E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
atrial fibrillation/atrial 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 the efficacy of dronedarone in preventing cardiovascular hospitalizations or death from any cause in a population of high risk patients with Atrial Fibrillation/Atrial FLutter (AF/AFL). |
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E.2.2 | Secondary objectives of the trial |
To assess that dronedarone is well tolerated in this population |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Patients aged 75 years or older are eligible with or without additional risk factors Or A minimum age of 70 years with one or more of the following risk factors must be present at the baseline: hypertension (taking antihypertensive drugs of at least two different classes), diabetes, prior cerebrovascular accident or systemic embolism, left atrium diameter greater than or equal to 50 mm by echocardiography, left ventricular ejection fraction less than 0.4 by 2D echocardiography. -Availibility of one 12-lead ECG within the last 6 months, showing that the patient was or is in AF/AFL, -Availibility of one 12-lead ECG within the last 6 months showing that the patient was or is in sinus rhythm. |
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E.4 | Principal exclusion criteria |
-Any non cardiovascular illness or disorder that could preclude participation or severely limit survival. -Pregnant women, women of child-bearing potential without adequat birth control, breast feeding women. - Patients in permanent atrial fibrillation - Patients in unstable hemodynamic condition such as acute pulmonary edema within 12 hours prior to start of study medication; cardiogenic shock; treatment with IV pressor agents; patients on respirator; congestive heart failure of stage NYHA IV within the last 4 weeks; uncorrected, hemodynamically significant primary obstructive valvular disease; hemodynamically significant obstructive cardiomyopathy; a cardiac operation or revascularization procedure within 4 weeks preceding randomization - Planned major non-cardiac or cardiac surgery or procedures - Acute myocarditis or constrictive pericarditis - Bradycardia < 50 bpm and/or PR-interval ³ 0.28 sec on the last 12-lead ECG. - Significant sinus node disease or 2nd or 3rd degree atrioventricular block unless treated with a pacemaker - Need of a concomitant medication that is prohibited in this trial - Plasma potassium < 3.5 mmol/l - A calculated GFR at baseline <10 ml/min (using the Cockroft Gault formula)
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E.5 End points |
E.5.1 | Primary end point(s) |
first occurence of hospitalization for cardiovascular reasons or death from any cause. |
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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 | No |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
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 | 9 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 148 |
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 | Yes |
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
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 6 |