NCT00035451

Efficacy and Safety Evaluation of Azimilide or Sotalol vs Placebo for Treatment of Patients With Atrial Fibrillation.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 658 (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 (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. The double-blind, placebo-controlled phase of this study is designed to evaluate the efficacy and safety of oral azimilide compared with placebo and with sotalol, an antiarrhythmic drug, in maintaining sinus rhythm in patients who require cardioversion (electric shock to correct heart rhythm) to correct 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 first study. The follow-up phase will continue to evaluate the long-term 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	tablets, twice daily for 6 months
DRUG	Sotalol	160 mg sot twice daily for 6 months

Timeline

• Start date: 2001-02-01
• Primary completion: 2003-06-01
• Completion: 2003-06-01
• First posted: 2002-05-06
• Last updated: 2011-10-03

Locations

129 sites across 9 countries: Belgium, France, Germany, Hungary, Italy, Netherlands, Poland, Russia, Spain