Clinical Trials Register

Summary
EudraCT Number:	2011-002789-18
Sponsor's Protocol Code Number:	RAF-01
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:	2011-09-19
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

Spain - AEMPS

A.2

EudraCT number

2011-002789-18

A.3

Full title of the trial

A RANDOMISED, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO-CONTROLLED, DOSE-RANGING PHASE II STUDY ASSESSING RANOLAZINE IN THE MAINTENANCE OF SINUS RHYTHM AFTER ELECTRICAL CARDIOVERSION IN PATIENTS WITH NON-PERMANENT ATRIAL FIBRILLATION

ESTUDIO DE FASE II DE BÚSQUEDA DE DOSIS ALEATORIZADO, DOBLE CIEGO, DOBLE EMMASCARAMIENTO, CONTROLADO CON PLACEBO, PARA EVALUAR EL EFECTO DE RANOLAZINA EN EL MANTENIMIENTO DEL RITMO SINUSAL TRAS CARDIOVERSIÓN ELÉCTRICA EN PACIENTES CON FIBRILACIÓN AURICULAR NO PERMANENTE

A.3.1

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

A PHASE II STUDY ASSESSING RANOLAZINE IN ATRIAL FIBRILLATION FOLLOWING AN ELECTRICAL CARDIOVERSION

ESTUDIO DE FASE II PARA EVALUAR LA RANOLAZINA EN FIBRILACIÓN AURICULAR TRAS CARDIOVERSIÓN ELÉCTRICA

A.3.2

Name or abbreviated title of the trial where available

RAFFAELLO

A.4.1

Sponsor's protocol code number

RAF-01

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	MENARINI RICERCHE S.P.A
B.1.3.4	Country	Italy
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	MENARINI RICERCHE S.P.A.
B.4.2	Country	Italy
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	MENARINI RICERCHE S.P.A.
B.5.2	Functional name of contact point	CLINICAL RESEARCH CORPORATE DIRECTO
B.5.3	Address:
B.5.3.1	Street Address	VIA SETTE SANTI 3
B.5.3.2	Town/ city	FLORENCIA
B.5.3.3	Post code	50131
B.5.3.4	Country	Italy
B.5.4	Telephone number	+3905556809933
B.5.5	Fax number	+390555680597
B.5.6	E-mail	acapriati@menarini-ricerche.it

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	RANEXA 375 mg
D.2.1.1.2	Name of the Marketing Authorisation holder	MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A.
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	Prolonged-release 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	RANOLAZINE
D.3.9.1	CAS number	95635-55-5
D.3.9.2	Current sponsor code	RANEXA
D.3.9.3	Other descriptive name	RANOLAZINE HYDROCHLORIDE EXTENDED RELEASE
D.3.9.4	EV Substance Code	SUB10259MIG
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	375 to 750
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	RANEXA 500 mg
D.2.1.1.2	Name of the Marketing Authorisation holder	MENARINI INTERNATIONAL LUXEMBOURG S. A.
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	RANOLAZINE
D.3.4	Pharmaceutical form	Prolonged-release 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	RANOLAZINE
D.3.9.1	CAS number	95635-55-5
D.3.9.2	Current sponsor code	RANEXA
D.3.9.3	Other descriptive name	RANOLAZINE HYDROCHLORIDE EXTENDED RELEASE
D.3.9.4	EV Substance Code	SUB10259MIG
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	375 to 750
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 3
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	RANEXA 750 mg
D.2.1.1.2	Name of the Marketing Authorisation holder	MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A.
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	RANOLAZINE
D.3.4	Pharmaceutical form	Prolonged-release 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	RANOLAZINE
D.3.9.1	CAS number	95635-55-5
D.3.9.2	Current sponsor code	RANEXA
D.3.9.3	Other descriptive name	RANOLAZINE HYDROCHLORIDE EXTENDED RELEASE
D.3.9.4	EV Substance Code	SUB10259MIG
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	375 to 750
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	Capsule, hard
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

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

NON-PERMANENT ATRIAL FIBRILLATION

FIBRILACIÓN AURICULAR NO PERMANENTE

E.1.1.1

Medical condition in easily understood language

ARRHYTHMIA OF THE CARDIAC ATRIA LEADING TO IRREGULAR ATRIAL COTRACTIONS (ARRHYTHMIA ABSOLUTA)

ARRITMIA DE LA AURÍCULA CARDÍACA CAUSANTE DE CONTRACCIONES AURICULARES IRREGULARES (ARRITMIA ABSOLUTA)

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	14.0
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.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

TO ASSESS THE EFFICACY OF RANOLAZINE ADMINISTERED AS 3 DIFFERENT DOSES REGIMENS (375, 500, 750 mg BID) VERSUS PLACEBO IN THE MAINTENANCE OF SINUS RHYTHM AFTER ELECTRICAL CARDIOVERSION IN PATIENTS WITH NON-PERMANENT AF (DEFINED AS A CONTINOUS AF WITH A MINIMUM DURATION OF 7 DAYS TO A MAXIMUM OF 6 MONTHS OR REQUIRING TERMINATION BY CARDIOVERSION).

VALORAR LA EFICACIA DE LA ADMINISTRACIÓN DE RANOLAZINA EN TRES REGÍMENES DE DOSIFICACIÓN DISTINTOS (375, 500, 750 mg BID) EN COMPARACIÓN CON PLACEBO PARA EL MANTENIMIENTO DEL RITMO SINUSAL TRAS CARDIOVERSIÓN ELÉCTRICA EN PACIENTES CON FA NO PERMANENTE (DEFINIDA COMO FA CONTINUA DE ENTRE 7 DÍAS Y 6 MESES DE DURACIÓN O QUE DEBA REVERTIRSE MEDIANTE CARDIOVERSIÓN).

E.2.2

Secondary objectives of the trial

TO EVALUATE DE DOSE-EFFECT RELATIONSHIP OF RANOLAZINE TO SUPPORT THE CHOICE OF THE DOSE TO BE STUDIED IN A SUBSEQUENT PHASE III STUDY. TO ASSESS THE SAFETY OF RANOLAZINE VERSUS PLACEBO AFTER ELECTRICAL CARDIOVERSION IN PATIENTS WITH NON PERMANENT AF.

VALORAR LA RELACIÓN DOSIS-EFECTO DE RANOLAZINA PARA JUSTIFICAR LA ELECCIÓN DE LA DOSIS QUE SE VA A ESTUDIAR EN UN ESTUDIO POSTERIOR DE FASE III. VALORAR LA SEGURIDAD DE RANOLAZINA FRENTE A PLACEBO TRAS CARDIOVERSIÓN ELÉCTRICA EN PACIENTES CON FA NO PERMANENTE.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Male or female patients 18 years and older;
2. Patients with persistent AF suitable for electrical direct current cardioversion (DCC);
NOTE: According to the ESC classification, persistent AF is defined as a continuous AF with a minimum duration of 7 days or requiring termination by cardioversion. Prior to randomisation, successful electrical cardioversion and maintenance of sinus rhythm at 2 hours shall be documented;
3. A female of childbearing potential may be enrolled providing she:
? has a negative pregnancy test at baseline and
? is routinely using an effective method of birth control resulting in a low failure rate (e.g.. hormonal contraception, intrauterine device, condoms in combination with a spermicidal cream, total sexual abstinence or sterilisation) until end of study which corresponds to the follow-up safety call, 2 weeks after end of treatment;
4. Able to give written informed consent before any study related procedure;
5. Able to attend all the visits scheduled in the study.

1. Hombres y mujeres de 18 años o más;
2. Pacientes con FA persistente que sea indicación para cardioversión mediante corriente eléctrica directa (DCC);
NOTA: según la clasificación de la ESC, la FA persistente se define como una FA continua con una duración mínima de 7 días o que deba revertirse mediante cardioversión. Antes de la aleatorización se debe documentar que se ha realizado con éxito la cardioversión eléctrica y que se mantiene el ritmo sinusal a las 2 horas;
3. Las mujeres en edad fértil podrán ser incluidas, siempre que:
? La prueba de embarazo basal sea negativa; y
? Empleen de forma habitual un método anticonceptivo eficaz con una baja tasa de fallos (p. ej., anticonceptivos hormonales, dispositivo intrauterino, preservativo combinado con una crema espermicida, abstinencia sexual completa o esterilización) hasta el final del estudio, que se corresponde con la llamada de seguimiento de seguridad a las 2 semanas de finalizar el tratamiento;
4. Capacidad de otorgar el consentimiento informado por escrito antes de cualquier intervención relacionada con el tratamiento;
5. Capacidad de acudir a todas las visitas programadas para el estudio.

E.4

Principal exclusion criteria

1. Patients with first diagnosed AF (namely first onset of AF irrespective of duration of arrhythmia or presence and severity of AF related symptoms) or patients with paroxysmal AF (namely self-terminating AF usually within 48 hours although it may continue for up to 7 days);
2. Patients with long-standing persistent AF (for this protocol defined as AF longer than 6 months) or permanent AF (i.e. AF accepted by the patient and by the physician);
3. Patients having known concurrent temporary secondary causes of AF such as alcohol intoxication, pulmonary embolism, hyperthyroidism, pneumonia, hypoxemia, acute pericarditis or myocarditis;
4. Patients having undergone atrial catheter ablation for AF;
5. Patients carrying a pacemaker;
6. Patients with electrolytes imbalances that may cause cardiac arrhythmias, e.g. potassium < 3.5 mmol/L or > 5.5 mmol/L;
7. Patients with severe renal impairment (creatinine clearance < 30 ml/min);
8. Patients with ALT or AST > 2.5x upper limits of normal at screening or severe hepatic impairment of any kind;
9. Patients taking potent CYP3A4 inhibitors (e.g. Itraconazole, Ketoconazole, Voriconazol, Posaconazol, HIV protease inhibitors, Clarithromycin, Telithromycin, Nefazodone);
10. Patients taking CYP3A4 inducers (e.g. Rifampicin, Phenytoin, Phenobarbital, Carbamazepine, St. John?s Wort);
11. Patients taking class I or Class III antiarrhythmic agents within 3 days of planned randomisation. NOTE: intravenous flecainide or propafenone are allowed up to 72 hours and 24 hours from the planned randomisation, respectively;
12. Patients taking beta-blockers unless used on stable doses for at least 2 weeks prior to the planned randomisation;
13. Patients taking Dronedarone or oral Amiodarone within 2 weeks and 3 months of planned randomisation, respectively. NOTE: Intravenous administration of Amiodarone is prohibited within 72 hours from planned randomisation;
14. Patients with a history of ECG abnormalities that in the opinion of the Investigator render the subject unsuitable for the trial, including history of congenital or a family history of long QT syndrome and a QTc interval ?500 msec at Screening;
15. Patients with congestive heart failure NYHA grade III and IV;
16. Patients known to be hypersensitive to Ranolazine or to any of the components of the formulation;
17. Pregnant or breast feeding women;
18. Patients with any serious intercurrent illness (including psychiatric and neurological disorders) which, in the opinion of the Investigator, is incompatible with the protocol;
19. Abuse of alcohol (>350 g ethanol/week), analgesics, or psychotropic drugs;
20. Patients concurrently participating in another study, or who have received an investigational drug within 30 days prior to screening;
21. Patients unable to communicate well with the Investigator and to comply with the requirements of the entire study.

1. Pacientes a los que se ha diagnosticado su primera FA (a saber, primer episodio de FA independientemente de la duración de la arritmia o de la presencia y gravedad de los síntomas asociados a la FA) o pacientes con una FA paroxística (FA que desaparece de forma espontánea, en general en 48 horas, aunque puede persistir hasta 7 días);
2. Pacientes con FA persistente de larga duración (en este protocolo se define como más de 6 meses) o permanente (es decir, FA aceptada por parte del paciente y el médico);
3. Pacientes con una causa secundaria temporal conocida de FA, como intoxicación enólica, embolia pulmonar, hipertiroidismo, neumonía, hipoxemia, pericarditis aguda o miocarditis;
4. Pacientes sometidos a una ablación auricular con catéter de una FA;
5. Portadores de marcapasos;
6. Pacientes con trastornos electrolíticos que pudieran producir arritmias cardíacas, como potasio < 3,5 mmol/l o > 5,5 mmol/l;
7. Pacientes con una alteración grave de la función renal (aclaramiento de creatinina < 30 ml/min.);
8. Pacientes con concentraciones de ALT o AST por encima de 2,5 veces el límite superior de la normalidad en la visita de selección o con una disfunción hepática grave de cualquier naturaleza;
9. Pacientes que toman inhibidores potentes del CYP3A4 (p. ej., itraconazol, ketoconazol, voriconazol, posaconazol, inhibidores de proteasas para el VIH, claritromicina, telitromicina, nefazodona);
10. Pacientes que toman inductores de CYP3A4 (p. ej., rifampicina, difenilhidantoína, fenobarbital, carbamacepina, hipérico);
11. Pacientes que han recibido antiarrítmicos de clase I o III en los 3 días previos a la fecha prevista de aleatorización. NOTA: se autoriza la administración intravenosa de flecainida o propafenona hasta 72 y 24 horas antes de la fecha prevista de aleatorización, respectivamente;
12. Pacientes que reciben betabloqueantes, salvo que se utilicen en dosis estables durante al menos 2 semanas antes de la fecha prevista de aleatorización;
13. Pacientes que han tomado dronedarona o amiodarona oral en las 2 semanas y 3 meses previos a la fecha prevista de aleatorización, respectivamente. NOTA: la administración intravenosa de amiodarona está prohibida durante las 72 horas previas a la fecha prevista de aleatorización;
14. Pacientes con antecedentes de alteraciones de ECG que condicionan, según el criterio del investigador, que estos no resulten adecuados para el estudio, como antecedentes de síndrome de QT largo congénito o familiar y un intervalo QTc ?500 ms en la visita de selección;
15. Pacientes con insuficiencia cardíaca congestiva de grado III y IV de la NYHA;
16. Pacientes con hipersensibilidad conocida a ranolazina o cualquiera de los componentes de la formulación del fármaco en estudio;
17. Mujeres gestantes o lactantes;
18. Pacientes con cualquier enfermedad intercurrente grave (incluidos trastornos psiquiátricos y neurológicos) que sea incompatible con este protocolo a juicio del investigador;
19. Abuso del alcohol (> 350 g de etanol semanales), analgésicos o fármacos psicotrópicos;
20. Pacientes que estén participando en este momento en otro estudio o que hayan recibido un fármaco en investigación en los 30 días previos a la selección;
21. Pacientes que no se puedan comunicar bien con el investigador ni cumplir los requisitos de todo el estudio.

E.5 End points

E.5.1

Primary end point(s)

? Time (median [days]) from randomisation to the first documented AF recurrence. Documented recurrence is defined as AF detected on TT-ECGs by the Core Central Lab or on 12-Lead ECGs performed during a study visit (scheduled or unscheduled).

? Tiempo (mediana [días] desde la aleatorización hasta la primera recurrencia documentada de la FA. Se define una recurrencia documentada de la FA como la detección de una FA en el ECG-TT confirmada por el laboratorio central o en un ECG de 12 derivaciones obtenido durante cualquier visita del estudio (programada o no)).

E.5.1.1

Timepoint(s) of evaluation of this end point

MAXIMUM EVALUATION PERIOD OF 4 MONTHS (112 DAYS)

PERIODO MÁXIMO DE EVALUCIÓN DE 4 MESES (112 DÍAS)

E.5.2

Secondary end point(s)

? Time (median [days]) from randomisation to first documented and confirmed AF recurrence. Confirmed AF recurrence is defined as a documented AF which is confirmed by a consecutive ECG performed at least 1 hour after its first documentation.
? Time (median [days]) from randomisation to first documented AF recurrence in the subpopulation of patients who are still in sinus rhythm 2 days after the electrical cardioversion.
? Dose-effect relationship comparing the time (median, days) from randomisation to first documented AF recurrence between Ranolazine doses.

? Tiempo (mediana [días]) desde la aleatorización hasta la primera recurrencia documentada y confirmada de la FA. Se define una recurrencia de la FA confirmada como una FA documentada que se confirma en un ECG consecutivo realizado al menos 1 hora después de la presentación inicial.
? Tiempo (mediana [días]) desde la aleatorización a la primera recurrencia documentada de FA en la subpoblación de pacientes que siguen en ritmo sinusal a los 2 días de la cardioversión eléctrica.
? Relación dosis-efecto mediante la comparación del tiempo (mediana, días) desde la aleatorización a la primera recurrencia documentada de la FA entre las distintas dosis de ranolazina.

E.5.2.1

Timepoint(s) of evaluation of this end point

MAXIMUM EVALUATION PERIOD OF 4 MONTHS (112 DAYS)

PERIODO MÁXIMO DE EVALUACIÓN DE 4 MESES (112 DÍAS)

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

Yes

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)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

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

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

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

LAST SAFETY FOLLOW UP TELEPHONE CONTACT (OR VISIT , IF NEEDED) OF THE LAST PATIENT.

ULTIMO CONTACTO TELEFÓNICO DE SEGUIMIENTO DE SEGURIDAD (O VISITA, DE SER NECESARIO) DEL ÚLTIMO PACIENTE.

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:

240

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

240

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

240

F.4.2.2

In the whole clinical trial

240

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)

STANDARD MEDICAL CARE ACCORDING TO THE INVESTIGATOR'S JUDGEMENT WILL BE APPLIED AFTER PATIENTS HAVE TERMINATED THE STUDY.

CUIDADOS MÉDICOS ESTÁNDAR SERÁN APLICADOS SEGÚN EL CRITERIO DEL INVESTIGADOR DESPUÉS DE QUE LOS PACIENTES HAYAN TERMINADO EL ESTUDIO.

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

2011-11-14

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2011-11-08

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2013-09-30

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