Efficacy and Safety Study of an Antiarrhythmic Drug to Treat Atrial Fibrillation in Patients With Pacemakers
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| ClinicalTrials.gov Identifier: NCT00389792 |
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Recruitment Status :
Completed
First Posted : October 19, 2006
Last Update Posted : March 11, 2009
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Sponsor:
ARYx Therapeutics
Information provided by:
ARYx Therapeutics
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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 |
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 (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 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Familial atrial fibrillation
MedlinePlus related topics:
Atrial Fibrillation
| 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. |
Primary Outcome Measures :
- Efficacy Measure: Atrial Fibrillation Burden
- Safety Measures: ECG, Laboratory and Adverse Events
Information from the National Library of Medicine
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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
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
| 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
| Study Chair: | Michael Ezekowitz, MBChB, PhD | Main Line Health | |
| Study Director: | Olga Bandman, MD | ARYx Therapeutics |
| 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 |