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| Sponsor: | ARYx Therapeutics |
|---|---|
| Information provided by: | ARYx Therapeutics |
| ClinicalTrials.gov Identifier: | NCT00389792 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Atrial Fibrillation |
Drug: ATI-2042 Drug: ATI-2042 200 mg |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| 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 |
| Enrollment: | 72 |
| Study Start Date: | July 2006 |
| Study Completion Date: | December 2008 |
| Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| ATI-2042 200 mg: No Intervention |
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.
|
| ATI-2042 400 mg: No Intervention |
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.
|
| ATI-2042 600 mg: No Intervention |
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.
|
| ATI-2042 Placebo: No Intervention |
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.
|
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.)
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Show 40 Study Locations| Study Chair: | Michael Ezekowitz, MBChB, PhD | Lankenau Institute for Medical Research |
| Study Director: | Olga Bandman, MD | ARYx Therapeutics |
More Information
| Responsible Party: | ARYx Therapeutics, 6300 Dumbarton Circle, Fremont, CA 94555 ( Eppie Chang, Senior Director of Clinical Operations ) |
| Study ID Numbers: | ATI 2042-CLN 205 |
| Study First Received: | October 17, 2006 |
| Last Updated: | March 10, 2009 |
| ClinicalTrials.gov Identifier: | NCT00389792 History of Changes |
| Health Authority: | United States: Food and Drug Administration; Canada: Health Canada; Germany: Federal Institute for Drugs and Medical Devices; Poland: Ministry of Health |
|
Pathologic Processes Heart Diseases Therapeutic Uses Cardiovascular Diseases Cardiovascular Agents |
Anti-Arrhythmia Agents Atrial Fibrillation Pharmacologic Actions Arrhythmias, Cardiac |
