Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00035490
Status:
COMPLETED
Last Update Posted:
2011-10-03
First Post:
2002-05-03
Brief Title:
Efficacy and Safety Evaluation of Azimilide Dihydrochloride in Patients With Implantable Cardioverter Defibrillators
Sponsor:
Forest Laboratories
Organization:
Forest Laboratories
Study Overview
Official Title:
Efficacy and Safety Evaluation of Azimilide Dihydrochloride in Patients With Implantable Cardioverter Defibrillators
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:
Implantable cardioverter defibrillators ICDs have been developed to treat ventricular tachycardia or fibrillation abnormal heart rhythms by electrical shock or by pacing the heart ICD therapy is established as highly effective for stopping life-threatening arrhythmias but it does not preclude the use of anti-arrhythmic drugs for prevention and to decrease the frequency of ICD shocks
The safety and effectiveness of oral azimilide dihydrochloride in reducing the frequency of ICD shocks has been investigated previously in a placebo-controlled study in patients with ICDs These results need to be confirmed in this larger double-blind placebo-controlled study with approximately 600 patients
The safety and effectiveness of oral azimilide dihydrochloride in reducing the frequency of ICD shocks has been investigated previously in a placebo-controlled study in patients with ICDs These results need to be confirmed in this larger double-blind placebo-controlled study with approximately 600 patients
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