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

NCT ID: NCT00389792

Last Updated: 2009-03-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2008-12-31

Brief Summary

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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

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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

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Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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ATI-2042 200 mg

Group Type NO_INTERVENTION

ATI-2042

Intervention Type DRUG

no intervention

ATI-2042 200 mg

Intervention Type DRUG

To stop the dosing of ATI-2042 for a designated time frame as determined by the medical monitor and Principal Investigator.

ATI-2042 400 mg

Group Type NO_INTERVENTION

ATI-2042

Intervention Type DRUG

no intervention

ATI-2042 200 mg

Intervention Type DRUG

To stop the dosing of ATI-2042 for a designated time frame as determined by the medical monitor and Principal Investigator.

ATI-2042 600 mg

Group Type NO_INTERVENTION

ATI-2042

Intervention Type DRUG

no intervention

ATI-2042 200 mg

Intervention Type DRUG

To stop the dosing of ATI-2042 for a designated time frame as determined by the medical monitor and Principal Investigator.

ATI-2042 Placebo

Group Type NO_INTERVENTION

ATI-2042

Intervention Type DRUG

no intervention

ATI-2042 200 mg

Intervention Type DRUG

To stop the dosing of ATI-2042 for a designated time frame as determined by the medical monitor and Principal Investigator.

Interventions

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ATI-2042

no intervention

Intervention Type DRUG

ATI-2042 200 mg

To stop the dosing of ATI-2042 for a designated time frame as determined by the medical monitor and Principal Investigator.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ARYx Therapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

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ARYx Therapeutics, 6300 Dumbarton Circle, Fremont, CA 94555

Principal Investigators

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Michael Ezekowitz, MBChB, PhD

Role: STUDY_CHAIR

Main Line Health

Olga Bandman, MD

Role: STUDY_DIRECTOR

ARYx Therapeutics

Locations

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ARYx Investigational Site

Phoenix, Arizona, United States

Site Status

ARYx Investigational Site

Scottsdale, Arizona, United States

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ARYx Investigational Site

Tucson, Arizona, United States

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ARYx Investigational Site

Larkspur, California, United States

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ARYx Investigational Site

Aurora, Colorado, United States

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ARYx Investigational Site

Hollywood, Florida, United States

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ARYx Investigational Site

Jacksonville Beach, Florida, United States

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ARYx Investigational Site

Atlanta, Georgia, United States

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ARYx Investigational Site

Marietta, Georgia, United States

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ARYx Investigational Site

Chicago, Illinois, United States

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ARYx Investigational Site

Towson, Maryland, United States

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ARYx Investigational Site

Saginaw, Michigan, United States

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ARYx Investigational Site

Minneapolis, Minnesota, United States

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ARYx Investigational Site

St Louis, Missouri, United States

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ARYx Investigational Site

Lincoln, Nebraska, United States

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ARYx Investigational Site

Warren Township, New Jersey, United States

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ARYx Investigational Site

Albuquerque, New Mexico, United States

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ARYx Investigational Site

Buffalo, New York, United States

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ARYx Investigational Site

Hershey, Pennsylvania, United States

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ARYx Investigational Site

Wynnewood, Pennsylvania, United States

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ARYx Investigational Site

Charleston, South Carolina, United States

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ARYx Investigational Site

Nashville, Tennessee, United States

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ARYx Investigational Site

Austin, Texas, United States

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ARYx Investigational Site

Houston, Texas, United States

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ARYx Investigational Site

Burlington, Vermont, United States

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ARYx Investigational Site

Newport News, Virginia, United States

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ARYx Investigational Site

Charleston, West Virginia, United States

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ARYx Investigational Site

Edmonton, Alberta, Canada

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ARYx Investigational Site

Edmonton, Alberta, Canada

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ARYx Investigational Site

Campbell River, British Columbia, Canada

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ARYx Investigational Site

Vancouver, British Columbia, Canada

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ARYx Investigational Site

Victoria, British Columbia, Canada

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ARYx Investigational Site

London, Ontario, Canada

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ARYx Investigational Site

Niagara Falls, Ontario, Canada

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ARYx Investigational Site

Ottawa, Ontario, Canada

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ARYx Investigational Site

Montreal, Quebec, Canada

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ARYx Investigational Site

Montreal, Quebec, Canada

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ARYx Investigational Sites

Montreal, Quebec, Canada

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ARYx Investigational Site

Sherbrooke, Quebec, Canada

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ARYx Investigational Site

Terrebonne, Quebec, Canada

Site Status

Countries

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United States Canada

Other Identifiers

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ATI 2042-CLN 205

Identifier Type: -

Identifier Source: org_study_id

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