Efficacy and Safety of Azimilide for the Treatment of Patients With Atrial Fibrillation
1 other identifier
interventional
446
2 countries
82
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 atrial-fibrillation
Started Sep 2000
Typical duration for phase_3 atrial-fibrillation
82 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2000
CompletedFirst Submitted
Initial submission to the registry
May 3, 2002
CompletedFirst Posted
Study publicly available on registry
May 6, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2003
CompletedOctober 3, 2011
September 1, 2011
3.1 years
May 3, 2002
September 30, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Prolong the time from start of teh efficacy period to the first symptomatic or asymptomatic event fo AFIB, etc
six months
Study Arms (2)
1
PLACEBO COMPARATORplacebo tablets in hospital and placebo tablets outpatient
2
EXPERIMENTALAzimilide tablets in hospital and azimilide tablets outpatient
Interventions
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 tablets once a day for 3 days in hospital and placebo tablets once a day for 6 months as outpatient
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (82)
The Heart Group, PC
Mobile, Alabama, 36608, United States
University Medical Center
Tucson, Arizona, 85742, United States
Cardiovascular Associates of Penisula
Burlingame, California, 94010, United States
San Diego Cardiovascular Research Associates
Encinitas, California, 92024, United States
La Mesa Cardiac Center, a Medical Group
La Mesa, California, 91942, United States
Good Samaritan Hospital
Los Angeles, California, 90017, United States
LAC + USC Medical Center
Los Angeles, California, 90033, United States
Cardiology Section, West Los Angeles VA Hospital
Los Angeles, California, 90073, United States
Merced Heart Associates
Merced, California, 95340, United States
Sutter Gould Medical Foundation
Modesto, California, 95335, United States
ARI Clinical Trials
Redondo Beach, California, 90277, United States
Inland Clinical Research
Riverside, California, 92501, United States
Regional Cardiology Assoc.
Sacramento, California, 95819, United States
Cardiology Associates
San Diego, California, 92120, United States
Western Cardiology Assoc.
Denver, Colorado, 80218, United States
Hartford Hospital
Hartford, Connecticut, 06102, United States
The George Washington University MFA
Washington D.C., District of Columbia, 20037, United States
Cardiology Consultants
Daytona Beach, Florida, 32114, United States
C/O Research Office Attn: Cardiovascular Research Dept.
Fort Lauderdale, Florida, 33316, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216, United States
Lakeland Regional Medical
Lakeland, Florida, 33805, United States
Khalid Hasan Sheikh 80 Fortenberry Road
Merritt Island, Florida, 32952, United States
Florida Cardiology
Orlando, Florida, 32803, United States
Cardiology Reasearch Assiocates
Ormond Beach, Florida, 32174, United States
VA Medical Center
Decatur, Georgia, 30033, United States
Elgin Cardiology Associates
Elgin, Illinois, 60120, United States
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453, United States
Heart Center Medical Group
Fort Wayne, Indiana, 46804, United States
The Care Group
Indianapolis, Indiana, 46260, United States
University of Louisville-Cardiology
Louisville, Kentucky, 40202, United States
Louisville Cardiology Medical Group, P.S.C.
Louisville, Kentucky, 40207, United States
Cardiovascular Institute of the South
Houma, Louisiana, 70360, United States
Richard Gilmore 501 S. Ryan Street
Lake Charles, Louisiana, 70601, United States
Cardiovascular Instiute of the South
Morgan City, Louisiana, 70380, United States
Tulane University
New Orleans, Louisiana, 70112, United States
Androscoggin Cardiology Associates Research
Auburn, Maine, 04201, United States
Maine Medical Center
Portland, Maine, 04102, United States
University of Massachusett
Worcester, Massachusetts, 01655, United States
Thoracic & Cardiovascular Healthcare Foundation
Lansing, Michigan, 48910, United States
Riverside Osteopathic Hospital
Trenton, Michigan, 48183, United States
Regional Heart Center
Duluth, Minnesota, 55805, United States
VA Medical Center Therapeutic Section
Minneapolis, Minnesota, 55417, United States
St. Paul Heart Clinic
Saint Paul, Minnesota, 55102, United States
Duke Medical Center
Durham, North Carolina, 27710, United States
Altru Health System Research Center
Grand Forks, North Dakota, 58201, United States
Lindner Clinical Trial Ctr.
Cincinnati, Ohio, 45219, United States
University Hospitals of Cleveland
Cleveland, Ohio, 44106, United States
Hillsboro Cardiology
Hillsboro, Oregon, 97123, United States
Oregon Health Sciences University
Portland, Oregon, 97201, United States
Heart Care Group PC
Allentown, Pennsylvania, 18106, United States
Tri-State Medical Group Cardiology
Beaver, Pennsylvania, 15009, United States
Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
The Pavillion
Jenkintown, Pennsylvania, 19046, United States
UPHS/Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104, United States
Cardiovascular and Critical Care Associates, P.C.
Pittsburgh, Pennsylvania, 15224, United States
Cardiology Foundation of Lankenau
Wynnewood, Pennsylvania, 19096, United States
Charleston Cardiology
Charleston, South Carolina, 29403, United States
Stern Cardiovascular Center Research Department
Memphis, Tennessee, 38120, United States
UT Southwestern Medical Center
Dallas, Texas, 75390, United States
Methodist Hospital
Houston, Texas, 77030, United States
Heart and Vascular Inst. of Texas, PA
San Antonio, Texas, 78217, United States
Riverside Regional Medical Center
Newport News, Virginia, 23601, United States
Daniel Gottlieb 16259 Sylvester Road SW Suite 401
Seattle, Washington, 98166, United States
FHS Research
Tacoma, Washington, 98405, United States
Beloit Clinic, SC
Beloit, Wisconsin, 53511, United States
Wisconsin Center for Clinical Research
Elkhorn, Wisconsin, 53121, United States
Dean/Riverview Clinic
Janesville, Wisconsin, 53547, United States
University of Wisconsin Madison
Madison, Wisconsin, 53792, United States
Wisconsin Center for Clinical Research
Milwaukee, Wisconsin, 53251, United States
University of Calgary
Calgary, Alberta, T2N 4N1, Canada
Rockyview General Hospital CV Lab Research
Calgary, Alberta, T2V 1P9, Canada
Cardiology Research St. Paul's Hospital
Vancouver, British Columbia, V6Z 1Y6, Canada
Health Sciences Centre
Winnipeg, Manitoba, R3E0Z3, Canada
Neureka Research Corporation
Greater Sudbury, Ontario, P3E6B4, Canada
Hamilton Health Sciences Crop
Hamilton, Ontario, L8L 2X2, Canada
Cardiac Investigation Unit
London, Ontario, N6A 5A5, Canada
University of Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W7, Canada
St. Michael's Hospital
Toronto, Ontario, M5B 1W8, Canada
Montreal Heart Institute
Montreal, Quebec, H1T1C8, Canada
Recherche Cardiologie
Montreal, Quebec, H2L4M1, Canada
Hospital Sacre-Coeur de Montreal
Montreal, Quebec, H4J1C5, Canada
Quebec Heart Institute
Sainte-Foy, Quebec, G1V4G5, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Preston M Dunnmon, MD
Procter and Gamble
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 3, 2002
First Posted
May 6, 2002
Study Start
September 1, 2000
Primary Completion
October 1, 2003
Study Completion
October 1, 2003
Last Updated
October 3, 2011
Record last verified: 2011-09