Clinical Trials Register

Summary
EudraCT Number:	2019-002226-79
Sponsor's Protocol Code Number:	AUGEAS
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2020-11-05
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

2019-002226-79

A.3

Full title of the trial

A 30-day, randomized, evalUator-blind, controlled, multi-centre, parallel Group, phase III study to evaluate the Effect of a Low Maintenance Dose TicAgrelor Regimen versus Standard Dose Clopidogrel on Coronary Flow Reserve in Diabetes Mellitus Patients with impaired microvascular function without Prior Myocardial Infarction or Stroke Undergoing Elective Percutaneous Coronary Intervention.

Studio clinico multicentrico di fase 3, randomizzato, controllato, a gruppi paralleli, con valutatore in cieco, della durata di 30 giorni per valutare l’effetto di un regime di mantenimento con Ticagrelor a bassa dose rispetto a Clopidogrel a dose standard sulla riserva di flusso coronarico in pazienti affetti da diabete mellito con compromessa funzione microvascolare in assenza di pregresso infarto del miocardio oppure ictus,
sottoposti a intervento coronarico percutaneo in elezione.

A.3.1

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

Study in diabetic patients undergoing elective Percutaneous Coronary Intervention (PCI) to investigate whether the blood clotting inhibitor ticagrelor can improve the blood flow in the heart instead of the standard treatment with clopidogrel.

Studio in pazienti diabetici sottoposti a intervento coronarico percutaneo in elezione per valutare se l'antiaggregante ticagrelor è in grado di migliorare il flusso sanguigno nel cuore rispetto al trattamento standard con clopidogrel.

A.3.2

Name or abbreviated title of the trial where available

AUGEAS

A.4.1

Sponsor's protocol code number

AUGEAS

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	Region Skåne
B.1.3.4	Country	Sweden
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	AstraZeneca
B.4.2	Country	Sweden
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Region Skåne
B.5.2	Functional name of contact point	Ulf Malmqvist
B.5.3	Address:
B.5.3.1	Street Address	Kliniska Studier Sverige - Forum Séder, Skàne University Hospital
B.5.3.2	Town/ city	Lund
B.5.3.3	Post code	SE 221 85
B.5.3.4	Country	Sweden
B.5.4	Telephone number	004646173333
B.5.6	E-mail	ulf.malmqvist@skane.se

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	Ticagrelor
D.2.1.1.2	Name of the Marketing Authorisation holder	AstraZeneca
D.2.1.2	Country which granted the Marketing Authorisation	Sweden
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
D.3.2	Product code	[Non Applicabile]
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	AstraZeneca
D.3.9.4	EV Substance Code	SUB30898
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: 2
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	Plavix
D.2.1.1.2	Name of the Marketing Authorisation holder	Sanofi Clir SNC
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	Clopidogrel
D.3.2	Product code	[Plavix]
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	Plavix, Clopidogrel
D.3.9.1	CAS number	113665-84-2
D.3.9.2	Current sponsor code	Sanofi Clir SNC
D.3.9.4	EV Substance Code	SUB12483MIG
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	75
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

Coronary Artery Disease (CAD)

Coronaropatia (CAD)

E.1.1.1

Medical condition in easily understood language

Impaired blood flow in the arteries of the hearth.

Compromissione del flusso sanguigno nelle arterie del cuore.

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	21.1
E.1.2	Level	PT
E.1.2	Classification code	10067585
E.1.2	Term	Type 2 diabetes mellitus
E.1.2	System Organ Class	10027433 - Metabolism and nutrition disorders

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	10011078
E.1.2	Term	Coronary artery disease
E.1.2	System Organ Class	10007541 - Cardiac disorders

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	10072685
E.1.2	Term	Microvascular coronary artery disease
E.1.2	System Organ Class	10007541 - Cardiac disorders

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.1
E.1.2	Level	PT
E.1.2	Classification code	10065608
E.1.2	Term	Percutaneous coronary intervention
E.1.2	System Organ Class	10042613 - Surgical and medical procedures

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 assess the effect of Ticagrelor on change from baseline in Coronary Flow Velocity Reserve (CFR) at 30 days.

Valutare l’effetto di Ticagrelor sulla variazione rispetto al baseline della riserva di flusso coronarico (RFC) misurata a 30 giorni.

E.2.2

Secondary objectives of the trial

To assess the effect of Ticagrelor on coronary flow parameters at 30 days.
To assess the safety and tolerability of Ticagrelor at 30 days.

Valutare l’effetto di Ticagrelor sui parametri di flusso coronarico a 30 giorni.
Valutare la sicurezza e la tollerabilità di Ticagrelor a 30 giorni.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Provision of informed consent prior to any study specific procedures
2. Men or women =18 years of age
3. Diagnosed with T2DM defined as treatment with ongoing glucose lowering drug (oral medications and/or insulin) for at least 1 month
4. Presence of CAD undergoing elective PCI
5. Impaired coronary microvascular function post PCI as defined by a CFR =2.5
6. TIMI 3 flow post PCI

1. Firma del consenso informato prima che venga eseguita qualsiasi procedura specifica
per lo studio
2. Soggetti di ambo i sessi e di età =18 anni
3. Diagnosi di T2DM definita in base al trattamento continuativo con farmaci ipoglicemizzanti (antidiabetici orali e/o insulina) da almeno 1 mese
4. Presenza di CAD per cui viene eseguita in elezione una procedura PCI
5. Compromissione della funzione microvascolare coronarica post-PCI definita in base a
un valore RFC =2,5
6. Punteggio TIMI flow 3 post-PCI

E.4

Principal exclusion criteria

1. Previous MI defined as a documented hospitalization with a final diagnosis of spontaneous MI (with the exception of definite secondary MI [e.g., due to coronary revascularization procedure, profound hypotension, hypertensive emergency, tachycardia, or profound anemia]).
2. Previous stroke (transient ischemic attack [TIA] is not included in the stroke definition)
3. Use of an intravenous antiplatelet therapy (i.e., cangrelor or GPI) during PCI
4. On treatment with clopidogrel, prasugrel, or ticagrelor due to a prior acute major CV event (MI or stroke) (on treatment with clopidogrel due to prior vascular intervention not secondary to a major CV event is allowed)
5. Planned use of aspirin treatment at doses >150 mg od
6. Anticipated concomitant oral or intravenous therapy with strong cytochrome P450 3A4 (CYP3A4) inhibitors or CYP3A4 substrates with narrow therapeutic indices that cannot be stopped for the course of the study:
a. Strong CYP3A4 inhibitors: ketoconazole, itraconazole, voriconazole, telithromycin, clarithromycin (but not erythromycin or azithromycin), nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir
b. CYP3A4 substrates with narrow therapeutic index: quinidine, simvastatin at doses >40 mg daily or lovastatin at doses >40 mg daily
7. Hypersensitivity to ticagrelor or any of its excipients
8. Need for chronic oral anticoagulant therapy or chronic low-molecular-weight heparin
9. Patients with known bleeding diathesis or coagulation disorder
10. History of intracerebral bleed at any time, gastrointestinal (GI) bleed within the past 6 months prior to randomization, or major surgery within 30 days prior to randomization
11. Increased risk of bradycardic events (e.g., known sick sinus syndrome, second or third-degree AV block or previous documented syncope suspected to be due to bradycardia) unless treated with a pacemaker
12. Known severe liver disease (e.g., ascites and/or clinical signs of coagulopathy)
13. Renal failure requiring dialysis
14. Known platelet count <145 x109 platelets/L
15. Known hemoglobin <9 g/dL
16. Women of child-bearing potential (WOCBP), who are not willing to use a method of contraception that is considered highly reliable per CTFG (Clinical Trial Facilitation Group), OR who have a positive pregnancy test at enrolment or randomization OR women who are breast-feeding
17. Inability of the patient to understand and/or comply with study procedures and/or follow up, in the opinion of the investigator, OR any conditions that, in the opinion of the investigator, may render the patient unable to complete the study
18. Life expectancy of less than 6 month based on investigator’s judgement
19. Participation in another clinical study with an investigational (defined as nonapproved) product, if taken within five half-lives or 28 days prior to the first administration of the trial medication, whichever is longer
20. Previous randomization in the present study
21. Severe asthma
22. Hypersensitivity to adenosine or mannitol
23. Long QT syndrome
24. Chronic obstructive lung disease, with evidence of bronchospasm
25. Severe low blood pressure
26. Unstable angina pectoris
27. Severe heart failure
28. Hypovolemia
29. Treatment with dipyradimol
30. Increased intracranial pressure

1. Pregresso IM definito in base a una ospedalizzazione documentata con diagnosi finale di IM spontaneo (ad eccezione di IM per cui sia stata confermata in maniera conclusiva la natura secondaria [es, causato da procedura di rivascolarizzazione coronarica, ipotensione profonda, emergenza ipertensiva, tachicardia oppure anemia profonda]).
2. Ictus pregresso (l’attacco ischemico transitorio [TIA] non rientra nella definizione
di ictus)
3. Utilizzo di terapia antiaggregante per via endovenosa (ovvero cangrelor o GPI) durante la procedura PCI
4. Trattamento in corso con clopidogrel, prasugrel o ticagrelor a causa di un pregresso evento cardiovascolare maggiore acuto (IM o ictus) (è permesso il trattamento con clopidogrel in caso di un pregresso intervento vascolare non secondario a un evento cardiovascolare maggiore)
5. Uso programmato di trattamento con aspirina a dosi >150 mg OD
6. Prevista terapia concomitante per via orale o per via endovenosa con un potente inibitore del citocromo P450 3A4 (CYP3A4) oppure con un substrato del CYP3A4 caratterizzato da un indice terapeutico ristretto che non sia possibile interrompere per l’intera durata dello studio:
a. Inibitori potenti del CYP3A4: ketoconazolo, itraconazolo, voriconazolo, telitromicina, claritromicina (sono invece permessi eritromicina o azitromicina), nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir
b. Agenti che sono substrati del CYP3A4 con indice terapeutico ristretto: chinidina, simvastatina a dosi >40 mg/die o lovastatina a dosi >40 mg/die
7. Ipersensibilità a ticagrelor o a qualsiasi fra i suoi eccipienti
8. Necessità di terapia cronica con anticoagulante orale oppure con eparina a basso peso molecolare
9. Pazienti con nota diatesi emorragica oppure disturbo della coagulazione
10. Storia di emorragia cerebrale intra-assiale in qualsiasi momento precedente la randomizzazione, di sanguinamento gastrointestinale (GI) nei 6 mesi precedenti la randomizzazione oppure intervento chirurgico maggiore nei 30 giorni precedenti la randomizzazione
11. Rischio aumentato di eventi bradicardici (es, nota sindrome del nodo del seno, BAV di secondo o terzo grado oppure sincope pregressa documentata di sospetta origine bradicardica) eccetto se trattato con un pacemaker
12. Nota epatopatia grave (es, ascite e/o segni clinici di coagulopatia)
13. Insufficienza renale che necessita di dialisi
14. Nota conta delle piastrine <145 x109 unità/L
15. Noto valore di emoglobina <9 g/dL
16. Donne in età fertile (WOCBP)*, che non sono disposte a utilizzare un metodo contraccettivo che è considerato altamente affidabile** in base a CTFG (Clinical Trial Facilitation Group) OPPURE donne con un risultato positivo al test di gravidanza eseguito all’arruolamento o alla randomizzazione OPPURE donne che stanno allattando
17. Incapacità del paziente, determinata in base al giudizio dello sperimentatore, di comprendere e/o attenersi alle procedure dello studio e/o al follow-up, OPPURE qualsiasi condizione che a giudizio dello sperimentatore può impedire al paziente di completare lo studio
18. Aspettativa di vita inferiore a 6 mesi, secondo il giudizio dello sperimentatore
19. Partecipazione a un altro studio clinico con un prodotto sperimentale (ovvero non approvato), oppure se assunto entro cinque emivite o 28 giorni prima della prima somministrazione del farmaco sperimentale, a seconda di quale sia il periodo più lungo
20. Precedente randomizzazione nell’ambito del presente studio
21. Asma grave
22. Ipersensibilità all’adenosina o al mannitolo
23. Sindrome del QT lungo
24. Broncopneumopatia cronica ostruttiva, con evidenza di broncospasmo
25. Ipotensione grave
26. Angina pectoris instabile
27. Scompenso cardiaco grave
28. Ipovolemia
29. Trattamento con dipiradimolo
30. Aumentata pressione intracranica

E.5 End points

E.5.1

Primary end point(s)

Difference in mean of individual absolute change from baseline to 30 days in Coronary Flow Velocity Reserve (CFR) in the middistal segment of the left anterior descending (LAD) coronary artery under adenosine infusion measured by Transthoracic
Doppler Echocardiography (TDE) between the two arms.

Differenza fra i due bracci del valore medio della variazione assoluta individuale rispetto al baseline della riserva di flusso coronarico (RFC) misurata a 30 giorni nel segmento medio distale dell’arteria coronarica discendente anteriore (IVA) in corso di infusione di adenosina misurata mediante ecocardiografia Doppler transtoracica (TDE).

E.5.1.1

Timepoint(s) of evaluation of this end point

The Endpoint for the study is at day 30+/- 3 days after Patient was randomized, got initial CFR measurement and medication was handed over.

L'end point per lo studio è rilevato al giorno 30+/- 3 giorni dopo che il paziente è stato randomizzato, ha eseguito la misurazione iniziale della RFC e il farmaco è stato consegnato.

E.5.2

Secondary end point(s)

Difference in mean of individual absolute change from baseline at 30 days in:
- LAD hyperemic mean diastolic flow velocity
- LAD resting mean diastolic flow velocity

- Bleeding complications (BARC 2, 3 and 5)
- Mortality
- Myocardial Infarction
- Definite and probable stent thrombosis
- Serious Adverse Events (SAEs)

Differenza rispetto al baseline del valore medio della variazione assoluta individuale dei seguenti parametri misurati a 30 giorni:
- velocità media di flusso iperemico diastolico nel ramo IVA
- velocità media di flusso diastolico a riposo nel ramo IVA

- Complicanze emorragiche (BARC 2, 3 e 5)
- Mortalità
- Infarto miocardico
- Trombosi intrastent certa e probabile
- Eventi avversi seri (SAE)

E.5.2.1

Timepoint(s) of evaluation of this end point

The Endpoint for the study is at day 30+/- 3 days after Patient was randomized, got initial CFR measurement and medication was handed over.

L'end point per lo studio è rilevato al giorno 30+/- 3 giorni dopo che il paziente è stato randomizzato, ha eseguito la misurazione iniziale della RFC e il farmaco è stato consegnato.

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

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)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

E.8.7

Trial has a data monitoring committee

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:

200

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

114

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

314

F.4.2.2

In the whole clinical trial

314

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 switched to current standard of care

I pazienti passeranno all'attuale terapia standard secondo normale pratica clinica

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

2019-09-26

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2019-11-21

P. End of Trial
P.	End of Trial Status	Prematurely Ended

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