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

ARYx Therapeutics

Status and phase: Completed; Phase 2

Conditions: Atrial Fibrillation

Treatments: Drug: ATI-2042 200 mg; Drug: ATI-2042

Study type: Interventional

Funder types: Industry

Identifiers

NCT00389792

ATI 2042-CLN 205

Details and patient eligibility

About

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.

Full 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.)

Enrollment: 72 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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72 participants in 4 patient groups

ATI-2042 200 mg

No Intervention group

Treatment:

Drug: ATI-2042

Drug: ATI-2042 200 mg

ATI-2042 400 mg

No Intervention group

Treatment:

Drug: ATI-2042

Drug: ATI-2042 200 mg

ATI-2042 600 mg

No Intervention group

Treatment:

Drug: ATI-2042

Drug: ATI-2042 200 mg

ATI-2042 Placebo

No Intervention group

Treatment:

Drug: ATI-2042

Drug: ATI-2042 200 mg