Efficacy and Safety of Azimilide for the Treatment of Patients With Atrial Fibrillation
- Conditions
- Atrial Fibrillation
- Interventions
- Drug: Placebo
- Registration Number
- NCT00035477
- Lead Sponsor
- Forest Laboratories
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 446
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Placebo placebo tablets in hospital and placebo tablets outpatient 2 Azimilide Dihydrochloride Azimilide tablets in hospital and azimilide tablets outpatient
- Primary Outcome Measures
Name Time Method Prolong the time from start of teh efficacy period to the first symptomatic or asymptomatic event fo AFIB, etc six months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (81)
Merced Heart Associates
🇺🇸Merced, California, United States
The Heart Group, PC
🇺🇸Mobile, Alabama, United States
Khalid Hasan Sheikh 80 Fortenberry Road
🇺🇸Merritt Island, Florida, United States
Cardiology Reasearch Assiocates
🇺🇸Ormond Beach, Florida, United States
University Medical Center
🇺🇸Tucson, Arizona, United States
La Mesa Cardiac Center, a Medical Group
🇺🇸La Mesa, California, United States
Lakeland Regional Medical
🇺🇸Lakeland, Florida, United States
Jacksonville Center for Clinical Research
🇺🇸Jacksonville, Florida, United States
ARI Clinical Trials
🇺🇸Redondo Beach, California, United States
San Diego Cardiovascular Research Associates
🇺🇸Encinitas, California, United States
Elgin Cardiology Associates
🇺🇸Elgin, Illinois, United States
Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
Richard Gilmore 501 S. Ryan Street
🇺🇸Lake Charles, Louisiana, United States
Riverside Regional Medical Center
🇺🇸Newport News, Virginia, United States
University of Massachusett
🇺🇸Worcester, Massachusetts, United States
Tri-State Medical Group Cardiology
🇺🇸Beaver, Pennsylvania, United States
Cardiac Investigation Unit
🇨🇦London, Ontario, Canada
Heart Care Group PC
🇺🇸Allentown, Pennsylvania, United States
Montreal Heart Institute
🇨🇦Montreal, Quebec, Canada
Hamilton Health Sciences Crop
🇨🇦Hamilton, Ontario, Canada
Good Samaritan Hospital
🇺🇸Los Angeles, California, United States
LAC + USC Medical Center
🇺🇸Los Angeles, California, United States
Advocate Christ Medical Center
🇺🇸Oak Lawn, Illinois, United States
University Hospitals of Cleveland
🇺🇸Cleveland, Ohio, United States
Cardiovascular and Critical Care Associates, P.C.
🇺🇸Pittsburgh, Pennsylvania, United States
UT Southwestern Medical Center
🇺🇸Dallas, Texas, United States
St. Michael's Hospital
🇨🇦Toronto, Ontario, Canada
Daniel Gottlieb 16259 Sylvester Road SW Suite 401
🇺🇸Seattle, Washington, United States
Methodist Hospital
🇺🇸Houston, Texas, United States
The Care Group
🇺🇸Indianapolis, Indiana, United States
Cardiovascular Associates of Penisula
🇺🇸Burlingame, California, United States
Cardiology Section, West Los Angeles VA Hospital
🇺🇸Los Angeles, California, United States
Inland Clinical Research
🇺🇸Riverside, California, United States
Cardiology Consultants
🇺🇸Daytona Beach, Florida, United States
C/O Research Office Attn: Cardiovascular Research Dept.
🇺🇸Fort Lauderdale, Florida, United States
Cardiovascular Institute of the South
🇺🇸Houma, Louisiana, United States
VA Medical Center
🇺🇸Decatur, Georgia, United States
Heart Center Medical Group
🇺🇸Ft. Wayne, Indiana, United States
Thoracic & Cardiovascular Healthcare Foundation
🇺🇸Lansing, Michigan, United States
Riverside Osteopathic Hospital
🇺🇸Trenton, Michigan, United States
The Pavillion
🇺🇸Jenkintown, Pennsylvania, United States
Cardiology Foundation of Lankenau
🇺🇸Wynnewood, Pennsylvania, United States
UPHS/Presbyterian Medical Center
🇺🇸Philadelphia, Pennsylvania, United States
FHS Research
🇺🇸Tacoma, Washington, United States
University of Calgary
🇨🇦Calgary, Alberta, Canada
University of Ottawa Heart Institute
🇨🇦Ottawa, Ontario, Canada
Cardiology Associates
🇺🇸San Diego, California, United States
Lindner Clinical Trial Ctr.
🇺🇸Cincinnati, Ohio, United States
Altru Health System Research Center
🇺🇸Grand Forks, North Dakota, United States
St. Paul Heart Clinic
🇺🇸St. Paul, Minnesota, United States
Regional Heart Center
🇺🇸Duluth, Minnesota, United States
Health Sciences Centre
🇨🇦Winnipeg, Manitoba, Canada
Hospital Sacre-Coeur de Montreal
🇨🇦Montreal, Quebec, Canada
Quebec Heart Institute
🇨🇦Sainte-Foy, Quebec, Canada
Stern Cardiovascular Center Research Department
🇺🇸Memphis, Tennessee, United States
Cardiology Research St. Paul's Hospital
🇨🇦Vancouver, British Columbia, Canada
Hillsboro Cardiology
🇺🇸Hillsboro, Oregon, United States
Beloit Clinic, SC
🇺🇸Beloit, Wisconsin, United States
Dean/Riverview Clinic
🇺🇸Janesville, Wisconsin, United States
Recherche Cardiologie
🇨🇦Montreal, Quebec, Canada
Hartford Hospital
🇺🇸Hartford, Connecticut, United States
Rockyview General Hospital CV Lab Research
🇨🇦Calgary, Alberta, Canada
The George Washington University MFA
🇺🇸Washington, District of Columbia, United States
Cardiovascular Instiute of the South
🇺🇸Morgan City, Louisiana, United States
Maine Medical Center
🇺🇸Portland, Maine, United States
Androscoggin Cardiology Associates Research
🇺🇸Auburn, Maine, United States
Western Cardiology Assoc.
🇺🇸Denver, Colorado, United States
VA Medical Center Therapeutic Section
🇺🇸Minneapolis, Minnesota, United States
Duke Medical Center
🇺🇸Durham, North Carolina, United States
Oregon Health Sciences University
🇺🇸Portland, Oregon, United States
Heart and Vascular Inst. of Texas, PA
🇺🇸San Antonio, Texas, United States
Neureka Research Corporation
🇨🇦Sudbury, Ontario, Canada
Sutter Gould Medical Foundation
🇺🇸Modesto, California, United States
Florida Cardiology
🇺🇸Orlando, Florida, United States
University of Louisville-Cardiology
🇺🇸Louisville, Kentucky, United States
Tulane University
🇺🇸New Orleans, Louisiana, United States
Regional Cardiology Assoc.
🇺🇸Sacramento, California, United States
Louisville Cardiology Medical Group, P.S.C.
🇺🇸Louisville, Kentucky, United States
Charleston Cardiology
🇺🇸Charleston, South Carolina, United States
Wisconsin Center for Clinical Research
🇺🇸Milwaukee, Wisconsin, United States
University of Wisconsin Madison
🇺🇸Madison, Wisconsin, United States