Clinical trial NCT00035477: Efficacy and Safety of Azimilide for the Treatment of Patients With Atrial Fibrillation
Official title: Efficacy and Safety of Azimilide for the Treatment of Patients With Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atrial Fibrillation
Lead sponsor: Forest Laboratories
Sponsor class: INDUSTRY
First posted: 2002-05-06
Enrollment: 446
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Atrial fibrillation (abnormal rhythm in the upper chamber of the heart) is a common supraventricular arrhythmia (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 maintaining sinus rhythm in patients who require cardioversion (electric shock to correct heart rhythm) to reduce atrial fibrillation. 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 to the study. This follow-up phase will continue 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:

* Documented (12-lead ECG) history of symptomatic atrial fibrillation occurring between 48 hours and 6 months before screening
* Require the procedure of cardioversion (electric shock to correct heart rhythm)
* In the investigator's opinion, be likely to maintain sinus rhythm after cardioversion.
* Be anticoagulated according to the recommendations of the Study Group on Atrial Fibrillation of the European Society of Cardiology guidelines.

Exclusion criteria:

* Previously unsuccessful electrical cardioversions
* 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

Primary outcomes:
measure: Prolong the time from start of teh efficacy period to the first symptomatic or asymptomatic event fo AFIB, etc
timeFrame: six months
Secondary outcomes:
Other outcomes:
Locations:
city: Mobile
country: United States
facility: The Heart Group, PC
state: Alabama
city: Tucson
country: United States
facility: University Medical Center
state: Arizona
city: Burlingame
country: United States
facility: Cardiovascular Associates of Penisula
state: California
city: Encinitas
country: United States
facility: San Diego Cardiovascular Research Associates
state: California
city: La Mesa
country: United States
facility: La Mesa Cardiac Center, a Medical Group
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: Riverside
country: United States
facility: Inland Clinical Research
state: California
city: Sacramento
country: United States
facility: Regional Cardiology Assoc.
state: California
city: San Diego
country: United States
facility: Cardiology Associates
state: California
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: Jacksonville
country: United States
facility: Jacksonville Center for Clinical Research
state: Florida
city: Lakeland
country: United States
facility: Lakeland Regional Medical
state: Florida
city: Merritt Island
country: United States
facility: Khalid Hasan Sheikh 80 Fortenberry Road
state: Florida
city: Orlando
country: United States
facility: Florida Cardiology
state: Florida
city: Ormond Beach
country: United States
facility: Cardiology Reasearch Assiocates
state: Florida
city: Decatur
country: United States
facility: VA Medical Center
state: Georgia
city: Elgin
country: United States
facility: Elgin Cardiology Associates
state: Illinois
city: Oak Lawn
country: United States
facility: Advocate Christ Medical Center
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: 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 501 S. Ryan Street
state: Louisiana
city: Morgan City
country: United States
facility: Cardiovascular Instiute of the South
state: Louisiana
city: New Orleans
country: United States
facility: Tulane University
state: Louisiana
city: Auburn
country: United States
facility: Androscoggin Cardiology Associates Research
state: Maine
city: Portland
country: United States
facility: Maine Medical Center
state: Maine
city: Worcester
country: United States
facility: University of Massachusett
state: Massachusetts
city: Lansing
country: United States
facility: Thoracic & Cardiovascular Healthcare Foundation
state: Michigan
city: Trenton
country: United States
facility: Riverside Osteopathic Hospital
state: Michigan
city: Duluth
country: United States
facility: Regional Heart Center
state: Minnesota
city: Minneapolis
country: United States
facility: VA Medical Center Therapeutic Section
state: Minnesota
city: St. Paul
country: United States
facility: St. Paul Heart Clinic
state: Minnesota
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: 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: Wynnewood
country: United States
facility: Cardiology Foundation of Lankenau
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: Newport News
country: United States
facility: Riverside Regional Medical Center
state: Virginia
city: Seattle
country: United States
facility: Daniel Gottlieb 16259 Sylvester Road SW Suite 401
state: Washington
city: Tacoma
country: United States
facility: FHS Research
state: Washington
city: Beloit
country: United States
facility: Beloit Clinic, SC
state: Wisconsin
city: Elkhorn
country: United States
facility: Wisconsin Center for Clinical Research
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: Milwaukee
country: United States
facility: Wisconsin Center for Clinical Research
state: Wisconsin
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
city: Calgary
country: Canada
facility: Rockyview General Hospital CV Lab Research
state: Alberta
city: Vancouver
country: Canada
facility: Cardiology Research St. Paul's Hospital
state: British Columbia
city: Winnipeg
country: Canada
facility: Health Sciences Centre
state: Manitoba
city: Hamilton
country: Canada
facility: Hamilton Health Sciences Crop
state: Ontario
city: London
country: Canada
facility: Cardiac Investigation Unit
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: Recherche Cardiologie
state: Quebec
city: Montreal
country: Canada
facility: Hospital Sacre-Coeur de Montreal
state: Quebec
city: Sainte-Foy
country: Canada
facility: Quebec Heart Institute
state: Quebec
Study officials:
affiliation: Procter and Gamble
name: Preston M Dunnmon, MD
role: STUDY_DIRECTOR
References: