Atrial Fibrillation Clinical Trial
Official title:
Efficacy and Safety of Azimilide in the Prophylactic Treatment of Patients
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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