Clinical Trials Register

Summary
EudraCT Number:	2010-022073-34
Sponsor's Protocol Code Number:	PST2238-DM-10-001
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:	2010-12-27
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

2010-022073-34

A.3

Full title of the trial

Antihypertensive effect of different doses of Rostafuroxin in comparison with Losartan, assessed by office and ambulatory blood pressure monitoring in a hypertensive population selected according to a specific genetic profile.

Effetto antipertensivo di differenti dosi del Rostafuroxin in
confronto con Losartan, valutato con Rilevazioni Pressorie Ambulatoriali e
Monitoraggio Pressorio nelle 24 ore in pazienti ipertesi portatori di uno
specifico profilo genetico.

A.3.1

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

A.3.2

Name or abbreviated title of the trial where available

PEARL-HT

A.4.1

Sponsor's protocol code number

PST2238-DM-10-001

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT01320397

A.5.4

Other Identifiers

Name:

Number:

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	CVIE THERAPEUTICS COMPANY LIMITED
B.1.3.4	Country	Hong Kong
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	Cvie Therapeutics Company Limited
B.4.2	Country	Hong Kong
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Ospedale San Raffaele
B.5.2	Functional name of contact point	Prof. Bianchi Giuseppe
B.5.3	Address:
B.5.3.1	Street Address	via Olgettina 60
B.5.3.2	Town/ city	Milano
B.5.3.3	Post code	20132
B.5.3.4	Country	Italy
B.5.4	Telephone number	+393488545560
B.5.5	Fax number	+390226432384
B.5.6	E-mail	bianchi.giuseppe@hsr.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	No
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	Rostafuroxin
D.3.2	Product code	PST2238
D.3.4	Pharmaceutical form	Capsule, hard
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	Rostafuroxin
D.3.9.1	CAS number	156722-18-8
D.3.9.2	Current sponsor code	PST2238
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(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	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
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	No
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	Rostafuroxin
D.3.2	Product code	PST2238
D.3.4	Pharmaceutical form	Capsule, hard
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	Rostafuroxin
D.3.9.1	CAS number	156722-18-8
D.3.9.2	Current sponsor code	PST2238
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	50
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	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
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	No
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	Rostafuroxin
D.3.2	Product code	PST2238
D.3.4	Pharmaceutical form	Capsule, hard
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	Rostafuroxin
D.3.9.1	CAS number	156722-18-8
D.3.9.2	Current sponsor code	PST2238
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	6
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	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
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: 4
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	Losaprex 50 mg cpr riv
D.2.1.1.2	Name of the Marketing Authorisation holder	SIGMATAU IND.FARM. RIUNITE 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	Losaprex 50 mg
D.3.2	Product code	Losartan 50 mg
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.3.11 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	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Capsule, hard
D.8.4	Route of administration of the placebo	Oral use
D.8 Placebo: 2
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Tablet
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Patients with arterial hypertension, bearers of a specific genetic profile (Presence of at least one mutated genotype or combination of genotypes corresponding to the list provided in Genetic Profile 1).

Pazienti Italiani e Cinesi, con ipertensione arteriosa, mai trattati prima, portatori di un profilo genetico specifico

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	SOC
E.1.2	Classification code	10007541
E.1.2	Term	Cardiac disorders
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

To demonstrate that the 2 highest doses of Rostafuroxin are able to show a statistically significant difference on reduction of office sitting systolic blood pressure in comparison to the group of patients treated with Losartan 50 mg in either the total population of patients carrying at least one of the following genotypes or combination (Genetic Profile 1) or in the subset of patients of this population carrying only at least one of the following combination of genotypes (Profile 2).

Dimostrare che le 2 dosi piu' alte di Rostafuroxin sono in grado di
mostrare una differenza statisticamente significativa sulla riduzione della pressione arteriosa
sistolica registrata nel Centro Clinico confrontata al gruppo dei pazienti trattati con
Losartan 50 mg nella popolazione totale dei pazienti portatori di almeno uno dei genotipi
oppure una combinazione degli stessi (Profilo Genetico 1) oppure nel sotto-gruppo dei
pazienti di questa popolazione portatori soltanto di almeno una delle combinazioni di
genotipi (Profilo Genetico 2).

E.2.2

Secondary objectives of the trial

•To demonstrate that the 2 highest doses of Rostafuroxin are able to show a statistically significant difference on reduction of office sitting systolic blood pressure in comparison to the group of patients treated with Losartan 50 mg in the subgroup of patients showing the Genetic Profile 3; •To demonstrate that the 2 highest doses of Rostafuroxin are able to show a statistically significant difference on office sitting diastolic blood pressure in comparison to Losartan in the general population and/or in the two pre-defined subgroups; •To compare one another the 3 doses of Rostafuroxin and each one versus Losartan; •To determine a dose/responder profile, if any; •To identify the oral doses of Rostafuroxin which lead to statistically significant differences in daytime, night-time and overall 24-hour ambulatory systolic blood pressure and/or diastolic blood pressure, peak effect, trough effect, trough-to-peak ratio and time to peak effect, in comparison with Losartan

Considerando le misurazioni della pressione arteriosa registrate
presso il Centro Clinico:Dimostrare che le 2 dosi più alte di Rostafuroxin sono in grado di
mostrare unadiff statisticamente significativa sulla riduzione della pressione arteriosa
sistolica confrontata al gruppo di paz tratt con Losartan 50 mg nel sotto-gruppo dei paz
portatori del Profilo Genetico 3;.Dimostrare che le 2 dosi più alte di Rostafuroxin sono in
grado di mostrare unadiff statisticamente significativa sulla pressione arteriosa diastolica
confrontata al Losartan nella pop di paz portata tori dei 3 profili;.Confr.tra loro le 3 dosi di
Rostafuroxin e ognuna di esse verso il Losartan;.Det.una dose dipendenza della caduta
pressoria,se esiste,nei portatori dei 3 profili.Secondo il Monitoraggio Pressorio nelle 24
Ore:.Identificare le dosi orali di Rostafuroxin che producono una significatica caduta
pressoria

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

The main criteria to be included in the study is to be a patient with arterial hypertension, bearers of a specific genetic profile (Genetic Profile 1). Patients have to be aged between 25 and 60 years, have already undertaken lifestyle recommendations and still having an abnormal systolic and diastolic blood pressure levels. They must not have been previously treated with any specific antihypertensive drug and they must not assume drugs like diuretics, �-blocker agents, Ca-antagonist, ACE inhibitors and AT1-receptor blockers, for other reasons. They must not be on statines treatment or to be Diabetic (fasting plasma glucose > 125 mg/dl). Their value of the sitting systolic blood pressure (SBP) must range between 140 and 169 mmHg and the sitting diastolic blood pressure (DBP) must range between 85 and 100 mmHg, after an adequate period of lifestyle changes. They do not have to present known causes of secondary hypertension, cardiac disease requiring prohibited pharmacological treatment or history of renal artery disease or a myocardial infarction occurred within the last 6 months.

Il principale criterio di inclusione e' quello di essere pazienti con ipertensione arteriosa,
portatori di un profilo genetico specifico (Profilo Genetico 1). I pazienti devono avere un'eta'
compresa tra i 25 e 60 anni, aver gia' seguito le raccomandazioni sullo stile di vita e
nonostante cio' avere ancora dei livelli di pressione sistolica e diastolica anormali. I pazienti
non devono essere stati precedentemente trattati con nessun farmaco specifico antipertensivo
e non devono assumere, per altre ragioni, farmaci come diuretici, agenti ß-bloccanti,
Calcio-antagonisti, ACE inibitori, bloccanti dei recettori AT1. Non devono essere sotto
trattamento di statine e non devono essere pazienti diabetici (glicemia a digiuno > 125
mg/dl). Il loro valore di Pressione Sistolica deve essere nel range compreso tra 140 e 169
mmHg e il valore di Pressione Diastolica deve essere nel range compreso tra 85 e 100
mmHg, dopo un adeguato periodo di cambiamento di stile di vita. Non devono presentare
cause conosciute di ipertensione secondaria, patologie cardiache che richiedono il
trattamento con farmaci non consentiti oppure storia clinica di stenosi dell.arteria renale o
di infarto del miocardio avvenuto nei 6 mesi precedenti lo studio.

E.4

Principal exclusion criteria

•Known causes of secondary hypertension; •Severe or malignant hypertension; •History of renal artery disease; •Significant renal (estimated creatinine clearance ≤ 50 mL/min) or hepatic disease (SGOT and/or SGPT greater than 2 times the upper limit of the normal range); •Cardiac disease requiring prohibited pharmacological treatment or history of myocardial infarction within the last 6 months; •Atrial Fibrillation.

Cause note di ipertensione secondaria; .Ipertensione severa o maligna; .Storia di malattia
renale arteriosa; .Malattia renale significativa (clearance della creatinina stimata 50
mL/min) o malattia epatica significativa (SGOT e/o SGPT maggiori di 2 volte il limite piu'
alto del range normale); .Malattie cardiache che hanno richiesto un trattamento
farmacologico con farmaci proibiti o una storia di infarto al miocardio negli ultimi 6 mesi;
Fibrillazione Atriale.

E.5 End points

E.5.1

Primary end point(s)

Change from baseline to Visit 6 in office blood sitting pressure (SBP).
Proportions of responders at Visit 6, defined as “Patients having the mean office SBP (mean of last three measurements) <= 135 mmHg or having a reduction in mean office SBP (mean of the three last measurements) > or = 10% with respect to the baseline measurement” at Visit 6 (after two months of therapy).

Cambiamento della pressione arteriosa sistolica da seduto alla visita 6 rispetto al basale (Visita 3)
Proporzione dei rispondenti alla visita 6, definiti come "pazienti con pressione sistolica media (media delle ultime tre misurazioni) <= 135 mmHg o con una riduzione della pressione sistolica media (media delle tre ultime misurazioni)> o = 10% alla visita 6 (dopo due mesi di terapia) rispetto al basale.

E.5.1.1

Timepoint(s) of evaluation of this end point

9 weeks

9 settimane

E.5.2

Secondary end point(s)

• Change from baseline to Visit 6 in office sitting DBP.
• Office sitting DBP and office sitting SBP values and changes from baseline at each study visit.
• 24 hours SBP and DBP measurements. 24 hours, Day-time and night-time weighted mean value of both SBP and DBP.
• All standard safety endpoints (AEs, vital signs, ECG, laboratory data and physical examination).
• Office sitting SBP and DBP corrected as per seasonal variation of temperature (confounding factor).

Cambiamento della pressione arteriosa diastolica da seduto alla visita 6 rispetto al basale (Visita 3)
• Valori di pressione diastolica e sistolica da seduto e variazioni dal basale a ogni visita.
• Misurazioni di pressione diastolica e sistolica, misurati nelle 24 ore e come valore medio ponderato giornaliero e notturno.
• Tutti gli endpoint standard di sicurezza (AEs, segni vitali, ECG, dati di laboratorio e esame fisico).
• Valori di pressione diastolica e sistolica da seduto corretti in base alla variazione stagionale della temperatura (fattore di confondimento).

E.5.2.1

Timepoint(s) of evaluation of this end point

9 weeks for OBP and tollerability, 24 hours for ABPM

9 settimane per la pressione arteriosa misurata al centro clinico (OBP) e tollerabilità, 24 ore
per le misurazioni ripetute (ABPM)

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

Yes

E.6.10

Pharmacogenetic

Yes

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

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

Yes

E.8.1.7.1

Other trial design description

4 arms in Italy and 3 arms in Taiwan

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

E.8.2.2

Placebo

Yes

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

stesso farmaco ad altro dosaggio

same drug (rostafuroxin) at other dosage

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Taiwan

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

It is expected that the study will end on 30/07/2016 with the last visit of the last patient and that the 31/10/2016 is frozen the data base.

E previsto che lo studio finisca il 30/07/2016 con l’ultima visita dell’ultimo paziente e che il 31/10/2016 venga congelato il data-base.

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

280

F.1.3

Elderly (>=65 years)

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

160

F.4.2

For a multinational trial

F.4.2.1

In the EEA

160

F.4.2.2

In the whole clinical trial

280

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)

Usual clinical practice for pathology under study

normale pratica clinica per la patologia in studio

G. Investigator Networks to be involved in the Trial
G.4 Investigator Network to be involved in the Trial: 1
G.4.1	Name of Organisation	AUSL di Parma
G.4.3.4	Network Country	Italy
G.4 Investigator Network to be involved in the Trial: 2
G.4.1	Name of Organisation	ASL n.1 di Sassari
G.4.3.4	Network Country	Italy
G.4 Investigator Network to be involved in the Trial: 3
G.4.1	Name of Organisation	ASL n1 Avezzano-Sulmona-L'Aquila
G.4.3.4	Network Country	Italy
G.4 Investigator Network to be involved in the Trial: 4
G.4.1	Name of Organisation	AUSL 8 Arezzo
G.4.3.4	Network Country	Italy
G.4 Investigator Network to be involved in the Trial: 5
G.4.1	Name of Organisation	AUSL di Rimini
G.4 Investigator Network to be involved in the Trial: 6
G.4.1	Name of Organisation	ASL N.4 Teramo
G.4.3.4	Network Country	Italy
G.4 Investigator Network to be involved in the Trial: 7
G.4.1	Name of Organisation	AUSL N.16
G.4.3.4	Network Country	Italy
G.4 Investigator Network to be involved in the Trial: 8
G.4.1	Name of Organisation	ULSS 2 Napoli Nord
G.4.3.4	Network Country	Italy
G.4 Investigator Network to be involved in the Trial: 9
G.4.1	Name of Organisation	ASREM di Isernia
G.4.3.4	Network Country	Italy
G.4 Investigator Network to be involved in the Trial: 10
G.4.1	Name of Organisation	AUSL di Ravenna
G.4.3.4	Network Country	Italy
G.4 Investigator Network to be involved in the Trial: 11
G.4.1	Name of Organisation	ASL di Taranto
G.4.3.4	Network Country	Italy

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2010-12-29

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2010-12-09

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