Clinical Trials Register

Summary
EudraCT Number:	2019-002391-13
Sponsor's Protocol Code Number:	PlinytheElder
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:	2020-10-07
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

2019-002391-13

A.3

Full title of the trial

Platelet inhibition with Ticagrelor 60 mg versus Ticagrelor 90 mg twice daily in elderly patients with acute coronary syndrome (ACS).

Inibizione dell'aggregazione piastrinica con Ticagrelor 60 mg versus Ticagrelor 90 mg BID in pazienti anziani con sindrome coronarica acuta (SCA).

A.3.1

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

Platelet inhibition with Ticagrelor 60 mg versus Ticagrelor 90 mg twice daily in elderly patients with acute coronary syndrome (ACS).

Inibizione dell'aggregazione piastrinica con Ticagrelor 60 mg versus Ticagrelor 90 mg BID in pazienti anziani con sindrome coronarica acuta (SCA).

A.3.2

Name or abbreviated title of the trial where available

Platelet inhibition with Ticagrelor 60 mg versus Ticagrelor 90 mg twice daily in elderly patients wi

Inibizione dell'aggregazione piastrinica con Ticagrelor 60 mg versus Ticagrelor 90 mg BID in pazient

A.4.1

Sponsor's protocol code number

PlinytheElder

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	AOU FEDERICO II
B.1.3.4	Country	Italy
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
B.4.2	Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	CD Pharma Group S.r.l.
B.5.2	Functional name of contact point	CRO
B.5.3	Address:
B.5.3.1	Street Address	Piazza De Angeli, 9
B.5.3.2	Town/ city	Milano
B.5.3.3	Post code	20146
B.5.3.4	Country	Italy
B.5.4	Telephone number	0289051076
B.5.5	Fax number	0289051088
B.5.6	E-mail	chiara.olgiati@cdpharma.it

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	BRILIQUE 90 MG COMPRESSE RIVESTITE CON FILM
D.2.1.1.2	Name of the Marketing Authorisation holder	ASTRAZENECA AB
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	TICAGRELOR 90 mg
D.3.2	Product code	[TICAGRELOR 90 mg]
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	TICAGRELOR
D.3.9.1	CAS number	274693-27-5
D.3.9.2	Current sponsor code	TICAGRELOR 90 mg
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	90
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	BRILIQUE 60 MG COMPRESSE RIVESTITE CON FILM
D.2.1.1.2	Name of the Marketing Authorisation holder	ASTRAZENECA AB
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	ticagrelor 60 MG
D.3.2	Product code	[ticagrelor 60 MG]
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	TICAGRELOR
D.3.9.1	CAS number	274693-27-5
D.3.9.2	Current sponsor code	TICAGRELOR 60 MG
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	60
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	Cardioaspirin 100 mg Compresse gastroresistenti
D.2.1.1.2	Name of the Marketing Authorisation holder	Bayer spa
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	Cardioaspirin 100 mg compresse gastroresistenti
D.3.2	Product code	[024840074]
D.3.4	Pharmaceutical form	Gastro-resistant 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	ACIDO ACETILSALICILICO
D.3.9.1	CAS number	50-78-2
D.3.9.2	Current sponsor code	Cardioaspirina
D.3.9.3	Other descriptive name	Cardioaspirin
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	100
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	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

Acute coronary syndrome

Sindrome coronarica acuta

E.1.1.1

Medical condition in easily understood language

Acute coronary syndrome

Sindrome coronarica acuta

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	PT
E.1.2	Classification code	10051592
E.1.2	Term	Acute coronary syndrome
E.1.2	System Organ Class	10007541 - Cardiac disorders

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

The main aim of the trial is to determine whether the efficacy of ticagrelor 60 mg twice daily is not inferior to that of ticagrelor 90 mg twice daily among elderly patients with ACS undergoing PCI.

L’obiettivo principale dello studio è determinare se l’efficacia di Ticagrelor 60mg due volte al giorno è non inferiore a quella di Ticagrelor 90 mg due volte al giorno in pazienti anziani con SCA sottoposti ad angioplastica coronarica percutanea.

E.2.2

Secondary objectives of the trial

To evaluate adverse events in patients treated with ticagrelor 60 mg and ticagrelor 90 mg.
To determine the pharmacokinetic profile of ticagrelor 60 mg twice daily versus ticagrelor 90 mg twice daily.

Valutare gli eventi avversi nei pazienti trattati con ticagrelor 60 mg e ticagrelor 90 mg.
Determinare il profilo farmacocinetico di Ticagrelor 60 mg due volte al giorno rispetto a Ticagrelor 90 mg due volte al giorno.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Ability to provide written informed consent in a time window 1 to 3 days after successful PCI;
2. Male or female, age = 75 years at screening; ¿
3. ACS at the time of the index hospitalization;
4. Use of a loading dose of 180 mg of ticagrelor administered after diagnosis of ACS or after PCI;
5. Use of a maintenance dose of 90 mg twice daily of ticagrelor of at least 48 hours after the loading dose;
6. Successful PCI (Thrombolysis In Myocardial Infarction [TIMI] flow 3 and residual coronary stenosis <30%) for non-ST-segment elevation ACS or ST-segment elevation myocardial infarction

1. Capacità di fornire il consenso informato scritto in una finestra di tempo tra 1 e 3 giorni dopo la PCI efficace
2. Uomini e donne di età = 75 anni al momento dello screening;
3. SCA al momento del ricovero;
4. Somministrazione di una dose di carico di 180 mg di ticagrelor ;
5. Somministrazione di una dose di mantenimento di ticagrelor 90 mg due volte al giorno per almeno 48 ore dopo la dose di carico;
6. PCI efficace (flusso coronarico anterogrado TIMI 3 e stenosi coronarica redisua < 30%) per infarto miocardico con o senza sopraslivellamento del segmento ST

E.4

Principal exclusion criteria

1. Use of glycoprotein IIb/IIIa receptor inhibitors;
2. Need for chronic oral anticoagulant therapy;
3. Prior fibrinolysis;
4. Unstable clinical status (hemodynamic or electrical instability);
5. Planned surgery requiring DAPT discontinuation during the study;
6. Prior stroke, transient ischemic attack or intracranial bleeding;
7. Active bleeding;
8. Severe anemia (hemoglobin < 8g/dL);
9. Platelet count =80x103/ml;
10. Renal failure (hemodialysis or creatinine clearance = 30 ml/min calculated with Cockroft- Gault formula);
11. Severe hepatic dysfunction (baseline alanine aminotransferase = 2.5 times the upper limit of normal);
12. Known hypersensitivity or contraindication to ticagrelor;
13. Inhability to sign informed consent;
14. Under judicial protection, tutorship or curatorship;
15. Unable to understand and follow study-related instructions;
16. Enrollment in another investigational device or drug study.

1. Somministrazione di inibitori del recettore Gp IIb/IIIa;
2. Indicazione a terapia anticoagulante a lungo termine;
3. Recente fibrinolisi;
4. Condizioni cliniche instabili (instabilità emodinamica o elettrica);
5. Interventi programmati di chirurgia che richiedono una sospensione della DAPT durante lo studio;
6. Precedente ictus, attacco ischemico transitorio, sanguinamento intracranico;
7. Sanguinamento attivo;
8. Anemia severa (emoglobina <8 g/dL);
9. Conta piastrinica = 80 x 103/ml;
10. Insufficienza renale (emodialisi o clearance della creatinina = 30 ml/min calcolata con formula di Cockroft- Gault);
11. Severa disfunzione epatica (livelli di transaminasi = 2.5 volte il limite superiore di normalità);
12. Ipersensibilità o controindicazioni all’utilizzo del ticagrelor;
13. Inabilità a firmare il consenso informato;
14. Soggetto sotto tutela giuridica;
15. Incapacità a comprendere e seguire le procedure previste dallo studio;
16. Arruolamento in altri studi clinici.

E.5 End points

E.5.1

Primary end point(s)

The primary endpoint of the trial will be the comparison of pre-dose P2Y12 reaction units (PRU) determined by VerifyNow- P2Y12 assay (Accumetrics, San Diego, California) at 14 days after treatment with ticagrelor 60 mg or 90 mg.

L’endpoint primario sarà confrontare il PRU (Unità di Reazione P2Y12) tra i due gruppi di trattamento, determinato mediante il VerifyNow-P2Y12 (Accumetrics, San Diego, California), 14 giorni dopo trattamento con ticagrelor 60 mg o 90 mg.

E.5.1.1

Timepoint(s) of evaluation of this end point

at baseline and 14 and 28 days after treatment with ticagrelor 60 mg or 90 mg.

al basale, 14 e 28 giorni dopo il trattamento con ticagrelor 60 mg o 90 mg

E.5.2

Secondary end point(s)

High platelet reactivity (HPR) and ADP-induced platelet reactivity measured through light transmittance aggregometry (LTA) and Multiplate Analyzer.; Non ADP-induced platelet reactivity in patients treated with ticagrelor 60 mg or ticagrelor 90 mg, measured through Multiplate Analyzer (arachidonic acid-, collagen-, and thrombin receptor-activating test).; Frequency of any revascularization; Frequency of Unstable angina; Frequency of Bleeding events according to the BARC, TIMI and GUSTO classification.; Plasma levels of ticagrelor and its active metabolite AR-C124910XX.; Frequency of Spontaneous myocardial infarction;; The composite of all-cause death, myocardial infarction, or stroke; The composite of cardiovascular death, myocardial infarction, urgent target-lesion revascularization;

Studio dell’aggregazione piastrinica indotta dall’ADP e determinazione di elevata reattività piastrinica (HPR) attraverso l’utilizzo l’Aggregometria a Luce Trasmessa (LTA) e il Multiplate.; Reattività piastrinica non indotta da ADP in pazienti trattati con ticagrelor 60 mg o ticagrelor 90 mg, misurata mediante Multiplate Analyzer (test di attivazione del recettore dell'acido arachidonico, del collagene e della trombina).; Frequenza di ogni rivascolarizzazione; Frequenza di angina instabile;; Frequenza degli eventi di sanguinamento in accordo con le classificazioni BARC,TIMI e GUSTO;; Livelli di Ticagrelor nel plasma e il suo metabolita attivo AR-C124910XX.; Frequenza di infarto miocardico spontaneo;; Composito di morte per tutte le cause, infarto miocardico o ictus;; Composito di morte cardiovascolare, infarto miocardico, rivascolarizzazione urgente della lesione target

E.5.2.1

Timepoint(s) of evaluation of this end point

3 time points:
1) Time 1: at baseline before randomization;
2) Time 2: 14 days after the first randomly assigned treatment, including 2 samples, before and 2 hours after the last dose of the initial assigned treatment;
3) Time: 14 days after the second randomly assigned treatment, including 2 samples, before and 2 hours after the last dose of the second assigned treatment; 3 time points:
1) Time 1: at baseline before randomization;
2) Time 2: 14 days after the first randomly assigned treatment, including 2 samples, before and 2 hours after the last dose of the initial assigned treatment;
3) Time: 14 days after the second randomly assigned treatment, including 2 samples, before and 2 hours af

3 time points:
1) Time 1: baseline, prima della randomizzazione;
2) Time 2: 14 giorni dopo l’inizio del primo trattamento assegnato , includendo 2 campioni, prima e 2 ore dopo l'ultima dose del primo trattamento assegnato;
3) Time 3: 14 giorni dopo l’inizio del secondo trattamento assegnato, includendo 2 campioni, prima e 2 ore dopo l'ultima dose del secondo trattamento assegnato; 3 time points:
1) Time 1: baseline, prima della randomizzazione;
2) Time 2: 14 giorni dopo l’inizio del primo trattamento assegnato , includendo 2 campioni, prima e 2 ore dopo l'ultima dose del primo trattamento assegnato;
3) Time 3: 14 giorni dopo l’inizio del secondo trattamento assegnato, includendo 2 campioni, prima e 2 ore dopo l'ultima dose del secondo trattamento assegnato; durante

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

Yes

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

Yes

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

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

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

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

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)

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

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

Yes

F.3.3.7.1

Details of other specific vulnerable populations

Elderly >75 years old

anziani >75 ann

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

F.4.2.2

In the whole clinical trial

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)

After study termination at 28 days, patients will resume initial antiplatelet therapy consisting of aspirin 100 mg and ticagrelor 90 mg BID, in according to current guidelines.

Dopo la fine dello studio (durata totale = 28 giorni), i pazienti torneranno ad assumere la terapia antipiastrinica iniziale con aspirina 100 mg e ticagrelor 90 mg due volte al giorno, in accordo alle correnti linee guida.

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

2020-03-20

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-01-08

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:
Results Status:
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