Clinical Trials Register

Summary
EudraCT Number:	2014-002606-20
Sponsor's Protocol Code Number:	CV185-325/B0661037
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2017-08-02
Trial results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Spain - AEMPS

A.2

EudraCT number

2014-002606-20

A.3

Full title of the trial

A RANDOMIZED, OPEN-LABEL, ACTIVE CONTROLLED, SAFETY AND EXTRAPOLATED EFFICACY STUDY IN PEDIATRIC SUBJECTS REQUIRING ANTICOAGULATION FOR THE TREATMENT OF A VENOUS THROMBOEMBOLIC EVENT

ESTUDIO ABIERTO, ALEATORIZADO Y COMPARATIVO CON TRATAMIENTO ACTIVO, DE LA SEGURIDAD Y LA EFICACIA EXTRAPOLADA EN PACIENTES PEDIÁTRICOS QUE REQUIEREN ANTICOAGULACIÓN PARA EL TRATAMIENTO DE UN ACONTECIMIENTO TROMBOEMBÓLICO VENOSO

A.3.1

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

A RANDOMIZED, OPEN-LABEL, ACTIVE CONTROLLED, SAFETY AND EXTRAPOLATED EFFICACY STUDY IN PEDIATRIC SUBJECTS REQUIRING ANTICOAGULATION FOR THE TREATMENT OF A VENOUS THROMBOEMBOLIC EVENT

A.4.1

Sponsor's protocol code number

CV185-325/B0661037

A.5.3

WHO Universal Trial Reference Number (UTRN)

U1111-1160-6336

A.5.4

Other Identifiers

Name:

USA IND Number

Number:

66,106

A.7

Trial is part of a Paediatric Investigation Plan

Yes

A.8

EMA Decision number of Paediatric Investigation Plan

P/235/2013

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	GCT-SU Representative
B.5.3	Address:
B.5.3.1	Street Address	Parc de l'Alliance - Avenue de Finlande, 4
B.5.3.2	Town/ city	Braine-l'Alleud
B.5.3.3	Post code	1420
B.5.3.4	Country	Belgium
B.5.5	Fax number	+3223517164
B.5.6	E-mail	gct-su@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	BMS-562247-01
D.3.4	Pharmaceutical form	Oral solution
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	APIXABAN
D.3.9.2	Current sponsor code	PF-0465257/BMS-562247-01
D.3.9.4	EV Substance Code	SUB25425
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	0.4
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	Yes
D.2.1.1.1	Trade name	Eliquis
D.2.1.1.2	Name of the Marketing Authorisation holder	Bristol-Myers Squibb/Pfizer EEIG
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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	PF-04652577/BMS-562247-01
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.3.9.2	Current sponsor code	PF-04652577/BMS-562247-01
D.3.9.4	EV Substance Code	SUB25425
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	Yes
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.3.4	Pharmaceutical form
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	NA
D.3.9.1	CAS number	NA
D.3.9.2	Current sponsor code	NA
D.3.9.3	Other descriptive name	WARFARIN SODIUM
D.3.9.4	EV Substance Code	SUB05128MIG
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: 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.2.1.2	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.3.4	Pharmaceutical form
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	ENOXAPARIN SODIUM
D.3.9.1	CAS number	9041-08-1
D.3.9.2	Current sponsor code	NA
D.3.9.3	Other descriptive name	ENOXAPARIN SODIUM
D.3.9.4	EV Substance Code	SUB11933MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	20 to 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	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: 5
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.2.1.2	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.3.4	Pharmaceutical form
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	NA
D.3.9.1	CAS number	NA
D.3.9.2	Current sponsor code	NA
D.3.9.3	Other descriptive name	DALTEPARIN SODIUM
D.3.9.4	EV Substance Code	SUB11889MIG
D.3.10	Strength
D.3.10.1	Concentration unit	IU/ml international unit(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	25000
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

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Venous Thromboembolism

Tromboembolismo Venoso

E.1.1.1

Medical condition in easily understood language

Blood Clot

Coágulo sanguíneo

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	LLT
E.1.2	Classification code	10043565
E.1.2	Term	Thromboembolic event
E.1.2	System Organ Class	100000023033

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

To assess the safety and extrapolated efficacy of apixaban in pediatric subjects requiring anticoagulation for the treatment of a VTE.

Evaluar la seguridad y la eficacia extrapolada de apixaban en pacientes pediátricos que requieren anticoagulación para el tratamiento de un TEV

E.2.2

Secondary objectives of the trial

To evaluate apixaban pharmacokinetic (PK) and anti-FXa activity in pediatric subjects requiring anticoagulation for the treatment of a VTE.

Evaluar la farmacocinética (FC) de apixaban y la actividad anti FXa en pacientes pediátricos que requieren anticoagulación para el tratamiento de un TEV

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1.Children 2 to <18 years of age at the time of consent (Age Groups 1 and 2). An approved protocol will be implemented prior to enrolment of each subsequent age group.

2.Presence of an index VTE which is confirmed by imaging. Index VTE include, but are not limited to, deep vein thrombosis, pulmonary embolus, cerebral sinovenous thrombosis, renal vein thrombosis, portal vein thrombosis, and splanchnic thrombosis.

3.Intention to manage the index VTE with anticoagulation treatment for at least 12 weeks or intention to manage the index VTE with anticoagulation treatment in neonates for at least 6 weeks.

4.Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study. Depending on local regulations, whenever the minor is able to give assent, the minor’s assent must also be obtained.

5.Subjects/legally acceptable representatives who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

6.Female subjects who, in the opinion of the investigator, are biologically capable of having children and are sexually active and at risk for pregnancy must agree to use a highly effective method of contraception throughout the study and for at least 33 days (5 half-lives plus 30 days) after the last dose of assigned treatment.

1.Niños de 2 a <18 años de edad en el momento del consentimiento (Grupos de edad 1 y 2).
•Antes de la inclusión de cada grupo de edad subsiguiente, se implementará una enmienda aprobada del protocolo.

2.Presencia de un TEV inicial que se confirme mediante imagen. El TEV inicial incluye, entre otros, trombosis venosa profunda, embolia pulmonar, trombosis del seno venoso cerebral, trombosis venosa renal, trombosis de la vena porta y trombosis esplácnica.

3.Intención de tratar el TEV inicial con tratamiento anticoagulante durante al menos 12 semanas o intención de tratar el TEV inicial con tratamiento anticoagulante en neonatos durante al menos 6 semanas.

4.Constancia de un documento de consentimiento informado, firmado y fechado personalmente, que indique que se ha informado al paciente (o a un representante legal) de todos los aspectos pertinentes del estudio. Dependiendo de la normativa local, siempre que el menor sea capaz de otorgar su consentimiento, deberá obtenerse asimismo el asentimiento del menor.

5.Los pacientes/representantes legales pueden y están dispuestos a cumplir en lo referente a las visitas programadas, el plan de tratamiento, las pruebas analíticas y demás procedimientos del estudio.

6.Las pacientes que, en opinión del investigador, sean biológicamente capaces de tener hijos, tengan una vida sexual activa y presenten riesgo de embarazo deben acceder a utilizar un método anticonceptivo altamente eficaz durante todo el estudio y, al menos, 33 días (5 semividas más 30 días) después de la última dosis del tratamiento asignado.

E.4

Principal exclusion criteria

1. Anticoagulant treatment for the index VTE for greater than 7 days prior to randomization.

2. Cerebral sinovenous thrombosis (in Germany only).

3. Thrombectomy, thrombolytic therapy, or insertion of a caval filter to treat the index VTE

4. A mechanical heart valve

5.Active bleeding or high risk of bleeding (e.g. central nervous system (CNS) tumors) at the time of randomization.

6.Intracranial bleed, including intraventricular hemorrhage, within 3 months prior to randomization.

7.Abnormal baseline liver function (ALT > 3 x upper limit of normal (ULN) or conjugated bilirubin > 2x ULN) at randomization.

8.At the time of randomization, inadequate renal function as defined in Section 7.2.2 Estimated Glomerular Filtration Rate Assessment of the protocol.

9.Platelet count < 50×109 per L at randomization.

10.At the time of randomization, uncontrolled severe hypertension as defined in Section 7.1 Physical Examination of the protocol.

11.At the time of randomization, use of prohibited concomitant medication as listed for apixaban in Section 5.5 Concomitant Medication of the protocol.

12.Known allergy to apixaban.

13.Female subjects who are either pregnant or breastfeeding a child.

14.Geographically unavailable for follow-up.

15.Family members who are either investigational site staff members directly involved in the conduct of this trial or site staff members otherwise supervised by the Investigator. Family members who are Pfizer or Bristol Myers Squibb (BMS) employees directly involved in the conduct of this trial.

16.Taking an investigational drug in other studies within 30 days before the first dose of apixaban and/or during study participation. N.B. using marketed medications commonly used in usual and customary practice, though not labeled for use in children, is acceptable.

17.Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.

1.Tratamiento anticoagulante para el TEV inicial durante más de 7 días antes de la aleatorización.
2.Trombosis del seno venoso cerebral (solamente en Alemania).
3.Trombectomía, terapia trombolítica o inserción de un filtro en la vena cava para tratar el TEV inicial.
4.Una válvula cardíaca mecánica.
5.Hemorragia activa o alto riesgo de hemorragia (p. ej., tumores en el sistema nervioso central [SNC]) en el momento de la aleatorización.
6.Sangrado intracraneal, incluida la hemorragia intraventricular, en los 3 meses previos a la aleatorización.
7.Función hepática inicial anómala (ALT >3 x límite superior de la normalidad [LSN] o bilirrubina conjugada >2 x LSN) en la aleatorización.
8.En el momento de la aleatorización, función renal inadecuada tal como se define en la sección 7.2.2. Evaluación de la tasa de filtración glomerular estimada.
9.Recuento de plaquetas <50 × 109 por litro en la aleatorización.
10.En el momento de la aleatorización, hipertensión grave no controlada tal como se define en la sección 7.1 Exploración física.
11.En el momento de la aleatorización, uso de medicación concomitante prohibida según se enumera en relación con apixaban en la sección 5.5 Medicación concomitante.
12.Alergia conocida a apixaban.
13.Mujeres que están embarazadas o en periodo de lactancia.
14.No disponibles para realizar el seguimiento por causas geográficas.
15.Pacientes que sean miembros del personal del centro de investigación implicados directamente en la realización de este ensayo o miembros del personal del centro supervisados de cualquier otro modo por el investigador, así como los miembros de sus familias. Empleados de Pfizer o Bristol Myers Squibb (BMS) directamente implicados en la realización de este ensayo y miembros de sus familias.
16.Recibir un fármaco en investigación en otros estudios en los 30 días anteriores a la primera dosis de apixaban y/o durante la participación en el estudio. Téngase en cuenta que se acepta el uso de medicamentos comercializados que se utilizan normalmente en la práctica habitual, aunque no esté indicado su uso en niños según la ficha técnica.
17.Otra afección médica o psiquiátrica grave, aguda o crónica, o anomalía analítica que pudieran aumentar el riesgo asociado a la participación en el estudio o a la administración del producto en investigación, o que pudieran interferir en la interpretación de los resultados del estudio y que, en opinión del investigador, harían inadecuada la participación del paciente en este estudio.

E.5 End points

E.5.1

Primary end point(s)

Primary Safety: The composite of major and clinically relevant non-major bleeding.

Primary Efficacy: A composite of: (i) all image-confirmed and adjudicated symptomatic and asymptomatic recurrent VTE defined as either contiguous progression or non-contiguous new thrombus and including DVT, PE and paradoxical embolism and (ii) VTE-related mortality.

Principal de seguridad: El resultado compuesto de sangrado mayor y sangrado no mayor clínicamente relevante.

Principal de eficacia: Un resultado compuesto de: (i) todo TEV recurrente, sintomático y asintomático, adjudicado y confirmado mediante imagen, definido como progresión contigua o nuevo trombo no contiguo, y que incluye trombosis venosa profunda (TVP), embolia pulmonar (EP) y embolia paradójica y (ii) mortalidad relacionada con el TEV.

E.5.1.1

Timepoint(s) of evaluation of this end point

Listed with Endpoints

Listados con los criterios de valoración

E.5.2

Secondary end point(s)

• All cause death
• Index VTE status (e.g. unchanged, regression, or resolution)
• Stroke
• New symptomatic or asymptomatic DVT
• New symptomatic PE
• Apixaban concentrations
• Anti-FXa activity

•Muerte por cualquier causa.
•Estado del TEV inicial (p. ej., sin cambios, en regresión o resolución).
•Accidente cerebrovascular.
•TVP nueva sintomática o asintomática.
•Nueva EP sintomática.
•Concentraciones de apixaban.
•Actividad anti FXa.

E.5.2.1

Timepoint(s) of evaluation of this end point

Listed with endpoints

Listados con los criterios de valoración

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

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

E.8.1.1

Randomised

Yes

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

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

Austria

Canada

Germany

Italy

Russian Federation

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

LVLS

Ultima Visita Ultimo Paciente ( 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:

150

F.1.1.1

In Utero

F.1.1.2

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

Yes

F.1.1.2.1

Number of subjects for this age range:

F.1.1.3

Newborns (0-27 days)

Yes

F.1.1.3.1

Number of subjects for this age range:

F.1.1.4

Infants and toddlers (28 days-23 months)

Yes

F.1.1.4.1

Number of subjects for this age range:

F.1.1.5

Children (2-11years)

Yes

F.1.1.5.1

Number of subjects for this age range:

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

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

Pediatric population

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

150

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)

None

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

2017-09-18

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2017-07-31

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

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Orphan Designation Number:
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