3.9.3Other descriptive nameTrimethoprim
    D.3.9.4EV Substance CodeSUB11310MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number160
    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 placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Complicated Urinary Tract Infections (cUTIs)
    Infezioni urinarie complicate
    E.1.1.1Medical condition in easily understood language
    Urinary Tract Infection
    Infezioni urinarie
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10021872
    E.1.2Term Infection urinary tract
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the noninferiority of ceftazidime-avibactam (CAZ-AVI, formerly CAZ104) compared with doripenem with respect to the following coprimary endpoints in the microbiological modified intent-totreat (mMITT) analysis set: •Symptomatic resolution (or return to premorbid state) of UTI-specific symptoms except flank pain (frequency/urgency/dysuria/suprapubic pain) and resolution of, or improvement in, flank pain based on the patient-reported symptom assessment response at the Day 5 visit •Both per-patient microbiological eradication and symptomatic resolution (or return to premorbid state) of all UTI-specific symptoms (frequency/urgency/dysuria/suprapubic pain/flank pain) based on the patient-reported symptom assessment response at the Test of Cure (TOC) visit.
    Valutare la non inferiorita' di ceftazidima-avibactam (CAZ-AVI, gia' CAZ104) rispetto a doripenem relativamente ai seguenti endpoint comprimari nel gruppo di analisi intent-to-treat modificata a livello microbiologico (mMITT): • Risoluzione sintomatica (o ritorno allo stato premorboso) di sintomi specifici per UTI, tranne dolore ai fianchi (frequenza/urgenza/disuria/dolore sovrapubico) e risoluzione o miglioramento del dolore ai fianchi sulla base della risposta di valutazione dei sintomi riferiti dai pazienti alla visita del Giorno 5. • Eliminazione microbiologica per paziente e risoluzione sintomatica (o ritorno allo stato premorboso) di tutti i sintomi specifici per UTI (frequenza/urgenza/disuria/dolore sovrapubico/dolore ai fianchi) sulla base della risposta di valutazione dei sintomi riferiti dai pazienti alla visita di Valutazione della cura (TOC).
    E.2.2Secondary objectives of the trial
    •To determine the efficacy of CAZ-AVI compared with doripenem with respect to the per patient microbiological response at the End of IV Therapy, TOC, and Late Follow-Up visits •To determine the efficacy of CAZ-AVI compared with doripenem with respect to the symptomatic resolution of UTI-specific symptoms (frequency/urgency/dysuria/suprapubic pain/flank pain) based on patient-reported symptom assessment at TOC and LFU visits •To determine the efficacy of CAZ-AVI compared with doripenem with respect to the per pathogen microbiological response at the EOT (IV), TOC, and LFU visits in patients who are in the mMITT, ME, and extended ME analysis sets.
    •Determinare l’efficacia di CAZ-AVI rispetto a doripenem relativamente alla risposta microbiologica per paziente alle visite di fine della terapia endovenosa,TOC e follow-up finale.•Determinare l’efficacia di CAZ-AVI rispetto a doripenem relativamente alla risoluzione sintomatica di tutti i sintomi specifici per UTI (frequenza/urgenza/disuria/dolore sovrapubico/dolore ai fianchi) sulla base della risposta di valutazione dei sintomi riferiti dai pazienti alle visite TOC e LFU.•Determinare l’efficacia di CAZ-AVI rispetto a doripenem relativamente alla risposta microbiologica per agente patogeno alle visite EOT (IV),TOC e LFU nei pazienti che si trovano nei gruppi di analisi mMITT,ME ed ME estesa.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Patient must be 18 to 90 years of age, inclusive. 2.Female patient is authorized to participate in this clinical study if she meets the following criteria ,is surgically sterilize or postmenopausal for at least 1 year or is capable of having children and agrees not to attempt pregnacy while received IV study therapy and for a period of 28 days after. 3.Patient has pyuria as determined by a midstream clean catch or catheterized urine specimen with ≥10 white blood cells (WBCs) per high-power field on standard examination of urine sediment or ≥10 WBCs/mm3 in unspun urine. 4.Demonstrates either acute pyelonephritis or complicated lower UTI without pyelonephritis.
    1. Il paziente deve avere un’eta' compresa tra 18 e 90 anni inclusi. 2. Per poter partecipare a questo studio, le pazienti di sesso femminile devono soddisfare i criteri elencati di seguito: essere state sottoposte a sterilizzazione chirurgica o essere in menopausa da almeno 1 anno o essere in eta' fertile ma accettare di non iniziare una gravidanza durante la terapia sperimentale endovenosa e per un periodo di 28 giorni dalla sua conclusione. 3. Il paziente presenta una condizione di piuria come dimostrato da mitto intermedio non contaminato o da un campione di urina cateterizzata con globuli bianchi (WBC) ≥ 10 per campo ad alto ingrandimento all’esame standard del sedimento urinario oppure ≥ 10 WBC/mm3 nell’urina non centrifugata. 4. Il paziente e' affetto da pielonefrite acuta o UTI inferiore complicata senza pielonefrite.
    E.4Principal exclusion criteria
    1.Urine pathogen is a Gram-positive pathogen or a uropathogen resistant to CAZ-AVI or Doripenemine culture 2.Where a urine culture result is available, patient's urine culture at study entry isolates more than 2 microorganisms regardless of the colony count or patient has a confirmed fungal UTI. 3.Patient is receiving hemodialysis or peritoneal dialysis or had a renal transplant. 4.Patient is immunocompromised. 5.Patient is considered unlikely to survive the 6 to 8 week study period or have a rapidly progressive or terminal illness.
    1. L’agente patogeno urinario e' un patogeno gram-positivo o un agente uropatogeno resistente a CAZ-AVI o a doripenem 2. Se e' disponibile un risultato di urinocoltura, l’urinocoltura del paziente all’ingresso nello studio isola piu' di 2 microorganismi, indipendentemente dal conteggio di colonie, oppure il paziente presenta una UTI micotica confermata. 3. Il paziente riceve emodialisi o dialisi peritoneale oppure e' stato sottoposto a trapianto renale. 4. Il paziente e' immunocompromesso. 5. Il paziente con tutta probabilita' non sopravvivra' per le 6-8 settimane del periodo in cui si svolgera' lo studio o presenta una malattia in rapida progressione o terminale.
    E.5 End points
    E.5.1Primary end point(s)
    •The proportion of patients with symptomatic resolution of UTI-specific symptoms based on patient-reported symptom assessment response at the Day 5 visit. Timeframe: Day 5 after start of study drug •The proportion of patients with a per patient microbiological eradication and symptomatic resolution of all UTI-specific symptoms based on the patient-reported symptom assessment response. Timeframe: 21 to 25 days after start of study drug
    •Proporzione di pazienti con risoluzione sintomatica dei sintomi specifici per UTI, sulla base della risposta di valutazione dei sintomi riferiti dal paziente alla visita del Giorno 5. •Proporzione di pazienti con eliminazione microbiologica per paziente e risoluzione sintomatica di tutti i sintomi specifici per UTI, sulla base della risposta di valutazione dei sintomi riferiti dal paziente 21-25 giorni dopo l'inizio del trattamento.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Primary Outcome measure 1 - Day 5 after start of study drug. Primary Outcome measure 2 - Day 21-25 after start of study drug.
    •5 Giorni dopo l'inizio del trattamento. •21-25 Giorni dopo l'inizio del trattamento.
    E.5.2Secondary end point(s)
    •The proportion of patients with a favorable per patient microbiological response in the microbiological mMITTanalysis sets. Timeframe: within 24 hours after last day of the study drug, 21 to 25 days and 45 to 52 days after the start of the study drug •The proportion of patients with symptomatic resolution of all UTIspecific symptoms based on the patient-reported symptom assessment response. Timeframe: within 21 to 25 days and 45 to 52 days after the start of the study drug •The proportion of favorable per-pathogen microbiological response in the microbiological modified Intent-To-Treat, microbiologically evaluable, and extended microbiologically evaluable analysis sets Timeframe: within 24 hours after last day of the study drug, 21 to 25 days and 45 to 52 days after the start of the study drug •The proportion of patients with an investigator-determined clinical cure in the microbiological MITT analysis sets. Timeframe: within 24 hours after last day of the study drug, 21 to 25 days and 45 to 52 days after the start of the study drug •The per pathogen microbiologic response by minimum inhibitory concentration in the microbiological mMITT analysis sets. Timeframe: within 24 hours after last day of the study drug, 21 to 25 days and 45 to 52 days after the start of the study drug •The proportion of patients with favorable investigator clinical response assessment in the microbiological mMITT analysis sets. Timeframe: within 21 to 25 days after the start of the study drug •The time to first defervescence while on IV study therapy in patients in the microbiological mMITT analysis sets who have fever at study entry. Timeframe: any time after the start to study drug to end of IV study therapy.
    Le variabili di esito di efficacia secondarie includono quanto segue: •Proporzione di pazienti con risposta microbiologica per paziente favorevole alle visite EOT (IV), TOC e LFU nei gruppi di analisi mMITT. •Proporzione di pazienti con risoluzione sintomatica di tutti i sintomi specifici per UTI, sulla base della risposta di valutazione dei sintomi riferiti dal paziente alle visite TOC e LFU nel gruppo di analisi mMITT. •Proporzione di risposta microbiologica per agente patogeno favorevole alle visite EOT (IV), TOC e LFU nei gruppi di analisi mMITT. •Proporzione di pazienti con guarigione clinica determinata dallo Sperimentatore alle visite EOT (IV), TOC e LFU nei gruppi di analisi mMITT. •Risposta microbiologica per agente patogeno favorevole alle visite EOT (IV), TOC e LFU per categorie di concentrazione inibitoria minima (MIC) nei gruppi di analisi mMITT. •Proporzione di pazienti con valutazione della risposta clinica favorevole da parte dello Sperimentatore e, separatamente, risposta microbiologica per paziente favorevole alla visita TOC per pazienti che presentano un agente patogeno resistente a ceftazidima nei gruppi di analisi mMITT. •Proporzione di pazienti con risoluzione sintomatica (definita nelle variabili comprimarie) al Giorno 5 e alla TOC per pazienti che presentano un agente patogeno resistente a ceftazidima nel gruppo di analisi mMITT. •Tempo che trascorre prima della prima defervescenza durante la terapia sperimentale endovenosa nei pazienti nei gruppi di analisi mMITT con febbre al momento dell’ingresso nello studio.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Within 21 to 25 days and 45 to 52 days.
    Tra il Giorno 21 e 25 e tra il Giorno 45 e 52.
    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 Yes
    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) Yes
    E.8.2.2Placebo No
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA55
    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
    Brazil
    Canada
    India
    Israel
    Korea, Republic of
    Mexico
    Peru
    Russian Federation
    Taiwan
    Ukraine
    E.8.7Trial has a data monitoring committee No
    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 months17
    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 months20
    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: 617
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 347
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 450
    F.4.2.2In the whole clinical trial 964
    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)
    Standard of care
    Terapia standard
    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 Decision2012-10-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-05-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-09-22
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