Clinical Trials Register

Summary
EudraCT Number:	2012-003837-41
Sponsor's Protocol Code Number:	H7T-MC-TADO
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:	2013-05-09
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

2012-003837-41

A.3

Full title of the trial

A Phase 3, Double-Blind, Randomized, Efficacy and Safety Comparison of Prasugrel and Placebo in Pediatric Patients with Sickle Cell Disease

Studio di fase 3, in doppio cieco, randomizzato, per confrontare l'efficacia e la sicurezza di prasugrel rispetto al placebo in pazienti pediatrici affetti da malattia a cellule falciformi

A.3.1

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

A Phase 3 study for the Efficacy and Safety Comparison of Prasugrel and Placebo in Pediatric Patients with Sickle Cell Disease

Studio di fase 3, in doppio cieco, randomizzato, per confrontare l'efficacia e la sicurezza di prasugrel rispetto al placebo in pazienti pediatrici affetti da malattia a cellule falciformi

A.3.2

Name or abbreviated title of the trial where available

A Phase 3 study for the Efficacy and Safety Comparison of Prasugrel and Placebo in Pediatric Patient

Studio di fase 3 per confrontare l'efficacia e la sicurezza di prasugrel rispetto al placebo in pazi

A.4.1

Sponsor's protocol code number

H7T-MC-TADO

A.5.3

WHO Universal Trial Reference Number (UTRN)

U1111-1139-7924

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	Eli Lilly and Company
B.1.3.4	Country	United States
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	Eli Lilly and Company
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Eli Lilly
B.5.2	Functional name of contact point	Clinical Trial Information
B.5.3	Address:
B.5.3.1	Street Address	N/A
B.5.3.2	Town/ city	N/A
B.5.4	Telephone number	N/A
B.5.5	Fax number	N/A
B.5.6	E-mail	EU_Lilly_Clinical_Trials@lilly.com

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	Prasugrel hydrochloride
D.3.2	Product code	LY640315
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	Yes
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	PRASUGREL
D.3.9.1	CAS number	389574-19-0
D.3.9.2	Current sponsor code	LY640315
D.3.9.3	Other descriptive name	PRASUGREL IDROCLORIDE
D.3.9.4	EV Substance Code	SUB21238
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	1
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	Prasugrel hydrochloride
D.3.2	Product code	LY640315
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	Yes
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	PRASUGREL
D.3.9.1	CAS number	389574-19-0
D.3.9.2	Current sponsor code	LY640315
D.3.9.3	Other descriptive name	PRASUGREL IDROCLORIDE
D.3.9.4	EV Substance Code	SUB21238
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	2
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	Prasugrel hydrochloride
D.3.2	Product code	LY640315
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	Yes
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	PRASUGREL
D.3.9.1	CAS number	389574-19-0
D.3.9.2	Current sponsor code	LY640315
D.3.9.3	Other descriptive name	PRASUGREL IDROCLORIDE
D.3.9.4	EV Substance Code	SUB21238
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	3
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	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	Prasugrel hydrochloride
D.3.2	Product code	LY640315
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	Yes
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	PRASUGREL
D.3.9.1	CAS number	389574-19-0
D.3.9.2	Current sponsor code	LY640315
D.3.9.3	Other descriptive name	PRASUGREL IDROCLORIDE
D.3.9.4	EV Substance Code	SUB21238
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	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	Tablet
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
D.8 Placebo: 3
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
D.8 Placebo: 4
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

Efficacy and Safety Comparison of Prasugrel and Placebo in Pediatric Patients with Sickle Cell Disease

efficacia e sicurezza di prasugrel rispetto al placebo in pazienti pediatrici affetti da malattia a cellule falciformi

E.1.1.1

Medical condition in easily understood language

Sickle Cell Disease

malattia a cellule falciformi

E.1.1.2

Therapeutic area

Diseases [C] - Blood and lymphatic diseases [C15]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	16.0
E.1.2	Level	LLT
E.1.2	Classification code	10040644
E.1.2	Term	Sickle cell disease
E.1.2	System Organ Class	100000004850

E.1.3

Condition being studied is a rare disease

Yes

E.2 Objective of the trial

E.2.1

Main objective of the trial

The primary objective of this study is to assess the efficacy of prasugrel compared to placebo in pediatric patients with SCD as measured by reduction in the rate of VOC, which is a composite endpoint of painful crisis or acute chest syndrome, throughout the study.

L'obiettivo primario di questo studio è la valutazione dell'efficacia di prasugrel rispetto al placebo in pazienti pediatrici affetti da malattia a cellule falciformi (SCD), misurata in termini di riduzione del tasso di crisi vaso-occlusive (VOC) che rappresenta un endpoint composito di crisi di dolore o sindrome toracica acuta, per tutto lo studio.

E.2.2

Secondary objectives of the trial

Major Secondary Efficacy Objectives
• Assess the efficacy of prasugrel compared to placebo in pediatric patients with SCD by assessment of the following key endpoints:
1. the reduction in the rate and intensity of sickle cell-related pain as recorded in patient pain diaries
2. the reduction in the rate of hospitalization for VOC

Safety Objectives:
• Assess the safety of prasugrel compared to placebo in pediatric patients with SCD.

•Determinare l'efficacia di prasugrel rispetto al placebo in pazienti pediatrici affetti da SCD mediante la valutazione dei seguenti endpoint in una procedura di gatekeeping a sequenza fissa:
1.riduzione del tasso di dolore correlato alla malattia a cellule falciformi, secondo quanto registrato nei diari del dolore del paziente
2.riduzione del tasso di ricoveri per VOC
malattia a cellule falciformi, secondo quanto registrato nei diari del dolore del paziente
Obiettivi di sicurezza:
• Valutare la sicurezza di prasugrel rispetto al placebo in pazienti pediatrici con malattia a cellule falciformi.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

a. Have SCD (HbSS or HbS0 thalassemia)

b. Are patients with SCD who have had ≥2 episodes of VOC (vaso-occlusive crisis) in the past year

c. Have a body weight ≥19 kg and are ≥2 and <18 years of age, inclusive at the time of screening.

a. Pazienti affetti da SCD (talassemia HbSS o HbS beta zero determinata in laboratorio)

b. pazienti che hanno avuto ≥2 episodi di VOC (crisi vaso-occlusive) nell'ultimo anno

c. Peso corporeo ≥19 kg e un'età compresa tra ≥2 e <18 anni al momento dello screening per il periodo di trattamento in doppio cieco

E.4

Principal exclusion criteria

a. History of: TIA/ ischemic or hemorrhagic stroke, severe head trauma, intracranial hemorrhage, intracranial neoplasm, arteriovenous malformation, or aneurysm

b. History of abnormal or conditional (velocity in middle or anterior cerebral, or internal carotid artery ≥170 cm/sec) transcranial Doppler within the last year

c. History of, or are undergoing treatment with, chronic RBC transfusion therapy

d. Are at an increased risk for bleeding complications
e. Are receiving treatment with oral NSAIDs exceeding 4 days per week or intravenous NSAIDs exceeding 2 days per week

a. Anamnesi di:TIA/ictus ischemico o emorragicodiatesi emorragica, grave trauma cranico, emoraggia intracranica, neoplasia intracranica, malformazione arteriovenosa, o aneurisma.

b. Anamnesi di Doppler intracranico anormale o condizionale (velocità nell'arteria cerebrale media o anteriore o carotide interna ≥170 cm/sec) nell'ultimo anno, indipendentemente dall'età

c.Anamnesi di o trattamento in corso con trasfusioni croniche di globuli rossi

d.hanno un maggior rischio di sanguinamento

e. stanno ricevendo trattamento con farmaci orali antinfiammatori non steroidei (FANS) superiore ai 4 giorni per settimana o farmaci intravenosi antinfiammatori non steroidei (FANS) superiori a 2 giorni per settimana.

E.5 End points

E.5.1

Primary end point(s)

The primary objective of this study is to test the hypothesis that prasugrel compared to placebo will reduce the rate of VOC, which is a composite endpoint of painful crisis or acute chest syndrome.

E.5.1.1

Timepoint(s) of evaluation of this end point

24 months

24 mesi

E.5.2

Secondary end point(s)

Major secondary efficacy measures include:
• Rate and intensity of sickle cell-related pain as recorded in patient pain diaries

• Rate of hospitalization for VOC

Principali misure secondarie di efficacia includono:

• riduzione del tasso e intensità di dolore correlato alla malattia a cellule falciformi, secondo quanto registrato nei diari del dolore del paziente
• durata del ricovero per VOC

E.5.2.1

Timepoint(s) of evaluation of this end point

36 months (3 years)

36 mesi (3 anni)

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

Yes

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

Yes

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

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

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

Option to continue on into an open label study after completion of randomised, double blind study

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

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

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

Belgium

Brazil

Canada

Egypt

France

Ghana

Italy

Kenya

Lebanon

Netherlands

Oman

Saudi Arabia

Turkey

United Arab Emirates

United Kingdom

United States

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

Yes

F.1.1

Number of subjects for this age range:

220

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)

Yes

F.1.1.5.1

Number of subjects for this age range:

145

F.1.1.6

Adolescents (12-17 years)

Yes

F.1.1.6.1

Number of subjects for this age range:

F.1.2

Adults (18-64 years)

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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2013-05-09.

Yes

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

Yes

F.3.3.6.1

Details of subjects incapable of giving consent

Some patients will be too young to give consent peronally. The investigator is responsible for ensuring that the patient and parent/legal representative understand the potential risks and benefits of participating in the study

alcuni pazienti saranno troppo giovani per dare il loro consenso personalmente. L’ investigator è responsabile nell’ assicurare che i pazienti e genitori/legali rappresentanti capiscano il rischio potenziale a beneficio di partecipare allo studio.

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

100

F.4.2.2

In the whole clinical trial

220

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

After the DB treatment period, patients will be eligible to receive treatment with prasugrel during the 1-year OLE.Following this the sponsor will either amend the protocol to further extend the study or take other actions to provide the option of continuing access to prasugrel for those ongoing study participants who show clear benefit from prasugrel until such time as prasugrel receives regulatory approval in the country in which they are enrolled in the study.

Dopo il periodo di trattamento double blind, i pazienti saranno eleggibili per ricevere il trattamento con prasugrel durante l’ anno dello studio di estensione in aperto. A seguito di questo studio lo Sponsor si impegna ad emendare il protocollo per estendere ulteriormente lo studio o a intraprendere altre azioni per fornire la possibilità di accesso continuo al prasugrel per quei partecipanti allo studio in corso che mostrano chiaro beneficio da prasugrel..

G. Investigator Networks to be involved in the Trial
G.4 Investigator Network to be involved in the Trial: 1

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

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2013-07-08

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2013-05-23

P. End of Trial
P.	End of Trial Status	Prematurely Ended
P.	Date of the global end of the trial	2015-09-16

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