E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Paroxysmal atrial fibrillation |
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MedDRA Classification |
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 accurately assess, by the use of long term beat to beat pacemaker Holter monitoring, the effect of of dronedarone upon atrial fibrillation (AF) burden. |
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E.2.2 | Secondary objectives of the trial |
To accurately assess the number of irregular heart beat episodes, the frequency of the episodes and average duration of normal heart rhythm (i.e. the pattern of the irregular heart rhythm).
To assess differences in patient experience of dronedarone and placebo therapies by means of questionnaires.
To assess the impact of dronedarone on the participants quality of life and daily activities.
Comparison of side effects and major adverse cardiac events.
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
INCLUSION CRITERIA • Patients with paroxysmal atrial fibrillation (AF burden 1-50% as defined by DDDRP PPM) during the 3 months prior to induction to the study. • Patients who have had DDDRP pacemaker implanted for a primary or secondary indication. • Patients must be on warfarin. • Patients must be over 18 years old. • Patients give informed consent form prior to participating in this study.
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E.4 | Principal exclusion criteria |
• Current or previous treatment with amiodarone. • Patient is suffering with unstable angina in last 1 week. • Patient has had a myocardial infarction within last 2 months. • Patient is expecting or has had major cardiac surgery within last 2 months. • Patient is participating in a conflicting study. • Patient is mentally incapacitated and cannot consent or comply with follow-up. • Patient has NYHA class III/ IV heart failure. • Pregnancy. • Patient suffers with other cardiac rhythm disorders. • Recent coronary artery intervention or other factors suggesting clinical instability (ECG, clinical or laboratory findings). • GFR<30mls/min.
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E.5 End points |
E.5.1 | Primary end point(s) |
Atrial fibrillation burden as measured by permanent pacemaker. |
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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 | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
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 | No |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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 | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
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
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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 | 12 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 12 |