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.
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.)
- ATI-2042 (Budiodarone)Drug
Intervention Desc: no intervention ARM 1: Kind: Experimental Label: ATI-2042 200 mg ARM 2: Kind: Experimental Label: ATI-2042 400 mg ARM 3: Kind: Experimental Label: ATI-2042 600 mg ARM 4: Kind: Experimental Label: ATI-2042 Placebo
- ATI-2042 200 mg Drug
Intervention Desc: To stop the dosing of ATI-2042 for a designated time frame as determined by the medical monitor and Principal Investigator. ARM 1: Kind: Experimental Label: ATI-2042 200 mg ARM 2: Kind: Experimental Label: ATI-2042 400 mg ARM 3: Kind: Experimental Label: ATI-2042 600 mg ARM 4: Kind: Experimental Label: ATI-2042 Placebo
- Allocation: Randomized
- Masking: Double Blind (Subject, Caregiver, Investigator)
- Purpose: Treatment
- Endpoint: Safety/Efficacy Study
- Intervention: Parallel Assignment
Patient will be randomized to one of four arms: 1) ATI-2042 200 mg., 2) ATI-2042 400 mg., 3) ATI-2042 600 mg., or 4) placebo. Dosing of ATI-2042 will be stopped for a designated time frame as determined by the medical monitor and Principal Investigator.
|Type||Measure||Time Frame||Safety Issue|
|Primary||Efficacy Measure: Atrial Fibrillation Burden; Safety Measures: ECG, Laboratory and Adverse Events.|
|Primary||Efficacy Measure: Atrial Fibrillation Burden|
|Primary||Safety Measures: ECG, Laboratory and Adverse Events|
- ARYx Therapeutics Lead