Clinical Trials Register

Summary
EudraCT Number:	2011-002234-39
Sponsor's Protocol Code Number:	BAY59-7939/15693
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:	2012-09-13
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

2011-002234-39

A.3

Full title of the trial

A prospective, randomized, open-label, parallel-group, active-controlled, multicenter study exploring the efficacy and safety of once-daily oral rivaroxaban (BAY 59-7939) compared with that of dose-adjusted oral vitamin K antagonist (VKA) for the prevention of stroke and non-central nervous system systemic embolism in subjects with non-valvular atrial fibrillation scheduled for cardioversion

Studio prospettico, randomizzato, controllato, in aperto, a gruppi paralleli, multicentrico per valutare l’efficacia e la sicurezza del trattamento orale con rivaroxaban una volta al giorno (BAY 59-7939) rispetto al trattamento orale con antagonisti della vitamina K (VKA) con aggiustamento della dose nella prevenzione di eventi cardiovascolari in soggetti con fibrillazione atriale non valvolare, per i quali è stata pianificata la cardioversione

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

Explore the efficacy and safety of once-daily oral rivaroxaban for the prevention of cardiovascular events in subjects with nonvalvular atrial fibrillation scheduled for cardioversion

Valutazione dell’efficacia e sicurezza del trattamento orale con rivaroxaban una volta al giorno nella prevenzione di eventi cardiovascolari in soggetti con fibrillazione atriale non valvolare, per i quali è stata pianificata la cardioversione

A.4.1

Sponsor's protocol code number

BAY59-7939/15693

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	BAYER HEALTHCARE AG
B.1.3.4	Country	Germany
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	BAYER HealthCare AG
B.4.2	Country	Germany
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Bayer HealthCare AG
B.5.2	Functional name of contact point	Bayer Clinical Trial Contact
B.5.3	Address:
B.5.3.1	Street Address	CTP Team/Ref:"EU CTR"/ Bayer Pharma AG
B.5.3.2	Town/ city	Berlin
B.5.3.3	Post code	13342
B.5.3.4	Country	Germany
B.5.4	Telephone number	NA
B.5.5	Fax number	NA
B.5.6	E-mail	clinical-trials-contact@bayerhealthcare.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	Yes
D.2.1.1.1	Trade name	XARELTO
D.2.1.1.2	Name of the Marketing Authorisation holder	Bayer Pharma AG
D.2.1.2	Country which granted the Marketing Authorisation	Germany
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	RIVAROXABAN
D.3.9.1	CAS number	366789-02-8
D.3.9.4	EV Substance Code	SUB29263
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	20
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	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	XARELTO
D.2.1.1.2	Name of the Marketing Authorisation holder	Bayer Pharma AG
D.2.1.2	Country which granted the Marketing Authorisation	Germany
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	RIVAROXABAN
D.3.9.1	CAS number	366789-02-8
D.3.9.2	Current sponsor code	BAY 59-7939
D.3.9.4	EV Substance Code	SUB29263
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	15
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	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	COUMADIN*30CPR 5MG
D.2.1.2	Country which granted the Marketing Authorisation	Italy
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	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	WARFARIN SODIUM
D.3.9.1	CAS number	129-06-6
D.3.9.4	EV Substance Code	SUB05128MIG
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	5
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

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

prevention of stroke and non-central nervous system systemic embolism in subjects with non-valvular atrial fibrillation scheduled for cardioversion

Prevenzione di eventi cardiovascolari in soggetti con fibrillazione atriale non valvolare per i quali è stata pianificata la cardioversione.

E.1.1.1

Medical condition in easily understood language

prevention of cardiovascular events in subjects with nonvalvular atrial fibrillation scheduled for Cardioversion

Prevenzione di eventi cardiovascolari in soggetti con fibrillazione atriale non valvolare per i quali è stata pianificata la cardioversione.

E.1.1.2

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	15.0
E.1.2	Level	PT
E.1.2	Classification code	10003658
E.1.2	Term	Atrial fibrillation
E.1.2	System Organ Class	10007541 - Cardiac disorders

E.1.2 Medical condition or disease under investigation

E.1.2	Version	15.0
E.1.2	Level	SOC
E.1.2	Classification code	10007541
E.1.2	Term	Cardiac disorders
E.1.2	System Organ Class	10007541 - Cardiac disorders

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

The primary efficacy and safety objectives are to explore the efficacy of rivaroxaban compared with that of dose-adjusted vitamin K antagonists (VKA) in the prevention of the events with regard to the combined efficacy endpoint of all stroke or transient ischemic attack (TIA), non-central nervous system (CNS) systemic embolism, myocardial infarction (MI), and cardiovascular death in subjects with atrial fibrillation scheduled for cardioversion; and to explore the safety of rivaroxaban compared with dose-adjusted VKA with regard to the safety endpoint of major bleeding events in subjects with atrial fibrillation scheduled for cardioversion

L’obiettivo primario è valutare l’efficacia di rivaroxaban rispetto agli antagonisti della vitamina K (VKA) con aggiustamento della dose nella prevenzione degli eventi cardiovascolari in relazione all’end-point combinato di efficacia per tutti i tipi di ictus, per attacchi ischemici transitori (TIA), per embolia sistemica non a carico del sistema nervoso centrale (CNS), per infarto del miocardio (MI), e per morte cardiovascolare in soggetti con fibrillazione atriale non valvolare, per i quali è stata pianificata la cardioversione; e valutare la sicurezza di rivaroxaban verso VKA con aggiustamento della dose rispetto all’end-point di sicurezza di episodi di sanguinamento maggiore in soggetti con fibrillazione atriale non valvolare, per i quali è stata pianificata la cardioversione.

E.2.2

Secondary objectives of the trial

Secondary objectives are to explore rivaroxaban treatment as compared with dose-adjusted VKA treatment with regard to the composite efficacy endpoint of stroke, TIA, non-central nervous system (CNS) systemic embolism, MI, and all-cause mortality (including cardiovascular death); the individual efficacy endpoints of all stroke, TIA, non-CNS systemic embolism, MI, cardiovascular death, and all-cause mortality (including cardiovascular death); and all bleeding events (major and non-major bleeding events)

Gli obiettivi secondari sono rappresentati dalla valutazione dell’effetto del trattamento con rivaroxaban verso VKA con aggiustamento della dose rispetto all’end-point combinato di efficacia di ictus ed embolia sistemica non-CNS; all’end-point combinato di efficacia di ictus, TIA, embolia sistemica non-CNS, MI e di morte per tutte le cause (inclusa la morte cardiovascolare); ai singoli end-point di efficacia di tutti i tipi di ictus, TIA, embolia sistemica non-CNS, MI, morte cardiovascolare, morte per tutte le cause (inclusa la morte cardiovascolare); e a tutti gli eventi di sanguinamento (sanguinamenti maggiori e non-maggiori).

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Subjects must meet the following criteria to be enrolled in the study: • Men or women aged ≥18 years • Hemodynamically stable non-valvular atrial fibrillation >48 hours or non-valvular atrial fibrillation of unknown duration • Scheduled for cardioversion (electrical or pharmacological) of atrial fibrillation • Provide written informed consent • Women of childbearing potential and men must agree to use adequate contraception when sexually active. This applies from the time of signing of the informed consent form until 30 days after the last study drug administration. The definition of adequate contraception will be based on the judgment of the investigator and local requirementsl.

-Adulti (≥18 anni di età) uomini o donne con fibrillazione atriale non valvolare emodinamicamente stabile di durata superiore a 48 ore o di durata sconosciuta, per i quali è stata pianificata la cardioversione (elettrica o farmacologica).
-Consenso informato scritto
-Donne/uomini fertili, sessualmente attivi, devono acconsentire all’uso di adeguati sistemi contraccettivi dal momento della firma del consenso informato e per i 30 giorni successivi all’ultima somministrazione di farmaco sperimentale. La definizione di contraccezione adeguata si baserà sul giudizio dello sperimentatore e sulle linee guida locali.
Metodi contraccettivi accettabili comprendono (i) preservativi (maschili e femminili) con o senza agente spermicida; (ii) diaframma o cappuccio cervicale con spermicida; (iii) dispositivo intrauterino; e (iv) contraccettivi ormonali.

E.4

Principal exclusion criteria

Subjects who meet any of the following criteria will be excluded from enrollment in the study: • Any stroke within the last 14 days prior to randomization • Transient ischemic attack within 3 days before randomization • Acute clinical signs of systemic thromboembolic events or thrombosis within the last 14 days prior to randomization • Acute MI within the last 14 days prior to randomization • Cardiac-related criteria: o Known presence of left atrial thrombus before study inclusion o Known presence of atrial myxoma o Known left ventricular or aortic thrombus o Valvular heart disease (either hemodynamically significant mitral valve stenosis or prosthetic heart valve) • Active bleeding or high risk for bleeding contraindicating anticoagulant therapy • Concomitant drugs/therapies: o Indication for anticoagulant therapy for a condition other than atrial fibrillation (eg, VTE) o Pretreatment with new anticoagulant drugs, such as factor IIa or factor Xa inhibitors, within 30 days prior to randomization o Aspirin >100 mg or dual antiplatelet therapy o Concomitant use of strong inhibitors of both cytochrome P450 (CYP)-3A4 and P-glycoprotein (Pgp), ie, all human immunodeficiency virus protease inhibitors and the following azole antimycotic agents: ketoconazole, itraconazole, voriconazole, posaconazole, if used systemically • Concomitant conditions: o Childbearing potential without proper contraceptive measures, pregnancy, or breast feeding o Hypersensitivity to investigational treatment or comparator treatment o Calculated CrCl <30 mL/minute (see Section 14.1) o Hepatic disease which is associated with coagulopathy leading to a clinically relevant bleeding risk o Any severe condition that would limit life expectancy to less than 6 months (eg, advanced malignancy, etc.) o Planned invasive procedure with potential for uncontrolled bleeding, including major surgery o Inability to take oral medication o Ongoing drug addiction or alcohol abuse • Any other contraindication listed in the local labeling for the comparator treatment or experimental treatment • Participation in a study with a investigational drug or medical device within 30 days prior to randomization • Previous randomization in this study • Inability to complete the study procedures according to protocol

Infarto grave, inabilitante (Rankin score modificato fino a 4-5 (cfr. Sezione 14.2 protocollo) entro 3 mesi o entro 14 giorni prima della visita di randomizzazione
-Attacco ischemico transitorio nei 3 giorni precedenti la randomizzazione
-Eventi tromboembolici acuti o trombosi (venosa/arteriosa) nei 14 giorni
precedenti la randomizzazione
-Infarto del Miocardio acuto nei 14 giorni precedenti la randomizzazione
-Presenza nota di trombosi nell’appendice atriale sinistra prima dell’inclusione nello studio
-Presenza nota di mixoma atriale
-Presenza nota di trombosi ventricolare sinistra o aortica
-Valvulopatia (stenosi valvolare mitralica emodinamicamente significativa o protesi valvolare)
-Sanguinamento in atto o elevato rischio di sanguinamento che rappresenti una controindicazione alla terapia anticoagulante
-Farmaci/terapie concomitanti:
-Indicazione per terapia anticoagulante per patologia diversa dalla fibrillazione (eg, VTE)
-Terapia cronica con aspirina > 100 mg die o terapia antipiastrinica
-uso concomitante di forti inibitori di citocromo P450 (CYP)-3A4
e P-glicoproteina (P-gp), ad es. tutti gli inibitori di proteasi per virus di immunodeficienza ed i seguenti agenti antimocotici azolici: ketoconazolo,
itraconazolo, voriconazolo, posaconazolo, se usato sistemicamente• Condizioni concomitanti:
-Fertilità senza adeguate misure contraccettive , gravidanza o allattamento
-Ipersensibilità al trattamento sperimentale o di confronto
-CrCl < 30 mL/minuto (cfr. Sezione14.1)
-Sindrome epatica associata a coagulopatia che porti ad un rischio di sanguinamento clinicamente rilevante
-Qualsiasi condizione grave che limiti l’aspettativa di vita a meno di 6 mesi
(es. malignità avanzata, ecc.)
-Procedura invasive pianificate con potenziale rischio di sanguinamento non controllato, inclusi gli interventi di chirurgia maggiore o di cateterizzazione cardiaca
-Incapacità ad assumere farmaci per via orale
-Assuefazione a farmaci o abuso alcolico
-Qualsiasi ulteriore controindicazione elencata nelle etichette in vigore per il trattamento di confronto o farmaco sperimentale
- Partecipazione ad altro studio clinico con farmaco o dispositivo medico nei 30 giorni precedenti la randomizzazione
-Precedente randomizzazione nello studio
-Incapacità di attenersi alle procedure sperimentali

E.5 End points

E.5.1

Primary end point(s)

The primary efficacy endpoint variable is the composite of the following efficacy outcomes (adjudicated centrally): stroke, transient ischemic attack, non-central nervous system systemic embolism, myocardial infarction and cardiovascular death. The primary safety endpoint variable is major bleeding (as per central adjudication)

La variabile primaria di efficacia è l’end-point composito dei seguenti eventi (secondo l’aggiudicazione del CEC): ictus, TIA, embolia sistemica non-CNS, MI e morte cardiovascolare. La variabile primaria di sicurezza sono i sanguinamenti maggiori (secondo l’aggiudicazione del CEC).

E.5.1.1

Timepoint(s) of evaluation of this end point

From randomization date up to the date of the last dose of study medication + 2 calendar days for subjects who complete the planned study medication period

Dalla data di randomizzazione fino a quella dell'ultimo dosaggio di farmaco sperimentale + 2 giorni per i Pz che completano il periodo di trattamento pianificato.

E.5.2

Secondary end point(s)

Composite of stroke and non-central nervous system systemic embolism Composite of stroke, transient ischemic attack, non-central nervous system systemic embolism, myocardial infarction, all- cause mortality Stroke Transient ischemic attack Non-central nervous system systemic embolism Myocardial infarction Cardiovascular death All cause mortality

Gli endpiont compositi secondari comprendoni i seguenti eventi: ictus, TIA, embolia sistemica del sistema nervoso non CNS, infarto miocardico, morte per tutte le cause.

E.5.2.1

Timepoint(s) of evaluation of this end point

From randomization date up to the date of the last dose of study medication + 2 calendar days for subjects who complete the planned study medication period

Dalla data di randomizzazione fino a quella dell'ultimo dosaggio di farmaco sperimentale + 2 giorni per i Pz che completano il periodo di trattamento pianificato.

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

Yes

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

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

Yes

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

Biomarkers of thrombolysis/fibrinolysis-Biomarkers of inflammatory response

Biomarcatori trombolisi/fibrinolisi-Biomarcatori risposta infiammatoria

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

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

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

Yes

E.8.2.3.1

Comparator description

VKA (Coumadin)

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

Brazil

Canada

China

Singapore

South Africa

United States

E.8.7

Trial 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

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:

700

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

800

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

670

F.4.2.2

In the whole clinical trial

1500

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)

None

Nessuno

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

2012-07-24

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-07-27

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2014-01-24

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IMP with orphan designation in the indication
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