Clinical Trials Register

Summary
EudraCT Number:	2019-002946-19
Sponsor's Protocol Code Number:	1245-0204
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:	2020-01-10
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

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Spain - AEMPS

A.2

EudraCT number

2019-002946-19

A.3

Full title of the trial

A multicentre, randomised, double-blind, 90-day superiority trial to evaluate the effect on clinical benefit, safety and tolerability of once daily oral EMPagliflozin 10 mg compared to placebo, initiated in patients hospitalised for acUte heart faiLure (de novo or decompensated chronic HF) who have been StabilisEd (EMPULSE)

Un ensayo de superioridad multicéntrico, aleatorizado, doble ciego y de 90 días de duración para evaluar el efecto sobre el beneficio clínico, la seguridad y la tolerabilidad de la empagliflozina 10 mg una vez al día por vía oral en comparación con el placebo, iniciada en pacientes hospitalizados por insuficiencia cardíaca aguda (de novo o IC crónica descompensada) que han sido estabilizados (EMPULSE)

A.3.1

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

A study to test the effect of empagliflozin in patients who are in hospital for acute heart failure

Un estudio para evaluar el efecto de la empagliflozina en pacientes que están hospitalizados por insuficiencia cardíaca aguda

A.3.2

Name or abbreviated title of the trial where available

EMPULSE

A.4.1

Sponsor's protocol code number

1245-0204

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	Boehringer Ingelheim España, S.A.
B.1.3.4	Country	Spain
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	Boehringer Ingelheim España, S.A.
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	Boehringer Ingelheim Pharma GmbH & Co. KG
B.5.2	Functional name of contact point	CT Disclosure and Data Transparency
B.5.3	Address:
B.5.3.1	Street Address	Binger Strasse 173
B.5.3.2	Town/ city	Ingelheim am Rhein
B.5.3.3	Post code	55216
B.5.3.4	Country	Germany
B.5.4	Telephone number	34934045100
B.5.5	Fax number	34934045580
B.5.6	E-mail	clintriage.rdg@boehringer-ingelheim.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	JARDIANCE
D.2.1.1.2	Name of the Marketing Authorisation holder	Boehringer Ingelheim International GmbH
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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	Empagliflozin
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	empagliflozin
D.3.9.1	CAS number	864070-44-0
D.3.9.3	Other descriptive name	EMPAGLIFLOZIN
D.3.9.4	EV Substance Code	SUB35915
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	10
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Film-coated tablet
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Heart Failure

Insuficiencia Cardíaca

E.1.1.1

Medical condition in easily understood language

Heart Faliure

Insuficiencia Cardíaca

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	10019279
E.1.2	Term	Heart failure
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

1. To assess whether in-hospital administration of empagliflozin results in improvements in HF-related clinical events and patient-reported outcomes (death, HFE and KCCQ-CSS as a measure of health status (symptoms and physical limitations)) in patients hospitalised for acute heart failure (de novo or decompensated chronic HF) and after initial stabilisation.

1. Evaluar si la administración hospitalaria de empagliflozina mejora los resultados relacionados con la IC (beneficio clínico que incluye la muerte, acontecimientos de insuficiencia cardíaca [AIC] y la carga de los síntomas y limitaciones físicas según la puntuación de resumen clínico del Cuestionario de cardiomiopatía de Kansas City [Kansas City Cardiomyopathy questionnaire, KCCQ]) en pacientes hospitalizados por insuficiencia cardíaca aguda (de novo o IC crónica descompensada) y después de la estabilización inicial.

E.2.2

Secondary objectives of the trial

1. To further assess whether it is safe to start empagliflozin in patients admitted to hospital in this setting

1. Evaluar en mayor profundidad si es seguro iniciar la administración de empagliflozina en pacientes hospitalizados en este contexto

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Currently hospitalised for the primary diagnosis of acute heart failure (de novo or decompensated chronic HF), regardless of ejection fraction (EF). Patients with a diagnosis of hospitalized heart failure must have HF symptoms at the time of hospital admission
2. Evidence of left ventricular ejection fraction (LVEF, either reduced or preserved EF) as per local reading preferably measured during current hospitalisation or in the 12 months prior to randomisation
3. Patients must be randomised after at least 24 hours and no later than 5 days after admission, as early as possible after stabilization and while still in hospital
4. Patients must fulfil the following stabilisation criteria (while in the hospital):
- SBP ≥100mm Hg and no symptoms of hypotension in the preceding 6 hours,
- no increase in i.v. diuretic dose for 6 hours prior to randomisation,
- no i.v. vasodilators including nitrates within the last 6 hours prior to randomisation
- no i.v. inotropic drugs for 24 hours prior to randomisation.
5. Elevated NT-proBNP ≥ 1600pg/mL or BNP ≥400 pg/mL according to the local lab, for patients without atrial fibrillation (AF); or elevated NT-proBNP ≥ 2400pg/mL or BNP ≥600 pg/mL for patients with AF, measured during the current hospitalization or in the 72 hours prior to hospital admission,. For patients treated with an angiotensin receptor neprilysin inhibitor (ARNI) in the previous 4 weeks prior to randomisation, only NT-proBNP values should be used
6. HF episode leading to hospitalisation must have been treated with a minimum dose of 40 mg of i.v. furosemide (or equivalent i.v. loop diuretic defined as 20 mg of torasemide or 1 mg of bumetanide)
7. Further Inclusion Criteria Apply

1. Paciente hospitalizado actualmente con diagnóstico principal de insuficiencia cardíaca aguda (de novo o IC crónica descompensada), independientemente de la fracción de eyección (FE). Los pacientes hospitalizados con diagnóstico de insuficiencia cardíaca deben presentar síntomas de IC en el momento del ingreso hospitalario.
2. Evidencia de fracción de eyección ventricular izquierda (FEVI, ya sea FE reducida o preservada) según la lectura local, preferiblemente determinada durante la hospitalización actual o en los 12 meses previos a la aleatorización.
3. Los pacientes deben ser aleatorizados después de al menos 24 horas y no más de 5 días después del ingreso, tan pronto como sea posible después de la estabilización y mientras aún permanezcan hospitalizados.
4. Los pacientes deben cumplir los siguientes criterios de estabilización (mientras permanecen hospitalizados):
- PAS ≥ 100 mm Hg y sin síntomas de hipotensión en las 6 horas anteriores,
- sin aumento de la dosis del diurético i.v. durante las 6 horas previas a la aleatorización,
- sin vasodilatadores i.v., incluyendo los nitratos, durante las 6 horas previas a la aleatorización,
- sin fármacos inotrópicos i.v. durante las 24 horas previas a la aleatorización.
5. Elevación de NT-proBNP ≥ 1600 pg/ml o BNP ≥ 400 pg/ml según el laboratorio local, en pacientes sin fibrilación auricular (FA); o elevación de NT-proBNP ≥ 2400 pg/ml o BNP ≥ 600 pg/ml en pacientes con FA, determinado durante la hospitalización actual o en las 72 horas previas al ingreso hospitalario. En los pacientes tratados con un inhibidor de los receptores de angiotensina y neprilisina (IRAN) en las 4 semanas previas a la aleatorización, solo deben usarse los valores de NT-proBNP.
6. El episodio de IC que conduce a la hospitalización debe haber sido tratado con una dosis mínima de 40 mg de furosemida i.v. (o un diurético del asa i.v. equivalente definido como 20 mg de torasemida o 1 mg de bumetanida).
7. Se aplican otros criterios de inclusión

E.4

Principal exclusion criteria

1. Cardiogenic shock
2. Current hospitalisation for acute heart failure primarily triggered by pulmonary embolism, cerebrovascular accident, or acute myocardial infarction (AMI)
3.Current hospitalisation for acute heart failure not caused primarily by intravascular volume overload;
4. Below interventions in the past 30 days prior to randomisation or planned during the study:
- Major cardiac surgery, or TAVI (Transcatheter Aortic Valve Implantation), or PCI, or Mitraclip
- All other surgeries that are considered major according to investigator judgement
- Implantation of cardiac resynchronisation therapy (CRT) device
- cardiac mechanical support implantation
- Carotid artery disease revascularisation (stent or surgery)
5. Acute coronary syndrome / myocardial infarction, stroke or transient ischemic attack (TIA) in the past 90 days prior to randomisation
6. Heart transplant recipient, or listed for heart transplant with expectation to receive a transplant during the course of this trial (according to investigator judgement), or planned for palliative care for HF, or currently using left ventricular assist device (LVAD) or intra-aortic balloon pump (IABP) or any other type of mechanical circulatory support, or patients on mechanical ventilation, or patients with planned inotropic support in an outpatient setting
7. Haemodynamically significant (severe) uncorrected primary cardiac valvular disease planned for surgery or intervention during the course of the study (note: secondary mitral regurgitation or tricuspid regurgitation due to dilated cardiomyopathy is not excluded unless planned for surgery or intervention during the course of the study)
8. Impaired renal function, defined as eGFR < 20 mL/min/1.73 m2 as measured during hospitalization (latest local lab measurement before randomisation) or requiring dialysis
9. Type 1 Diabetes Mellitus (T1DM)
10. History of ketoacidosis, including diabetic ketoacidosis (DKA)
11. Further Exclusion Criteria Apply

1. Choque cardiogénico
2. Hospitalización actual por insuficiencia cardíaca aguda
3. Hospitalización actual por insuficiencia cardíaca aguda no causada principalmente por sobrecarga del volumen intravascular
4. Alguna de las siguientes intervenciones en los últimos 30 días previos a la aleatorización o planificadas durante el estudio:
- Cirugía cardíaca mayor, IVAT (implante de válvula aórtica transcatéter), intervención coronaria percutánea (ICP) o Mitraclip
- Cualquier otra intervención quirúrgica que sea considerada mayor a juicio del investigador
- Implantación de dispositivo de tratamiento de resincronización cardíaca (TRC)
- Implante de soporte mecánico cardíaco
- Revascularización de arteriopatía carotídea (stent o cirugía)
5. Sindrome coronario agudo/infarto de miocardio, accidente cerebrovascular o accidente isquémico transitorio (AIT) en los últimos 90 días previos a la aleatorización
6. Recepción de un trasplante de corazón, o en la lista de espera para trasplante de corazón con la expectativa de recibir un trasplante durante el transcurso de este ensayo (según el criterio del investigador), o programación para recibir cuidados paliativos para la IC, o uso actual de un dispositivo de asistencia ventricular izquierda (DAVI) o balón de contrapulsación intraaórtico (BCIA) o cualquier otro tipo de soporte circulatorio mecánico, o pacientes con ventilación mecánica, o pacientes con soporte inotrópico programado en un entorno ambulatorio
7. Valvulopatía cardíaca primaria no corregida hemodinámicamente significativa (grave) con cirugía o intervención programada durante el curso del estudio (nota: la regurgitación mitral secundaria o la regurgitación tricuspídea debido a miocardiopatía dilatada no supone un criterio de exclusión, a menos que haya programada una cirugía o intervención durante el curso del estudio) desencadenada principalmente po runa embolia pulmonar, un accidente cerebrovascular o un infarto agudo de miocardio (IAM)
8. Insuficiencia renal definida como TFGe < 20 ml/min/1.73 m2 determinada durante la hospitalización (última determinación del laboratorio local antes de la aleatorización) o que requiere diálisis
9. Diabetes Mellitus Tipo 1 (DM1)
10. Antecedentes de cetoacidosis, incluida la cetoacidosis diabética (CAD)
11. Se aplican otros criterios de exclusión

E.5 End points

E.5.1

Primary end point(s)

1. The net clinical benefit, a composite of death, number of heart failure events (HFE) (including hospitalisations for heart failure (HHFs), urgent heart failure visits and unplanned outpatient visits), time to first HFE and change from baseline in KCCQ-CSS after 90 days of treatment.

1. Beneficio clínico neto, un compuesto de muerte, número de acontecimientos de insuficiencia cardíaca (AIC) (incluidas hospitalizaciones por insuficiencia cardíaca (HIC), visitas de urgencia por insuficiencia cardíaca y visitas ambulatorias no programadas), tiempo hasta el primer AIC y cambio respecto al inicio del Cuestionario de cardiomiopatía de Kansas City – Puntuación de resumen clínico (Kansas City Cardiomyopathy Questionnaire – Clinical Summary Score [KCCQ-CSS]) después de 90 días de tratamiento.

E.5.1.1

Timepoint(s) of evaluation of this end point

1. Baseline and after 90 days of treatment

1. Al inicio y después de 90 días de tratamiento

E.5.2

Secondary end point(s)

1. Proportion of patients with an improvement in KCCQ-CSS of ≥ 10 points.
2. Change from baseline in KCCQ-CSS after 90 days of treatment.
3. Change from baseline in log-transformed N-Terminal Pro-Brain Natriuretic Peptide (NTproBNP) level over 30 days of treatment (area under the curve (AUC)).
4. Days alive and out of hospital from study drug initiation until 30 days after initial hospital discharge.
5. Days alive and out of hospital from study drug initiation until 90 days after randomisation.
6. Time to first occurrence of CV death or HFE until end of trial visit.
7. Occurrence of HHF until 30 days after initial hospital discharge.
8. Occurrence of chronic dialysis or renal transplant or sustained reduction of ≥40% eGFR Chronic Kidney Disease Epidemiology Collaboration Equation ((CKD-EPI)cr), or
-sustained eGFR (CKD-EPI)cr <15 mL/min/1.73 m2 for patients with baseline eGFR ≥30 mL/min/1.73 m2
-sustained eGFR (CKD-EPI)cr <10 mL/min/1.73 m2 for patients with baseline eGFR <30 mL/min/1.73 m2
9. Diuretic effect as assessed by weight loss per mean daily loop diuretic dose after 15 days of treatment.
10. Diuretic effect as assessed by weight loss per mean daily loop diuretic dose after 30 days of treatment.

1. Proportion of patients with an improvement in KCCQ-CSS of ≥ 10 points
2. Cambio respecto al inicio en el custionario KCCQ-CSS después de 90 días de tratamiento
3. Cambio respecto al inicio en el nivel de prohormona N-terminal del péptido natriurético cerebral (NT-proBNP) transformado logarítmicamente durante 30 días de tratamiento (área bajo la curva, AUC)
4. Días de supervivencia y fuera del hospital desde el inicio del fármaco del estudio hasta 30 días después del alta hospitalaria inicial
5. Días de supervivencia y fuera del hospital desde el inicio del fármaco del estudio hasta 90 días después de la aleatorización
6. Tiempo hasta la primera aparición de muerte por causas cardiovasculares o AIC hasta la visita final del ensayo
7. Aparición de HIC hasta 30 días después del alta hospitalaria inicial
8. Aparición de diálisis crónica o trasplante renal o reducción mantenida ≥ 40 % de la tasa de filtración glomerular estimada (TFGe), Ecuación de la Colaboración epidemiológica para la enfermedad renal crónica ((CKD-EPI)cr [Chronic Kidney Disease Epidemiology Collaboration Equation]), o
- TFGe mantenida (CKD-EPI)cr <15 mL/min/1.73 m2 en pacientes con una TFGe inicial ≥30 mL/min/1.73 m2
- TFGe mantenida (CKD-EPI)cr <10 mL/min/1.73 m2 en pacientes con una TFGe inicial <30 mL/min/1.73 m2
9. Efecto diurético evaluado por la pérdida de peso según la dosis media diaria de diurético del asa después de 15 días de tratamiento
10. Efecto diurético evaluado por la pérdida de peso según la dosis media diaria de diurético del asa después de 30 días de tratamiento

E.5.2.1

Timepoint(s) of evaluation of this end point

1. After 90 days of treatment
2. Baseline and after 90 days of treatment
3. Baseline and after 30 days of treatment
4. 30 days after initial hospital discharge
5. 90 days after randomisation
6. End of Trial Visit (day 90 or 97 after randomisation)
7. 30 days after initial hospital discharge
8. End of Trial Visit (day 90 or 97 after randomisation)
9. After 15 days of treatment
10. After 30 days of treatment

1. Después de 90 días de tratamiento
2. Al inicio y después de 90 días de tratamiento
3. Al inicio y después de 90 días de tratamiento
4. 30 días después del alta hospitalaria inicial
5. 90 días después de la aleatorización
6. Visita final del ensayo (día 90 o 97 después de la aleatorización)
7. 30 días después del alta hospitalaria inicial
8. Visita final del ensayo (día 90 o 97 después de la aleatorización)
9. Después de 15 días de tratamiento
10. Después de 30 días de 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

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

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Belgium

Canada

China

Czech Republic

Denmark

Germany

Hungary

Italy

Japan

Netherlands

Norway

Poland

Spain

Sweden

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

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

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

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:

300

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

200

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

415

F.4.2.2

In the whole clinical trial

500

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)

Patients will continue with standard medical care. Patients receive SOC during study and will continue. Study medication is on top.

Los pacientes continuarán con el tratamiento estándar. Los pacientes reciben el tratamiento estándar durante el estudio y continuarán haciéndolo. La medicación en estudio es complementaria.

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

2020-02-25

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2020-02-13

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2021-06-02

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials