Clinical Trials Register

Summary
EudraCT Number:	2018-001936-23
Sponsor's Protocol Code Number:	BRAKE-AF
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2018-08-02
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

Spain - AEMPS

A.2

EudraCT number

2018-001936-23

A.3

Full title of the trial

A multicenter, randomized, open-label, phase III clinical trial to compare the efficacy and safety of Ivabradine versus Digoxine in the chronic control of heart rate in patients with permanent atrial fibrillation under treatment with beta-blockers or calcium antagonists.
(IvaBRAdine blocK of funny current for heart rate control in permanEnt Atrial Fibrillation). BRAKE-AF study.

Ensayo clínico aleatorizado, multicéntrico, abierto, controlado, fase III, paralelo, para evaluar la eficacia y seguridad de Ivabradina versus Digoxina en el control crónico de la frecuencia cardíaca en pacientes con fibrilación auricular permanente en tratamiento con betabloqueantes o calcioantagonistas.

A.3.1

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

Multicenter study to evaluate the effect and safety of Ivabradine compared to Digoxin in the control of heart rate in patients with permanent atrial fibrillation.

Estudio multicéntrico para evaluar el efecto y la seguridad de Ivabradina en comparación a Digoxina en el control de la frecuencia cardíaca en pacientes con fibrilación auricular permanente.

A.3.2

Name or abbreviated title of the trial where available

BRAKE-AF study

Estudio BRAKE-AF

A.4.1

Sponsor's protocol code number

BRAKE-AF

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	Dr. Adolfo Fontenla Cerezuela
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	Instituto de Salud Carlos III
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	Dr. Adolfo Fontenla Cerezuela
B.5.2	Functional name of contact point	Servicio de Cardiología
B.5.3	Address:
B.5.3.1	Street Address	U. Arritmias, Servicio Cardiología, CAA, bloque B, 4ª planta, Avda de Córdoba, s/n
B.5.3.2	Town/ city	Madrid
B.5.3.3	Post code	28041
B.5.3.4	Country	Spain
B.5.4	Telephone number	3491390 8070
B.5.5	Fax number	34917792953
B.5.6	E-mail	adolforamon.fontela@salud.madrid.org

D. IMP Identification
D.IMP: 1
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	Digoxina Kern Pharma 0.25 mg comprimidos
D.2.1.1.2	Name of the Marketing Authorisation holder	Kern Pharma
D.2.1.2	Country which granted the Marketing Authorisation	Spain
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	Digoxine
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	DIGOXIN
D.3.9.1	CAS number	20830-75-5
D.3.9.4	EV Substance Code	SUB07135MIG
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	Ivabradina Kern Pharma 5 mg or 7.5 mg comprimidos EFG
D.2.1.1.2	Name of the Marketing Authorisation holder	Kern Pharma
D.2.1.2	Country which granted the Marketing Authorisation	Spain
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	Ivabradine
D.3.2	Product code	C01EB17
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	IVABRADINE
D.3.9.1	CAS number	155974-00-8
D.3.9.4	EV Substance Code	SUB08357MIG
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

Heart rate control in patients with chronic atrial fibrillation.

Control de la frecuencia cardíaca en pacientes con fibrilación auricular permanente.

E.1.1.1

Medical condition in easily understood language

Chronic atrial fibrillation.

Fibrilación auricular crónica.

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	10071668
E.1.2	Term	Permanent atrial fibrillation
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

To compare the effect of two treatment strategies with respect to the reduction of the mean daytime HR measured with Holter-ECG at three months and compare the safety of the two treatment strategies with respect to syncope, severe bradycardia and serious adverse reactions that condition hospitalization, emergency visit or result in death.

De eficacia: Comparar el efecto de dos estrategias de tratamiento con respecto a la reducción de la FC media diurna medida con Holter-ECG a los tres meses.
De seguridad: comparar la seguridad de las dos estrategias de tratamiento con respecto a sincope, bradicardia grave y reacciones adversas graves que condicionen hospitalización, visita a urgencias o produzcan la muerte.

E.2.2

Secondary objectives of the trial

To compare the effect of the two treatment strategies, and depending on the basic treatment, with respect to:
- Symptoms according to the EHRA Score scale evaluated at one and three months of treatment.
- Distance in the 6-minute test.
- Quality of life parameters analyzed in the questionnaires SF-36 and AFEQT.
- Average daytime FC measured with a Holter-ECG.
- FC at rest measured with an ECG.
- Maximum FC measured with a Holter-ECG.
- Average FC in 24 hours measured with a Holter-ECG.
- FC Delta (difference between maximum HR and mean HR) measured with a Holter-ECG.
- FC in moderate exercise measured with a Holter-ECG during the 6-minute test).

To compare the safety of the two treatment strategies with respect to:
- Bradycardia not serious.
- Any adverse reaction to the study drugs.
- Voluntary withdrawal of the drug by the patient
- Hospitalizations, emergency visits and mortality due to a major cardiovascular event during treatment with the study drugs.

Comparar el efecto de las dos estrategias de tratamiento, y en función del tratamiento de base, con respecto a:
- Síntomas de acuerdo a la escala EHRA Score.
- Distancia recorrida en el test de 6 minutos.
- Parámetros de calidad de vida analizados en los cuestionarios SF-36 y AFEQT.
- FC media diurna medida con un Holter-ECG.
- FC en reposo medida con un ECG.
- FC máxima medida con un Holter-ECG.
- FC media en 24 horas medida con un Holter-ECG.
- Delta de FC (diferencia entre FC máxima y FC media) medida con un Holter-ECG.
- FC en ejercicio moderado medida con un Holter-ECG durante la realización del test de 6 minutos).

Comparar la seguridad de las 2 estrategias de tratamiento con respecto a:
- Bradicardia no grave.
- Cualquier reacción adversa a los fármacos del estudio.
- Abandono voluntario del fármaco por parte del paciente
- Hospitalizaciones, visitas a urgencias y mortalidad por un evento cardiovascular mayor durante el tratamiento con los fármacos del estudio.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Age equal to or greater than 18 years.
2. Permanent FA at the time of randomization, with no prospect of cardioversion, antiarrhythmic treatment with group I or III drugs, or pulmonary vein ablation.
3. Symptoms attributable to AF associated with the presence of at least one of the following inadequate FC control criteria:
a) HR at rest> 110 bpm (on ECG performed in the 14 days prior to inclusion).
b) HR at rest between 80 and 110 bpm (on ECG performed in the 14 days prior to inclusion) and at least one of the following criteria:
i. HR in exercise of moderate intensity> 130 bpm (measured in an ergometry or in a Holter-ECG performed in the 60 days prior to inclusion).
ii. Average daytime HR ≥ 80 bpm (measured on a Holter-ECG performed in the 60 days prior to inclusion).
4. Be receiving treatment with beta-blockers or non-dihydropyridine calcium channel blockers (verapamil or diltiazem) at the maximum dose recommended or tolerated by the patient.
5. Be able to voluntarily give their informed consent (the subject himself, his legal representative or an impartial witness).
6. Blood test carried out in the 6 months prior to inclusion, including: blood count, thyroid hormones and creatinine, in order to rule out secondary causes of poor FC control. The creatinine figure will be used to calculate the creatinine clearance in order to adjust the dose of patients who are randomized to the Digoxin group.
7. Transthoracic echocardiogram to rule out, eg, severe valvular heart disease, hypertrophic cardiomyopathy. The one performed in the year prior to inclusion in the study will be considered acceptable provided that the patient's clinical situation has been stable in that period of time.

1. Edad igual o superior a 18 años.
2. FA permanente en el momento de la aleatorización, sin perspectiva de cardioversión, tratamiento antiarrítmico con fármacos del grupo I o III, o ablación de venas pulmonares.
3. Síntomas atribuibles a FA asociados a la presencia de al menos uno de los siguientes criterios de control inadecuado de la FC:
a) FC en reposo > 110 lpm (en ECG realizado en los 14 días previos a la inclusión).
b) FC en reposo entre 80 y 110 lpm (en ECG realizado en los 14 días previos a la inclusión) y al menos uno de los siguientes criterios:
i. FC en ejercicio de intensidad moderada > 130 lpm (medida en una ergometría o en un Holter-ECG realizados en los 60 días previos a la inclusión).
ii. FC media diurna ≥ 80 lpm (medida en un Holter-ECG realizados en los 60 días previos a la inclusión).
4. Estar recibiendo tratamiento con betabloqueantes o calcioantagonistas no dihidropiridínicos (verapamilo o diltiazem) a la dosis máxima recomendada o tolerada por el paciente.
5. Ser capaz de otorgar voluntariamente su consentimiento informado (el propio sujeto, su representante legal o ante testigo imparcial).
6. Analítica de sangre realizada en los 6 meses previos a la inclusión que incluya: hemograma, hormonas tiroideas y creatinina, de cara a descartar causas secundarias de un mal control de la FC. La cifra de creatinina se utilizará para calcular el aclaramiento de creatinina con el objetivo de poder ajustar la dosis de los pacientes que se aleatoricen al grupo de Digoxina.
7. Ecocardiograma transtorácico para descartar, por ej., valvulopatías graves, miocardiopatía hipertrófica. Se considerará aceptable el realizado en el año previo a la inclusión en el estudio siempre y cuando la situación clínica del paciente haya sido estable en ese periodo de tiempo.

E.4

Principal exclusion criteria

1. Previous treatment or known contraindication to Ivabradine or Digoxin.
2. Paroxysmal or intermittent complete AV block in patients not carrying a pacemaker.
3. Decompensated heart failure requiring inotropic and / or intravenous diuretics in the week prior to randomization or in NYHA functional class IV or on the cardiac transplant waiting list.
4. Acute pericarditis, acute myocarditis or constrictive pericarditis.
5. Obstructive hypertrophic cardiomyopathy.
6. Valvular disease requiring surgical or percutaneous correction.
7. Medical causes that justify poor control of heart rate: fever, anemia, hyperthyroidism, pheochromocytoma, etc.
8. Severe hypotension (blood pressure <90/50 mmHg).
9. Concomitant treatment with potent cytochrome P450 3A4 inhibitors such as azole antifungals (ketoconazole, itraconazole), macrolide antibiotics (clarithromycin, oral erythromycin, josamycin, telithromycin), HIV protease inhibitors (nelfinavir, ritonavir) and nefazodone.
10. Severe renal insufficiency (CrCl <30 ml / Kg / min) or in a hemodialysis program.
11. Severe hepatic insufficiency.
12. Major surgery (including cardiac surgery) in the month prior to randomization.
13. Severe concomitant illness that supposes a life expectancy of less than one year.
14. Impossibility of carrying out scheduled visits to the protocol.
15. Suspected pregnancy or confirmed pregnancy.
16. Participation in a clinical trial in the previous 6 months.

1. Tratamiento previo o contraindicación conocida a la Ivabradina o Digoxina.
2. Bloqueo AV completo paroxístico o intermitente en pacientes no portadores de marcapasos.
3. Insuficiencia cardiaca descompensada, que requiera inotrópicos y/o diuréticos intravenosos en la semana previa a la aleatorización o en clase funcional IV de la NYHA o en lista de espera de trasplante cardíaco.
4. Pericarditis aguda, miocarditis aguda o pericarditis constrictiva.
5. Miocardiopatía hipertrófica obstructiva.
6. Enfermedad valvular que requiera corrección quirúrgica o percutánea.
7. Causas médicas que justifiquen un mal control de la frecuencia cardiaca: fiebre, anemia, hipertiroidismo, feocromocitoma, etc.
8. Hipotensión grave (presión arterial < 90/50 mmHg).
9. Tratamiento concomitante con inhibidores potentes del citocromo P450 3A4 tales como antifúngicos azólicos (ketoconazol, itraconazol), antibióticos macrólidos (claritromicina, eritromicina por vía oral, josamicina, telitromicina), inhibidores de la proteasa del VIH (nelfinavir, ritonavir) y nefazodona.
10. Insuficiencia renal grave (ClCr < 30 ml/Kg/min) o en programa en hemodiálisis.
11. Insuficiencia hepática grave.
12. Cirugía mayor (incluida la cardiaca) en el mes previo a la aleatorización.
13. Enfermedad concomitante grave que suponga una expectativa de vida menor a un año.
14. Imposibilidad de realizar las visitas programadas en el protocolo.
15. Sospecha de embarazo o embarazo confirmado.
16. Participación en un ensayo clínico en los 6 meses previos.

E.5 End points

E.5.1

Primary end point(s)

Reducción de la Frecuencia Cardiaca media diurna registrada en Holter-ECG a los tres meses de tratamiento con Ivabradina o Digoxina.

Reduction of the mean daytime heart rate registered in Holter-ECG after three months of treatment with Ivabradine or Digoxin.

E.5.1.1

Timepoint(s) of evaluation of this end point

Three months

3 meses

E.5.2

Secondary end point(s)

1. Percentage of patients who experience a reduction in the scale of AF symptoms according to the EHRA Score modified at month and 3 months of treatment with Ivabradine or Digoxin.
2. Increase in the distance in the walking test 6 minutes after 3 months of treatment with Ivabradine or Digoxin.
3. Increase in the score obtained in global quality of life parameters analyzed by the SF-36 questionnaire after 3 months of treatment with Ivabradine or Digoxin.
4. Increase in the score obtained in parameters of quality of life quality of life associated with AF analyzed by the AFEQT questionnaire at 3 months of treatment with Ivabradine or Digoxin.
5. Reduction of the average daytime HR recorded in Holter-ECG after one month of treatment with Ivabradine or Digoxin.
6. Reduction of resting HR recorded on one ECG at one month and at 3 months of treatment with Ivabradine or Digoxin.
7. Reduction of the maximum HR recorded in Holter-ECG at one month and at 3 months of treatment with Ivabradine or Digoxin.
8. Reduction of the mean HR in 24 hours recorded in Holter-ECG at one month and at 3 months of treatment with Ivabradine or Digoxin.
9. Reduction of the HR delta (difference between maximum HR and mean HR in 24 hours) recorded in Holter-ECG at one month and at 3 months of treatment with Ivabradine or Digoxin.
10. Reduced HR in moderate exercise (maximum HR measured by Holter-ECG during the 6-minute walk test) during 3 months of treatment with Ivabradine or Digoxin.

1. Porcentaje de pacientes que experimentan una reducción en la escala de síntomas de FA de acuerdo al EHRA Score modificado al mes y a los 3 meses de tratamiento con Ivabradina o Digoxina.
2. Incremento en la distancia recorrida en el test de caminar 6 minutos a los 3 meses de tratamiento con Ivabradina o Digoxina.
3. Incremento en la puntuación obtenida en parámetros de calidad de vida global analizados por el cuestionario SF-36 a los 3 meses de tratamiento con Ivabradina o Digoxina.
4. Incremento en la puntuación obtenida en parámetros de calidad de vida calidad de vida asociados a FA analizados por el cuestionario AFEQT a los 3 meses de tratamiento con Ivabradina o Digoxina.
5. Reducción de la FC media diurna registrada en Holter-ECG al mes de tratamiento con Ivabradina o Digoxina.
6. Reducción de la FC en reposo registrada en un ECG al mes y a los 3 meses de tratamiento con Ivabradina o Digoxina.
7. Reducción de la FC máxima registrada en Holter-ECG al mes y a los 3 meses de tratamiento con Ivabradina o Digoxina.
8. Reducción de la FC media en 24 horas registrada en Holter-ECG al mes y a los 3 meses de tratamiento con Ivabradina o Digoxina.
9. Reducción del delta de FC (diferencia entre la FC máxima y la FC media en 24 horas) registrada en Holter-ECG al mes y a los 3 meses de tratamiento con Ivabradina o Digoxina.
10. Reducción de la FC en ejercicio moderado (FC máxima medida por Holter-ECG durante la realización del test de caminar 6 minutos) los 3 meses de tratamiento con Ivabradina o Digoxina.

E.5.2.1

Timepoint(s) of evaluation of this end point

Three months after the start of treatment.

A los tres meses de iniciado el tratamiento.

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

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

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

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

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

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

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

Última visita del último paciente

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

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:

200

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

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

232

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.

Ninguno

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

2018-09-21

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2018-09-18

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2022-06-30

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