Status:
COMPLETED
Efficacy and Safety Study of an Antiarrhythmic Drug to Treat Atrial Fibrillation in Patients With Pacemakers
Lead Sponsor:
ARYx Therapeutics
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 desi...
Eligibility Criteria
Inclusion
- Proven paroxysmal atrial fibrillation
- Pacemaker with appropriate AF diagnostics and recording capabilities
Exclusion
- Known allergy to Amiodarone or previous treatment for severe Amiodarone toxicity
- Cardioversion within one month of screening
- Severe left ventricular dysfunction or CHF with NYHA Class III or above
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT00389792
Start Date
July 1 2006
End Date
December 1 2008
Last Update
March 11 2009
Active Locations (40)
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1
ARYx Investigational Site
Phoenix, Arizona, United States, 85306
2
ARYx Investigational Site
Scottsdale, Arizona, United States, 85251
3
ARYx Investigational Site
Tucson, Arizona, United States, 85715
4
ARYx Investigational Site
Larkspur, California, United States, 94939