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

• ClinicalTrials.gov Identifier: NCT00389792
• Recruitment Status: Completed
• First Posted: October 19, 2006
• Last Update Posted: March 11, 2009
• Sponsor: ARYx Therapeutics
• Information provided by: ARYx Therapeutics

Tracking Information

• First Submitted Date: October 17, 2006
• First Posted Date: October 19, 2006
• Last Update Posted Date: March 11, 2009
• Study Start Date: July 2006
• Actual Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 17, 2006)

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

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Efficacy and Safety Study of an Antiarrhythmic Drug to Treat Atrial Fibrillation in Patients With Pacemakers
• 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
• 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.

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 Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment
• Condition: Atrial Fibrillation

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.

Study Arms

• No Intervention: ATI-2042 200 mg
  Interventions:

  • Drug: ATI-2042
  • Drug: ATI-2042 200 mg
• No Intervention: ATI-2042 400 mg
  Interventions:

  • Drug: ATI-2042
  • Drug: ATI-2042 200 mg
• No Intervention: ATI-2042 600 mg
  Interventions:

  • Drug: ATI-2042
  • Drug: ATI-2042 200 mg
• No Intervention: ATI-2042 Placebo
  Interventions:

  • Drug: ATI-2042
  • Drug: ATI-2042 200 mg

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 10, 2009): 72
• Original Enrollment (submitted: October 17, 2006): 140
• Actual Study Completion Date: December 2008
• Actual Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada, United States

Administrative Information

• NCT Number: NCT00389792
• Other Study ID Numbers: ATI 2042-CLN 205
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Eppie Chang, Senior Director of Clinical Operations, ARYx Therapeutics, 6300 Dumbarton Circle, Fremont, CA 94555
• Study Sponsor: ARYx Therapeutics
• Collaborators: Not Provided

Investigators

• Study Chair: Michael Ezekowitz, MBChB, PhD; Main Line Health
• Study Director: Olga Bandman, MD; ARYx Therapeutics

• PRS Account: ARYx Therapeutics
• Verification Date: March 2009