Efficacy and Safety of Azimilide in the Prophylactic Treatment of Patients With Atrial Fibrillation.
- Conditions
- Atrial Fibrillation
- Interventions
- Drug: Placebo
- Registration Number
- NCT00035464
- Lead Sponsor
- Forest Laboratories
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 431
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Placebo Placebo tablets 2 Azimilide Dihydrochloride 125 mg azimilide tablets
- Primary Outcome Measures
Name Time Method To prolong the tachycardia-free period in patients 6 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (101)
VA Central California Health Care System
🇺🇸Fresno, California, United States
Regional Heart Center
🇺🇸Duluth, Minnesota, United States
C/O Research Office Attn: Cardiovascular Research Dept.
🇺🇸Fort Lauderdale, Florida, United States
Thoracic & Cardiovascular Healthcare Foundation
🇺🇸Lansing, Michigan, United States
Cardiology Section, West Los Angeles VA Hospital
🇺🇸Los Angeles, California, United States
Good Samaritan Hospital
🇺🇸Los Angeles, California, United States
LAC+USC Medical Center
🇺🇸Los Angeles, California, United States
Mount Sinal Hospital Medical Center
🇺🇸Chicago, Illinois, United States
University Hospitals of Cleveland
🇺🇸Cleveland, Ohio, United States
MidWest Cardiology Research Foundation
🇺🇸Columbus, Ohio, United States
Methodist Hospital
🇺🇸Houston, Texas, United States
San Diego Cardiovascular Associates
🇺🇸La Jolla, California, United States
The Center for Advanced Cardiology
🇺🇸Park Ridge, Illinois, United States
Elgin Cardiology Associates
🇺🇸Elgin, Illinois, United States
Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
Heart Center Medical Group
🇺🇸Ft. Wayne, Indiana, United States
Cardiology Consultants
🇺🇸Daytona Beach, Florida, United States
Merced Heart Associates
🇺🇸Merced, California, United States
ARI Clinical Trials
🇺🇸Redondo Beach, California, United States
SW Florida Heart Group/Health Park Medical Center
🇺🇸Ft. Myers, Florida, United States
Khalid Hassan Sheikh 80 Fontenberry Road
🇺🇸Merritt Island, Florida, United States
Maine Medical Center
🇺🇸Portland, Maine, United States
Neureka Research Corporation
🇨🇦Sudbury, Ontario, Canada
Grass Valley Cardiology
🇺🇸Grass Valley, California, United States
The George Washington University MFA
🇺🇸Washington, District of Columbia, United States
Fairview Range Regional Health Services
🇺🇸Hibbing, Minnesota, United States
William Olney, MD 21 Whitehall Rd, Suite 200
🇺🇸Rochester, New Hampshire, United States
Dean/Riverview Clinic
🇺🇸Janesville, Wisconsin, United States
Hartford Hospital
🇺🇸Hartford, Connecticut, United States
Cardiology Research Assiocates
🇺🇸Ormond Beach, Florida, United States
Internal Medical Associates
🇺🇸Grand Island, Nebraska, United States
Stern Cardiovascular Center Research Department
🇺🇸Memphis, Tennessee, United States
Medical Research Institute
🇺🇸Slidell, Louisiana, United States
Riverside Osteopathic Hospital
🇺🇸Trenton, Michigan, United States
University of Massachusett
🇺🇸Worcester, Massachusetts, United States
Heart Care Group PC
🇺🇸Allentown, Pennsylvania, United States
Jacksonville Center for Clinical Research
🇺🇸Jacksonville, Florida, United States
Watson Clinic, LLP
🇺🇸Lakeland, Florida, United States
Nisus Research
🇺🇸Petoskey, Michigan, United States
Cardiology & Int. Medicine
🇺🇸Williamsville, New York, United States
The Pavillion
🇺🇸Jenkintown, Pennsylvania, United States
Altru Health System Research Center
🇺🇸Grand Forks, North Dakota, United States
Marshfield Clinic
🇺🇸Marshfield, Wisconsin, United States
Illinois Heart & Lung Research Center, SC
🇺🇸Normal, Illinois, United States
Professional Research Network of Kansas
🇺🇸Wichita, Kansas, United States
Richard Gilmore, MD 501 S Ryan Street
🇺🇸Lake Charles, Louisiana, United States
Tri-State Medical Group Cardiology
🇺🇸Beaver, Pennsylvania, United States
UT Southwestern Medical Center
🇺🇸Dallas, Texas, United States
University of Calgary
🇨🇦Calgary, Alberta, Canada
UPHS/Presbyterian Medical Center
🇺🇸Philadelphia, Pennsylvania, United States
Cardiology Research St. Paul's Hospital
🇨🇦Vancouver, British Columbia, Canada
Recharche Cardiologie
🇨🇦Montreal, Quebec, Canada
St. Michael's Hospital
🇨🇦Toronto, Ontario, Canada
Beloit Clinic, SC
🇺🇸Beloit, Wisconsin, United States
Quebec Heart Institute
🇨🇦Sainte-Foy, Quebec, Canada
Heart Health Research Center
🇨🇦Calgary, Alberta, Canada
Montreal Heart Institute
🇨🇦Montreal, Quebec, Canada
Boston Medical Center
🇺🇸Boston, Massachusetts, United States
Daniel Gottlieb, MD 16259 Sylvester Road SW, Suite 401
🇺🇸Seattle, Washington, United States
The Care Group
🇺🇸Indianapolis, Indiana, United States
Cardiology Associates
🇺🇸San Diego, California, United States
Duke Medical Center
🇺🇸Durham, North Carolina, United States
Oklahoma Foundation for Cardiovascular Research
🇺🇸Oklahoma City, Oklahoma, United States
Heart and Vascular Inst. of Texas, PA
🇺🇸San Antonio, Texas, United States
Lindner Clinical Trial Ctr.
🇺🇸Cincinnati, Ohio, United States
Cardiovascular Assoc. PC
🇺🇸Birmingham, Alabama, United States
Western Cardiology Assoc.
🇺🇸Denver, Colorado, United States
Oregon Health Sciences University
🇺🇸Portland, Oregon, United States
Heart Health Institute
🇨🇦Calgary, Alberta, Canada
Cardiac Investigation Unit
🇨🇦London, Ontario, Canada
Niagara Health System Greater Niagara General Hospital
🇨🇦Niagara Falls, Ontario, Canada
Chum Hotel Dieu
🇨🇦Montreal, Quebec, Canada
Hospital Sacre-Soeur de Montreal
🇨🇦Montreal, Quebec, Canada
Southern Arizona VA Health Care System, Section of Cardiology (1-111C)
🇺🇸Tucson, Arizona, United States
University of Arkansas Medical Center
🇺🇸Little Rock, Arkansas, United States
The Heart Group, PC
🇺🇸Mobile, Alabama, United States
Valley Research
🇺🇸Fresno, California, United States
Capitol Interventional Cardiology
🇺🇸Carmichael, California, United States
Cardiovascular Associates of Penisula
🇺🇸Burlingame, California, United States
Cardiovascular Institute of the South
🇺🇸Thibodaux, Louisiana, United States
Cardiovascular of the South
🇺🇸Morgan City, Louisiana, United States
VA Medical Center Therapeutic Section
🇺🇸:Minneapolis, Minnesota, United States
Hillsboro Cardiology
🇺🇸Hillsboro, Oregon, United States
Cardiovascular and Critical Care Associates, P.C.
🇺🇸Pittsburgh, Pennsylvania, United States
MedSource, Inc
🇺🇸Chesapeake, Virginia, United States
Riverside Regional Medical Center
🇺🇸Newport News, Virginia, United States
Hamilton Health Science Corp.
🇨🇦Hamilton, Ontario, Canada
University of Ottawa Heart Institute
🇨🇦Ottawa, Ontario, Canada
University Medical Center
🇺🇸Tucson, Arizona, United States
Sutter Gould Medical Foundation
🇺🇸Modesto, California, United States
VA Medical Center
🇺🇸Decatur, Georgia, United States
St. Patrick Hosp/Western Mt. Clinic Cardiology
🇺🇸Missoula, Montana, United States
Regional Cardiology Assoc.
🇺🇸Sacramento, California, United States
Sacramento Heart and Vascular Medical Associates
🇺🇸Sacramento, California, United States
Aurora Denver Cardiology
🇺🇸Aurora, Colorado, United States
Florida Cardiology
🇺🇸Orlando, Florida, United States
University of Louisville-Cardiology
🇺🇸Louisville, Kentucky, United States
Louisville Cardiology Medical Group, P.S.C
🇺🇸Louisville, Kentucky, United States
Tulane University
🇺🇸New Orleans, Louisiana, United States
Charleston Cardiology
🇺🇸Charleston, South Carolina, United States
University of Wisconsin Madison
🇺🇸Madison, Wisconsin, United States