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

Phase 2

Completed

• Conditions: Atrial Fibrillation
• Interventions: Drug: ATI-2042; Drug: ATI-2042 200 mg

• Registration Number: NCT00389792
• Lead Sponsor: ARYx Therapeutics

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.)

Study Timeline

• Study Start: 2006-07
• Study First Submitted: 2006-10-17
• Study First Submitted QC: 2006-10-17
• Study First Posted: 2006-10-19
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Status Verified: 2009-03
• Last Update Submitted: 2009-03-10
• Last Update Posted: 2009-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ATI-2042 200 mg	ATI-2042 200 mg	-
ATI-2042 400 mg	ATI-2042 200 mg	-
ATI-2042 200 mg	ATI-2042	-
ATI-2042 600 mg	ATI-2042	-
ATI-2042 600 mg	ATI-2042 200 mg	-
ATI-2042 Placebo	ATI-2042	-
ATI-2042 Placebo	ATI-2042 200 mg	-
ATI-2042 400 mg	ATI-2042	-

Primary Outcome Measures

Name	Time	Method
Efficacy Measure: Atrial Fibrillation Burden
Safety Measures: ECG, Laboratory and Adverse Events

Trial Locations

Locations (2)

ARYx Investigational Sites; 🇨🇦 Montreal, Quebec, Canada

ARYx Investigational Site; 🇨🇦 Terrebonne, Quebec, Canada