E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
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 |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10003658 |
E.1.2 | Term | Atrial fibrillation |
|
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 whether the addition of dronedarone (Multaq®) to existing conventional rate control therapy leads to a reduced ventricular rate after 1 week in patients with a high HR at rest during AF in comparison to an increase of conventional therapy. |
|
E.2.2 | Secondary objectives of the trial |
To compare both study arms with regard to: - Ventricular rate after 3 months. - Number of registered AF episodes. - Number of symptomatic AF episodes. - Severity of AF and AF-like symptoms. - Adverse events. - Rate of premature study discontinuation (“going off study prematurely”). - Number of symptomatic episodes of bradycardia. - Incidence of low heart rate (<60 bpm). |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Paroxysmal or persistent AF (according to ACC/AHA/ESC 2006 definition) with HR >80 bpm at rest despite treatment with ≤2 rate control agents (i.e. beta blocker and/or calcium antagonist). Patients using digoxin are eligible. • Documented AF at randomisation or documented AF in the past 24 hours. • Treated with the following rate control medication: - beta blocker or - calcium antagonist or - beta blocker plus calcium antagonist or - beta blocker plus digoxin or - calcium antagonist plus digoxin. • > 45 years of age. • Anticoagulant treatment in line with local guidelines. |
|
E.4 | Principal exclusion criteria |
• Incapacitated patients. • Permanent AF (according to ACC/AHA/ESC 2006 definition). • Use of class I or III AADs. • Patients scheduled for cardioversion or pulmonary vein ablation. • Unstable NYHA class III and all class IV HF. • AV block grade 2 or 3. • Known severe renal impairment (serum creatinine >180 μmol/l). • Known severe hepatic impairment (AST, ALT >3x ULN). • Contra-indication for dronedarone. • Participation in a clinical drug study in the 3 months prior to inclusion. • Women of childbearing potential, who do not use adequate contraception (in the opinion of the investigator). • Lactating women. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Ventricular rate after 1 week. |
|
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 | 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 | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
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) | Yes |
E.8.2.2 | Placebo | No |
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 | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 30 |
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
|
Last visit of last subject. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 9 |
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 | 9 |
E.8.9.2 | In all countries concerned by the trial days | 0 |