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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00389792
Recruitment Status : Completed
First Posted : October 19, 2006
Last Update Posted : March 11, 2009
Sponsor:
Information provided by:
ARYx Therapeutics

Study Description
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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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Drug: ATI-2042 Drug: ATI-2042 200 mg Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Study of ATI-2042 in Patients With Paroxysmal Atrial Fibrillation and Pacemakers With Atrial Fibrillation Data Logging Capabilities
Study Start Date : July 2006
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

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Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Efficacy Measure: Atrial Fibrillation Burden
  2. Safety Measures: ECG, Laboratory and Adverse Events

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00389792


Locations
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United States, Arizona
ARYx Investigational Site
Phoenix, Arizona, United States, 85306
ARYx Investigational Site
Scottsdale, Arizona, United States, 85251
ARYx Investigational Site
Tucson, Arizona, United States, 85715
United States, California
ARYx Investigational Site
Larkspur, California, United States, 94939
United States, Colorado
ARYx Investigational Site
Aurora, Colorado, United States, 80012
United States, Florida
ARYx Investigational Site
Hollywood, Florida, United States, 33021
ARYx Investigational Site
Jacksonville Beach, Florida, United States, 32250
United States, Georgia
ARYx Investigational Site
Atlanta, Georgia, United States, 30309
ARYx Investigational Site
Marietta, Georgia, United States, 30060
United States, Illinois
ARYx Investigational Site
Chicago, Illinois, United States, 60611
United States, Maryland
ARYx Investigational Site
Towson, Maryland, United States, 21204
United States, Michigan
ARYx Investigational Site
Saginaw, Michigan, United States, 48601
United States, Minnesota
ARYx Investigational Site
Minneapolis, Minnesota, United States, 55442
United States, Missouri
ARYx Investigational Site
St. Louis, Missouri, United States, 63110
United States, Nebraska
ARYx Investigational Site
Lincoln, Nebraska, United States, 68506
United States, New Jersey
ARYx Investigational Site
Warren, New Jersey, United States, 07059
United States, New Mexico
ARYx Investigational Site
Albuquerque, New Mexico, United States, 87102
United States, New York
ARYx Investigational Site
Buffalo, New York, United States, 14215
United States, Pennsylvania
ARYx Investigational Site
Hershey, Pennsylvania, United States, 17033
ARYx Investigational Site
Wynnewood, Pennsylvania, United States, 19096
United States, South Carolina
ARYx Investigational Site
Charleston, South Carolina, United States, 29425
United States, Tennessee
ARYx Investigational Site
Nashville, Tennessee, United States, 37203
United States, Texas
ARYx Investigational Site
Austin, Texas, United States, 78756
ARYx Investigational Site
Houston, Texas, United States, 77030
United States, Vermont
ARYx Investigational Site
Burlington, Vermont, United States, 05401
United States, Virginia
ARYx Investigational Site
Newport News, Virginia, United States, 23601
United States, West Virginia
ARYx Investigational Site
Charleston, West Virginia, United States, 25304
Canada, Alberta
ARYx Investigational Site
Edmonton, Alberta, Canada, T6G 2B7
ARYx Investigational Site
Edmonton, Alberta, Canada, T6K4C1
Canada, British Columbia
ARYx Investigational Site
Campbell River, British Columbia, Canada, V9W3V1
ARYx Investigational Site
Vancouver, British Columbia, Canada, V6Z1Y6
ARYx Investigational Site
Victoria, British Columbia, Canada, V8R 4R2
Canada, Ontario
ARYx Investigational Site
London, Ontario, Canada, N6A 5A5
ARYx Investigational Site
Niagara Falls, Ontario, Canada, L2E 7H1
ARYx Investigational Site
Ottawa, Ontario, Canada, K1Y 4W7
Canada, Quebec
ARYx Investigational Site
Montreal, Quebec, Canada, H1T 1C8
ARYx Investigational Site
Montreal, Quebec, Canada, H2L 4M1
ARYx Investigational Sites
Montreal, Quebec, Canada, H4J1C5
ARYx Investigational Site
Sherbrooke, Quebec, Canada, J1H5N4
ARYx Investigational Site
Terrebonne, Quebec, Canada, J6V 2H2
Sponsors and Collaborators
ARYx Therapeutics
Investigators
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Study Chair: Michael Ezekowitz, MBChB, PhD Main Line Health
Study Director: Olga Bandman, MD ARYx Therapeutics
More Information
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Responsible Party: Eppie Chang, Senior Director of Clinical Operations, ARYx Therapeutics, 6300 Dumbarton Circle, Fremont, CA 94555
ClinicalTrials.gov Identifier: NCT00389792    
Other Study ID Numbers: ATI 2042-CLN 205
First Posted: October 19, 2006    Key Record Dates
Last Update Posted: March 11, 2009
Last Verified: March 2009
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes