Clinical Trials Register

Summary
EudraCT Number:	2010-021258-20
Sponsor's Protocol Code Number:	EAST
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2012-09-26
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

2010-021258-20

A.3

Full title of the trial

Early treatment of Atrial fibrillation for Stroke prevention Trial (EAST)

Trattamento precoce di fibrillazione atriale per la prevenzione dell'ictus cerebrale

A.3.1

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

A clinical trial to demonstrate that an early as possible treatment of atrial fibrillation can prevent a stroke.

Studio clinico finalizzato a dimostrare che un trattamento il piu' precoce possibile della fibrillazione atriale puo' prevenire l’ictus.

A.3.2

Name or abbreviated title of the trial where available

EAST

A.4.1

Sponsor's protocol code number

EAST

A.5.1

ISRCTN (International Standard Randomised Controlled Trial) Number

ISRCTN04708680

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT01288352

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	KOMPETENZNETZ VORHOFFLIMMERN E.V. (AFNET)
B.1.3.4	Country	Germany
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Kompetenznetz Vorhofflimmern e.V. (AFNET)
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	Kompetenznetz Vorhofflimmern e.V. (AFNET)
B.5.2	Functional name of contact point	Clinical Trials Information
B.5.3	Address:
B.5.3.1	Street Address	ALBERT-SCHWEITZER-CAMPUS 1 / GEBAEUDE D11, DOMAGKSTR. 11
B.5.3.2	Town/ city	Muenster
B.5.3.3	Post code	48149
B.5.3.4	Country	Germany
B.5.4	Telephone number	0049 251 8345340
B.5.5	Fax number	0049 251 8345343
B.5.6	E-mail	east@ukmuenster.de

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.2.1.2	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	AMIODARONE HYDROCHLORIDE
D.3.9.1	CAS number	19774-82-4
D.3.9.4	EV Substance Code	SUB00472MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	up to
D.3.10.3	Concentration number	200
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.2.1.2	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	FLECAINIDE ACETATE
D.3.9.1	CAS number	54143-56-5
D.3.9.4	EV Substance Code	SUB13894MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	up to
D.3.10.3	Concentration number	100
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.2.1.2	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	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	PROPAFENONE HYDROCHLORIDE
D.3.9.1	CAS number	34183-22-7
D.3.9.4	EV Substance Code	SUB04077MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	up to
D.3.10.3	Concentration number	300
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.2.1.2	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	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	DRONEDARONE HYDROCHLORIDE
D.3.9.1	CAS number	141625-93-6
D.3.9.4	EV Substance Code	SUB28992
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	up to
D.3.10.3	Concentration number	400
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

Atrial fibrillation, stroke, heart failure, myocardial infarction, cognitive dysfunction

Fibrillazione atriale, ictus, insufficienza cardiaca, infarto del miocardio, disfunzione cognitiva

E.1.1.1

Medical condition in easily understood language

Atrial fibrillation is a common type of cardiac rhythm disorder, which represents an important cause for stroke but also for myocardial infarction and heart muscle weakness (heart failure).

La fibrillazione atriale è un diffuso disturbo del ritmo cardiaco, che rappresenta un’importante causa di ictus, ma anche di infarto del miocardio e debolezza del muscolo cardiaco.

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	HLGT
E.1.2	Classification code	10019280
E.1.2	Term	Heart failures
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	PT
E.1.2	Classification code	10061256
E.1.2	Term	Ischaemic stroke
E.1.2	System Organ Class	10029205 - Nervous system disorders

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	10028596
E.1.2	Term	Myocardial infarction
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

To test whether an early, comprehensive, rhythm control therapy can prevent adverse cardiovascular outcomes in patients with recent-onset atrial fibrillation (AF) compared to usual care

Il presente Studio mira a verificare se una terapia precoce di controllo del ritmo sia in grado di prevenire gravi complicanze cardiovascolari in pazienti con recente diagnosi di fibrillazione atriale (FA). Il trattamento precoce viene confrontato con la attuale terapia convenzionale (“usual care”).

E.2.2

Secondary objectives of the trial

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

The following main criteria must be present for eligibility into the study: Recent onset AF, i.e. AF with a known history of ≤1 year prior to randomisation; Risk for stroke as evidenced by EITHER a) one of the following: age > 75 years, prior stroke or transient ischemic attack (TIA) OR b) two of the following: hypertension, diabetes mellitus, left ventricular hypertrophy, age > 65 years, female sex, peripheral artery disease, kidney disease (MDRD stage III or IV), stable heart failure (NYHA II or LVEF <50%), severe coronary artery disease (previous myocardial infarction, CABG or PCI)

Ai fini dell’inclusione nello Studio devono essere soddisfatti i seguenti requisiti: 1. Diagnosi di fibrillazione atriale inferiore a un anno (recente diagnosi di fibrillazione atriale) e 2. Presenza di fattori di rischio di ictus, precisamente: a) uno dei seguenti fattori di rischio: Età > 75 anni, ictus pregresso o attacchi ischemici transitori (TIA) o b) due dei seguenti fattori di rischio: ipertensione, diabete mellito, ipertrofia ventricolare sinistra, età > 65 anni, sesso femminile, arteriopatia aterosclerotica periferica, insufficienza renale (MDRD Stadio III o IV), insufficienza cardiaca stabile (NYHA II o LVEF < 50%), grave coronaropatia (infarto pregresso del miocardio, Bypass coronarico o PCI)

E.4

Principal exclusion criteria

1. Any disease that limits life expectancy to less than 1 year. 2. Participation in another clinical trial, either within the past two months or ongoing 3. Previous participation in the EAST trial. 4. Pregnant women or women of childbearing potential not on adequate birth control: only women with a highly effective method of contraception [oral contraception or intra-uterine device (IUD)] or sterile women can be randomized. 5. Breastfeeding women. 6. Drug abuse. 7. Prior AF ablation or surgical therapy of AF. 8. Previous therapy failure on amiodarone, e.g. patients who suffered from symptomatic recurrent AF that required escalation of therapy while on amiodarone. 9. Patients not suitable for rhythm control of AF. 10. Severe mitral valve stenosis. 11. Prosthetic mitral valve. 12. Clinically relevant hepatic dysfunction requiring specific therapy. 13. Clinically manifest thyroid dysfunction requiring therapy. After successful treatment of thyroid dysfunction, patients may be enrolled when their thyroid function is controlled. 14. Severe renal dysfunction (stage V, requiring or almost requiring dialysis)

1. Qualsiasi malattia con aspettativa di vita inferiore ad 1 anno; 2. Partecipazione antecedente o in corso (entro gli ultimi due mesi) ad un altro studio clinico; 3. Precedente partecipazione allo studio EAST; 4. Le donne in gravidanza o in età fertile senza contraccezione adeguata: solo le donne con un metodo contraccettivo molto efficace [contraccettivi orali o IUD] o sterili possono essere randomizzate); 5. Donne che allattano; 6. Abuso di farmaci; 7. Precedente ablazione di FA o precedente terapia chirurgica di FA; 8. Precedente fallimento della terapia con amiodarone (per esempio, pazienti con fibrillazione atriale recidiva sintomatica che ha richiesto una escalation in terapia con Amiodarone); 9. Pazienti ai quali non si adatta il trattamento di mantenimento del ritmo di FA; 10. Grave stenosi della valvola mitralica; 11. Storico protesica valvola mitrale; 12. Disfunzione epatica clinicamente rilevante che richiede una terapia specifica; 13. Disfunzione tiroidea clinicamente manifesta. Dopo i risultati soddisfacenti conseguiti con il trattamento di disfunzione della tiroide, il paziente può essere randomizzato; 14. Grave disfunzione renale (Stadio V, probabile dialisi o probabilmente già in corso).

E.5 End points

E.5.1

Primary end point(s)

A composite of cardiovascular death, stroke / transient ischemic attack (TIA), and hospitalization due to worsening of heart failure or due to acute coronary syndrome. The 1st co-primary outcome parameter is defined as the time to the first occurrence of a composite of the above mentioned components. The 2nd co-primary outcome is nights spent in hospital per year.

Una combinazione di decesso per evento cardiovascolare, ictus / attacco ischemico transitorio e ricovero ospedaliero per cardiaca scompenso cardiaco o sindrome coronarica acuta. Il 1° end-point co-primario è definito come periodo fino alla prima insorgenza dei sopra citati eventi. Il 2° end-point co-primario è il numero di notti trascorse in ospedale nell’anno.

E.5.1.1

Timepoint(s) of evaluation of this end point

A first interim analysis is to be performed when the first 171 events in the 1st co-primary outcome have been observed. If the assumptions are met, this will happen 32 months after the first patient was randomized. The second interim analysis is to be performed when the first 343 events in the 1st co-primary outcome have been observed (approximately 47 months after the first patient was randomized). The third interim analysis is to be performed when the first 514 events have been observed (approximately 59 (11) months after the first (last) patient was randomized). The final analysis is to be performed when 685 events have been observed. If the assumptions are met, this will happen 72 (24) months after the first (last) patient was randomized.

Una prima analisi ad interim dovrà essere eseguita all’avvenuta osservazione dei primi 171 eventi del primo end-point co-primario. Se le ipotesi sono confermate, ciò accadrà 32 mesi dopo la randomizzazione del primo paziente. La seconda analisi ad interim dovrà essere eseguita all’avvenuta osservazione dei primi 343 eventi del primo end-point co-primario (circa 47 mesi dopo la randomizzazione del primo paziente). La terza analisi ad interim dovrà essere eseguita all’avvenuta osservazione dei primi 514 eventi (circa 59 (11) mesi dopo la randomizzazione del primo (ultimo) paziente). L’analisi finale dovrà essere eseguita all’avvenuta osservazione di 685 eventi. Se le ipotesi sono confermate, ciò accadrà 72 (24) mesi dopo la randomizzazione del primo (ultimo) paziente.

E.5.2

Secondary end point(s)

1. Cardiovascular death 2. stroke 3. worsening of heart failure assessed by hospitalizations 4. acute coronary syndrome assessed by hospitalizations 5. time to recurrent atrial fibrillation 6. cardiovascular hospitalisations 7. all-cause hospitalisations 8. left ventricular function assessed by transthoracic echocardiography 9. quality of life changes assessed by EQ-5D and SF-12 10. cognitive function assessed by MoCA

1. Decesso per evento cardiovascolare 2. Ictus 3. Peggioramento dell’insufficienza cardiaca accertato mediante ricovero ospedaliero 4. Sindrome coronarica acuta accertata mediante ricovero ospedaliero 5. Periodo intercorrente tra le recidive di fibrillazione atriale 6. Ricoveri ospedalieri per eventi cardiovascolari 7. Ricoveri ospedalieri per altre cause 8. Funzionalità ventricolare sinistra accertata mediante ecocardiografia transtoracica 9. Qualità di vita accertata mediante EQ-5D e SF-12 10. Funzione cognitiva accertata mediante MoCA test

E.5.2.1

Timepoint(s) of evaluation of this end point

Evaluation of secondary end points no. 1-7 at the end of the trial (i.e. after 6 years). Evaluation of secondary end points no. 8-10 at month 24 after randomisation.

Analisi degli end-point secondari 1-7 al completamento dello Studio (cioè dopo 6 anni). Analisi degli end-point secondary 8-10 al mese 24 successivo alla randomizzazione.

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

E.6.5

Efficacy

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

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)

E.7.4

Therapeutic use (Phase IV)

Yes

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)

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

Terapia standard conform. alle attuali Linee ESC

usual care as defined by the current ESC guideline

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

192

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

European Union

Switzerland

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

EAST is an event-driven trial. The final analysis will be performed if 685 events in the 1st co-primary outcome have been observed. If the statistical assumptions are met, this will happen 6 years after the first patient has been randomised in the study.

Studio EAST è basato sugli eventi. L’analisi finale sarà eseguita all’avvenuta osservazione di 685 eventi del primo end-point co-primario. Se sono confermati i requisiti statistici, il completamento avverrà 6 anni dopo la randomiz. del primo pazient

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:

810

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

2000

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

500

F.4.2

For a multinational trial

F.4.2.1

In the EEA

2660

F.4.2.2

In the whole clinical trial

2810

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)

All medications and treatments applied during the EAST study are inline therapies approved by health authorities and marketed. They are used in line with European approval and in line with the current guidelines. The patients' treatment after termination of the study participation will be decided by the responsible investigator and will be in accordance with local clinical routine.

Tutti i farmaci e i trattamenti applicati durante lo Studio EAST sono terapie inline approvate dalle Autorità sanitarie competenti e in commercio. Il loro utilizzo è stato approvato dalle Autorità europee competenti e in linea con le direttive vigenti. La decisione sul trattamento dei pazienti al termine dello Studio spetta al Medico Sperimentatore Responsabile conformemente alla pratica clinica locale.

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

2012-10-29

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-09-18

P. End of Trial
P.	End of Trial Status	Ongoing

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