Clinical Trials Register

Summary
EudraCT Number:	2014-003890-40
Sponsor's Protocol Code Number:	1160.204
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2015-01-26
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

Spain - AEMPS

A.2

EudraCT number

2014-003890-40

A.3

Full title of the trial

Randomized Evaluation of dabigatran etexilate Compared to warfarIn in pulmonaRy vein ablation: assessment of an uninterrupted periproCedUral alntIcoagulation sTrategy (The RE-CIRCUIT Trial)

Evaluación del tratamiento ininterrumpido aleatorizado con dabigatrán etexilato comparado con warfarina en la ablación de venas pulmonares: Valoración de la terapia anticoagulante ininterrumpida periprocedimiento. (Estudio RE-CIRCUIT).

A.3.1

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

Uninterrupted dabigatran etexilate in comparison to uninterrupted warfarin in pulmonary vein ablation (RE-CIRCUIT)

Dabigatrán etexilato ininterrumpido en comparación con warfarina ininterrumpida en la ablación de venas pulmonares (RE-CIRCUIT)

A.3.2

Name or abbreviated title of the trial where available

RE-CIRCUIT

A.4.1

Sponsor's protocol code number

1160.204

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	Boehringer Ingelheim España, S.A.
B.1.3.4	Country	Spain
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	Boehringer Ingelheim España, S.A.
B.4.2	Country	Spain
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Boehringer Ingelheim GmbH & Co. KG
B.5.2	Functional name of contact point	QRPE PSC CT information Disclosure
B.5.3	Address:
B.5.3.1	Street Address	Binger Str. 173
B.5.3.2	Town/ city	Ingelheim am Rhein
B.5.3.3	Post code	55216
B.5.3.4	Country	Germany
B.5.4	Telephone number	+34 93 404 5100
B.5.5	Fax number	+34 93 404 5580
B.5.6	E-mail	clintriage.rdg@boehringer-ingelheim.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	Pradaxa
D.2.1.1.2	Name of the Marketing Authorisation holder	Boehringer Ingelheim International GmbH
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	dabigatran etexilate 150 mg
D.3.2	Product code	BIBR 1048 MS
D.3.4	Pharmaceutical form	Capsule, hard
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	dabigatran etexilate
D.3.9.1	CAS number	-
D.3.9.2	Current sponsor code	BIBR 1048 MS
D.3.9.3	Other descriptive name	DABIGATRAN ETEXILATE MESILATE
D.3.9.4	EV Substance Code	SUB27581
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	150
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	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	Warfarin 1mg Tablets
D.2.1.1.2	Name of the Marketing Authorisation holder	Teva UK Limited
D.2.1.2	Country which granted the Marketing Authorisation	United Kingdom
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	Warfarin 1 mg
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	warfarin
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	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: 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	Warfarin 3mg Tablets
D.2.1.1.2	Name of the Marketing Authorisation holder	Teva UK Limited
D.2.1.2	Country which granted the Marketing Authorisation	United Kingdom
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	Warfarin 3 mg
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	warfarin
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	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	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	Warfarin 5mg Tablets
D.2.1.1.2	Name of the Marketing Authorisation holder	Teva UK Limited
D.2.1.2	Country which granted the Marketing Authorisation	United Kingdom
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	Warfarin 5 mg
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	warfarin
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.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

Patients with non-valvular atrial fibrillation (NVAF) undergoing catheter ablation for atrial fibrillation

Pacientes con fibrilación auricular no valvular (NVAF) sometidos a una ablación con catéter para la fibrilación auricular.

E.1.1.1

Medical condition in easily understood language

Patients with atrial fibrillation that will undergo pulmonary vein ablation

Pacientes con fibrilación auricular que serán sometidos a una ablación de venas pulmonares.

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	18.0
E.1.2	Level	PT
E.1.2	Classification code	10003658
E.1.2	Term	Atrial fibrillation
E.1.2	System Organ Class	10007541 - Cardiac disorders

E.1.2 Medical condition or disease under investigation

E.1.2	Version	18.0
E.1.2	Level	PT
E.1.2	Classification code	10043634
E.1.2	Term	Thrombosis 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

To assess the safety of an uninterrupted dabigatran etexilate periprocedural anticoagulant regimen compared to an uninterrupted peri-procedural warfarin regimen in non-valvular atrial fibrillation (NVAF) patients undergoing AF ablation

Evaluar la seguridad del tratamiento anticoagulante ininterrumpido con dabigatrán etexilato en comparación con el tratamiento ininterrumpido con warfarina durante el periodo periprocedimiento en pacientes con fibrilación auricular no valvular (NVAF) a los que se realice ablación para la AF.

E.2.2

Secondary objectives of the trial

Secondary objectives are to assess safety and efficacy in this clinical setting.

Los objetivos secundarios consisten en evaluar la seguridad y eficacia en esta situación clínica.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- Male or female patients aged >= 18 years.
- Patients eligible for treatment with dabigatran etexilate 150 mg b.i.d. according to local label.
- Treatment naïve patients or patients on oral anticoagulant treatment with a VKA, dabigatran etexilate, rivaroxaban, apixaban or edoxaban(1).
- Patient with paroxysmal or persistent NVAF with a planned catheter ablation for AF unless it is performed an investigational ablation technique.
- AF must have been documented at least once either by ECG, Holter monitoring, loop recorder, telemetry, trans-telephonic monitoring, pacemaker or cardiac defibrillator read outs within 24 months prior to screening (Visit 1).
- The patient must be able to give informed consent in accordance with International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) guidelines and local legislation and/or regulations.

(1) In Spain only treatment naïve patients will be enrolled in the trial

-Varones o mujeres >= 18 años.
-Pacientes aptos para el tratamiento con dabigatrán etexilato 150 mg dos veces al día, según la ficha técnica local.
-Pacientes que no han recibido tratamiento previo o pacientes en tratamiento anticoagulante oral con un VKA, dabigatrán etexilato, rivaroxabán, apixabán o edoxabán (1).
-Pacientes con NVAF paroxística o persistente con programación de ablación con catéter para la AF, a menos que se aplique una técnica de ablación en fase de investigación.
-La AF debe haberse documentado al menos una vez mediante ECG, monitorización Holter, Holter implantable, telemetría, monitorización transtelefónica, marcapasos o lectura del desfibrilador cardíaco en los 24 meses previos a la selección (visita 1).
-El paciente debe poder otorgar el consentimiento informado de conformidad con las normas de Buena Práctica Clínica (GCP) de la Conferencia Internacional de Armonización (ICH) y la legislación y/o las regulaciones locales.

(1) En España únicamente se incluirán en el ensayo pacientes naïve.

E.4

Principal exclusion criteria

- Patients with permanent AF.
- Patients with AF felt to be secondary to an obvious reversible cause such as, but not limited to, an acute myocardial infarction, pulmonary embolism, recent surgery, pericarditis or thyrotoxicosis.
- Patients with LA size >= 60 mm
- Patients with contraindications to systemic anticoagulation with heparin, warfarin or dabigatran etexilate
- Patients with a known allergy to warfarin tablets and it excipients or to dabigatran etexilate or its excipients
- Mechanical or biological heart valve prosthesis
- Severe renal impairment
- Stroke within 1 month prior to screening visit
- Major surgery per investigator judgement within the previous month prior to screening.
- Patient has received an organ transplant or is on a waiting list for an organ transplant
- History of intracranial haemorrhage, intraocular, spinal, retroperitoneal or non-traumatic intra-articular bleeding
- Gastrointestinal haemorrhage within one month prior to screening, unless, in the opinion of the investigator, the cause has been permanently eliminated (e.g. by surgery).
- Major bleeding episode (ISTH definition) one month prior to the screening visit.
- Haemorrhagic disorder or bleeding diathesis (e.g. von Willebrand disease, haemophilia A or B or other hereditary bleeding disorder, history of spontaneous intra-articular bleeding, history of prolonged bleeding after surgery/intervention)
- Anaemia (haemoglobin <10g/dL) or thrombocytopenia including heparin-induced thrombocytopenia (platelet count <100 x 10^9/L) at screening
- Recent malignancy or radiation therapy (<=6 months prior to screening) unless, in the opinion of the Investigator, the estimated life expectancy is greater than 36 months
- Active liver disease as indicated by at least one of the following:
-- Prior and persistent alanine aminotransferase or Aspartate transaminase or alkaline phosphatase >3x upper limit of normal
and/or -- Known active hepatitis C
and/or -- Known active hepatitis B
and/or -- Known active hepatitis A
- Need for continued treatment with systemic ketoconazole, itraconazole, posaconazole cyclosporine, tacrolimus, dronedarone, rifampicin, phenytoin, carbamazepine, St. John?s Wort or any cytotoxic/myelosuppressive therapy.
- Pre-menopausal (last menstruation <=1 year prior to screening) who:
-- Are pregnant or breast-feeding or plan to become pregnant during study or
-- Are not surgically sterile or
-- Are of child bearing potential and not practising two acceptable method of birth control, or do not plan to continue practising an acceptable method of birth control throughout the trial
- Patients who have participated in another trial with an investigational drug or device within the past 30 days preceding the screening visit or are participating in another trial (patients participating in an observational study only will not be excluded)
- Patients not willing or able to comply with the protocol requirements or considered unreliable by the Investigator concerning the requirements for follow-up during the study and/or compliance with study drug administration, who have a life expectancy less than the expected duration of the trial due to concomitant disease and/or subjects who are institutionalised due to official or court orders and/or vulnerable subjects who are dependent on the Sponsor or the Investigator or the site, or patients who have any condition which in the opinion of the Investigator, would not allow safe participation in the study (e.g. drug addiction, alcohol abuse).

-Pacientes con AF permanente
-Pacientes con AF que se considere secundaria a una causa reversible obvia como, entre otras, un infarto agudo de miocardio, embolia pulmonar, cirugía reciente, pericarditis o tirotoxicosis.
-Pacientes con un tamaño de la LA ? 60 mm
-Pacientes con contraindicaciones de anticoagulación sistémica con heparina, warfarina o dabigatrán etexilato.
-Pacientes con alergia conocida a los comprimidos de warfarina y a sus excipientes o a dabigatrán etexilato o a sus excipientes.
-Pacientes con una prótesis valvular cardíaca mecánica o biológica.
-Insuficiencia renal grave
-Ictus en el mes previo a la visita de selección
-Cirugía mayor según el criterio del investigador durante el mes previo a la selección.
-El paciente ha recibido un trasplante de órganos o está en lista de espera para un trasplante de órganos
-Antecedentes de hemorragia intracraneal, intraocular, medular, retroperitoneal o intraauricular no traumática.
-Hemorragia gastrointestinal (GI) en el mes previo a la selección, a menos que, en opinión del investigador, la causa haya sido eliminada de forma definitiva (p. ej., mediante cirugía).
-Episodio hemorrágico grave (definición de la ISTH [R05-0344]) en el mes previo a la visita de selección.
-Trastorno hemorrágico o diátesis hemorrágica (p. ej., enfermedad de Willebrand, hemofilia A o B u otro trastorno hemorrágico hereditario, antecedentes de hemorragia intraarticular espontánea, antecedentes de hemorragia prolongada tras cirugía/intervención).
-Anemia (hemoglobina < 10 g/dl) o trombocitopenia, incluida trombocitopenia inducida por heparina, (cifra de plaquetas < 100 x 10^9/l) en la selección.
-Neoplasia maligna o radioterapia previas (? 6 meses antes de la selección) a menos que, en opinión del investigador, la esperanza de vida estimada sea superior a 36 meses.
-Hepatopatía activa indicada por uno de los siguientes signos como mínimo:
--Niveles previos y persistentes de alanina-aminotransferasa (ALT), aspartato-transaminasa (AST) o fosfatasa alcalina (AP) > 3 veces el límite superior de la normalidad
y/o --Diagnóstico de hepatitis C activa
y/o --Diagnóstico de hepatitis B activa
y/o --Diagnóstico de hepatitis A activa
-Necesidad de tratamiento continuado con ketoconazol sistémico, itraconazol, posaconazol, ciclosporina, tacrolimús, dronedarona, rifampicina, fenitoína, carbamazepina, hipérico (hierba de San Juan) o cualquier tratamiento citotóxico/mielosupresor.
-Mujeres premenopáusicas (última menstruación ? 1 año antes de la selección) que:
--Estén embarazadas o en periodo de lactancia o que tengan la intención de quedarse embarazadas durante el estudio, o
--No hayan sido esterilizadas quirúrgicamente, o
--Tengan capacidad reproductora y no utilicen dos métodos anticonceptivos aceptados o no tengan intención de seguir utilizándolos durante el estudio.
-Pacientes que hayan participado en otro estudio con un fármaco o producto sanitario en fase de investigación en los 30 días previos a la visita de selección o que estén participando en otro estudio
-Pacientes que no puedan o no quieran cumplir los requisitos del protocolo o sobre los que el investigador tenga dudas acerca de su posible cumplimiento de los requisitos de seguimiento durante el estudio y/o de su cumplimiento con la administración del fármaco del estudio, que tengan una esperanza de vida menor que la duración prevista del estudio debido a una enfermedad concomitante y/o pacientes recluidos por orden judicial o administrativa y/o pacientes vulnerables que dependen del promotor, el investigador o el centro, o pacientes que tengan alguna afección que en opinión del investigador no permitiría una participación segura en el estudio (p. ej., drogadicción o alcoholismo).

E.5 End points

E.5.1

Primary end point(s)

1: The incidence of Major Bleeding Events according to the ISTH definition

1: La incidencia de acontecimientos hemorrágicos graves según la definición de la ISTH.

E.5.1.1

Timepoint(s) of evaluation of this end point

1: during ablation and up 2 months post ablation

1: Durante el procedimiento de ablación y hasta 2 meses después de su realización.

E.5.2

Secondary end point(s)

1: Stroke/SE/TIA events.

2: Minor bleeding events.

3: A composite of major bleeding events and thromboembolic events (Stroke, SE and TIA).

1: Ictus/SE/TIA

2: Acontecimientos hemorrágicos leves.

3:Una combinación de acontecimientos hemorrágicos graves y de acontecimientos tromboembólicos (ictus, SE y TIA).

E.5.2.1

Timepoint(s) of evaluation of this end point

1: during ablation and up 2 months post ablation

2: during ablation and up 2 months post ablation

3: during ablation and up 2 months post ablation

1: durante el procedimiento de ablación y hasta 2 meses después de su realización.

2: durante el procedimiento de ablación y hasta 2 meses después de su realización.

3: durante el procedimiento de ablación y hasta 2 meses después de su realización.

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

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)

E.7.4

Therapeutic use (Phase IV)

Yes

E.8 Design of the trial

E.8.1

Controlled

Yes

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

Yes

E.8.1.6

Cross over

E.8.1.7

Other

Yes

E.8.1.7.1

Other trial design description

PROBE (prospectivo, aleatorizado, abierto y ciego respecto a los criterios de valoración)

PROBE (Prospective, randomized, open label, blinded end point)

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

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

Australia

Belgium

Canada

France

Germany

Ireland

Italy

Japan

Netherlands

Spain

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

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:

507

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

217

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

F.4.2

For a multinational trial

F.4.2.1

In the EEA

495

F.4.2.2

In the whole clinical trial

795

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)

Patients will be treated according to clinical practice.

Los pacientes serán tratados de acuerdoa las prácticas clínicas.

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

2015-05-27

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2015-05-05

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2016-11-14

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
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Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
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