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

March 10, 2009 updated by: ARYx Therapeutics

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

72

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2B7
        • ARYx Investigational Site
      • Edmonton, Alberta, Canada, T6K4C1
        • ARYx Investigational Site
    • British Columbia
      • Campbell River, British Columbia, Canada, V9W3V1
        • ARYx Investigational Site
      • Vancouver, British Columbia, Canada, V6Z1Y6
        • ARYx Investigational Site
      • Victoria, British Columbia, Canada, V8R 4R2
        • ARYx Investigational Site
    • Ontario
      • London, Ontario, Canada, N6A 5A5
        • ARYx Investigational Site
      • Niagara Falls, Ontario, Canada, L2E 7H1
        • ARYx Investigational Site
      • Ottawa, Ontario, Canada, K1Y 4W7
        • ARYx Investigational Site
    • Quebec
      • Montreal, Quebec, Canada, H1T 1C8
        • ARYx Investigational Site
      • Montreal, Quebec, Canada, H2L 4M1
        • ARYx Investigational Site
      • Montreal, Quebec, Canada, H4J1C5
        • ARYx Investigational Sites
      • Sherbrooke, Quebec, Canada, J1H5N4
        • ARYx Investigational Site
      • Terrebonne, Quebec, Canada, J6V 2H2
        • ARYx Investigational Site
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85306
        • ARYx Investigational Site
      • Scottsdale, Arizona, United States, 85251
        • ARYx Investigational Site
      • Tucson, Arizona, United States, 85715
        • ARYx Investigational Site
    • California
      • Larkspur, California, United States, 94939
        • ARYx Investigational Site
    • Colorado
      • Aurora, Colorado, United States, 80012
        • ARYx Investigational Site
    • Florida
      • Hollywood, Florida, United States, 33021
        • ARYx Investigational Site
      • Jacksonville Beach, Florida, United States, 32250
        • ARYx Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • ARYx Investigational Site
      • Marietta, Georgia, United States, 30060
        • ARYx Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60611
        • ARYx Investigational Site
    • Maryland
      • Towson, Maryland, United States, 21204
        • ARYx Investigational Site
    • Michigan
      • Saginaw, Michigan, United States, 48601
        • ARYx Investigational Site
    • Minnesota
      • Minneapolis, Minnesota, United States, 55442
        • ARYx Investigational Site
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • ARYx Investigational Site
    • Nebraska
      • Lincoln, Nebraska, United States, 68506
        • ARYx Investigational Site
    • New Jersey
      • Warren, New Jersey, United States, 07059
        • ARYx Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • ARYx Investigational Site
    • New York
      • Buffalo, New York, United States, 14215
        • ARYx Investigational Site
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • ARYx Investigational Site
      • Wynnewood, Pennsylvania, United States, 19096
        • ARYx Investigational Site
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • ARYx Investigational Site
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • ARYx Investigational Site
    • Texas
      • Austin, Texas, United States, 78756
        • ARYx Investigational Site
      • Houston, Texas, United States, 77030
        • ARYx Investigational Site
    • Vermont
      • Burlington, Vermont, United States, 05401
        • ARYx Investigational Site
    • Virginia
      • Newport News, Virginia, United States, 23601
        • ARYx Investigational Site
    • West Virginia
      • Charleston, West Virginia, United States, 25304
        • ARYx Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: ATI-2042 200 mg
Drug: ATI-2042
no intervention
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.
NO_INTERVENTION: ATI-2042 400 mg
Drug: ATI-2042
no intervention
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.
NO_INTERVENTION: ATI-2042 600 mg
Drug: ATI-2042
no intervention
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.
NO_INTERVENTION: ATI-2042 Placebo
Drug: ATI-2042
no intervention
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Efficacy Measure: Atrial Fibrillation Burden
Safety Measures: ECG, Laboratory and Adverse Events

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ARYx Therapeutics

Investigators

  • Study Chair: Michael Ezekowitz, MBChB, PhD, Main Line Health
  • Study Director: Olga Bandman, MD, ARYx Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Primary Completion (ACTUAL)

December 1, 2008

Study Completion (ACTUAL)

December 1, 2008

Study Registration Dates

First Submitted

October 17, 2006

First Submitted That Met QC Criteria

October 17, 2006

First Posted (ESTIMATE)

October 19, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

March 11, 2009

Last Update Submitted That Met QC Criteria

March 10, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ATI 2042-CLN 205

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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