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

This study has been completed.
Sponsor:
Information provided by:
ARYx Therapeutics
ClinicalTrials.gov Identifier:
NCT00389792
First received: October 17, 2006
Last updated: March 10, 2009
Last verified: March 2009
History of Changes
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by ARYx Therapeutics:

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

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
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.

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.)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00389792

  Show 40 Study Locations
Sponsors and Collaborators
ARYx Therapeutics
Investigators
Study Chair: Michael Ezekowitz, MBChB, PhD Main Line Health
Study Director: Olga Bandman, MD ARYx Therapeutics
  More Information

No publications provided

Responsible Party: Eppie Chang, Senior Director of Clinical Operations, ARYx Therapeutics, 6300 Dumbarton Circle, Fremont, CA 94555
ClinicalTrials.gov Identifier: NCT00389792     History of Changes
Other Study ID Numbers: ATI 2042-CLN 205
Study First Received: October 17, 2006
Last Updated: March 10, 2009
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Germany: Federal Institute for Drugs and Medical Devices
Poland: Ministry of Health

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
 Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013