Efficacy and Safety Study of an Antiarrhythmic Drug to Treat Atrial Fibrillation in Patients With Pacemakers
A Randomized, Double-Blind, Placebo-Controlled Study of ATI-2042 in Patients With Paroxysmal Atrial Fibrillation and Pacemakers With Atrial Fibrillation Data Logging Capabilities
1 other identifier
interventional
72
2 countries
40
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 atrial-fibrillation
Started Jul 2006
Typical duration for phase_2 atrial-fibrillation
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2006
CompletedFirst Submitted
Initial submission to the registry
October 17, 2006
CompletedFirst Posted
Study publicly available on registry
October 19, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedMarch 11, 2009
March 1, 2009
2.4 years
October 17, 2006
March 10, 2009
Conditions
Outcome Measures
Primary Outcomes (2)
Efficacy Measure: Atrial Fibrillation Burden
Safety Measures: ECG, Laboratory and Adverse Events
Study Arms (4)
ATI-2042 200 mg
NO INTERVENTIONATI-2042 400 mg
NO INTERVENTIONATI-2042 600 mg
NO INTERVENTIONATI-2042 Placebo
NO INTERVENTIONInterventions
To stop the dosing of ATI-2042 for a designated time frame as determined by the medical monitor and Principal Investigator.
Eligibility Criteria
You may qualify if:
- Proven paroxysmal atrial fibrillation
- Pacemaker with appropriate AF diagnostics and recording capabilities
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (40)
ARYx Investigational Site
Phoenix, Arizona, 85306, United States
ARYx Investigational Site
Scottsdale, Arizona, 85251, United States
ARYx Investigational Site
Tucson, Arizona, 85715, United States
ARYx Investigational Site
Larkspur, California, 94939, United States
ARYx Investigational Site
Aurora, Colorado, 80012, United States
ARYx Investigational Site
Hollywood, Florida, 33021, United States
ARYx Investigational Site
Jacksonville Beach, Florida, 32250, United States
ARYx Investigational Site
Atlanta, Georgia, 30309, United States
ARYx Investigational Site
Marietta, Georgia, 30060, United States
ARYx Investigational Site
Chicago, Illinois, 60611, United States
ARYx Investigational Site
Towson, Maryland, 21204, United States
ARYx Investigational Site
Saginaw, Michigan, 48601, United States
ARYx Investigational Site
Minneapolis, Minnesota, 55442, United States
ARYx Investigational Site
St Louis, Missouri, 63110, United States
ARYx Investigational Site
Lincoln, Nebraska, 68506, United States
ARYx Investigational Site
Warren Township, New Jersey, 07059, United States
ARYx Investigational Site
Albuquerque, New Mexico, 87102, United States
ARYx Investigational Site
Buffalo, New York, 14215, United States
ARYx Investigational Site
Hershey, Pennsylvania, 17033, United States
ARYx Investigational Site
Wynnewood, Pennsylvania, 19096, United States
ARYx Investigational Site
Charleston, South Carolina, 29425, United States
ARYx Investigational Site
Nashville, Tennessee, 37203, United States
ARYx Investigational Site
Austin, Texas, 78756, United States
ARYx Investigational Site
Houston, Texas, 77030, United States
ARYx Investigational Site
Burlington, Vermont, 05401, United States
ARYx Investigational Site
Newport News, Virginia, 23601, United States
ARYx Investigational Site
Charleston, West Virginia, 25304, United States
ARYx Investigational Site
Edmonton, Alberta, T6G 2B7, Canada
ARYx Investigational Site
Edmonton, Alberta, T6K4C1, Canada
ARYx Investigational Site
Campbell River, British Columbia, V9W3V1, Canada
ARYx Investigational Site
Vancouver, British Columbia, V6Z1Y6, Canada
ARYx Investigational Site
Victoria, British Columbia, V8R 4R2, Canada
ARYx Investigational Site
London, Ontario, N6A 5A5, Canada
ARYx Investigational Site
Niagara Falls, Ontario, L2E 7H1, Canada
ARYx Investigational Site
Ottawa, Ontario, K1Y 4W7, Canada
ARYx Investigational Site
Montreal, Quebec, H1T 1C8, Canada
ARYx Investigational Site
Montreal, Quebec, H2L 4M1, Canada
ARYx Investigational Sites
Montreal, Quebec, H4J1C5, Canada
ARYx Investigational Site
Sherbrooke, Quebec, J1H5N4, Canada
ARYx Investigational Site
Terrebonne, Quebec, J6V 2H2, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Michael Ezekowitz, MBChB, PhD
Main Line Health
- STUDY DIRECTOR
Olga Bandman, MD
ARYx Therapeutics
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 17, 2006
First Posted
October 19, 2006
Study Start
July 1, 2006
Primary Completion
December 1, 2008
Study Completion
December 1, 2008
Last Updated
March 11, 2009
Record last verified: 2009-03