Efficacy and Safety Evaluation of Azimilide or Sotalol vs Placebo for Treatment of Patients With Atrial Fibrillation.
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.
|Atrial Fibrillation||Drug: Azimilide Dihydrochloride Drug: Placebo Drug: Sotalol||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
|Official Title:||Efficacy and Safety Evaluation of Azimilide or Sotalol vs Placebo for Treatment of Patients With Atrial Fibrillation.|
- To prolong the time to first symptomatic or asymptomatic AFIB, etc event [ Time Frame: 6 month ]
|Study Start Date:||February 2001|
|Study Completion Date:||June 2003|
|Primary Completion Date:||June 2003 (Final data collection date for primary outcome measure)|
Placebo Comparator: 1
tablets, twice daily for 6 months
Active Comparator: 2
160 mg sot twice daily for 6 months
Drug: Azimilide Dihydrochloride
125 mg azimilide tablets, twice a day for 6 months
Please refer to this study by its ClinicalTrials.gov identifier: NCT00035451
Show 129 Study Locations
|Study Director:||Paloma Cuenca, MD||Procter and Gamble|