Efficacy and Safety of Azimilide in the Prophylactic Treatment of Patients With Atrial Fibrillation.
Status:
Completed
Trial end date:
2004-01-01
Target enrollment:
Participant gender:
Summary
Atrial fibrillation (an 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.
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 prolonging the time to the first symptomatic arrhythmia
recurrence in patients with a history of atrial fibrillation and congestive heart failure
and/or ischemic heart disease) and those without these conditions. 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. The follow-up phase of the study is designed
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.