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NCT00389792 Clinical Trial

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

Atrial Fibrillation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00389792
Other study ID # ATI 2042-CLN 205
Secondary ID
Status Completed
Phase Phase 2
First received October 17, 2006
Last updated March 10, 2009
Start date July 2006
Est. completion date December 2008

Study information
Verified date March 2009
Source ARYx Therapeutics
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationCanada: Health CanadaGermany: Federal Institute for Drugs and Medical DevicesPoland: Ministry of Health
Study type Interventional

Clinical Trial 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.

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.)

Recruitment information / eligibility
Status Completed
Enrollment 72
Est. completion date December 2008
Est. primary completion date December 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• ATI-2042
no intervention
• 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.

Locations
Country Name City State
Canada ARYx Investigational Site Campbell River British Columbia
Canada ARYx Investigational Site Edmonton Alberta
Canada ARYx Investigational Site Edmonton Alberta
Canada ARYx Investigational Site London Ontario
Canada ARYx Investigational Site Montreal Quebec
Canada ARYx Investigational Site Montreal Quebec
Canada ARYx Investigational Sites Montreal Quebec
Canada ARYx Investigational Site Niagara Falls Ontario
Canada ARYx Investigational Site Ottawa Ontario
Canada ARYx Investigational Site Sherbrooke Quebec
Canada ARYx Investigational Site Terrebonne Quebec
Canada ARYx Investigational Site Vancouver British Columbia
Canada ARYx Investigational Site Victoria British Columbia
United States ARYx Investigational Site Albuquerque New Mexico
United States ARYx Investigational Site Atlanta Georgia
United States ARYx Investigational Site Aurora Colorado
United States ARYx Investigational Site Austin Texas
United States ARYx Investigational Site Buffalo New York
United States ARYx Investigational Site Burlington Vermont
United States ARYx Investigational Site Charleston South Carolina
United States ARYx Investigational Site Charleston West Virginia
United States ARYx Investigational Site Chicago Illinois
United States ARYx Investigational Site Hershey Pennsylvania
United States ARYx Investigational Site Hollywood Florida
United States ARYx Investigational Site Houston Texas
United States ARYx Investigational Site Jacksonville Beach Florida
United States ARYx Investigational Site Larkspur California
United States ARYx Investigational Site Lincoln Nebraska
United States ARYx Investigational Site Marietta Georgia
United States ARYx Investigational Site Minneapolis Minnesota
United States ARYx Investigational Site Nashville Tennessee
United States ARYx Investigational Site Newport News Virginia
United States ARYx Investigational Site Phoenix Arizona
United States ARYx Investigational Site Saginaw Michigan
United States ARYx Investigational Site Scottsdale Arizona
United States ARYx Investigational Site St. Louis Missouri
United States ARYx Investigational Site Towson Maryland
United States ARYx Investigational Site Tucson Arizona
United States ARYx Investigational Site Warren New Jersey
United States ARYx Investigational Site Wynnewood Pennsylvania

Sponsors (1)
Lead Sponsor Collaborator
ARYx Therapeutics

Countries where clinical trial is conducted

United States,  Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Efficacy Measure: Atrial Fibrillation Burden
Primary Safety Measures: ECG, Laboratory and Adverse Events
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