NCT00035477

Efficacy and Safety of Azimilide for the Treatment of Patients With Atrial Fibrillation

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 446 (actual)
• Sponsor: Forest Laboratories · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
DRUG	Azimilide Dihydrochloride	125 mg azimilide tablets once a day for 3 days in hospital and 125 mg azimilide tablets once a day for 6 months as outpatient
DRUG	Placebo	placebo tablets once a day for 3 days in hospital and placebo tablets once a day for 6 months as outpatient

Timeline

• Start date: 2000-09-01
• Primary completion: 2003-10-01
• Completion: 2003-10-01
• First posted: 2002-05-06
• Last updated: 2011-10-03

Locations

82 sites across 2 countries: United States, Canada