Efficacy and Safety of Azimilide for the Treatment of Patients With Atrial Fibrillation
Status:
Completed
Trial end date:
2003-10-01
Target enrollment:
Participant gender:
Summary
Atrial fibrillation (abnormal rhythm in the upper chamber of the heart) is a common
supraventricular arrhythmia (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. Azimilide may have an effect
on increasing the time to first recurrence of symptomatic atrial fibrillation or atrial
flutter and symptomatic paroxysmal supraventricular tachycardia (other types of abnormal
heart rhythms).
This double-blind, placebo-controlled study is designed to evaluate the efficacy and safety
of azimilide compared with placebo in maintaining sinus rhythm in patients who require
cardioversion (electric shock to correct heart rhythm) to reduce 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 study. This follow-up
phase will continue to evaluate the long-term efficacy and safety of a daily oral dose of
azimilide in patients who complete the double-blind, placebo-controlled phase of this study.