Efficacy and Safety of Azimilide for the Treatment of Patients With Atrial Fibrillation
NCT ID: NCT00035477
Last Updated: 2011-10-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
446 participants
INTERVENTIONAL
2000-09-30
2003-10-31
Brief Summary
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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
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
placebo tablets in hospital and placebo tablets outpatient
Placebo
placebo tablets once a day for 3 days in hospital and placebo tablets once a day for 6 months as outpatient
2
Azimilide tablets in hospital and azimilide tablets outpatient
Azimilide Dihydrochloride
125 mg azimilide tablets once a day for 3 days in hospital and 125 mg azimilide tablets once a day for 6 months as outpatient
Interventions
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Azimilide Dihydrochloride
125 mg azimilide tablets once a day for 3 days in hospital and 125 mg azimilide tablets once a day for 6 months as outpatient
Placebo
placebo tablets once a day for 3 days in hospital and placebo tablets once a day for 6 months as outpatient
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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Forest Laboratories
INDUSTRY
Responsible Party
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Procter & Gamble Pharmaceuticals
Principal Investigators
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Preston M Dunnmon, MD
Role: STUDY_DIRECTOR
Procter and Gamble
Locations
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The Heart Group, PC
Mobile, Alabama, United States
University Medical Center
Tucson, Arizona, United States
Cardiovascular Associates of Penisula
Burlingame, California, United States
San Diego Cardiovascular Research Associates
Encinitas, California, United States
La Mesa Cardiac Center, a Medical Group
La Mesa, California, United States
Good Samaritan Hospital
Los Angeles, California, United States
LAC + USC Medical Center
Los Angeles, California, United States
Cardiology Section, West Los Angeles VA Hospital
Los Angeles, California, United States
Merced Heart Associates
Merced, California, United States
Sutter Gould Medical Foundation
Modesto, California, United States
ARI Clinical Trials
Redondo Beach, California, United States
Inland Clinical Research
Riverside, California, United States
Regional Cardiology Assoc.
Sacramento, California, United States
Cardiology Associates
San Diego, California, United States
Western Cardiology Assoc.
Denver, Colorado, United States
Hartford Hospital
Hartford, Connecticut, United States
The George Washington University MFA
Washington D.C., District of Columbia, United States
Cardiology Consultants
Daytona Beach, Florida, United States
C/O Research Office Attn: Cardiovascular Research Dept.
Fort Lauderdale, Florida, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
Lakeland Regional Medical
Lakeland, Florida, United States
Khalid Hasan Sheikh 80 Fortenberry Road
Merritt Island, Florida, United States
Florida Cardiology
Orlando, Florida, United States
Cardiology Reasearch Assiocates
Ormond Beach, Florida, United States
VA Medical Center
Decatur, Georgia, United States
Elgin Cardiology Associates
Elgin, Illinois, United States
Advocate Christ Medical Center
Oak Lawn, Illinois, United States
Heart Center Medical Group
Fort Wayne, Indiana, United States
The Care Group
Indianapolis, Indiana, United States
University of Louisville-Cardiology
Louisville, Kentucky, United States
Louisville Cardiology Medical Group, P.S.C.
Louisville, Kentucky, United States
Cardiovascular Institute of the South
Houma, Louisiana, United States
Richard Gilmore 501 S. Ryan Street
Lake Charles, Louisiana, United States
Cardiovascular Instiute of the South
Morgan City, Louisiana, United States
Tulane University
New Orleans, Louisiana, United States
Androscoggin Cardiology Associates Research
Auburn, Maine, United States
Maine Medical Center
Portland, Maine, United States
University of Massachusett
Worcester, Massachusetts, United States
Thoracic & Cardiovascular Healthcare Foundation
Lansing, Michigan, United States
Riverside Osteopathic Hospital
Trenton, Michigan, United States
Regional Heart Center
Duluth, Minnesota, United States
VA Medical Center Therapeutic Section
Minneapolis, Minnesota, United States
St. Paul Heart Clinic
Saint Paul, Minnesota, United States
Duke Medical Center
Durham, North Carolina, United States
Altru Health System Research Center
Grand Forks, North Dakota, United States
Lindner Clinical Trial Ctr.
Cincinnati, Ohio, United States
University Hospitals of Cleveland
Cleveland, Ohio, United States
Hillsboro Cardiology
Hillsboro, Oregon, United States
Oregon Health Sciences University
Portland, Oregon, United States
Heart Care Group PC
Allentown, Pennsylvania, United States
Tri-State Medical Group Cardiology
Beaver, Pennsylvania, United States
Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
The Pavillion
Jenkintown, Pennsylvania, United States
UPHS/Presbyterian Medical Center
Philadelphia, Pennsylvania, United States
Cardiovascular and Critical Care Associates, P.C.
Pittsburgh, Pennsylvania, United States
Cardiology Foundation of Lankenau
Wynnewood, Pennsylvania, United States
Charleston Cardiology
Charleston, South Carolina, United States
Stern Cardiovascular Center Research Department
Memphis, Tennessee, United States
UT Southwestern Medical Center
Dallas, Texas, United States
Methodist Hospital
Houston, Texas, United States
Heart and Vascular Inst. of Texas, PA
San Antonio, Texas, United States
Riverside Regional Medical Center
Newport News, Virginia, United States
Daniel Gottlieb 16259 Sylvester Road SW Suite 401
Seattle, Washington, United States
FHS Research
Tacoma, Washington, United States
Beloit Clinic, SC
Beloit, Wisconsin, United States
Wisconsin Center for Clinical Research
Elkhorn, Wisconsin, United States
Dean/Riverview Clinic
Janesville, Wisconsin, United States
University of Wisconsin Madison
Madison, Wisconsin, United States
Wisconsin Center for Clinical Research
Milwaukee, Wisconsin, United States
University of Calgary
Calgary, Alberta, Canada
Rockyview General Hospital CV Lab Research
Calgary, Alberta, Canada
Cardiology Research St. Paul's Hospital
Vancouver, British Columbia, Canada
Health Sciences Centre
Winnipeg, Manitoba, Canada
Neureka Research Corporation
Greater Sudbury, Ontario, Canada
Hamilton Health Sciences Crop
Hamilton, Ontario, Canada
Cardiac Investigation Unit
London, Ontario, Canada
University of Ottawa Heart Institute
Ottawa, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
Montreal Heart Institute
Montreal, Quebec, Canada
Recherche Cardiologie
Montreal, Quebec, Canada
Hospital Sacre-Coeur de Montreal
Montreal, Quebec, Canada
Quebec Heart Institute
Sainte-Foy, Quebec, Canada
Countries
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Other Identifiers
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2000038
Identifier Type: -
Identifier Source: org_study_id