E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Ventricular arrhythmia triggered ICD interventions |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 7.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10003131 |
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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 |
To assess the efficacy of SSR149744C for the prevention of ventricular-arrhythmia triggered ICD interventions |
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E.2.2 | Secondary objectives of the trial |
To assess versus placebo the tolerability of the different dose regimens of SSR149744C; To document SSR149744C plasma levels |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Patients with an ICD implanted during the previous year for documented spontaneous life-threatening ventricular arrhythmia or implanted with an ICD and with at least one appropriate ICD therapy (shock or ATP) for VT or VF in the previous year; LVEF measured by 2D-echocardiography must have been documented to less than 40% in the last 6 months; The ICD must have the following characteristics : data logging function with cumulative counting of device intervention (shocks and antitachycardia pacing [ATP]); electrogram storage capabilities; ventricular demand pacing.
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E.4 | Principal exclusion criteria |
Criteria related to a cardiac condition : Recent unstable angina pectoris or myocardial infarction (< 4 weeks); History of torsade de pointes; Congenital long QR syndrome; QT-interval> 500 ms on the last 12-lead ECG before randomization; Wolff-Parkinson-White syndrome; Clinically overt congestive heart failure with NYHA class III or IV at the time of randomization; Incessant sustained VT/VF Criteria related to laboratory abnormalities Criteria related to concomitant medication : Patients for whom the washout requirements for previous amiodarone treatment cannot be respected; Patients in whom a contraindicated concomitant treatment is mandatory; Treatment with other class I or III antiarrhythmic drugs which cannot be discontinued with the required washout period before the first study drug administration Women of child bearing potential without adequate birth control, pregnant women and breastfeeding women. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy endpoint will be the time from randomization to all VT or VF arrhythmia episodes (documented by ICD interrogation including stored electrograms (EGMs) leading to any ICD intervention (ATP or ICD shock) |
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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 | Yes |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
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) | Information not present in EudraCT |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | Information not present in EudraCT |
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.8.5 | The trial involves multiple Member States | Yes |
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 | Information not present in EudraCT |
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
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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 | 0 |
E.8.9.1 | In the Member State concerned days | |
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 | 0 |