Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00035451
Status:
COMPLETED
Last Update Posted:
2011-10-03
First Post:
2002-05-03
Brief Title:
Efficacy and Safety Evaluation of Azimilide or Sotalol vs Placebo for Treatment of Patients With Atrial Fibrillation
Sponsor:
Forest Laboratories
Organization:
Forest Laboratories
Study Overview
Official Title:
Efficacy and Safety Evaluation of Azimilide or Sotalol vs Placebo for Treatment of Patients With Atrial Fibrillation
Status:
COMPLETED
Status Verified Date:
2011-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None