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Efficacy and Safety of Azimilide in the Prophylactic Treatment of Patients With Atrial Fibrillation. Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about Efficacy and Safety of Azimilide in the Prophylactic Treatment of Patients With Atrial Fibrillation. conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Efficacy and Safety of Azimilide in the Prophylactic Treatment of Patients With Atrial Fibrillation. Clinical research trials and Efficacy and Safety of Azimilide in the Prophylactic Treatment of Patients With Atrial Fibrillation. medical trials happen in hundreds of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as Efficacy and Safety of Azimilide in the Prophylactic Treatment of Patients With Atrial Fibrillation.. Efficacy and Safety of Azimilide in the Prophylactic Treatment of Patients With Atrial Fibrillation. Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Efficacy and Safety of Azimilide in the Prophylactic Treatment of Patients With Atrial Fibrillation. clinical trial. Participants frequently get the best healthcare available for their Efficacy and Safety of Azimilide in the Prophylactic Treatment of Patients With Atrial Fibrillation. condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "E" Clinical Trials Conditions > Efficacy and Safety of Azimilide in the Prophylactic Treatment of Patients With Atrial Fibrillation. Efficacy and Safety of Azimilide in the Prophylactic Treatment of Patients With Atrial Fibrillation.
Efficacy and Safety of Azimilide in the Prophylactic Treatment of Patients With Atrial Fibrillation.
For Condition: Atrial Fibrillation
Status: Completed
Sponsor(s): Procter & Gamble Pharmaceuticals ,
Synopsis: 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.
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion criteria: - History of symptomatic atrial fibrillation that significantly disrupts the patient's customary daily living activities - History of congestive heart failure and/or ischemic heart disease - Sinus rhythm (normal heart rhythm) upon entry to the 30 day screening period for the study - At least one episode of symptomatic atrial fibrillation during the screening period, with a spontaneous return to sinus rhythm. - Sinus rhythm immediately prior to dosing Exclusion criteria: - Previously unsuccessful cardioversions within 60 days of screening period - 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 - Previously in an azimilide study
Total Enrollment: 660
Location and Contact Information:
Sutter Gould Medical Foundation
Modesto, California, 95355
United States
Marshfield Clinic
Marshfield, Wisconsin, 54449
United States
Medical Research Institute
Slidell, Louisiana, 70458
United States
William Olney, MD 21 Whitehall Rd, Suite 200
Rochester, New Hampshire, 03867
United States
MedSource, Inc
Chesapeake, Virginia, 23321
United States
Cardiovascular of the South
Morgan City, Louisiana, 70380
United States
Niagara Health System Greater Niagara General Hospital
Niagara Falls, Ontario, L2E7H1
Canada
Aurora Denver Cardiology
Aurora, Colorado, 80012
United States
Western Cardiology Assoc.
Denver, Colorado, 80218
United States
University of Massachusett
Worcester, Massachusetts, 01655
United States
University of Arkansas Medical Center
Little Rock, Arkansas, 72205
United States
Cardiovascular Institute of the South
Houma, Louisiana, 70360
United States
The George Washington University MFA
Washington D.C., District of Columbia, 20037
United States
UT Southwestern Medical Center
Dallas, Texas, 75390-9047
United States
Stern Cardiovascular Center Research Department
Memphis, Tennessee, 38120
United States
Khalid Hassan Sheikh 80 Fontenberry Road
Merritt Island, Florida, 32952
United States
Duke Medical Center
Durham, North Carolina, 27710
United States
Neureka Research Corporation
Sudbury, Ontario, P3E6B4
Canada
Heart Health Institute
Calgary, Alberta, T2E7C5
Canada
Regional Heart Center
Duluth, Minnesota,
United States
Illinois Heart & Lung Research Center, SC
Normal, Illinois, 61761-3587
United States
Cardiology Consultants
Daytona Beach, Florida, 32114
United States
Quebec Heart Institute
Sainte-Foy, Quebec, G1V4G5
Canada
Heart and Vascular Inst. of Texas, PA
San Antonio, Texas, 78217
United States
Richard Gilmore, MD 501 S Ryan Street
Lake Charles, Louisiana, 70601
United States
Cardiology Research St. Paul's Hospital
Vancouver, British Columbia, V6Z1Y6
Canada
Maine Medical Center
Portland, Maine, 04102
United States
Mount Sinal Hospital Medical Center
Chicago, Illinois, 60608
United States
Florida Cardiology
Orlando, Florida, 32803
United States
Watson Clinic, LLP
Lakeland, Florida, 33805
United States
The Pavillion
Jenkintown, Pennsylvania, 19046
United States
Oregon Health Sciences University
Portland, Oregon, 97201
United States
Hartford Hospital
Hartford, Connecticut, 06102
United States
Dean/Riverview Clinic
Janesville, Wisconsin, 53547-0551
United States
Cardiovascular Institute of the South
New Iberia, Louisiana, 70560
United States
Heart Health Research Center
Calgary, Alberta, T2E7C5
Canada
Merced Heart Associates
Merced, California, 95340
United States
Cardiovascular Associates of Penisula
Burlingame, California, 94010
United States
Elgin Cardiology Associates
Elgin, Illinois, 60120
United States
Oklahoma Foundation for Cardiovascular Research
Oklahoma City, Oklahoma, 73104
United States
Cardiology & Int. Medicine
Williamsville, New York, 14221
United States
The Heart Group, PC
Mobile, Alabama, 36608
United States
ARI Clinical Trials
Redondo Beach, California, 90277
United States
VA Medical Center Therapeutic Section
Minneapolis, Minnesota, 55417
United States
Hamilton Health Science Corp.
Hamilton, Ontario, L8L2X2
Canada
VA Central California Health Care System
Fresno, California, 93703
United States
Cardiology Section, West Los Angeles VA Hospital
Los Angeles, California, 90073
United States
Cardiology Associates
San Diego, California, 92120
United States
Hillsboro Cardiology
Hillsboro, Oregon, 97123
United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216
United States
Fairview Range Regional Health Services
Hibbing, Minnesota, 55746
United States
University of Louisville-Cardiology
Louisville, Kentucky, 40202
United States
Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033-0850
United States
University Medical Center
Tucson, Arizona, 85742
United States
Riverside Osteopathic Hospital
Trenton, Michigan, 48183
United States
Internal Medical Associates
Grand Island, Nebraska, 68803
United States
Valley Research
Fresno, California, 93720
United States
Tri-State Medical Group Cardiology
Beaver, Pennsylvania, 15009
United States
Montreal Heart Institute
Montreal, Quebec, H1T1C8
Canada
Riverside Regional Medical Center
Newport News, Virginia, 23601
United States
Lindner Clinical Trial Ctr.
Cincinnati, Ohio, 45219
United States
SW Florida Heart Group/Health Park Medical Center
Ft. Myers, Florida, 33919
United States
The Care Group
Indianapolis, Indiana, 46260-1919
United States
The Center for Advanced Cardiology
Park Ridge, Illinois, 60068
United States
Thoracic & Cardiovascular Healthcare Foundation
Lansing, Michigan, 48910
United States
Boston Medical Center
Boston, Massachusetts, 02118
United States
Beloit Clinic, SC
Beloit, Wisconsin, 53511
United States
Good Samaritan Hospital
Los Angeles, California, 90017
United States
Altru Health System Research Center
Grand Forks, North Dakota, 58201
United States
Cardiology Research Assiocates
Ormond Beach, Florida, 32174
United States
Chum Hotel Dieu
Montreal, Quebec, H2WIT8
Canada
Cardiovascular Assoc. PC
Birmingham, Alabama, 35213
United States
Cardiovascular and Critical Care Associates, P.C.
Pittsburgh, Pennsylvania, 15224
United States
Southern Arizona VA Health Care System, Section of Cardiology (1-111C)
Tucson, Arizona, 85723
United States
Cardiac Investigation Unit
London, Ontario, N6A5A5
Canada
VA Medical Center
Decatur, Georgia, 30033
United States
University of Calgary
Calgary, Alberta, T2N4N1
Canada
St. Patrick Hosp/Western Mt. Clinic Cardiology
Missoula, Montana, 59802
United States
Heart Center Medical Group
Ft. Wayne, Indiana, 46804
United States
Methodist Hospital
Houston, Texas, 77030
United States
Nisus Research
Petoskey, Michigan, 49770
United States
Cardiovascular Institute of the South
Thibodaux, Louisiana, 70301
United States
Tulane University
New Orleans, Louisiana, 70112
United States
Charleston Cardiology
Charleston, South Carolina, 29403
United States
Grass Valley Cardiology
Grass Valley, California, 95945
United States
University of Ottawa Heart Institute
Ottawa, Ontario, K1Y4W7
Canada
Professional Research Network of Kansas
Wichita, Kansas, 67203
United States
University Hospitals of Cleveland
Cleveland, Ohio, 44106-5038
United States
C/O Research Office Attn: Cardiovascular Research Dept.
Ft. Lauderdale, Florida, 33316
United States
MidWest Cardiology Research Foundation
Columbus, Ohio, 43214
United States
Heart Care Group PC
Allentown, Pennsylvania, 18106-0880
United States
San Diego Cardiovascular Associates
La Jolla, California, 92037
United States
Sacramento Heart and Vascular Medical Associates
Sacramento, California, 95825
United States
LAC+USC Medical Center
Los Angeles, California, 90033
United States
Hospital Sacre-Soeur de Montreal
Montreal, Quebec, H4J1C5
Canada
Daniel Gottlieb, MD 16259 Sylvester Road SW, Suite 401
Seattle, Washington, 95165
United States
Capitol Interventional Cardiology
Carmichael, California, 95608
United States
Regional Cardiology Assoc.
Sacramento, California, 95819
United States
Louisville Cardiology Medical Group, P.S.C
Louisville, Kentucky, 40207
United States
St. Michael's Hospital
Toronto, Ontario, M5B1W6
Canada
University of Wisconsin Madison
Madison, Wisconsin, 53792
United States
Recharche Cardiologie
Montreal, Quebec, H2L4M1
Canada
UPHS/Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104
United States
Additional Information:
Study ID Numbers: 2000037;
Study Start Date:
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00035464
Other Atrial Fibrillation Studies:
1. A safety and efficacy trial evaluating the use of SanOrg34006 compared to warfarin or acenocoumarol in patients with atrial fibrillation
2. Efficacy and Safety of Azimilide for the Treatment of Patients With Atrial Fibrillation
3. Compare the effects of amiodarone, sotalol, and placebo in maintaining sinus rhythm in patients with atrial fibrillation converted to sinus rhythm
4. Epidemiology of Symptomatic Arrhythmias
5. Efficacy and Safety Evaluation of Azimilide or Sotalol vs placebo for Treatment of Patients With Atrial Fibrillation.
Related Studies:
Other Atrial Fibrillation Clinical Trials
Other Ontario Clinical Trials
Other London Clinical Trials
Efficacy and Safety of Azimilide in the Prophylactic Treatment of Patients With Atrial Fibrillation.
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