Clinical Trials Register

Summary
EudraCT Number:	2017-002485-40
Sponsor's Protocol Code Number:	REBOOT-CNIC
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:	2021-01-15
Trial 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

2017-002485-40

A.3

Full title of the trial

TREatment with Beta-blockers after myOcardial infarction withOut reduced ejection fracTion (REBOOT)

TREatment with Beta-blockers after myOcardial infarction withOut reduced ejection fracTion (REBOOT).

A.3.1

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

Treatment with beta-blockers after myocardial infarction without reduced ejection fraction

Trattamento con beta-bloccante dopo infarto miocardico senza ridotta frazione di eiezione

A.3.2

Name or abbreviated title of the trial where available

REBOOT

A.4.1

Sponsor's protocol code number

REBOOT-CNIC

A.5.4

Other Identifiers

Name:

REBOOT

Number:

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	CENTRO NACIONAL DE INVESTIGACIONES CARDIOVASCULARES CARLOS III
B.1.3.4	Country	Spain
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	Spain Goverment
B.4.2	Country	Spain
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	IRCCS ISTITUTO DI RICERCHE FARMACOLOGICHE MARIO NEGRI
B.5.2	Functional name of contact point	DIP. RICERCA CARDIOVASCOLARE
B.5.3	Address:
B.5.3.1	Street Address	VIA LA MASA 19
B.5.3.2	Town/ city	MILANO
B.5.3.3	Post code	21056
B.5.3.4	Country	Italy
B.5.6	E-mail	roberto.latini@marionegri.it

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	METOPROLOLO DOC GENERICI - 100 MG COMPRESSE 30 COMPRESSE
D.2.1.1.2	Name of the Marketing Authorisation holder	DOC GENERICI SRL
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.3.1	Product name	METOPROLOLO
D.3.2	Product code	[C07AB02]
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	METOPROLOLO
D.3.9.1	CAS number	37350-58-6
D.3.9.2	Current sponsor code	METOPROLOLO
D.3.9.3	Other descriptive name	METOPROLOL
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	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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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	ATENOLOLO AHCL - 50 MG COMPRESSE 14 COMPRESSE IN BLISTER PVC/PVDC/AL
D.2.1.1.2	Name of the Marketing Authorisation holder	ACCORD HEALTHCARE LIMITED
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.3.1	Product name	ATENOLOLO
D.3.2	Product code	[C07AB03]
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	ATENOLOLO
D.3.9.1	CAS number	29122-68-7
D.3.9.2	Current sponsor code	ATENOLOLO
D.3.9.3	Other descriptive name	ATENOLOL
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	50
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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	BISOPROLOLO ACTAVIS - 5 MG COMPRESSE 28 COMPRESSE IN BLISTER PVC/PVDC/AL
D.2.1.1.2	Name of the Marketing Authorisation holder	ACTAVIS GROUP PTC EHF
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.3.1	Product name	Bisoprololo
D.3.2	Product code	[C04AB07]
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	BISOPROLOLO FUMARATO
D.3.9.1	CAS number	66722-44-9
D.3.9.2	Current sponsor code	BISOPROLOLO
D.3.9.3	Other descriptive name	BISOPROLOL
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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	CARVEDILOLO RANBAXY - 25 MG COMPRESSE 30 COMPRESSE DIVISIBILI
D.2.1.1.2	Name of the Marketing Authorisation holder	RANBAXY ITALIA S.P.A.
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.3.1	Product name	Carvedilolo
D.3.2	Product code	[C07AG02]
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	CARVEDILOLO
D.3.9.1	CAS number	72956-09-3
D.3.9.2	Current sponsor code	CARVEDILOLO
D.3.9.3	Other descriptive name	CARVEDILOL
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	25
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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: 5
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	NEBIVOLOLO SANDOZ - 5 MG COMPRESSE 30 COMPRESSE IN BLISTER PVC/AL
D.2.1.1.2	Name of the Marketing Authorisation holder	SANDOZ S.P.A.
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.3.1	Product name	NEBIVOLOLO
D.3.2	Product code	[C07AB12]
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	NEBIVOLOLO
D.3.9.1	CAS number	99200-09-6
D.3.9.2	Current sponsor code	NEBIVOLOLO
D.3.9.3	Other descriptive name	NEBIVOLOL
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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

STEMI or NSTEMI patients being discharged from the index hospitalization with a LVEF>40% without previous heart failure

pazienti con STEMI o NSTEMI con frazione di eiezione del ventricolo sinistro >40% e senza insufficienza cardiaca pregressa

E.1.1.1

Medical condition in easily understood language

Patients discharged from an acute myocardial infarction-related admission without reduced cardiac function and without heart failure

Pazienti con infarto miocardico e funzione sistolica del l ventricolo sinistro conservata

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	20.0
E.1.2	Level	LLT
E.1.2	Classification code	10021758
E.1.2	Term	Infarct myocardial
E.1.2	System Organ Class	100000004849

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Incidence rate of the composite of ¿all-cause death, nonfatal reinfarction, or heart failure hospitalization¿.

incidenza cumulativa della combinazione di morte per ogni causa, reinfarto e ri-ospedalizzazione per insufficienza cardiaca.

E.2.2

Secondary objectives of the trial

1) Incidence rate of individual components of the primary outcome. 2) Incidence rate of cardiac mortality.

(1) incidenza cumulativa delle singole componenti dell¿endpoint primario; (2) incidenza cumulativa della morte cardiaca.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1) > 18 years old or 18 years old
2) STEMI or STEMI patient
3) LVEF >40%
4) INFORM CONSENT SIGNED

1) Età =18 anni,
2) ricoverati per trattamento invasivo di STEMI o NSTEMI (i.e. angiografia coronarica durante il ricovero indice),
3) LVEF>40% valutata con qualsiasi metodo nel corso del ricovero,
4) consenso informato firmato.

E.4

Principal exclusion criteria

1) Known allergy or intolerance to beta-blockers
2) Absolute contraindication to beta-blocker therapy according to treating physician judge
3) Prior history of HF, Killip class on admission or during hospitalization = II
4) Severe valvular heart disease (> 3+ for aortic or mitral insufficiency, aortic or mitral valve area =1.0 cm2).
5) Any condition (appart from AMI) that requires beta-blocker prescription on discharge according to treating physician judge
6) Any medical condition that, in the investigator´s judgment, would seriously limit life expectancy (less than one year),
7) Patients participating in other clinical trials.

1) Allergia o intolleranza note ai beta-bloccanti,
2) controindicazione assoluta ai beta-bloccanti, secondo il giudizio del Curante,
3) storia di insufficienza cardiaca, classe Killip=II alla ammissione o durante il ricovero,
4) valvulopatia grave (insufficienza aortica o mitralica >3+, area valvolare aortica o mitralica =1,0 cm2,
5) una condizione (eccettuato IMA), che richieda una prescrizione di beta-bloccante alla dimissione secondo il giudizio del Curante,
6) una condizione clinica che, a giudizio del Curante, può limitare significativamente la attesa di vita (< 1 anno),
7) paziente che partecipa ad un altro trial clinico.

E.5 End points

E.5.1

Primary end point(s)

To assess the benefits of beta-blocker maintenance therapy in patients discharged after an acute myocardial infarction (MI) with a left ventricular ejection fraction >40%. Beta-blocker treatment will be associated with a 20% reduction in the incidence rate of the primary composite endpoint: incidence rate of the composite of “all-cause death, non fatal reinfarction, or heart failure hospitalization”.

Valutare i benefici di una terapia prolungata con beta-bloccanti nei pazienti dimessi dopo un infarto miocardico acuto (AMI) con frazione di eiezione del VSx >40%. L'effetto atteso della terapia beta-bloccante è una riduzione del 20% della incidenza cumulativa dell’endpoint primario combinato: incidenza cumulativa della combinazione di morte per ogni causa, reinfarto e ri-ospedalizzazione per insufficienza cardiaca.

E.5.1.1

Timepoint(s) of evaluation of this end point

Minimum follow-up 2 years, maximum follow-up 3 years. Estimated median follow-up 2.75 years

Follow-up minimo di 2 anni e massimo di 3 anni. Tempo mediano stimato di follow-up: 2.75 anni.

E.5.2

Secondary end point(s)

Incidence rate of individual components of the primary outcome;; Incidence of cardiac mortality.

Incidenza cumulativa delle singole componenti dell¿endpoint primario;; Incidenza cumulativa della morte cardiaca

E.5.2.1

Timepoint(s) of evaluation of this end point

Minimum follow-up 2 years, maximum follow-up 3 years. Estimated median follow-up 2.75 years; Minimum follow-up 2 years, maximum follow-up 3 years. Estimated median follow-up 2.75 years

Follow-up minimo di 2 anni e massimo di 3 anni. Tempo mediano stimato di follow-up: 2.75 anni.; Follow-up minimo di 2 anni e massimo di 3 anni. Tempo mediano stimato di follow-up: 2.75 anni

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

E.6.4

Safety

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

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

Yes

E.8.1.7.1

Other trial design description

Verr¿ effettuato un esame della incidenza globale degli eventi in cieco

A blinded examination of the study overall event rate will be done.

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

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

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

A blinded examination of the study overall event rate
Patient follow up is done at 3 moments: 3, 15, and 36 months. After 36 months follow-up trial is finished.

Two years after last patient enrollment, all subjects without the last visit done will undergo this and the trial finished.

Verr¿ effettuato un esame della incidenza globale degli eventi in cieco. Le visite di follow-up saranno eseguite a 3,15,36 mesi.

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.1.1.1

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:

2000

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

6468

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

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

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

1000

F.4.2

For a multinational trial

F.4.2.1

In the EEA

8468

F.4.2.2

In the whole clinical trial

8468

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)

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

2018-07-26

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2018-12-12

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

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IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
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