NCT00035464

Efficacy and Safety of Azimilide in the Prophylactic Treatment of Patients With Atrial Fibrillation.

Efficacy and Safety of Azimilide in the Prophylactic Treatment of Patients

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 431 (actual)
• Sponsor: Forest Laboratories · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
DRUG	Azimilide Dihydrochloride	125 mg azimilide tablets, twice a day for 6 months
DRUG	Placebo	placebo tablets, twice a day for 6 months

Timeline

• Start date: 2000-12-01
• Primary completion: 2004-01-01
• Completion: 2004-01-01
• First posted: 2002-05-06
• Last updated: 2011-10-03

Locations

103 sites across 2 countries: United States, Canada