E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Non permanent Atrial fibrillation |
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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 | 10003658 |
E.1.2 | Term | Atrial fibrillation |
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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 evaluate the change in quality of life defined as change in SF-36 Physical Component Summary Scale Score after 3 months of treatment |
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E.2.2 | Secondary objectives of the trial |
• To evaluate the change in quality of life defined as change in SF-36 Physical Component Summary Scale Score after 6 months of treatment • To evaluate the change in quality of life defined as change in the EQ-5D Descriptive System Score, EQ-5D Visual Analogue Scale Score and SF-36 Mental Component Summary Scale Score after 3 and 6 months of treatment • To evaluate AF recurrence • To assess safety |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Clinically stable patients with a history of, or current, symptomatic non-permanent Atrial Fibrillation (AF) in whom anti-arrhythmic treatment is indicated • Patients able to understand the patient information leaflet and sign the Informed Consent form for this study protocol • Patients aged ≥ 18 years • Documented AF within the last 6 months prior to inclusion or at the time of inclusion • Documented sinus rhythm within the last 6 months prior to inclusion or at the time of inclusion
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E.4 | Principal exclusion criteria |
Criteria stated in the Summary of Product Characteristics ------------------------------------------------------------------------ • Hypersensitivity to the active substance or to any of the excipients • Second- or third-degree atrio-ventricular block or sick sinus syndrome (except when used in conjunction with a functioning pacemaker) • Bradycardia < 50 beats per minute (bpm) • Patients in unstable hemodynamic conditions including patients with symptoms of heart failure at rest or with minimal exertion (corresponding to NYHA class IV and unstable class III patients) • Co-administration with potent cytochrome P450 (CYP) 3A4 inhibitors, such as ketoconazole, itraconazole, voriconazole, posaconazole, telithromycin, clarithromycin, nefazodone, and ritonavir • Usage of medicinal products inducing torsade de pointes such as phenothiazines, cisapride, bepridil, tricyclic antidepressants, terfenadine, and certain oral macrolides, class I and III anti-arrhythmics • QTc Bazett interval ≥ 500 milliseconds • Severe hepatic impairment • Severe renal impairment (CrCl < 30 ml/min) • Left Ventricular Ejection Fraction (LVEF) < 35% • Stable patients with recent (1 to 3 months) NYHA class III heart failure • Electrolytes imbalance; hypokalemia, serum potassium (< 3.5 mmol/l or > 5.5 mmol/l), or magnesium imbalance must be corrected before inclusion • Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency, or glucose-galactose mal-absorption • Treatment with other class I or III anti-arrhythmic drugs which cannot be discontinued • Pregnancy • Breastfeeding women
General Criteria -------------------- • Clinically relevant gastro-intestinal, psychiatric, or neurological disease • Women of childbearing potential without adequate birth control (e.g. oral contraception or intra-uterine device [IUD]), not menopaused, not sterile, or not hysterectomized • Participation in the preceding 2 months or current participation in another clinical trial with an investigational (under development) drug, or with an investigational device • Inability to follow the protocol requirements • Patient unable or unwilling to complete the Quality of Life questionnaires • Patient unable or unwilling to participate in the Holter monitoring procedure • Any non-cardiovascular illness or disorder that could preclude participation or severely limit survival
Criteria linked to cardiac condition ------------------------------------------- • Patients with asymptomatic Atrial Fibrillation • Patients unwilling to start with or change anti-arrhythmic therapy • Patients already treated with dronedarone during the preceding 6 months • Planned major non-cardiac or cardiac surgery, or procedures including surgery for valvular heart disease, coronary artery bypass graft (CABG), percutaneous coronary intervention (PCI), or on urgent cardiac transplantation list • Documented AF episode motivating inclusion in the study after an acute condition known to cause AF (e.g. alcohol intake, thyrotoxicosis, acute infection, pericarditis, pulmonary embolism, cardiac surgery) •Patients known to have chronic AF defined as permanent AF for more than 6 months • Ablated patients • Unstable angina pectoris (ischemic symptoms during the last 7 days), or recent myocardial infarction (< 6 weeks) • First-degree family history of sudden cardiac death below age of 50 years in the absence of coronary heart disease • Ongoing potentially dangerous symptoms when in AF, such as angina pectoris, transient ischemic attacks, stroke, syncope, as judged by the investigator • Single chamber ventricular pacemaker • Wolff-Parkinson-White Syndrome
Criteria linked to Concomitant Medication ---------------------------------------------------- • Patients in whom contraindicated concomitant treatment is mandatory • Contraindication to oral anticoagulation |
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary Endpoint: ============= • Change in quality of life, defined as change in the SF-36 Physical Component Summary Scale Score after 3 months of treatment
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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 | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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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 | No |
E.7.1.3 | Other | No |
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 | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
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 | Information not present in EudraCT |
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.8.4.1 | Number of sites anticipated in Member State concerned | 21 |
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 treatment period per patient is 6 to 7 months. The end of the study is defined as the last patient last visit date. |
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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 | 3 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |