Efficacy and Safety Evaluation of Azimilide or Sotalol vs Placebo for Treatment of Patients With Atrial Fibrillation.
Efficacy and Safety Evaluation of Azimilide or Sotalol vs Placebo for Treatment of Patients With Atrial Fibrillation.
Atrial fibrillation (abnormal rhythm in the upper chamber of the heart) is a common supraventricular arrhythmia (a type of abnormal heart rhythm) for which antiarrhythmic therapy is often prescribed. The primary goals of therapy are to maintain sinus rhythm (normal heart rhythm) and to reduce the occurrence of episodes of atrial fibrillation.
The double-blind, placebo-controlled phase of this study is designed to evaluate the efficacy and safety of oral azimilide compared with placebo and with sotalol, an antiarrhythmic drug, in maintaining sinus rhythm in patients who require cardioversion (electric shock to correct heart rhythm) to correct atrial fibrillation. Once this phase of the study is completed, a second phase with a different study design will be conducted. The second phase is an open-label, follow-up phase to the first study. The follow-up phase will continue to evaluate the long-term safety of a daily oral dose of azimilide in patients who complete the double-blind, placebo-controlled phase of this study.
Inclusion criteria:
Exclusion criteria:
Brandenburg, 14770, Germany
Frieburg, 79016, Germany
Hamburg, 20246, Germany
Leipzig, 04103, Germany
Ludwigshafen, 67063, Germany
Tübingen, 72076, Germany
Wilhelmshafen, 26389, Germany
Catania, 95100, Italy
JW Zwolle, 8011, Netherlands
Ul Ujejskiego 75, Bydgoszcz 85-168, Poland
Ul Ujejskiego 75, Bydgoszcz 85-168, Poland
Moscow, 111020, Russia
Moscow, 113096, Russia
Moscow, 117292, Russia
Moscow, 121309, Russia
Moscow, 121356, Russia
Moscow, 121552, Russia
Moscow, 125206, Russia
Moscow, 127018, Russia
Saint Petersburg, 197022, Russia
Basurto-Bilbao, 48013, Spain