Clinical Trials Register

Summary
EudraCT Number:	2007-001557-26
Sponsor's Protocol Code Number:	CV185-048
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:	2008-09-19
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

2007-001557-26

A.3

Full title of the trial

Apixaban Versus Acetylsalicyclic Acid (ASA) to Prevent Stroke in Atrial Fibrillation Patients Who Have Failed or are Unsuitable for Vitamin K Antagonist Treatment: A Randomized Double Blind Trial + Effectiveness of Apixaban for Prevention of Embolic Stroke MRI Assessment Amendment Number 02 - Site Specific Site (Version 2.0 - dated 22-Jun-2007) + Revised Protocol 04 incorporating Amendment 04, 06, 09, 11 & Admin letters 02, 07, 08 and 09

Apixaban verso Acido Acetilsalicilico (ASA) nella prevenzione dell`ictus in pazienti con fibrillazione atriale che abbiano fallito o non siano sottoponibili al trattamento con antagonisti della Vitamina K: studio randomizzato in doppio cieco + Emendamento 02 relativo all`esame MRI per valutare l`efficacia di Apixaban nella prevenzione di ictus embolico + Protocollo Revised 04 che include gli Emendamenti 04, 06, 09, 11 e le Administartive Letters 02, 07, 08, 09

A.3.1

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

The purpose of this clinical research is to learn if apixaban is more effective than Acetylsalicyclic Acid (ASA) in preventing strokes associated with subjects who have atrial fibrillation. The safety of this treatment will also be studied.

Lo scopo di questa ricerca clinica e` quello di sapere se apixaban e` piu` efficace dell’ Acido Acetilsalicilico (ASA) nella prevenzione dell’ictus in soggetti con fibrillazione atriale. Sara` anche studiata la sicurezza di questo trattamento.

A.4.1

Sponsor's protocol code number

CV185-048

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	Bristol Myers Squibb International Corporation
B.1.3.4	Country	Belgium
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	Bristol Myers Squibb International Corporation
B.4.2	Country	Belgium
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Bristol Myers Squibb International Corporation
B.5.2	Functional name of contact point	EU Start Up Department
B.5.3	Address:
B.5.3.1	Street Address	Parc de l`Alliance, avenue de Finlande 8
B.5.3.2	Town/ city	Braine-l`Alleud
B.5.3.3	Post code	1420
B.5.3.4	Country	Belgium
B.5.6	E-mail	clinical.trials@bms.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	apixaban
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	apixaban
D.3.9.1	CAS number	503612-47-3
D.3.9.2	Current sponsor code	BMS-562247-01
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	2.5
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.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	apixaban
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	apixaban
D.3.9.1	CAS number	503612-47-3
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.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	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	Acetylsalicylic Acid
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	Acetylsalicylic acid
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	81
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	Film-coated 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	Film-coated 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	Film-coated 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 atrial fibrillation and at least one additional risk factor for stroke who have failed or are unsuitable for vitamin K antagonist therapy

Pazienti con fibrillazione atriale e con almeno un fattore di rischio per ictus, che abbiano fallito o non siano sottoponibili al trattamento con antagonisti della Vitamina K

E.1.1.1

Medical condition in easily understood language

Atrial Fibrillation

Fibrillazione atriale

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	14.1
E.1.2	Level	SOC
E.1.2	Classification code	10047065
E.1.2	Term	Vascular disorders
E.1.2	System Organ Class	10047065 - Vascular disorders

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To determine if apixaban 5 mg BID (2.5 mg BID in selected patients) is superior to ASA (81 to 324 mg QD) for preventing the composite outcome of stroke or systemic embolism in patients with atrial fibrillation and at least one additional risk factor for stroke who have failed or are unsuitable for vitamin K antagonist therapy

Determinare se Apixaban 5 mg x 2/die (2,5 mg x 2/die in pazienti selezionati) sia superiore ad Acido Acetilsalicilico 81-324 mg/die nella prevenzione dell`evento composito di ictus o embolismo sistemico in pazienti con fibrillazione atriale e con almeno un fattore addizionale di rischio per ictus, che abbiano fallito o non siano sottoponibili al trattamento con antagonisti della Vitamina K

E.2.2

Secondary objectives of the trial

To determine if, in the same patients, apixaban is superior to ASA for the prevention of the composite outcome of: -Stroke, systemic embolism, myocardial infarction or vascular death (major vascular events)

determinare negli stessi pazienti se Apixaban e` superiore ad ASA nella prevenzione dell`evento composito di: -ictus, embolismo sistemico, infarto del miocardio o morte per cause vascolari (eventi vascolari maggiori)

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 SUBSTUDIES:
Effectiveness of Apixaban for Prevention of Embolic Stroke MRI Assessment (Amendment Number 02 - Site Specific dated 22-Jun-07)

ALTRI SOTTOSTUDI:
RMN per la valutazione dell`efficacia di Apixaban nella prevenzione di ictus embolico (emendamento 2 datato 22-jun-2007)

E.3

Principal inclusion criteria

1) Signed written informed consent form 2) Target Population b) Permanent, paroxysmal or persistent atrial fibrillation documented by 12 lead ECG on the day of screening OR If not in atrial fibrillation at screening, atrial fibrillation must be documented in the 6 months prior to enrollment by 12 lead ECG, or as an episode at least 5 minutes in duration on a rhythm strip or Holter recording. Pacemaker or ICD electrogram recordings may be used to document AF but the duration of atrial fibrillation must be at least 30 minutes if this is the only documentation of AF. c) Presence of at least one of the following risk factors for stroke: prior stroke or TIA;Age >/= 75 years; Arterial hypertension on treatment; Diabetes mellitus;Heart failure. NYHA Class 2 or greater at time of enrollment;Left ventricular ejection fraction 35% or less, documented within 6 months of enrollment; Documented peripheral arterial disease (previous arterial revascularization, limb or foot amputation, or current intermittent claudication with ankle-arm systolic blood pressure ratio < 0.9) d) The patient is not currently receiving vitamin K antagonist therapy for one of the following reasons: Previous vitamin K antagonist therapy has been demonstrated to be unsuitable and its use has been discontinued (e.g., poor anticoagulant control, adverse events, need for other treatments that may interact with VKA, patient unable or unwilling to adhere to dose or INR monitoring instructions); Vitamin K antagonist therapy has not been previously used but would be expected to be unsuitable (e.g., unlikely to comply with dosing or monitoring requirement, need for other treatments which may interact with VKA, unlikely to adhere to restrictions on alcohol, diet or nonprescription medications, risk of VKA therapy considered to outweigh the risk of stroke or systemic embolism, patient is unwilling to take VKA). 3) Age and Sex e) Men and women >/= 50 years of age LONG TERM OPEN LABEL EXTENSION 1) Signed Written Informed a) All subjects must provide signed written informed consent to participate in the Long-Term Open-Label Extension 2) Target Population a) All subjects must be receiving double-blind study medication (i.e., not having permanently or temporarily [for >30 days] discontinued study medication) at the time they present for their last double-blind study visit (Month 36/EOT).

1)Firma del consenso informato scritto a)Tutti i soggetti devono firmare un consenso informato scritto. 2)Popolazione target b)Fibrillazione atriale permanente, parossistica o persistente documentata da un ECG a 12 derivazioni il giorno dello screening OPPURE in assenza di fibrillazione atriale allo screening, la fibrillazione atriale deve essere documentata nei 6 mesi precedenti l`arruolamento nello studio da un ECG a 12 derivazioni, o essere presente come episodio della durata di almeno 5 minuti su una striscia di registrazione del ritmo o alla registrazione Holter. Le registrazioni dell`elettrogramma derivanti da pacemaker o da defibrillatore impiantabile (ICD) possono essere utilizzate per documentare la fibrillazione atriale ma, nel caso in cui la fibrillazione atriale sia documentata unicamente con questa metodica, la sua durata deve essere di almeno 30 minuti. c)Presenza di almeno uno dei seguenti fattori di rischio per ictus: pregresso ictus o attacco ischemico temporaneo (TIA); eta` >=75 anni; ipertensione in corso di trattamento; diabete mellito; scompenso cardiaco. Classificazione NYHA di classe 2 o superiore al momento dell`arruolamento nello studio;frazione di eiezione ventricolare sinistra pari o inferiore al 35%, documentata nei 6 mesi precedenti l`arruolamento nello studio; arteriopatia periferica documentata (pregressa rivascolarizzazione arteriosa, amputazione dell`arto o del piede o claudicatio intermittente in corso con un rapporto pressione sistolica caviglia-braccio <0,9); d)Il paziente non e` attualmente in terapia con Antagonisti della Vitamina K (AVK) per uno dei seguenti motivi: una precedente terapia con antagonisti della vitamina K si e` dimostrata inadeguata ed e` stata interrotta (per esempio, scarso effetto anticoagulante, eventi avversi, necessita` di altre terapie che possono interagire con gli antagonisti della vitamina K, incapacita` o non disponibilita` del paziente a seguire il dosaggio o le istruzioni per il monitoraggio INR); la terapia con antagonisti della vitamina K non e` stata utilizzata in precedenza ma si prevede che sara` inadeguata (per esempio, scarsa probabilita` di adesione al dosaggio o alle esigenze di monitoraggio, necessita` di altre terapie che possono interagire con gli AVK, scarsa probabilita` di adesione alle limitazioni riguardanti il consumo di alcol, il regime alimentare o i farmaci da banco, rischio legato alla terapia con AVK ritenuto superiore al rischio di ictus o di embolismo sistemico, non disponibilita` del paziente ad assumere AVK). 3)Eta` e sesso e)Uomini e donne di eta` maggiore o uguale a 50 anni. Criteri di Inclusione LTOLE 1.Consenso informato scritto firmato a)Tutti i pazienti devono fornire un consenso informato scritto per partecipare alla fase di estensione a lungo termine in aperto. 2.Popolazione target a)Tutti i pazienti devono essere in trattamento con il farmaco sperimentale in doppio cieco (non devono aver permanentemente o temporaneamente discontinuato da piu` di 30 giorni il farmaco sperimentale) al momento in cui si presentano per la loro ultima visita della fase in doppio cieco (Mese 36/fine Trattamento).

E.4

Principal exclusion criteria

The following exclusion criteria are the changed ones. For the rest part of exclusion criteria refer to protocol numebr 4 issued on 22/06/2011 Patients entering the Long-Term Open-Label Extension who do not initially meet laboratory criteria but have qualifying values at the time of the Month LTOLE 1 visit may continue to participate in the LTOLE. If the value of serum creatinine at Month 1 is > 221umol/L or > 2.5 mg/dL you should do the following: • Patient should be instructed to temporarily discontinue open-label apixaban until renal function recovers • Repeat serum creatinine tests should be performed (locally or centrally via unscheduled lab request) to confirm recovery of renal function before considering restarting apixaban If repeat test results show that value is < 221 umol/L or 2.5 mg/dL, open-label apixaban may be resumed as long as the patient has not temporarily discontinued study drug for > 60 days. If patient has temporarily discontinued study drug for > 60 days, they are no longer eligible to participate in the LTOLE phase of the trial. Study drug must permanently discontinued and the Final LTOLE Visit must occur.

I criteri di esclusione elencati di seguito rappresentano soltanto la parte aggiunta. Per i restanti fare riferiemento ai criteri di esclusione del protocollo numero 4 del 22/06/2011. I pazienti arruolati nella LTOLE, che inizialmente non soddisfano i criteri di laboratorio, ma hanno valori qualificanti alla visita LTOLE del mese 1 possono continuare a partecipare alla LTOLE. Se il valore della creatinina sierica al Mese 1 è >221umol / L o >2.5mg / dL si dovrebbe procedere come segue: il paziente deve essere informato di sospendere temporaneamente il trattamento con apixaban in aperto fino a quando ha recuperato la funzione renale; ripetere i test di creatinina sierica (a livello locale o centrale, richiedendo un esame di lab. non programmato) per confermare il recupero della funzione renale prima di decidere se ripartire con apixaban. Se i risultati dei test ripetuti mostrano che il valore è <221 umol / L o 2,5 mg / dL, il trattamento in aperto con apixaban può essere ripreso nel caso in cui il paziente non abbia temporaneamente sospeso il farmaco in studio per più di 60 giorni. Se il paziente ha temporaneamente sospeso il farmaco in studio per più di 60 giorni, non sussitono più i requisiti per partecipare alla fase LTOLE ed il paziente deve definitivamente sospendere il farmaco in studio ed eseguire la Visita LTOLE finale.

E.5 End points

E.5.1

Primary end point(s)

The following outcomes will be examined: - Primary efficacy outcome: time to the composite of stroke or systemic embolism - Primary safety outcome: time to major bleeding - Secondary Efficacy Outcome: time to stroke, systemic embolism, myocardial infarction or vascular death (major vascular events)

Saranno esaminati i seguenti eventi: - outcome primario di efficacia: tempo all`insorgenza dell`evento composito di ictus od embolismo sistemico; - outcome primario di sicurezza: tempo all`insorgenza di un`emorragia importante;

E.5.1.1

Timepoint(s) of evaluation of this end point

Time to first occurrence

Tempo prima dell`insorgenza dell`evento

E.5.2

Secondary end point(s)

The secondary efficacy outcome will be the time (days) from first dose of study drug to first occurrence of unrefuted Ischemic stroke, hemorrhagic stroke, systemic embolism, myocardial infarction or vascular deaths. CV185-048-AF-IT-V10-CA.pdf 01-Jun-2012

Il risultato di efficacia secondario sarà il tempo (in giorni) dalla prima somministrazione della dose del farmaco in studio alla prima occorrenza non confutabile di ictus ischemico, ictus emorragico, embolia sistemica, infarto miocardico o morte vascolare.

E.5.2.1

Timepoint(s) of evaluation of this end point

Time to first occurrence

Tempo prima dell`insorgenza dell`evento

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

Yes

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

MRI assessment

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

Open label for the long term part of the study

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

195

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

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Hong Kong

India

Indonesia

Israel

Korea, Republic of

Malaysia

Mexico

Philippines

Russian Federation

Singapore

Taiwan

Turkey

Ukraine

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

LPLV

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

Number of subjects for this age range:

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:

1478

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

4682

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

103

F.4.2

For a multinational trial

F.4.2.1

In the EEA

2360

F.4.2.2

In the whole clinical trial

6160

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)

Availability of an optional Long Term Open Label Extension of Apixaban treatment for subjects in both the Apixaban and ASA treatment groups.

Disponibilita` di una fase opzionale a lungo termine in aperto con apixaban per i gruppi di trattamento in Apixaban e Aspirina

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

2007-11-23

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2007-10-30

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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