Clinical Trials Register

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

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A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2011-005722-21

A.3

Full 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.3.1

Title 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.4.1

Sponsor's protocol code number

D4280C00004

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	ASTRAZENECA AB
B.1.3.4	Country	Sweden
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	AstraZeneca AB
B.4.2	Country	Sweden
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	AstraZeneca
B.5.2	Functional name of contact point	Information Centre
B.5.3	Address:
B.5.3.1	Street Address	-
B.5.3.2	Town/ city	-
B.5.3.3	Post code	-
B.5.3.4	Country	United States
B.5.4	Telephone number	-
B.5.5	Fax number	-
B.5.6	E-mail	information.center@astrazeneca.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	ceftazidime avibactam
D.3.2	Product code	CAZ-AVI
D.3.4	Pharmaceutical form	Powder for solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	CEFTAZIDIME PENTAHYDRATE
D.3.9.1	CAS number	78439-06-2
D.3.9.4	EV Substance Code	SUB01134MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	2000
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	avibactam
D.3.9.1	CAS number	1192491-61-4
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	500
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Doribax
D.2.1.1.2	Name of the Marketing Authorisation holder	Janssen-Cilag International NV
D.2.1.2	Country which granted the Marketing Authorisation	Belgium
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Powder for solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	DORIPENEM
D.3.9.1	CAS number	148016-81-3
D.3.9.4	EV Substance Code	SUB22196
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	500
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 3
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Ciproxin
D.2.1.1.2	Name of the Marketing Authorisation holder	Bayer plc, Bayer Schering Pharma
D.2.1.2	Country which granted the Marketing Authorisation	United Kingdom
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	ciprofloxacina
D.3.9.1	CAS number	85721-33-1
D.3.9.4	EV Substance Code	SUB07470MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	500
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 4
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Septrin Forte
D.2.1.1.2	Name of the Marketing Authorisation holder	Aspen Pharma Trading Limited
D.2.1.2	Country which granted the Marketing Authorisation	Ireland
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Sulfametoxazolo
D.3.9.1	CAS number	723-46-6
D.3.9.4	EV Substance Code	SUB10711MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	800
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.1	CAS number	738-70-5
D.3.9.3	Other descriptive name	Trimethoprim
D.3.9.4	EV Substance Code	SUB11310MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	160
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Solution for infusion
D.8.4	Route of administration of the placebo	Intravenous use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Complicated Urinary Tract Infections (cUTIs)

Infezioni urinarie complicate

E.1.1.1

Medical condition in easily understood language

Urinary Tract Infection

Infezioni urinarie

E.1.1.2

Therapeutic area

Diseases [C] - Bacterial Infections and Mycoses [C01]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.1
E.1.2	Level	LLT
E.1.2	Classification code	10021872
E.1.2	Term	Infection urinary tract
E.1.2	System Organ Class	10021881 - Infections and infestations

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main 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.2.2

Secondary 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.2.3

Trial contains a sub-study

E.3

Principal 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.4

Principal 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.5.1

Primary 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.5.1.1

Timepoint(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.5.2

Secondary 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.5.2.1

Timepoint(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.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If 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.8.7

Trial has a data monitoring committee

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

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1

Number of subjects for this age range:

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

617

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

347

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

450

F.4.2.2

In 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

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2012-10-24

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-05-14

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2014-09-22

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Select Date Range: to
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IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
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