E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Insuficiencia Cardiaca Crónica y Disfunción ventricular Sistólica con riesgo de arritmia ventricular // Chronic Heart Failure and left ventricular systolic dysfunction at risk for ventricular arrhythmia |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10007558 |
E.1.2 | Term | Cardiac failure chronic |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10049694 |
E.1.2 | Term | Left ventricular dysfunction |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10047281 |
E.1.2 | Term | Ventricular arrhythmia |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Evaluar la eficacia antiarritmica de S44121 frente a placebo administrado por via oral durante 12 semanas a pacientes con insuficiencia cardiaca crónica y disfinción ventricular izquierda sistólica portadores de un desfibrilador cardioversos implantable para la prevención primaria o secundaria de arritmias ventriculares//To evaluate the anti-arrhythmic efficacy of S 44121 versus placebo administered orally for a total of 12 weeks in patients with chronic heart failure (CHF) and left ventricular systolic dysfunction who received an implanted cardioverter defibrillator (ICD) for primary or secondary prevention of ventricular arrhyhthmia. |
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E.2.2 | Secondary objectives of the trial |
Evaluar el perfil de seguridad de S 44121 // To evaluate the safety profile of S 44121. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Hombres o mujeres. - De edad entre 18 y 75 años(inclusive) - DCI para la prevención primaria o secundaria de arritmias desde al menos 3 meses antes de la selección - ICC sintomática desde al menos 6 meses antes de la selección. - Clase funcional II o III según la NYHA - cardiopatía isquémica o miocardiopatía idiopática dilatada como causa principal de la ICC - Tratamiento con betabloquenates desde al menos 3 meses antes de la selección - promedio documentado de al menos 100complejos ventriculares prematuros por hora en el registro ECG de un Holter de 48horas - FEVI menor o igual a 40% en un examen ecocardiográfico - Ritmo sinusal |
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E.4 | Principal exclusion criteria |
-Situación inestable en las 4 semanas previas a la selección - Infarto de miocardio, angina inestable o revascularización coronaria recientes (en los 3 meses previos a la selección). - Antecedentes de ictus o accidente isquémico cerebral transitorio en los 3 meses previos a la selección - Estenosis o regurgitación aortica o mitral primaria severa - Enfermedad congénita del corazón - Miocardiopatía obstructiva hipertrófica - Terapia de resincronización cardiaca iniciada en los 6 meses previos a ala selección - Episodio de fibrilación ventricular o Torsade de Pointes revertida en las 4 últimas semanas - Bloqueo auriculo ventricular de segundo o tercer grado. - Duración del intervalo QT corregido(fórmula de Bazett) > 480 ms. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Numero medio de complejos ventriculares prematuris por hora en el registro ECG de un Holter de 48 horas. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
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 | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 37 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
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 Visit of Last Patient as stated in the protocol. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 5 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 5 |
E.8.9.2 | In all countries concerned by the trial days | 0 |