Clinical Trials Register

Summary
EudraCT Number:	2017-004073-14
Sponsor's Protocol Code Number:	1245-0168
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2021-02-09
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

2017-004073-14

A.3

Full title of the trial

A phase III randomised, double-blind trial to evaluate the effect of 12
weeks treatment of once daily EMPagliflozin 10 mg compared with placebo
on ExeRcise ability and heart failure symptoms, In patients with chronic
HeArt FaiLure with reduced Ejection Fraction (HFrEF) (EMPERIAL-reduced)

Studio di fase III randomizzato in doppio cieco, volto a valutare l’effetto di 12 settimane di trattamento con empagliflozin 10mg una volta al dì, confronto a placebo, sulla capacità di esercizio fisico ed i sintomi di scompenso cardiaco in pazienti con scompenso cardiaco cronico con frazione ridotta di eiezione (EMPERIAL – reduced)

A.3.1

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

This study tests empagliflozin in patients with chronic heart failure with reduced ejection fraction (HFrEF). The study looks at how far patients can walk in 6 minutes and at their heart failure symptoms

Studio per valutare empagliflozin in pazienti con scompenso cardiaco cronico con frazione ridotta di eiezione.

A.3.2

Name or abbreviated title of the trial where available

EMPERIAL – reduced

A.4.1

Sponsor's protocol code number

1245-0168

A.5.4

Other Identifiers

Name:

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	BOEHRINGER-INGELHEIM ITALIA S.P.A.
B.1.3.4	Country	Italy
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 Italia Spa
B.4.2	Country	Italy
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Boehringer Ingelheim
B.5.2	Functional name of contact point	QRPE PSC CT Information Disclosure
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	00498002430127
B.5.5	Fax number	00498008217119
B.5.6	E-mail	clintriage.rdg@boehringeringelheim.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.3.2	Product code	[-]
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.3.9.2	Current sponsor code	-
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	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
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

Chronic Heart Failure with reduced Ejection Fraction (HFrEF)

pazienti con scompenso cardiaco cronico con frazione ridotta di eiezione

E.1.1.1

Medical condition in easily understood language

Chronic Heart Failure with reduced Ejection Fraction (HFrEF)

pazienti con scompenso cardiaco cronico con frazione ridotta di eiezione

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	10011949
E.1.2	Term	Decompensation cardiac
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

The primary objective of the study is to evaluate the effect of
empagliflozin 10 mg versus placebo on exercise ability using the 6
minute walk test in patients with chronic HF with reduced ejection
fraction (LVEF = 40%)

Obiettivo primario dello studio è valutare l’effetto di empagliflozin 10mg verso placebo sulla capacità di esercizio fisico usando il test del cammino in 6 minuti (6 minute walk test o 6MWT) in pazienti con scompenso cardiaco cronico e frazione di eiezione ridotta (LVEF = 40%)

E.2.2

Secondary objectives of the trial

Secondary objectives are to assess Patient-Reported Outcome (PRO)

Obiettivi secondari saranno le valutazioni dei questionari compilati dai pazienti (Patient-Reported Outcomes, o PRO).

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Of full age of consent (according to local legislation, usually = 18
years) at screening.
2. Male or female patients. Women of childbearing potential (WOCBP)1
must be ready and able to use highly effective methods of birth control
per ICH M3 (R2) that result in a low failure rate of less than 1% per year
when used consistently and correctly. A list of contraception methods
meeting these criteria is provided in the patient information.
3. Signed and dated written informed consent in accordance with ICHGCP
and local legislation prior to admission to the trial
4. 6MWT distance =350 m at screening and at baseline.
5. Patients with chronic HF diagnosed for at least 3 months before Visit 1
and currently in NYHA class II-IV
6. Chronic HF with reduced EF defined as LVEF = 40 % as per
echocardiography at Visit 1 as per local reading (obtained under stable
condition).
7. Elevated NT-proBNP > 450 pg/ml for patients without atrial fibrillation (AF) OR NT-proBNP > 600 pg/ml for patients with AF as analysed at the Central laboratory at Visit 1
8. Patients must be clinically stable and on appropriate and stable dose
of medical therapy for HF (such as ACEi, ARB, ß-blocker, oral diuretics,
MRA, ARNI, ivabradine), consistent with prevailing CV guidelines, stable
for at least 4 weeks prior to Visit 1(screening) with the exception of
diuretics which must have been stable for at least two weeks prior to
Visit 1. The investigator must document the reason in case the patient is not on such medication or if not on target dose of any heart failure medication as per local guidelines.
9. Clinically stable at randomization with no signs of heart failure
decompensation (as per investigator judgement).
10. Appropriate use of medical devices such as cardioverter defibrillator
(ICD) or a cardiac resynchronization therapy (CRT) consistent with
prevailing local or international CV guidelines, and if a device is required,
it must have been implanted for at least 3 months prior to visit 1 for CRT
and 1 month prior to visit 1 for ICD.

1. Pazienti maggiorenni allo screening.
2. Pazienti di entrambi i sessi. Donne in età fertile1 devono essere in grado e disposte ad usare metodi contraccettivi ad alta efficacia secondo le ICH M3 (R2) che risultano in un tasso di fallimento inferiore all’1% annuo se usati correttamente e continuativamente. Una lista metodi contraccettivi con tali caratteristiche viene fornita nell’informativa al paziente.
3. Firma e data sul modulo di consenso informato in accordo alle ICH-GCP e normative locali, prima dell’ammissione allo studio.
4. Distanza camminata nel 6MWT =350 mt allo screening ed al baseline.
5. Pazienti con diagnosi di scompenso da almeno 3 mesi prima della visita 1e correntemente nella classe NYHA II-IV
6. Scompenso cardiaco con frazione ridotta di eiezione definita da LVEF =40% come da referto ecocardiografico effettuato localmente alla visita 1 (in condizioni stabili).
7. Valori elevati di NT-proBNP > 450 pg / ml per i pazienti senza fibrillazione atriale (FA) O NT-proBNP> 600 pg / ml per i pazienti con FA, come da referto del laboratorio centralizzato alla visita 1.
8. Pazienti devono essere clinicamente stabili e trattati con dosaggio stabile appropriato di terapie mediche per lo scompenso (ad es. ACEi, ARB, ß-bloccanti, diuretici orali, MRA, ARNI, ivabradina), in coerenza con le linee guida CV vigenti, stabili pe almeno 4 settimane prima della visita 1 (screening) fatta eccezione per i diuretici che devono essere stabili da almeno 2 settimane prima della visita 1. Il medico dello studio deve documentare nel caso cui il paziente non sia in terapia con questo tipo di medicinali o non prenda il dosaggio terapeutico di qualunque terapia per lo scompenso secondo linee guida locali.
9. Clinicamente stabile alla randomizzazione senza segni di decompensazione dello scompenso (secondo giudizio del medico sperimentatore).
10. Uso appropriato di device medici quali defibrillatore cardio-invertitore (ICD) o terapia di ri-sincronizzazione cardiaca (CRT) consistente con le linee guida locali o internazionali prevalenti . Laddove il device sia necessario, deve essere stato impiantato almeno 3 mesi prima della visita 1 per il CRT e 1 mese prima per la CRT.

E.4

Principal exclusion criteria

1. Myocardial infarction (increase in cardiac enzymes in combination
with symptoms of ischaemia or newly developed ischaemic ECG
changes), coronary artery bypass graft surgery or other major
cardiovascular surgery, stroke or TIA in past 90 days prior to Visit 1
2. Acute decompensated HF (exacerbation of chronic HF) requiring
intravenous (i.v.) diuretics, i.v. inotropes or i.v. vasodilators, or left
ventricular assist device within 4 weeks prior to Visit 1, and/or during
screening period until Visit 2
3. Previous or current randomisation in another Empaglifozin Heart Failure
trial (i.e. studies 1245.110, 1245.121, 1245-0167)
4. Type 1 Diabetes Mellitus (T1DM)
5. Impaired renal function, defined as eGFR < 20 mL/min/1.73 m2
(CKD-EPIcr) or requiring dialysis, as determined at Visit 1
6. Symptomatic hypotension or a SBP < 100 mmHg at Visit 1 or 2
7. Systolic blood pressure (SBP) = 180 mmHg at Visit 1 or 2, or SBP
>160mmHg at both Visit 1 and 2
8. Atrial fibrillation or atrial flutter with a resting heart rate >110 bpm
documented by ECG at Visit 1 (Screening)
9. Unstable angina pectoris in past 30 days prior to Visit 1
10. Largest distance walked in 6 minutes (6MWTD) at baseline <100m.
11. Any presence of condition that precludes exercise testing such as:
- claudication,
- uncontrolled (according to investigator judgement) bradyarrhythmia or
tachyarrhythmia,
- significant musculoskeletal disease,
- primary pulmonary hypertension,
- severe obesity (body mass index =40.0 kg/m2),
- orthopedic conditions that limit the ability to walk (such as arthritis in
the leg, knee or hip injuries)
- amputation with artificial limb without stable prosthesis function for
the past 3 months
- Any condition that, in the opinion of the investigator, would
contraindicate the assessment of 6MWT
12. Patients in a structured (according to Investigator judgement)
exercise training program in the 1 month prior to screening or planned
to start one during the course of this trial.
13. Planned implantation of ICD or CRT during the course of the trial.
14. Treatment with i.v. iron therapy or erythropoietin within 3 months
prior to screening
15. Treatment with i.v. iron therapy or erythropoietin within 3 months
prior to screening
16. Further exclusion criteria applies

1. Infarto del miocardio (aumento degli enzimi cardiaci in combinazione con sintomatologia ischemica o nuovi segni di ischemia insorta come da ECG), chirurgia di innesto bypass coronarico od altro intervento cardiovascolare rilevante, ictus od attacco ischemico transitorio nei 90 giorni precedenti la visita 1.
2. Scompenso decompensato in acuto (esacerbazione) che richieda somministrazione i.v. di diuretici, farmaci inotropi o vasodilatatori o dispositivi per il l’azione ventricolare sinistra entro 4 settimane prima della visita 1 e/o durante lo screening fino alla Visita 2.
3. Precedente o corrente randomizzazione ad altri studi clinici sullo scompenso cardiaco con Empaglifozin (i.e. studi 1245.110, 1245.121, 1245-0168)
4. Diabete mellito di tipo 1 (T1DM)
5. Funzione renale compromessa definita da valori eGFR < 20 mL/min/1.73 m2 (CKD-EPIcr) o che richieda dialisi, determinate alla Visita 1.
6. Ipotensione sintomatica o pressione sistolica (SBP) < 100 mmHg alla Visita 1 o 2
7. SBP = 180 mmHg alla Visita 1 o 2 o SBP >160mmHg ad entrambe le visite 1 e 2
8. Fibrillazione atriale o flutter atriale con battito cardiaco a riposo > 110 bpm documentato da ECG
Alla visita 1 (Screening).
9. Angina pectoris instabile nei 30 giorni precedenti la visita 1.
10. Massima distanza camminata nella prova del cammino in 6 minuti (6MWTD) al baseline <100m.
11. Qualunque condizione che precluda la corretta espletazione dei test di esercizio fisico, quale:
-claudicatio
-bradiaritmie o tachiaritmie incontrollate (secondo giudizio del medico sperimentatore)
-patologia muscolo-scheletrica significativa
-ipertensione polmonare primaria
-obesità severa (BMI =40.0 kg/m2),
-condizioni ortopediche che limitino la capacità di camminare (ad es. artrite agli arti inferiori, danno al ginocchio o all’anca)
-amputazione con presenza di arto artificiale senza protesi stabile per i 3 mesi precedenti
-qualunque condizione che a giudizio del medico sperimentatore controindichi la valutazione della prova del 6MWT.
12. Pazienti che partecipano a programmi di training strutturati (a giudizio del medico sperimentatore) nel mese precedente lo screening o che ne pianifichino l’inizio durante il corso dello studio.
13. Riceventi trapianto cardiaco o in lista per trapianto
14. Presenza di impianto di dispositivo di assistenza ventricolare (LVAD)
15. Cardiomiopatia dovuta a patologie infiltrative (e.g. amiloidosi), patologie da accumulo
(e.g. emocromatosi, Fabry disease), distrofie muscolari, cardiomiopatie con cause reversibili (e.g. da stress), cardiomiopatie ipertrofiche ostruttive o nota costrizione pericardica.
16. Qualunque patologia cardio valvolare severa (ostruttiva o da rigurgito) che rappresenti un fattore di rischio per la conduzione del 6MWT o che ci si aspetti possa portare a intervento chirurgico durante il periodo dello studio – secondo l’opinione del medico sperimentatore.

Per gli altri criteri, fare riferimento alla sinossi in italiano

E.5 End points

E.5.1

Primary end point(s)

1. The primary endpoint is the change from baseline to week 12 in exercise capacity as measured by the distance walked in 6 minutes in standardised conditions

1) Variazione dal basale alla settimana 12 nella capacità di esercizio fisico misurata in distanza camminata in 6 minuti.

E.5.1.1

Timepoint(s) of evaluation of this end point

1. Week 0 and Week 12

1) Settimana 0 e Settimana 12

E.5.2

Secondary end point(s)

1. Change from baseline to week 12 in Kansas City Cardiomyopathy
Questionnaire (KCCQ) Total Symptom Score (TSS)
2. Change from baseline to week 12 in Chronic Heart Failure
Questionnaire Self- Administered Standardized format (CHQ-SAS)
dyspnea score
3. Change from baseline to week 6 in exercise capacity as measured by
the distance walked in 6 minutes
4. Change from baseline in Clinical Congestion Score at week 12
5. Change from baseline in Patient Global Impression of Severity (PGI-S)
of Heart Failure Symptoms at week 12
6. Change from baseline in Patient Global Impression of Dyspnea
Severity at week 12
7. Patient Global Impression of Change (PGI-C) in Heart Failure
Symptoms at week 12
8. Patient Global Impression of Change in Dyspnea at week 12
9. Change from baseline in N-terminal pro-brain natriuretic peptide
(NTproBNP) at week 12

Endpoints Secondari Chiave:
1. Variazione dal basale alla settimana 12 nel Kansas City Cardiomyopathy Questionnaire (KCCQ) Total Symptom Score (TSS);
2. Variazione dal basale alla settimana 12 nel Chronic Heart Failure Questionnaire Self-Administered Standardized format (CHQSAS) dyspnea score;

Altri Endpoints Secondari:
3. Variazione dal basale alla settimana 6 nella capacità di esercizio misurata come distanza camminata in 6 minuti;
4. Variazione dal basale in Clinical Congestion Score at week 12.
5. Variazione dal basale in Patient Global Impression of Severity (PGI-S) of Heart Failure Symptoms at week 12.
6. Variazione dal basale nel Patient Global Impression of Dyspnea Severity alla settimana 12.
7. Patient Global Impression of Change (PGI-C) per i sintomi da scompenso alla settimana 12.
8. Patient Global Impression of Change per la Dyispnea alla settimana 12.
9. Variazione dal basale in N-terminal pro-brain natriuretic peptide (NT-proBNP) alla settimana 12

E.5.2.1

Timepoint(s) of evaluation of this end point

1. Week 0 and Week 12
2. Week 0 and Week 12
3. Week 0 and Week 6
4. Week 0 and Week 12
5. Week 0 and Week 12
6. Week 0 and Week 12
7. Week 12
8. Week 12
9. Week 0 and Week 12

1. settimana 0 e settimana 12
2. settimana 0 e settimana 12
3. settimana 0 e settimana 6
4. settimana 0 e settimana 12
5. settimana 0 e settimana 12
6. settimana 0 e settimana 12
7. settimana 12
8. settimana 12
9. settimana 0 e settimana 12

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)

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

Information not present in EudraCT

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

Canada

United States

Germany

Greece

Italy

Poland

Portugal

Spain

E.8.7

Trial has a data monitoring committee

Yes

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

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:

280

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

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

218

F.4.2.2

In the whole clinical trial

300

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 be offered standard medical care

Cura secondo standard clinico

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

2018-05-11

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2018-03-07

P. End of Trial
P.	End of Trial Status	Completed

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Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
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