Clinical Trials Register

Summary
EudraCT Number:	2012-004180-43
Sponsor's Protocol Code Number:	BAY59-7939/15786
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:	2013-03-28
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

2012-004180-43

A.3

Full title of the trial

A randomized controlled trial of rivaroxaban for the prevention of major cardiovascular events in patients with coronary or peripheral artery disease (COMPASS - Cardiovascular OutcoMes for People using Anticoagulation StrategieS)

Studio randomizzato e controllato volto a valutare il rivaroxaban per la prevenzione degli eventi cardiovascolari maggiori in pazienti affetti da arteriopatia coronarica o periferica

A.3.1

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

Rivaroxaban for the prevention of major cardiovascular events in coronary or peripheral artery disease

rivaroxaban per la prevenzione degli eventi cardiovascolari maggiori in pazienti affetti da arteriopatia coronarica o periferica

A.3.2

Name or abbreviated title of the trial where available

COMPASS

A.4.1

Sponsor's protocol code number

BAY59-7939/15786

A.5.4

Other Identifiers

Name:

COMPASS

Number:

COMPASS

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	BAYER AG
B.1.3.4	Country	Germany
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	Bayer AG
B.4.2	Country	Germany
B.4.1	Name of organisation providing support	Hamilton Health Sciences Corporation, Population H
B.4.2	Country	Canada
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Bayer AG
B.5.2	Functional name of contact point	Bayer Clinical Trials Contact
B.5.3	Address:
B.5.3.1	Street Address	CTP Team/REF:"EU CTR"/Bayer Pharma AG
B.5.3.2	Town/ city	Berlino
B.5.3.3	Post code	D-13353
B.5.3.4	Country	Germany
B.5.4	Telephone number	000000
B.5.5	Fax number	000000
B.5.6	E-mail	clinical-trials-contact@bayer.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	Yes
D.2.1.1.1	Trade name	XARELTO - 2,5 MG - COMPRESSE RIVESTITE CON FILM - USO ORALE - BLISTER (PP/ALU) - 100X1 COMPRESSE
D.2.1.1.2	Name of the Marketing Authorisation holder	BAYER AG
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	Xarelto 2.5mg
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	RIVAROXABAN
D.3.9.1	CAS number	366789-02-8
D.3.9.2	Current sponsor code	BAY 59-7939
D.3.9.4	EV Substance Code	SUB29263
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	2500
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	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	rivaroxaban 5 mg
D.3.2	Product code	[BAY59-7939]
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	RIVAROXABAN
D.3.9.1	CAS number	366789-02-8
D.3.9.2	Current sponsor code	BAY 59-7939
D.3.9.4	EV Substance Code	SUB29263
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: 3
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	ASPIRINA
D.2.1.1.2	Name of the Marketing Authorisation holder	Bayer AG
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	Aspirina 100 mg
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	ACIDO ACETILSALICILICO
D.3.9.1	CAS number	50-78-2
D.3.9.2	Current sponsor code	XXX
D.3.9.4	EV Substance Code	SUB12730MIG
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	100
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: 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	Yes
D.2.1.1.1	Trade name	PANTOPRAZOLO
D.2.1.1.2	Name of the Marketing Authorisation holder	Teva Zaragoza
D.2.1.2	Country which granted the Marketing Authorisation	Spain
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	Pantoprazolo 40 mg
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	PANTOPRAZOLO
D.3.9.1	CAS number	102625-70-7
D.3.9.2	Current sponsor code	XXX
D.3.9.4	EV Substance Code	SUB09608MIG
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	40
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
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

Prevention of major cardiovascular events in patients with coronary or peripheral artery disease

Prevenzione di eventi cardiovascolari maggiori in pazienti con malattie arteriose coronariche o periferiche

E.1.1.1

Medical condition in easily understood language

Prevention of heart attacks, strokes and death in patients with (atherosclerotic) narrowing of the arteries of the heart or legs

Prevenzione di eventi cardiovascolari maggiori in pazienti con malattie arteriose coronariche o periferiche

E.1.1.2

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.1
E.1.2	Level	PT
E.1.2	Classification code	10064939
E.1.2	Term	Cardiovascular event prophylaxis
E.1.2	System Organ Class	10042613 - Surgical and medical procedures

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Primary objectives for rivaroxaban randomization:
•To determine whether rivaroxaban 2.5 mg twice daily (bid) + aspirin 100 mg once daily (od) compared with aspirin 100 mg od reduces the risk of a composite of myocardial infarction, stroke, or cardiovascular death in subjects with CAD or PAD
•To determine whether rivaroxaban 5 mg bid compared with aspirin 100 mg od reduces the risk of a composite of myocardial infarction, stroke or cardiovascular death in subjects with CAD or PAD

• Determinare se il rivaroxaban alla dose di 2,5 mg 2 volte al giorno + aspirina 100 mg 1 volta al giorno, rispetto alla sola aspirina 100 mg 1 volta al giorno , è in grado di ridurre il rischio di infarto miocardico (IM), ictus ischemico o morte cardiovascolare (CV) in pazienti affetti da arteriopatia coronarica (AC) o arteriopatia periferica (AP).

E.2.2

Secondary objectives of the trial

Secondary objectives for rivaroxaban randomization:
•To determine whether each of rivaroxaban 2.5 mg bid + aspirin 100 mg od and rivaroxaban 5 mg bid alone reduces the risk of the composite of major thrombotic events (coronary heart disease death, myocardial infarction, ischemic stroke, acute limb ischemia; cardiovascular death, myocardial infarction, ischemic stroke, acute limb ischemia) compared with aspirin 100 mg od in subjects with CAD or PAD
•To determine whether each of rivaroxaban 2.5 mg bid + aspirin 100 mg od and rivaroxaban 5 mg bid alone reduces the risk of mortality in subjects with CAD or PAD

Determinare se rivaroxaban alla dose di 2,5 mg 2 volte al giorno + aspirina 100 mg 1 volta al giorno e rivaroxaban dose di 5 mg 2 volte al giorno da solo, riduce il rischio di maggiori eventi trombotici
(1) morte per malattia coronarica , infarto miocardico, ictus ischemico , ischemia acuta dell'arto ( 2 ) morte cardiovascolare , infarto miocardico , ictus ischemico, ischemia acuta dell’arto in confronto all’aspirina 100 mg 1 volta al giorno nei pazienti con AC o AP
• Determinare se rivaroxaban alla dose di 2,5 mg 2 volte al giorno + aspirina 100 mg 1 volta al giorno e rivaroxaban 5 mg 2 volte al giorno riduce il rischio di mortalità in pazienti con AC o AP

E.2.3

Trial contains a sub-study

Yes

E.2.3.1

Full title, date and version of each sub-study and their related objectives

Other types of substudies
Specify title, date and version of each substudy with relative objectives: The COMPASS MIND substudy is included in section 14 of
the COMPASS protocol
Objective: Magnetic resonance imaging (MRI) substudy evaluating the
incidence of clinically silent brain infarcts and subclinical brain ischemia. Italy will not participate in this substudy

Altre tipologie di sottostudi
specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: : COMPASS MIND Questo sottostudio è descritto nella sezione 14 del protocollo principale.
Si tratta di un sottostudio di MRI che ha l’obiettivo di valutare l’incidenza di infarti cerebrali clinicamente silenti e ischemia cerebrale subclinica. L’Italia non parteciperà al sottostudio.

E.3

Principal inclusion criteria

-- Coronary or peripheral artery disease
Patients with coronary artery disease must also meet at least one of the following:
-- Age =65, or
-- Age <65 and documented atherosclerosis or revascularization involving at least 2 vascular beds, or at least 2 additional risk factors

I pazienti sono eleggibili per l’inclusione se:
hanno i criteri per AC * e/o per AP
I pazienti con AC devono anche avere almeno 1 dei seguenti criteri:

o età = 65 anni;
o età <65 anni con aterosclerosi documentata o rivascolarizzazione almeno in due letti vascolari o almeno 2 fattori di rischio cardiovascolare addizionali :
o fumatore (entro 1 anno dalla randomizzazione);
o diabete mellito;
o disfunzione renale con eGFR <60 ml/min;
o scompenso cardiaco;
o pregresso ictus ischemico non lacunare ( =1 mese prima).
* Poiché AC coinvolge la malattia del sistema vascolare coronarico, solo un ulteriore letto vascolare è richiesto: es. l’aorta e il flusso arterioso al cervello, tratto gastro-intestinale, gli arti inferiori e superiori o i reni

E.4

Principal exclusion criteria

-Need for dual antiplatelet therapy, other non-aspirin antiplatelet therapy or oral anticoagulant therapy
-Stroke within 1 month or any history of hemorrhagic or lacunar stroke
-Severe heart failure with known ejection fraction <30% or New York Heart Association (NYHA) class III or IV symptoms
-Estimated glomerular filtration rate (eGFR) <15 mL/min

• rischio elevato di emorragie;
• ictus entro 1 mese o qualsiasi tipo di ictus emorragico o lacunare pregresso;
• insufficienza cardiaca grave con frazione di eiezione <30% diagnosticata o sintomi di classe III o IV secondo la New York Heart Association (NYHA);
• eGFR<15 ml/min (insufficienza renale grave);
• necessità di terapia di doppia antiaagregazione, altra terapia antipiastrinica senza aspirina o terapia anticoagulante orale;
• malattia non cardiovascolare nota, associata a prognosi infausta (per es. neoplasia metastatica) o che aumenta il rischio di reazione avversa agli interventi dello studio;
• ipersensibilità all'anamnesi o controindicazione nota per rivaroxaban, aspirina, pantoprazolo o loro eccipienti;
• trattamento sistemico con potenti inibitori di entrambe CYP 3A4 e della glicoproteina P (P-gp), per es. antimicotici azolici sistemici quali il chetoconazolo e inibitori della HIV-proteasi quali il ritonavir; o potenti induttori di CYP 3A4, es. rifampicina, rifabutina, fenobarbitolo, fenitoina e carbamazepina
• qualsiasi malattia epatica associata a coagulopatia;
• donne incinte, che allattano o sono potenzialmente fertili e sessualmente attive e non adottano alcun metodo di controllo delle nascite (per es. sterilizzate chirurgicamente, contraccettivi orali su prescrizione, iniezioni contraccettive, dispositivi contraccettivi intrauterini, metodo di barriera doppio, cerotto contraccettivo, sterilizzazione del partner maschile) prima e durante l'intera durata dello studio; donne in età fertile che hanno un test di gravidanza positivo allo screening;
• precedente assegnazione al trattamento durante lo studio.
• partecipazione simultanea ad un altro studio con farmaco sperimentale
• nota controindicazione a qualche procedura dello studio
Un criterio di esclusione aggiuntivo per la randomizzazione per il pantoprazolo è:
• necessità di trattamento continuo con un inibitore della pompa protonica.

E.5 End points

E.5.1

Primary end point(s)

Efficacy end point: Time from randomization to the first occurrence of either myocardial infarction, stroke, or cardiovascular death

Safety end point: Time from randomization to the first occurrence of major bleeding (modified International Society on Thrombosis and Haemostasis)

1. Combinazione di IM, ictus ischemico e morte CV.
Endpoint primario di sicurezza
Combinazione di emorragia fatale e /o
Emorragia sintomatica in un’area critica o organo, come intracranio, intraspinale, intraoculare, retroperitoneale, intraarticolare o pericardiale, o intramuscolare con compartment syndrome, o emorragia nel sito operato richiedendo un reintervento, e / o Emorragia che richiede un’ospedalizzazione

E.5.1.1

Timepoint(s) of evaluation of this end point

Approximately 5 years

circa 5 anni

E.5.2

Secondary end point(s)

Time from randomization to first occurrence of either Coronary heart disease death, myocardial infarction, ischemic stroke, acute limb ischemia

Time from randomization to first occurrence of either Cardiovascular death, myocardial infarction, ischemic stroke, acute limb ischemia

Time from randomization to first occurrence of all cause mortality

¿ 1. IM, ictus ischemico, morte coronarica o Ischemia periferica acuta
¿ 2. IM, ictus ischemico, morte CV o Ischemia periferica acuta
¿ 3. Mortalità totale

E.5.2.1

Timepoint(s) of evaluation of this end point

Approximately 5 years

circa 5 anni

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

Yes

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

Yes

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

Yes

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

To make rivaroxaban 2.5 mg twice daily twice daily + aspirin 100 mg once daily available to COMPASS trial subjects until the rivaroxaban treatment is commercially available for this indication or for
approximately 3 years from regulatory approval of the long term open label extension in a country, whichever comes first.

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

Yes

E.8.1.6

Cross over

E.8.1.7

Other

Yes

E.8.1.7.1

Other trial design description

3x2 partial factorial

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

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

215

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

Information not present in EudraCT

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

Argentina

Australia

Belgium

Brazil

Canada

Chile

China

Colombia

Czechia

Denmark

Ecuador

Finland

France

Germany

Hungary

Ireland

Israel

Italy

Japan

Korea, Republic of

Malaysia

Netherlands

Philippines

Poland

Romania

Russian Federation

Slovakia

South Africa

Sweden

Switzerland

Ukraine

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

For each participating European Union (EU) country, the end of the study according to the EU Clinical Trial Directive will be reached when the telephone call at the end of the 30 day washout period for the last subject for all centers in the respective country has occurred. The end of the study as a whole will be reached as soon as the end of the study according to the above definition has been reached in all participating countries (EU and non-EU).

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:

4491

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

25449

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

839

F.4.2

For a multinational trial

F.4.2.1

In the EEA

11377

F.4.2.2

In the whole clinical trial

29940

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)

At the conclusion of treatment with study medication, the study staff should encourage the subject to begin treatment with open-label aspirin or other antithrombotic therapy, as indicated.

Al termine del trattamento con il farmaco sperimentale lo staff clinico dovrebbe incoraggiare i Pazienti partecipanti ad iniziare il trattamento con aspirina in aperto o altra terapia antitrombotica indicata.

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

2013-05-25

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2013-05-08

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

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IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
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