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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00389792
Recruitment Status : Completed
First Posted : October 19, 2006
Last Update Posted : March 11, 2009
Sponsor:
Information provided by:
ARYx Therapeutics

Tracking Information
First Submitted Date  ICMJE October 17, 2006
First Posted Date  ICMJE October 19, 2006
Last Update Posted Date March 11, 2009
Study Start Date  ICMJE July 2006
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 17, 2006)
  • Efficacy Measure: Atrial Fibrillation Burden
  • Safety Measures: ECG, Laboratory and Adverse Events
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety Study of an Antiarrhythmic Drug to Treat Atrial Fibrillation in Patients With Pacemakers
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Atrial Fibrillation
Intervention  ICMJE
  • 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  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 10, 2009)
72
Original Enrollment  ICMJE
 (submitted: October 17, 2006)
140
Actual Study Completion Date  ICMJE December 2008
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00389792
Other Study ID Numbers  ICMJE ATI 2042-CLN 205
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Eppie Chang, Senior Director of Clinical Operations, ARYx Therapeutics, 6300 Dumbarton Circle, Fremont, CA 94555
Study Sponsor  ICMJE ARYx Therapeutics
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Michael Ezekowitz, MBChB, PhD Main Line Health
Study Director: Olga Bandman, MD ARYx Therapeutics
PRS Account ARYx Therapeutics
Verification Date March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP