E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Atrial fibrillation/flutter |
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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 | 10003658 |
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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 versus placebo the efficacy of SSR149744C for the conversion of atrial fibrillation/flutter to sinus rhythm at the time of the planned electrical cardioversion. |
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E.2.2 | Secondary objectives of the trial |
-To assess versus placebo the efficacy of SSR149744C for the control of ventricular rate in patients not converted at the time of the planned electrical cardioversion. -To assess versus placebo the tolerability of the different dose regimens of SSR149744C in the selected population. -To document SSR149744C plasma levels during the study.
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
- AF/AFL for >72 hours and documented by 2 12-lead ECG recorded prior to randomization, separated by at least 72 hours and both showing AF/AFL - Indication for cardioversion of the current AF/AFL episode as judged by the investigator |
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E.4 | Principal exclusion criteria |
-Women of childbearing potential without adequat birthcontrol, pregnant women and breastfeeding women. -Contraindication to oral anti-coagulant
Criteria related to a cardiac condition or a disease resistance : -Permanent cardiac pacemaker or ICD -Unstable angina pectoris or recent myocardial infarction -Acute condition known to cause AF/AFL -History of torsades de pointes -Congenital long QT syndrome -QT-interval > 500 msec on the last 12-lead ECG before randomization -Family history of sudden cardiac death below age 50 years in the absence of coronary heart disease -Wolff-Parkinson-White syndrome -History of high degree atrio-ventricular block -PR-interval ³ 0.28 sec -Significant sinus node disease -Bradycardia < 50 bpm on the last 12-lead ECG before randomization -Clinically overt congestive heart failure with NYHA class III or IV at the time of randomization, -Left ventricular ejection fraction less than 35% on the screening 2D-echocardiogram -Ongoing potentially dangerous symptoms when in AF/AFL such as angina pectoris, transient ischemic attacks, stroke, syncope as judged by the investigator -Patients known to have permanent AF/AFL -Patients in whom 3 (on different days) consecutive electrical cardioversions were unsuccessful in re-establishing sinus rhythm.
Other exclusion criteria : related to clinically relevant laboratory abnormalities and related to some concommitant medications. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Rate of conversion to sinus rhythm documented by ECG at the time of planned electrical cardioversion on D3 i.e. after 48 hours following the first study drug administration. |
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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 | 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) | 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.8.5 | 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 | |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 9 |