Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00035464
Status:
COMPLETED
Last Update Posted:
2011-10-03
First Post:
2002-05-03
Brief Title:
Efficacy and Safety of Azimilide in the Prophylactic Treatment of Patients With Atrial Fibrillation
Sponsor:
Forest Laboratories
Organization:
Forest Laboratories
Study Overview
Official Title:
Efficacy and Safety of Azimilide in the Prophylactic Treatment of Patients
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 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 andor 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
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 andor 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
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