Efficacy and Safety Study of an Antiarrhythmic Drug to Treat Atrial Fibrillation in Patients With Pacemakers

Completed

Phase 2 Results N/A

Trial Description

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.)

Conditions

Interventions

  • 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

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Patient Involvement

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.

Outcomes

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

Sponsors