Clinical Trials Register

Summary
EudraCT Number:	2020-002340-23
Sponsor's Protocol Code Number:	MEIN/19/ZoNe-HYP/001
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:	2021-06-07
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

Italy - Italian Medicines Agency

A.2

EudraCT number

2020-002340-23

A.3

Full title of the trial

Open-label, multicenter, multinational, interventional clinical trial to assess effectiveness and safety of the extemporaneous combination of nebivolol and zofenopril calcium in grade 1 to 2 hypertensive patients versus each monotherapy

Sperimentazione clinica interventistica, in aperto, multicentrica, multinazionale per valutare l’efficacia e la sicurezza dell'associazione estemporanea di nebivololo e zofenopril calcio in pazienti affetti da ipertensione di grado 1 o 2, rispetto a ciascuna monoterapia

A.3.1

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

Effectiveness and safety of combination of nebivolol and zofenopril calcium in mild to moderate hypertensive patients

Efficacia e sicurezza della combinazione di nebivololo e zofenopril calcio in pazienti affetti da ipertensione da lieve a moderata

A.3.2

Name or abbreviated title of the trial where available

MASACCIO

A.4.1

Sponsor's protocol code number

MEIN/19/ZoNe-HYP/001

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	MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG SA
B.1.3.4	Country	Luxembourg
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	Menarini International Operations Luxembourg SA
B.4.2	Country	Luxembourg
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Menarini
B.5.2	Functional name of contact point	Clinical Operation Director
B.5.3	Address:
B.5.3.1	Street Address	Via Sette Santi 1-3
B.5.3.2	Town/ city	Firenze
B.5.3.3	Post code	50131
B.5.3.4	Country	Italy
B.5.4	Telephone number	+39055568091
B.5.6	E-mail	pfabrizzi@menarini.it

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	LOBIVON - 28 COMPRESSE 5 MG
D.2.1.1.2	Name of the Marketing Authorisation holder	A. MENARINI INDUSTRIE FARMACEUTICHE RIUNITE S.R.L.
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	Nebivolol
D.3.2	Product code	[na]
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	NEBIVOLOLO
D.3.9.1	CAS number	99200-09-6
D.3.9.2	Current sponsor code	na
D.3.9.4	EV Substance Code	SUB09175MIG
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	5
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	ZOPRANOL - 28 COMPRESSE RIVESTITE CON FILM 30 MG IN BLISTER (PVDC/PVC/AL)
D.2.1.1.2	Name of the Marketing Authorisation holder	LABORATORI GUIDOTTI S.P.A.
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	Zofenopril calcium
D.3.2	Product code	[na]
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	ZOFENOPRIL CALCIO
D.3.9.1	CAS number	81938-43-4
D.3.9.2	Current sponsor code	na
D.3.9.4	EV Substance Code	SUB05191MIG
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	30
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

Grade 1 and 2 hypertension

Ipertenzione di grado 1 e 2

E.1.1.1

Medical condition in easily understood language

Hypertension

Ipertensione

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	10020772
E.1.2	Term	Hypertension
E.1.2	System Organ Class	10047065 - Vascular 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

To assess the antihypertensive effect of the extemporaneous combination of nebivolol 5 mg and zofenopril calcium 30 mg in lowering sitting diastolic blood pressure (DBP) after 8 weeks of treatment, in patients with uncontrolled blood pressure (BP) who were previously treated with nebivolol or zofenopril calcium monotherapies for at least 4 weeks

¿ Valutare l’effetto antipertensivo della combinazione estemporanea di NEB 5 mg e ZOF 30 mg nel ridurre la PAD in posizione seduta dopo 8 settimane di trattamento in pazienti con PA non controllata, precedentemente trattati con monoterapia NEB o ZOF per almeno 4 settimane.

E.2.2

Secondary objectives of the trial

To assess the antihypertensive effect of the extemporaneous combination of nebivolol 5 mg and zofenopril calcium 30 mg in lowering sitting systolic blood pressure (SBP) after 8 weeks of treatment in patients with uncontrolled blood pressure after at least 4 weeks of treatment with nebivolol or zofenopril calcium monotherapies
To evaluate the total number and percentage of patients who achieved the blood pressure goal (sitting blood pressure =130/80 mmHg) at Visit 2 and Visit 3
To assess compliance to the monotherapy and extemporaneous combination (actual doses taken versus doses to be taken)
To evaluate the safety and tolerability of the zofenopril calcium and nebivolol monotherapies, and the extemporaneous combination of nebivolol 5 mg and zofenopril calcium 30 mg after 8 weeks of treatment

¿ Valutare l’effetto antipertensivo della combinazione estemporanea di NEB 5 mg e ZOF 30 mg nel ridurre la PAS in posizione seduta dopo 8 settimane di trattamento in pazienti con PA non controllata, dopo almeno 4 settimane di trattamento con monoterapia NEB o ZOF.
¿ Valutare il numero totale e la percentuale di pazienti che hanno raggiunto l’obiettivo di PA (PA in posizione seduta =°130/80 mmHg) alla Visita 2 e alla Visita 3.
¿ Valutare la conformità alla monoterapia e all’associazione estemporanea (dosi effettive assunte rispetto alle dosi programmate da prendere).
¿ Valutare la sicurezza e la tollerabilità delle monoterapie con ZOF e NEB e la combinazione estemporanea di NEB 5 mg e ZOF 30 mg dopo 8 settimane di trattamento.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Male or female Caucasian uncontrolled hypertensive patients =18 and <65 years of age (see definition in criterion 3), in monotherapy either with ACE-i or BBs since at least 1 month, at Screening.
2. Patients are able to understand and have freely given written informed consent at Screening.
3. Patients with mean sitting SBP =140 mmHg and =179 mmHg and/or mean sitting DBP = 90 mmHg and =109 mmHg at Screening.
4. Patients who are able to comply with all study procedures and who are available for the duration of the study.
5. Ability to take oral medication and willing to adhere to the drug regimen.
6. A female patient of childbearing potential is eligible to participate if she is not pregnant, or not breastfeeding. A woman is considered fertile following menarche and until becoming postmenopausal unless permanently sterile. Women of childbearing potential must agree to use of highly effective contraception (eg, method of birth control throughout the study period and for 4 weeks after study completion defined as a method which results in a failure rate of less than 1% per year) and also must refrain from donating or storing eggs during this time. Highly effective contraception methods can be:
¿ combined (estrogen- and progestogen-containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal)
¿ progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable)
¿ intrauterine device (IUD)
¿ intrauterine hormone-releasing system (IUS)
¿ bilateral tubal occlusion
¿ vasectomized partner (provided that partner is the sole sexual partner of the trial participant and that the vasectomized partner has received medical assessment of the surgical success).
7. A male patient with female partner must agree to use contraception during the whole study period and for at least 1 week after the last dose of study treatment and refrain from donating sperms during this period.

1. Pazienti caucasici di entrambi i sessi con ipertensione non controllata (vedere definizione nel criterio 3) di età =°18 e <°65 anni, in monoterapia con ACE-I o BB da almeno 1 mese, allo Screening (Visita 1).
2. I pazienti sono in grado di comprendere e hanno fornito liberamente il proprio consenso informato scritto allo Screening.
3. Pazienti con PAS media in posizione seduta =°140 mmHg e =°179 mmHg e/o PAD media in posizione seduta =°90 mmHg e =°109 mmHg allo Screening (Visita 1).
4. Pazienti in grado di attenersi a tutte le procedure dello studio e disponibili per tutta la durata dello studio.
5. Capacità di assumere farmaci orali e disponibilità ad aderire al regime farmacologico.
6. Le pazienti di sesso femminile in età fertile sono idonee a partecipare se non sono in gravidanza o non stanno allattando. Una donna è considerata potenzialmente fertile dopo il menarca e fino alla post menopausa, salvo se permanentemente sterile. Le donne in età fertile devono accettare di utilizzare un metodo contraccettivo altamente efficace (ad es., un metodo di controllo delle nascite per l’intero periodo dello studio e per 4 settimane dopo il completamento dello studio, definito come un metodo con un tasso di insuccesso inferiore all’1% annuo) e inoltre devono astenersi dalla donazione o dalla conservazione degli ovuli durante questo periodo. Metodi contraccettivi altamente efficaci possono essere:
• Contraccezione ormonale combinata (contenente estrogeno e progestinico) associata all’inibizione dell’ovulazione (orale, intravaginale, transdermica)
• Contraccezione ormonale a base di solo progestinico associata all’inibizione dell’ovulazione (orale, iniettabile, impiantabile)
• Dispositivo intrauterino (IUD)
• Sistema intrauterino a rilascio di ormoni (IUS)
• Occlusione bilaterale delle tube
• Compagno vasectomizzato (a condizione che il compagno sia l’unico partner sessuale della partecipante alla sperimentazione e che il compagno vasectomizzato si sia sottoposto a una valutazione medica del successo chirurgico)
7. Un paziente di sesso maschile con compagna di sesso femminile deve accettare di usare un metodo contraccettivo durante l’intero periodo dello studio e per almeno 1 settimana dopo l’ultima dose del trattamento dello studio e astenersi dalla donazione di sperma durante questo periodo.

E.4

Principal exclusion criteria

1. Known contraindications, allergies, or hypersensitivities to any of the study medications or excipient as outlined in the investigators brochures IBs, summary of product characteristics (SmPCs) or local package inserts for nebivolol and zofenopril calcium.
2. Patients with serious disorders (in the opinion of the Investigator) which may limit the ability to evaluate the efficacy or safety of the tested medications, including cerebrovascular, cardiovascular, renal, respiratory, hepatic, gastrointestinal, endocrine or metabolic, hematological, or oncological, neurological, and psychiatric diseases. The same applies for immunocompromised and/or neutropenic patients.
3. Patients having a history of the following within the last 6 months: myocardial infarction, unstable angina pectoris, percutaneous coronary intervention, bypass surgery, heart failure, hypertensive encephalopathy, cerebrovascular accident (stroke), or transient ischemic attack.
4. Patients with secondary hypertension of any etiology such as renal diseases, pheochromocytoma, or Cushing’s syndrome.
5. Patients with severe heart failure (New York Heart Association classification III-IV), a narrowing of the aortic or bicuspid valve, an obstruction of cardiac outflow (obstructive, hypertrophic cardiomyopathy) or symptomatic coronary disease.
6. Patients with clinical evidence of renal disease as per the Investigator’s judgement (including renovascular occlusive disease, nephrectomy and/or renal transplant, bilateral renal artery stenosis or unilateral renal artery stenosis in a solitary kidney, or severe renal impairment).
7. History of angioneurotic edema.
8. Patients with clinically relevant hepatic impairment.
9. Patients with sick sinus syndrome, including sino-atrial block.
10. Patients with second- or third-degree heart block (without a pacemaker).
11. History of bronchospasm and bronchial asthma.
12. Patients with bradycardia (heart rate <60 bpm).
13. Patient with metabolic acidosis.
14. Patients with severe peripheral circulatory disturbances.
15. Participation in another study within the last 4 weeks.
16. Patients with diseases that, in the opinion of the Investigator, prevent a careful adherence to the protocol
17. Pregnant and breastfeeding women. NOTE: a pregnancy test will be performed on all women of childbearing potential at each study visit.

1. Controindicazioni note, allergie o ipersensibilità a qualsiasi farmaco dello studio o eccipiente, come indicato nelle Investigator Brochure (IB), nel riassunto delle caratteristiche del prodotto (RCP) o nei fogli illustrativi locali di NEB e ZOF.
2. Pazienti con patologie gravi (a giudizio dello Sperimentatore) che possono limitare la capacità di valutare l’efficacia o la sicurezza dei farmaci testati, tra cui malattie cerebrovascolari, cardiovascolari, renali, respiratorie, epatiche, gastrointestinali, endocrine o metaboliche, ematologiche, oppure oncologiche, neurologiche e psichiatriche. Lo stesso vale per i pazienti immunocompromessi e/o neutropenici.
3. Pazienti che, negli ultimi 6 mesi, hanno un’anamnesi di: infarto miocardico, angina pectoris instabile, intervento coronarico percutaneo, intervento di bypass, insufficienza cardiaca, encefalopatia ipertensiva, eventi cerebrovascolari (ictus) o attacco ischemico transitorio.
4. Pazienti con ipertensione secondaria di qualsiasi eziologia, come malattie renali, feocromocitoma o sindrome di Cushing.
5. Pazienti con insufficienza cardiaca grave (classe III-IV secondo la New York Heart Association), restringimento della valvola aortica o bicuspide, ostruzione del deflusso cardiaco (cardiomiopatia ostruttiva, ipertrofica) o coronaropatia sintomatica.
6. Pazienti con evidenza clinica di malattia renale in base al giudizio dello Sperimentatore (tra cui malattia occlusiva renovascolare, nefrectomia e/o trapianto renale, stenosi bilaterale dell’arteria renale o stenosi unilaterale dell’arteria renale in un unico rene, o grave insufficienza renale).
7. Anamnesi di edema angioneurotico.
8. Pazienti con insufficienza epatica clinicamente rilevante.
9. Pazienti con sindrome del nodo del seno, incluso blocco seno atriale.
10. Pazienti con blocco cardiaco di secondo o terzo grado (senza pacemaker).
11. Anamnesi di broncospasmo e asma bronchiale.
12. Pazienti con bradicardia (frequenza cardiaca <°60 bpm).
13. Paziente con acidosi metabolica.
14. Pazienti con gravi disturbi circolatori periferici.
15. Partecipazione a un altro studio nelle ultime 4 settimane.
16. Pazienti affetti da malattie che, a giudizio dello Sperimentatore, impediscono un’attenta aderenza al protocollo.
17. Donne in gravidanza e in allattamento. NOTA: a ogni visita dello studio, sarà eseguito un test di gravidanza su tutte le donne potenzialmente fertili.

E.5 End points

E.5.1

Primary end point(s)

Change in mean sitting DBP between Week 0 (Visit 2) and Week 8 (Visit 3)

¿ Variazione della PAD media in posizione seduta tra la Settimana 0 (Visita 2) e la Settimana 8 (Visita 3).

E.5.1.1

Timepoint(s) of evaluation of this end point

Week 0 and Week 8

E.5.2

Secondary end point(s)

¿ Change in mean sitting SBP between Week 0 (Visit 2) and Week 8 (Visit 3)
¿ Total number and proportion of patients achieving the BP goal (sitting BP =130/80 mmHg) at Week 0 (Visit 2) and Week 8 (Visit 3)
¿ Adherence to treatment will be measured through treatment compliance which is 100 × (actual doses taken versus planned doses to be taken) from Visit 1 to Visit 2 for the monotherapies, and from Visit 2 to Visit 3 for the extemporaneous combination
¿ Safety and tolerability of the nebivolol and zofenopril calcium monotherapies, as well as extemporaneous combination between nebivolol 5 mg and zofenopril calcium 30 mg will be measured by Adverse Events (AEs),Serious Adverse Events (SAEs),Adverse Events Of Special Interest (AEOSI), vital signs, physical examination, ECG, and concomitant medications at Week 0 (Visit 2) and Week 8 (Visit 3)

¿ Variazione della PAS media in posizione seduta tra la settimana 0 (Visita 2) e la settimana 8 (Visita 3).
¿ Numero totale e percentuale di pazienti che raggiungono l’obiettivo di PA (PA in posizione seduta =°130/80 mmHg) alla settimana 0 (Visita 2) e alla settimana 8 (Visita 3).
¿ L’aderenza al trattamento sarà misurata con un valore di conformità al trattamento pari a 100 × (dosi effettive assunte rispetto alle dosi programmate da assumere) dalla Visita 1 alla Visita 2 per le monoterapie e dalla Visita 2 alla Visita 3 per l'associazione estemporanea.
¿ La sicurezza e la tollerabilità delle monoterapie NEB e ZOF, nonché l’associazione estemporanea di NEB 5 mg e ZOF 30 mg, saranno misurate in base a eventi avversi (EA), eventi avversi seri (SAE), EA di particolare interesse (AESI), segni vitali, esame obiettivo, elettrocardiogramma (ECG) e farmaci concomitanti alla Settimana 0 (Visita 2) e alla Settimana 8 (Visita 3).

E.5.2.1

Timepoint(s) of evaluation of this end point

Week 0 and Week 8
Week 0 and Week 8
Week 0 and Week 8
Week 0 and Week 8

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)

E.7.4

Therapeutic use (Phase IV)

Yes

E.8 Design of the trial

E.8.1

Controlled

E.8.1.1

Randomised

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

Yes

E.8.1.7.1

Other trial design description

Periodo di run-in con neb o zof come monoterapia + periodo di valutazione con combinazione neb/zof

Run in period with neb or zof as monotherapy + assessment period with neb/zof combination

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

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

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

Last Patient Last Visit

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:

216

F.1.3

Elderly (>=65 years)

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

216

F.4.2.2

In the whole clinical trial

216

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)

Standard of care as per local practice

Standard of care per pratica locale

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

2021-04-20

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-03-18

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

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