Clinical Trials Register

Summary
EudraCT Number:	2015-003149-24
Sponsor's Protocol Code Number:	Ranolazine¿AOUPi/001
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2021-01-27
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

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2015-003149-24

A.3

Full title of the trial

Ranolazine in patients with post systolic thickening due to stable effort angina: a phase II, randomized, open-label, standard therapy controlled, parallel group study assessing the effects on left ventricular function, exercise capacity and symptomatic status

Ranolazina in pazienti con ispessimento post-sistolico secondario ad angina stabile: studio di fase II randomizzato, in aperto, controllato verso terapia standard, a gruppi paralleli, per la valutazione dell¿efficacia del farmaco sulla funzione ventricolare sinistra, la capacit¿ di esercizio e lo stato sintomatologico

A.3.1

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

Effect of Ranolazine in patients with impaired left ventricular function due to their stable angina for the presence of an abnormal ventricular contractile status that is maintained in the post-systolic

Effetto della Ranolazina in pazienti con funzione ventricolare sinistra compromessa a causa della loro angina stabile per la presenza di un anomalo stato contrattile ventricolare che si mantiene nella fase post-sistolica

A.3.2

Name or abbreviated title of the trial where available

Ranolazine - AOUPi/001

A.4.1

Sponsor's protocol code number

Ranolazine¿AOUPi/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	AZIENDA OSPEDALIERO-UNIVERSITARIA PISANA
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	Menarini Internatinal Operations Luxemburg S.A.
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	AZIENDA OSPEDALIERO-UNIVERSITARIA PISANA
B.5.2	Functional name of contact point	U.O. CARDIO - ANGIOLOGIA
B.5.3	Address:
B.5.3.1	Street Address	VIA PARADISA, 2 - CISANELLO
B.5.3.2	Town/ city	PISA
B.5.3.3	Post code	56100
B.5.3.4	Country	Italy
B.5.4	Telephone number	050-995315
B.5.5	Fax number	050-995316
B.5.6	E-mail	vitantonio.dibello@med.unipi.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	RANEXA - 375 MG-COMPRESSA A RILASCIO PROLUNGATO-USO ORALE-BLISTER(PVC/PVDC/ALLUMINIO) 30 COMPRESSE
D.2.1.1.2	Name of the Marketing Authorisation holder	MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.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	RANEXA
D.3.4	Pharmaceutical form	Prolonged-release 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	RANOLAZINA
D.3.9.1	CAS number	95635-55-5
D.3.9.2	Current sponsor code	NON DISPONIBILE
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	375
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	RANEXA - 500 MG-COMPRESSA A RILASCIO PROLUNGATO-USO ORALE-BLISTER(PVC/PVDC/ALLUMINIO) 30 COMPRESSE
D.2.1.1.2	Name of the Marketing Authorisation holder	MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.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	RANEXA
D.3.4	Pharmaceutical form	Prolonged-release 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	RANOLAZINA
D.3.9.1	CAS number	95635-55-5
D.3.9.2	Current sponsor code	NON DISPONIBILE
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	500
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	RANEXA - 750 MG-COMPRESSA A RILASCIO PROLUNGATO-USO ORALE-BLISTER(PVC/PVDC/ALLUMINIO) 30 COMPRESSE
D.2.1.1.2	Name of the Marketing Authorisation holder	MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.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	RANEXA
D.3.4	Pharmaceutical form	Prolonged-release 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	RANOLAZINA
D.3.9.1	CAS number	95635-55-5
D.3.9.2	Current sponsor code	NON DISPONIBILE
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	750
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

Stable angina with normal ejection fraction

Angina stabile con frazione di eiezione nella norma

E.1.1.1

Medical condition in easily understood language

Stable angina

Angina stabile

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	10002383
E.1.2	Term	Angina pectoris
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

Demonstrate the efficacy of ranolazine in reducing segmentary post systolic thickening due to myocardial ischemia - allowing the synchronisation of the impaired myocardial segments - using strain imaging (SI) derived from 2-dimensional speckle-tracking echocardiography in patients with stable effort angina.

Dimostrare l¿efficacia della ranolazina nel ridurre l¿inspessimento segmentario post sistolico secondario a ischemia miocardica, permettendo cos¿ la sincronizzazione dei segmenti miocardici compromessi ¿ mediante la strain imaging (SI) derivata dalla ecocardiografia speckle tracking a 2 dimensioni in pazienti affetti da angina stabile

E.2.2

Secondary objectives of the trial

Demonstrate the efficacy of ranolazine on exercise capacity in patients affected by stable effort angina using the supine bicycle exercise test and the symptomatic status. The assessment of safety by evaluation of adverse events, laboratory findings, the rest standard 12-lead ECG, and physical examination will also be considered as secondary study objectives.

Dimostrare l¿efficacia di ranolazina sulla capacit¿ di esercizio in pazienti affetti da angina stabile mediante l¿utilizzo del test di esercizio con la bicicletta in posizione supina e la rilevazione dello stato sintomatico. Verr¿ inoltre studiata nella stessa popolazione la safety di ranolazina.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

• Male and female gender (females of childbearing potential must be using adequate contraceptive precautions such as implants, injectables, combined oral contraceptives, intrauterine devices, sexual abstinence or vasectomised partner);
• Females of childbearing potential or within two years from the menopause must have a negative urine pregnancy test;
• Patients which diagnosis of stable effort chronic angina based on clinical symptoms (angina; ischemic equivalents) or ischemia tests (stress ECG/stress-exercise echocardiography/Miocardial perfusion scintigraphy) independently from baseline antianginal therapy.
• Patients aged = 18 years;
• Patients with normal LV ejection fraction (EF) without LV wall motion abnormalities detected by standard echocardiography or if abnormalities are present, the post systolic thickening must be present in a different, non-contiguous segment;
• Patients with post systolic thickening independently from baseline antianginal therapy, defined as the presence of SI = 50%, 5 min. during and/or after the supine bicycle speckle tracking echo stress (speckle tracking) test performed by using the standard Bruce protocol;
• Presence of sinus rhythm;
• Written informed consent prior to enrolment into the study.

• Uomini e Donne (le donne in età fertile dovranno precauzionalmente fare uso di adeguate metodiche contraccettive);
• Le donne in età fertile o entro due anni dalla presumibile data della menopausa dovranno avere un test urinario di gravidanza negativo;
• Pazienti con diagnosi clinica di angina stabile (angina; equivalenti ischemici) o mediante test ischemici (ECG da stress/Ecocardiografia da stress/scintigrafia perfusionale miocardica) indipendente dalla terapia antianginosa di base;
• Pazienti di età = 18 anni;
• Pazienti con Frazione di Eiezione ventricolare sinistra normale (EF) senza anomalie della motilità della ventricolare sinistra diagnosticata mediante ecocardiografia standard o, in caso di presenza di dette anomalie, presenza di inspessimento post sistolico in un segmento differente non contiguo;
• Pazienti con inspessimento post sistolico indipendente dalla terapia antiangionosa di base, definite come presenza di un SI = 50%, 5 min. durante e/o dopo il test di ecco stress mediante bicicletta supina speckle tracking eseguito secondo il protocollo standard di Bruce;
• Presenza di ritmo sinusale;
• Consenso informato scritto prima dell’ingresso nello studio.

E.4

Principal exclusion criteria

• Females of childbearing potential not using adequate contraceptive precautions;
• Presence of unstable angina, left main trunk disease, previous myocardial infarction, previous cardiac surgery, artificial pacemaker, non-sinus rhythm, significant valvular heart disease;
• Presence of congestive heart failure;
• Presence of Chronic Obstructive Airways Disease;
• Concomitant administration of potent CYP3A4 inhibitors (e.g. itraconazole, ketoconazole, voriconazol, posaconazol, HIV protease inhibitors, clarithromycin, telithromycin, nefazodone). Grapefruit juice is also a potent CYP3A4 inhibitor.
• Concomitant administration of Class Ia (e.g. quinidine) or Class III (e.g. dofetilide, sotalol) antiarrhythmics other than amiodarone.
• Any clinically relevant haematological or biochemical abnormality on routine screening, according to Investigator’s judgment;
• Severe concurrent pathology, including terminal illness (cancer, AIDS, etc.);
• Severe renal impairment defined as GFR < 29 mL/min; creatinine level > 2.5 mg/dL; BUN >60 mg/dL;
• Moderate or severe hepatic impairment or hepatic insufficiency defined as SGOT or SGPT > 2 times greater than normal upper limit or total serum bilirubin > 1.5 times greater than normal upper limit;
• Dementia, psychosis, alcoholism (>350 g ethanol/week) or chronic abuse of medicines, drugs or psychoactive substances;
• Females who are pregnant or lactating;
• Conditions which in the Investigator’s opinion may interfere with the study’s execution or due to which the patient should not participate for safety reasons;
• Risk of low patient cooperation;
• Inability or unwillingness to issue the informed consent;
• Inability to perform an exercise stress test.

• Donne in età fertile che non fanno uso di adeguate precauzioni contraccettive;
• Presenza di angina instabile, left main trunk disease, pregresso infarto del miocardio, pregresso intervento chirurgico cardiaco, presenza di pacemaker artificiale, ritmo non sinusale, malattia valvolare cardiaca significativa;
• Presenza di scompenso cardiaco congestizio;
• Presenza di Broncopneumopatia Cronica Ostruttiva;
• Somministrazione concomitante di potenti inibitori del citocromo CYP3A4 (es. itraconazole, ketoconazole, voriconazol, posaconazol, HIV protease inhibitors, clarithromycin, telithromycin, nefazodone). Anche il succo di pompelmo è un potente inibitore del citocromo CYP3A4;
• Somministrazione concomitante di antiaritmici di Classe Ia )es. chinidina) o di Classe III (es. dofetilide, sotalolo) diversi dall’amiodarone;
• Qualunque anormalità ematologica o biochimica clinicamente rilevante, presente nei test di screening, secondo il giudizio dello sperimentatore;
• Patologia concomitante di grado severo, incluse le malattie in stadio terminale (Cnacro, AIDS….);
• Insufficienza renale di grado severo definita come GFR < 29 mL/min; creatininemia > 2.5 mg/dL; BUN >60 mg/dL;
• Alterazione della funzionalità epatica di grado moderato o severo, o insufficienza epatica definite come presenza di valori di GOT o GPT > 2 volte la norma o bilirubina totale > 1.5 oltre la norma;
• Demenza, psicosi, alcolismo (>350 g etanolo/settimana) o abuso cronico di medicine, sostanze stupefacenti o psicostimolanti;
• Donne in gravidanza o allattamento;
• Condizioni che a giudizio dello Sperimentatore possono interferire con l’esecuzione dello studio o per le quali, per motivi di safety i pazienti non possono parteciparvi;
• Pazienti a rischio di scarsa collaborazione;
• Incapacità o riluttanza a firmare il consenso informato;
• Incapacità ad eseguire un test da stress.

E.5 End points

E.5.1

Primary end point(s)

Evaluation of SI in patients with stable effort angina after 2 months and 3 weeks of treatment with ranolazine + standard therapy (ST) or standard therapy (ST) alone using the 2-dimensional speckle-tracking echocardiography.

Valutazione della SI in pazienti con angina stabile dopo 2 mesi di trattamento e tre settimane con ranolazina + ST o ST mediante l’utilizzo ecocardiografia speckle tracking a 2 dimensioni.

E.5.1.1

Timepoint(s) of evaluation of this end point

2 MONTHS AND 3 WEEKS

2 MESI E 3 SETTIMANE

E.5.2

Secondary end point(s)

The change in Exercise capacity after 2 months and 3 weeks of treatment with ranolazine 375/500/750 mg /bid + ST or ST alone in the two study groups; The change in Symptomatic Status Evaluation using the Seattle Angina Questionnaire, after 2 months and 3 weeks of treatment with ranolazine 375/500/750 mg /bid + ST or ST alone in the two study groups; The change in Symptomatic Status Evaluation using the Seattle Angina Questionnaire, after 1 month of treatment with ranolazine 375/500/750 mg /bid + ST or ranolazine 500 mg/bid + ST in the two study groups from visit 7 to visit 8 (end study visit).; The change in SI, after 1 month of treatment with ranolazine 375/500/750 mg /bid + ST or ranolazine 500 mg/bid + ST in the two study groups from visit 7 to visit 8 (end study visit).; The change in Exercise capacity, after 1 month of treatment with ranolazine 375/500/750 mg /bid + ST or ranolazine 500 mg/bid + ST in the two study groups from visit 7 to visit 8 (end study visit).

Il cambiamento nella capacit¿ di esercizio dopo 2 mesi e 3 settimane di trattamento con ranolazina 375/500/750 mg / bid + ST o solo ST nei due gruppi di studio; La variazione del Symptomatic Status Evaluation utilizzando il Seattle Angina Questionnaire, dopo 2 mesi e 3 settimane di trattamento con ranolazina 375/500/750 mg / bid + ST o solo ST nei due gruppi di studio; La variazione di Symptomatic Status Evaluation utilizzando il Seattle Angina Questionnaire, dopo 1 mese di trattamento con ranolazina 375/500/750 mg / bid + ST o ranolazina 500 mg / bid + ST nei due gruppi di studio dalla visita 7 alla visita 8 (fine visita di studio).; Il cambiamento di SI, dopo 1 mese di trattamento con ranolazina 375/500/750 mg / bid + ST o ranolazina 500 mg / bid + ST nei due gruppi di studio dalla visita 7 alla visita 8 (visita di studio fine).; Il cambiamento nella capacit¿ di esercizio, dopo 1 mese di trattamento con ranolazina 375/500/750 mg / bid + ST o ranolazina 500 mg / bid + ST nei due gruppi di studio da visita 7 alla visita 8 (visita di studio finale).

E.5.2.1

Timepoint(s) of evaluation of this end point

2 MONTHS and 3 WEEKS; 2 MONTHS AND 3 WEEKS; 1 MONTH; 1 MONTH; 1 MONTH

2 MESI e 3 SETTIMANE; 2 MESI E 3 SETTIMANE; 1 MESE; 1 MESE; 1 MESE

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

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)

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

Terapia standard

Standard therapy

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.8.5.1

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

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:

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

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)

Patients will continue with the assistance programs that would perform regardless of the participation in the study.

I pazienti proseguiranno con i programmi assistenziali che effettuerebbero indipendentemente dalla partecipazione allo studio.

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

2016-01-12

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2015-09-24

P. End of Trial
P.	End of Trial Status	Ongoing

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