Ignite Creation Date:
2024-05-05 @ 5:06 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00389792
Status:
COMPLETED
Last Update Posted:
2009-03-11
First Post:
2006-10-17
Brief Title:
Efficacy and Safety Study of an Antiarrhythmic Drug to Treat Atrial Fibrillation in Patients With Pacemakers
Sponsor:
ARYx Therapeutics
Organization:
ARYx Therapeutics
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Study of ATI-2042 in Patients With Paroxysmal Atrial Fibrillation and Pacemakers With Atrial Fibrillation Data Logging Capabilities
Status:
COMPLETED
Status Verified Date:
2009-03
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:
The purpose of this study is to determine the safety and efficacy of an investigational antiarrhythmic drug ATI-2042 in the treatment of atrial fibrillation in patients with a dual chamber pacemaker
Detailed Description:
ATI-2042 is being developed as an alternative to amiodarone which is considered a first-line therapy for patients with atrial fibrillation and is known to have serious side effects ATI-2042 was designed to have a reduced plasma half-life and a lower volume of distribution which is expected to result in an improved safety profile In contrast to amiodarone ATI-2042 undergoes rapid metabolism via plasma and tissue esterases which may reduce tissue accumulation and toxicity The current trial will determine if ATI-2042 retains the efficacy profile of amiodarone without the side effects attributable to tissue accumulation seen with long-term dosing
This study is an early phase trial and some specific protocol information is proprietary and not publicly available at this time Full information is available to trial participants
This study is an early phase trial and some specific protocol information is proprietary and not publicly available at this time Full information is available to trial participants
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