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

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ATI-2042
ATI-2042 200 mg
Sponsored by
ARYx Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • ARYx Investigational Site
  • ARYx Investigational Site
  • ARYx Investigational Site
  • ARYx Investigational Site
  • ARYx Investigational Site
  • ARYx Investigational Site
  • ARYx Investigational Site
  • ARYx Investigational Site
  • ARYx Investigational Site
  • ARYx Investigational Site
  • ARYx Investigational Site
  • ARYx Investigational Site
  • ARYx Investigational Site
  • ARYx Investigational Site
  • ARYx Investigational Site
  • ARYx Investigational Site
  • ARYx Investigational Site
  • ARYx Investigational Site
  • ARYx Investigational Site
  • ARYx Investigational Site
  • ARYx Investigational Site
  • ARYx Investigational Site
  • ARYx Investigational Site
  • ARYx Investigational Site
  • ARYx Investigational Site
  • ARYx Investigational Site
  • ARYx Investigational Site
  • ARYx Investigational Site
  • ARYx Investigational Site
  • ARYx Investigational Site
  • ARYx Investigational Site
  • ARYx Investigational Site
  • ARYx Investigational Site
  • ARYx Investigational Site
  • ARYx Investigational Site
  • ARYx Investigational Site
  • ARYx Investigational Site
  • ARYx Investigational Sites
  • ARYx Investigational Site
  • ARYx Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

No Intervention

No Intervention

No Intervention

Arm Label

ATI-2042 200 mg

ATI-2042 400 mg

ATI-2042 600 mg

ATI-2042 Placebo

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
October 17, 2006
Last Updated
March 10, 2009
Sponsor
ARYx Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT00389792
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
ARYx Therapeutics

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ATI-2042 200 mg
Arm Type
No Intervention
Arm Title
ATI-2042 400 mg
Arm Type
No Intervention
Arm Title
ATI-2042 600 mg
Arm Type
No Intervention
Arm Title
ATI-2042 Placebo
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
ATI-2042
Intervention Description
no intervention
Intervention Type
Drug
Intervention Name(s)
ATI-2042 200 mg
Intervention Description
To stop the dosing of ATI-2042 for a designated time frame as determined by the medical monitor and Principal Investigator.
Primary Outcome Measure Information:
Title
Efficacy Measure: Atrial Fibrillation Burden
Title
Safety Measures: ECG, Laboratory and Adverse Events

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Ezekowitz, MBChB, PhD
Organizational Affiliation
Main Line Health
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Olga Bandman, MD
Organizational Affiliation
ARYx Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
ARYx Investigational Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85306
Country
United States
Facility Name
ARYx Investigational Site
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85251
Country
United States
Facility Name
ARYx Investigational Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85715
Country
United States
Facility Name
ARYx Investigational Site
City
Larkspur
State/Province
California
ZIP/Postal Code
94939
Country
United States
Facility Name
ARYx Investigational Site
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States
Facility Name
ARYx Investigational Site
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
ARYx Investigational Site
City
Jacksonville Beach
State/Province
Florida
ZIP/Postal Code
32250
Country
United States
Facility Name
ARYx Investigational Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
ARYx Investigational Site
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
ARYx Investigational Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
ARYx Investigational Site
City
Towson
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
ARYx Investigational Site
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
48601
Country
United States
Facility Name
ARYx Investigational Site
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55442
Country
United States
Facility Name
ARYx Investigational Site
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
ARYx Investigational Site
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68506
Country
United States
Facility Name
ARYx Investigational Site
City
Warren
State/Province
New Jersey
ZIP/Postal Code
07059
Country
United States
Facility Name
ARYx Investigational Site
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
ARYx Investigational Site
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States
Facility Name
ARYx Investigational Site
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
ARYx Investigational Site
City
Wynnewood
State/Province
Pennsylvania
ZIP/Postal Code
19096
Country
United States
Facility Name
ARYx Investigational Site
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
ARYx Investigational Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
ARYx Investigational Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78756
Country
United States
Facility Name
ARYx Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
ARYx Investigational Site
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Facility Name
ARYx Investigational Site
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23601
Country
United States
Facility Name
ARYx Investigational Site
City
Charleston
State/Province
West Virginia
ZIP/Postal Code
25304
Country
United States
Facility Name
ARYx Investigational Site
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Facility Name
ARYx Investigational Site
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6K4C1
Country
Canada
Facility Name
ARYx Investigational Site
City
Campbell River
State/Province
British Columbia
ZIP/Postal Code
V9W3V1
Country
Canada
Facility Name
ARYx Investigational Site
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z1Y6
Country
Canada
Facility Name
ARYx Investigational Site
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8R 4R2
Country
Canada
Facility Name
ARYx Investigational Site
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
Facility Name
ARYx Investigational Site
City
Niagara Falls
State/Province
Ontario
ZIP/Postal Code
L2E 7H1
Country
Canada
Facility Name
ARYx Investigational Site
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4W7
Country
Canada
Facility Name
ARYx Investigational Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 1C8
Country
Canada
Facility Name
ARYx Investigational Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4M1
Country
Canada
Facility Name
ARYx Investigational Sites
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4J1C5
Country
Canada
Facility Name
ARYx Investigational Site
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H5N4
Country
Canada
Facility Name
ARYx Investigational Site
City
Terrebonne
State/Province
Quebec
ZIP/Postal Code
J6V 2H2
Country
Canada

12. IPD Sharing Statement

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

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