A Randomized, Double-Blind, Placebo-Controlled Study of ATI-2042 in Patients With Paroxysmal Atrial Fibrillation and Pacemakers With Atrial Fibrillation Data Logging Capabilities

ARYx Therapeutics2 sites in 1 country72 target enrollmentJuly 2006

ConditionsAtrial Fibrillation

InterventionsATI-2042 ATI-2042 200 mg

DrugsATI-2042 ATI-2042 200 mg

Overview

Phase: Phase 2
Intervention: ATI-2042
Conditions: Atrial Fibrillation
Sponsor: ARYx Therapeutics
Enrollment: 72
Locations: 2
Primary Endpoint: Efficacy Measure: Atrial Fibrillation Burden
Status: Completed
Last Updated: 17 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.)

Registry

clinicaltrials.gov

Start Date

July 2006

End Date

December 2008

Last Updated

17 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

ARYx Therapeutics

Eligibility Criteria

Inclusion Criteria

•Proven paroxysmal atrial fibrillation
•Pacemaker with appropriate AF diagnostics and recording capabilities

Exclusion Criteria

•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