Clinical trial NCT00035464: Efficacy and Safety of Azimilide in the Prophylactic Treatment of Patients With Atrial Fibrillation.
Official title: Efficacy and Safety of Azimilide in the Prophylactic Treatment of Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atrial Fibrillation
Lead sponsor: Forest Laboratories
Sponsor class: INDUSTRY
First posted: 2002-05-06
Enrollment: 431
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: Atrial fibrillation (an abnormal rhythm in the upper chamber of the heart) is a common supraventricular arrhythmia (a type of abnormal heart rhythm) for which antiarrhythmic therapy is often prescribed. The primary goals of therapy are to maintain sinus rhythm (normal heart rhythm) and to reduce the occurrence of episodes of atrial fibrillation. Azimilide may have an effect on increasing the time to first recurrence of symptomatic atrial fibrillation or atrial flutter and symptomatic paroxysmal supraventricular tachycardia (other types of abnormal heart rhythms).

This double-blind, placebo-controlled study is designed to evaluate the efficacy and safety of azimilide compared with placebo in prolonging the time to the first symptomatic arrhythmia recurrence in patients with a history of atrial fibrillation and congestive heart failure and/or ischemic heart disease) and those without these conditions. Once this phase of the study is completed, a second phase with a different study design will be conducted. The second phase is an open-label, follow-up phase. The follow-up phase of the study is designed to evaluate the long-term efficacy and safety of a daily oral dose of azimilide in patients who complete the double-blind, placebo-controlled phase of this study.


Eligibility criteria: Inclusion criteria:

* History of symptomatic atrial fibrillation that significantly disrupts the patient's customary daily living activities
* History of congestive heart failure and/or ischemic heart disease
* Sinus rhythm (normal heart rhythm) upon entry to the 30 day screening period for the study
* At least one episode of symptomatic atrial fibrillation during the screening period, with a spontaneous return to sinus rhythm.
* Sinus rhythm immediately prior to dosing

Exclusion criteria:

* Previously unsuccessful cardioversions within 60 days of screening period
* Failed to respond to any Class III antiarrhythmic drugs
* Qualifying arrhythmia due to acute reversible illness, acute myocardial infarction, and/or cardiac or thoracic surgery within one month prior to randomization
* Previously in an azimilide study

Primary outcomes:
measure: To prolong the tachycardia-free period in patients
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Cardiovascular Assoc. PC
state: Alabama
city: Mobile
country: United States
facility: The Heart Group, PC
state: Alabama
city: Tucson
country: United States
facility: Southern Arizona VA Health Care System, Section of Cardiology (1-111C)
state: Arizona
city: Tucson
country: United States
facility: University Medical Center
state: Arizona
city: Little Rock
country: United States
facility: University of Arkansas Medical Center
state: Arkansas
city: Burlingame
country: United States
facility: Cardiovascular Associates of Penisula
state: California
city: Carmichael
country: United States
facility: Capitol Interventional Cardiology
state: California
city: Fresno
country: United States
facility: VA Central California Health Care System
state: California
city: Fresno
country: United States
facility: Valley Research
state: California
city: Grass Valley
country: United States
facility: Grass Valley Cardiology
state: California
city: La Jolla
country: United States
facility: San Diego Cardiovascular Associates
state: California
city: Los Angeles
country: United States
facility: Good Samaritan Hospital
state: California
city: Los Angeles
country: United States
facility: LAC+USC Medical Center
state: California
city: Los Angeles
country: United States
facility: Cardiology Section, West Los Angeles VA Hospital
state: California
city: Merced
country: United States
facility: Merced Heart Associates
state: California
city: Modesto
country: United States
facility: Sutter Gould Medical Foundation
state: California
city: Redondo Beach
country: United States
facility: ARI Clinical Trials
state: California
city: Sacramento
country: United States
facility: Regional Cardiology Assoc.
state: California
city: Sacramento
country: United States
facility: Sacramento Heart and Vascular Medical Associates
state: California
city: San Diego
country: United States
facility: Cardiology Associates
state: California
city: Aurora
country: United States
facility: Aurora Denver Cardiology
state: Colorado
city: Denver
country: United States
facility: Western Cardiology Assoc.
state: Colorado
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
city: Washington
country: United States
facility: The George Washington University MFA
state: District of Columbia
city: Daytona Beach
country: United States
facility: Cardiology Consultants
state: Florida
city: Fort Lauderdale
country: United States
facility: C/O Research Office Attn: Cardiovascular Research Dept.
state: Florida
city: Ft. Myers
country: United States
facility: SW Florida Heart Group/Health Park Medical Center
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Center for Clinical Research
state: Florida
city: Lakeland
country: United States
facility: Watson Clinic, LLP
state: Florida
city: Merritt Island
country: United States
facility: Khalid Hassan Sheikh 80 Fontenberry Road
state: Florida
city: Orlando
country: United States
facility: Florida Cardiology
state: Florida
city: Ormond Beach
country: United States
facility: Cardiology Research Assiocates
state: Florida
city: Decatur
country: United States
facility: VA Medical Center
state: Georgia
city: Chicago
country: United States
facility: Mount Sinal Hospital Medical Center
state: Illinois
city: Elgin
country: United States
facility: Elgin Cardiology Associates
state: Illinois
city: Normal
country: United States
facility: Illinois Heart & Lung Research Center, SC
state: Illinois
city: Park Ridge
country: United States
facility: The Center for Advanced Cardiology
state: Illinois
city: Ft. Wayne
country: United States
facility: Heart Center Medical Group
state: Indiana
city: Indianapolis
country: United States
facility: The Care Group
state: Indiana
city: Wichita
country: United States
facility: Professional Research Network of Kansas
state: Kansas
city: Louisville
country: United States
facility: University of Louisville-Cardiology
state: Kentucky
city: Louisville
country: United States
facility: Louisville Cardiology Medical Group, P.S.C
state: Kentucky
city: Houma
country: United States
facility: Cardiovascular Institute of the South
state: Louisiana
city: Lake Charles
country: United States
facility: Richard Gilmore, MD 501 S Ryan Street
state: Louisiana
city: Morgan City
country: United States
facility: Cardiovascular of the South
state: Louisiana
city: New Iberia
country: United States
facility: Cardiovascular Institute of the South
state: Louisiana
city: New Orleans
country: United States
facility: Tulane University
state: Louisiana
city: Slidell
country: United States
facility: Medical Research Institute
state: Louisiana
city: Thibodaux
country: United States
facility: Cardiovascular Institute of the South
state: Louisiana
city: Portland
country: United States
facility: Maine Medical Center
state: Maine
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Worcester
country: United States
facility: University of Massachusett
state: Massachusetts
city: Lansing
country: United States
facility: Thoracic & Cardiovascular Healthcare Foundation
state: Michigan
city: Petoskey
country: United States
facility: Nisus Research
state: Michigan
city: Trenton
country: United States
facility: Riverside Osteopathic Hospital
state: Michigan
city: :Minneapolis
country: United States
facility: VA Medical Center Therapeutic Section
state: Minnesota
city: Duluth
country: United States
facility: Regional Heart Center
state: Minnesota
city: Hibbing
country: United States
facility: Fairview Range Regional Health Services
state: Minnesota
city: Missoula
country: United States
facility: St. Patrick Hosp/Western Mt. Clinic Cardiology
state: Montana
city: Grand Island
country: United States
facility: Internal Medical Associates
state: Nebraska
city: Rochester
country: United States
facility: William Olney, MD 21 Whitehall Rd, Suite 200
state: New Hampshire
city: Williamsville
country: United States
facility: Cardiology & Int. Medicine
state: New York
city: Durham
country: United States
facility: Duke Medical Center
state: North Carolina
city: Grand Forks
country: United States
facility: Altru Health System Research Center
state: North Dakota
city: Cincinnati
country: United States
facility: Lindner Clinical Trial Ctr.
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals of Cleveland
state: Ohio
city: Columbus
country: United States
facility: MidWest Cardiology Research Foundation
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma Foundation for Cardiovascular Research
state: Oklahoma
city: Hillsboro
country: United States
facility: Hillsboro Cardiology
state: Oregon
city: Portland
country: United States
facility: Oregon Health Sciences University
state: Oregon
city: Allentown
country: United States
facility: Heart Care Group PC
state: Pennsylvania
city: Beaver
country: United States
facility: Tri-State Medical Group Cardiology
state: Pennsylvania
city: Hershey
country: United States
facility: Milton S. Hershey Medical Center
state: Pennsylvania
city: Jenkintown
country: United States
facility: The Pavillion
state: Pennsylvania
city: Philadelphia
country: United States
facility: UPHS/Presbyterian Medical Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Cardiovascular and Critical Care Associates, P.C.
state: Pennsylvania
city: Charleston
country: United States
facility: Charleston Cardiology
state: South Carolina
city: Memphis
country: United States
facility: Stern Cardiovascular Center Research Department
state: Tennessee
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
city: Houston
country: United States
facility: Methodist Hospital
state: Texas
city: San Antonio
country: United States
facility: Heart and Vascular Inst. of Texas, PA
state: Texas
city: Chesapeake
country: United States
facility: MedSource, Inc
state: Virginia
city: Newport News
country: United States
facility: Riverside Regional Medical Center
state: Virginia
city: Seattle
country: United States
facility: Daniel Gottlieb, MD 16259 Sylvester Road SW, Suite 401
state: Washington
city: Beloit
country: United States
facility: Beloit Clinic, SC
state: Wisconsin
city: Janesville
country: United States
facility: Dean/Riverview Clinic
state: Wisconsin
city: Madison
country: United States
facility: University of Wisconsin Madison
state: Wisconsin
city: Marshfield
country: United States
facility: Marshfield Clinic
state: Wisconsin
city: Calgary
country: Canada
facility: Heart Health Institute
state: Alberta
city: Calgary
country: Canada
facility: Heart Health Research Center
state: Alberta
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
city: Vancouver
country: Canada
facility: Cardiology Research St. Paul's Hospital
state: British Columbia
city: Hamilton
country: Canada
facility: Hamilton Health Science Corp.
state: Ontario
city: London
country: Canada
facility: Cardiac Investigation Unit
state: Ontario
city: Niagara Falls
country: Canada
facility: Niagara Health System Greater Niagara General Hospital
state: Ontario
city: Ottawa
country: Canada
facility: University of Ottawa Heart Institute
state: Ontario
city: Sudbury
country: Canada
facility: Neureka Research Corporation
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Montreal
country: Canada
facility: Montreal Heart Institute
state: Quebec
city: Montreal
country: Canada
facility: Recharche Cardiologie
state: Quebec
city: Montreal
country: Canada
facility: Chum Hotel Dieu
state: Quebec
city: Montreal
country: Canada
facility: Hospital Sacre-Soeur de Montreal
state: Quebec
city: Sainte-Foy
country: Canada
facility: Quebec Heart Institute
state: Quebec
Study officials:
affiliation: Procter and Gamble
name: Martin Phillips, MD
role: STUDY_DIRECTOR
References: