Clinical trial NCT00389792: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atrial Fibrillation
Lead sponsor: ARYx Therapeutics
Sponsor class: INDUSTRY
First posted: 2006-10-19
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.)

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

Primary outcomes:
measure: Efficacy Measure: Atrial Fibrillation Burden
measure: Safety Measures: ECG, Laboratory and Adverse Events
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: ARYx Investigational Site
state: Arizona
city: Scottsdale
country: United States
facility: ARYx Investigational Site
state: Arizona
city: Tucson
country: United States
facility: ARYx Investigational Site
state: Arizona
city: Larkspur
country: United States
facility: ARYx Investigational Site
state: California
city: Aurora
country: United States
facility: ARYx Investigational Site
state: Colorado
city: Hollywood
country: United States
facility: ARYx Investigational Site
state: Florida
city: Jacksonville Beach
country: United States
facility: ARYx Investigational Site
state: Florida
city: Atlanta
country: United States
facility: ARYx Investigational Site
state: Georgia
city: Marietta
country: United States
facility: ARYx Investigational Site
state: Georgia
city: Chicago
country: United States
facility: ARYx Investigational Site
state: Illinois
city: Towson
country: United States
facility: ARYx Investigational Site
state: Maryland
city: Saginaw
country: United States
facility: ARYx Investigational Site
state: Michigan
city: Minneapolis
country: United States
facility: ARYx Investigational Site
state: Minnesota
city: St. Louis
country: United States
facility: ARYx Investigational Site
state: Missouri
city: Lincoln
country: United States
facility: ARYx Investigational Site
state: Nebraska
city: Warren
country: United States
facility: ARYx Investigational Site
state: New Jersey
city: Albuquerque
country: United States
facility: ARYx Investigational Site
state: New Mexico
city: Buffalo
country: United States
facility: ARYx Investigational Site
state: New York
city: Hershey
country: United States
facility: ARYx Investigational Site
state: Pennsylvania
city: Wynnewood
country: United States
facility: ARYx Investigational Site
state: Pennsylvania
city: Charleston
country: United States
facility: ARYx Investigational Site
state: South Carolina
city: Nashville
country: United States
facility: ARYx Investigational Site
state: Tennessee
city: Austin
country: United States
facility: ARYx Investigational Site
state: Texas
city: Houston
country: United States
facility: ARYx Investigational Site
state: Texas
city: Burlington
country: United States
facility: ARYx Investigational Site
state: Vermont
city: Newport News
country: United States
facility: ARYx Investigational Site
state: Virginia
city: Charleston
country: United States
facility: ARYx Investigational Site
state: West Virginia
city: Edmonton
country: Canada
facility: ARYx Investigational Site
state: Alberta
city: Edmonton
country: Canada
facility: ARYx Investigational Site
state: Alberta
city: Campbell River
country: Canada
facility: ARYx Investigational Site
state: British Columbia
city: Vancouver
country: Canada
facility: ARYx Investigational Site
state: British Columbia
city: Victoria
country: Canada
facility: ARYx Investigational Site
state: British Columbia
city: London
country: Canada
facility: ARYx Investigational Site
state: Ontario
city: Niagara Falls
country: Canada
facility: ARYx Investigational Site
state: Ontario
city: Ottawa
country: Canada
facility: ARYx Investigational Site
state: Ontario
city: Montreal
country: Canada
facility: ARYx Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: ARYx Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: ARYx Investigational Sites
state: Quebec
city: Sherbrooke
country: Canada
facility: ARYx Investigational Site
state: Quebec
city: Terrebonne
country: Canada
facility: ARYx Investigational Site
state: Quebec
Study officials:
affiliation: Main Line Health
name: Michael Ezekowitz, MBChB, PhD
role: STUDY_CHAIR
affiliation: ARYx Therapeutics
name: Olga Bandman, MD
role: STUDY_DIRECTOR
References: