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Home > "E" Clinical Trials Conditions > Efficacy and Safety of Azimilide for the Treatment of Patients With Atrial Fibrillation

Efficacy and Safety of Azimilide for the Treatment of Patients With Atrial Fibrillation



Efficacy and Safety of Azimilide for the Treatment of Patients With Atrial Fibrillation

For Condition: Atrial Fibrillation
Status: Completed
Sponsor(s): Procter & Gamble Pharmaceuticals ,
Synopsis: 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.
Details:
Eligibility:
Study Type:
  Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/80 Years
Genders: Both
Protocol Entry Criteria: Inclusion criteria: - 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. Exclusion criteria: - 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
Total Enrollment: 440

Location and Contact Information:

VA Medical Center Therapeutic Section
Minneapolis,  Minnesota,  55417
United States
 

Cardiovascular Associates of Penisula
Burlingame,  California,  94010
United States
 

Recherche Cardiologie
Montreal,  Quebec,  H2L4M1
Canada
 

University Medical Center
Tucson,  Arizona,  85742
United States
 

FHS Research
Tacoma,  Washington,  98405
United States
 

Duke Medical Center
Durham,  North Carolina,  27710
United States
 

Cardiology Section, West Los Angeles VA Hospital
Los Angeles,  California,  90073
United States
 

Heart Center Medical Group
Ft. Wayne,  Indiana,  46804
United States
 

LAC + USC Medical Center
Los Angeles,  California,  90033
United States
 

St. Michael's Hospital
Toronto,  Ontario,  M5B 1W8
Canada
 

VA Medical Center
Decatur,  Georgia,  30033
United States
 

Cardiology Associates
San Diego,  California,  92120
United States
 

The Pavillion
Jenkintown,  Pennsylvania,  19046
United States
 

Altru Health System Research Center
Grand Forks,  North Dakota,  58201
United States
 

Heart and Vascular Inst. of Texas, PA
San Antonio,  Texas,  78217
United States
 

ARI Clinical Trials
Redondo Beach,  California,  90277
United States
 

Good Samaritan Hospital
Los Angeles,  California,  90017
United States
 

Androscoggin Cardiology Associates Research
Auburn,  Maine,  04201
United States
 

Charleston Cardiology
Charleston,  South Carolina,  29403
United States
 

Lakeland Regional Medical
Lakeland,  Florida,  33805
United States
 

Hospital Sacre-Coeur de Montreal
Montreal,  Quebec,  H4J1C5
Canada
 

Elgin Cardiology Associates
Elgin,  Illinois,  60120
United States
 

University of Louisville-Cardiology
Louisville,  Kentucky,  40202
United States
 

The Care Group
Indianapolis,  Indiana,  46260
United States
 

Cardiovascular Institute of the South
Houma,  Louisiana,  70360
United States
 

Wisconsin Center for Clinical Research
Elkhorn,  Wisconsin,  53121
United States
 

Lindner Clinical Trial Ctr.
Cincinnati,  Ohio,  45219
United States
 

Heart Care Group PC
Allentown,  Pennsylvania,  18106
United States
 

The George Washington University MFA
Washington D.C.,  District of Columbia,  20037
United States
 

Methodist Hospital
Houston,  Texas,  77030
United States
 

Florida Cardiology
Orlando,  Florida,  32803
United States
 

La Mesa Cardiac Center, a Medical Group
La Mesa,  California,  91942
United States
 

Rockyview General Hospital CV Lab Research
Calgary,  Alberta,  T2V 1P9
Canada
 

Riverside Regional Medical Center
Newport News,  Virginia,  23601
United States
 

C/O Research Office Attn: Cardiovascular Research Dept.
Ft. Lauderdale,  Florida,  33316
United States
 

Hartford Hospital
Hartford,  Connecticut,  06102
United States
 

Wisconsin Center for Clinical Research
Milwaukee,  Wisconsin,  53251
United States
 

Montreal Heart Institute
Montreal,  Quebec,  H1T1C8
Canada
 

University Hospitals of Cleveland
Cleveland,  Ohio,  44106
United States
 

San Diego Cardiovascular Research Associates
Encinitas,  California,  92024
United States
 

Merced Heart Associates
Merced,  California,  95340
United States
 

Sutter Gould Medical Foundation
Modesto,  California,  95335
United States
 

Khalid Hasan Sheikh 80 Fortenberry Road
Merritt Island,  Florida,  32952
United States
 

St. Paul Heart Clinic
St. Paul,  Minnesota,  55102
United States
 

University of Ottawa Heart Institute
Ottawa,  Ontario,  K1Y 4W7
Canada
 

Richard Gilmore 501 S. Ryan Street
Lake Charles,  Louisiana,  70601
United States
 

Western Cardiology Assoc.
Denver,  Colorado,  80218
United States
 

Cardiology Foundation of Lankenau
Wynnewood,  Pennsylvania,  19096
United States
 

Neureka Research Corporation
Sudbury,  Ontario,  P3E6B4
Canada
 

Oregon Health Sciences University
Portland,  Oregon,  97201
United States
 

Dean/Riverview Clinic
Janesville,  Wisconsin,  53547
United States
 

Regional Heart Center
Duluth,  Minnesota,  55805
United States
 

University of Massachusett
Worcester,  Massachusetts,  01655
United States
 

Stern Cardiovascular Center Research Department
Memphis,  Tennessee,  38120
United States
 

Louisville Cardiology Medical Group, P.S.C.
Louisville,  Kentucky,  40207
United States
 

Quebec Heart Institute
Sainte-Foy,  Quebec,  G1V4G5
Canada
 

Cardiovascular Instiute of the South
Morgan City,  Louisiana,  70380
United States
 

University of Wisconsin Madison
Madison,  Wisconsin,  53792
United States
 

UT Southwestern Medical Center
Dallas,  Texas,  75390
United States
 

Hamilton Health Sciences Crop
Hamilton,  Ontario,  L8L 2X2
Canada
 

Tulane University
New Orleans,  Louisiana,  70112
United States
 

Advocate Christ Medical Center
Oak Lawn,  Illinois,  60453
United States
 

Milton S. Hershey Medical Center
Hershey,  Pennsylvania,  17033
United States
 

Cardiac Investigation Unit
London,  Ontario,  N6A 5A5
Canada
 

Jacksonville Center for Clinical Research
Jacksonville,  Florida,  32216
United States
 

Inland Clinical Research
Riverside,  California,  92501
United States
 

Hillsboro Cardiology
Hillsboro,  Oregon,  97123
United States
 

UPHS/Presbyterian Medical Center
Philadelphia,  Pennsylvania,  19104
United States
 

Tri-State Medical Group Cardiology
Beaver,  Pennsylvania,  15009
United States
 

Health Sciences Centre
Winnipeg,  Manitoba,  R3E0Z3
Canada
 

Regional Cardiology Assoc.
Sacramento,  California,  95819
United States
 

Cardiovascular and Critical Care Associates, P.C.
Pittsburgh,  Pennsylvania,  15224
United States
 

Riverside Osteopathic Hospital
Trenton,  Michigan,  48183
United States
 

Cardiology Consultants
Daytona Beach,  Florida,  32114
United States
 

Beloit Clinic, SC
Beloit,  Wisconsin,  53511
United States
 

Cardiology Research St. Paul's Hospital
Vancouver,  British Columbia,  V6Z 1Y6
Canada
 

Daniel Gottlieb 16259 Sylvester Road SW Suite 401
Seattle,  Washington,  98166
United States
 

Thoracic & Cardiovascular Healthcare Foundation
Lansing,  Michigan,  48910
United States
 

University of Calgary
Calgary,  Alberta,  T2N 4N1
Canada
 

Maine Medical Center
Portland,  Maine,  04102
United States
 

Cardiology Reasearch Assiocates
Ormond Beach,  Florida,  32174
United States
 

The Heart Group, PC
Mobile,  Alabama,  36608
United States
 


Additional Information:
Study ID Numbers:
  2000038; 
Study Start Date: 
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00035477

Other Atrial Fibrillation Studies:
1. Epidemiology of Symptomatic Arrhythmias

2. A safety and efficacy trial evaluating the use of SanOrg34006 compared to warfarin or acenocoumarol in patients with atrial fibrillation

3. Atrial Fibrillation Follow-up Investigation of Rhythm Management (AFFIRM)

4. Compare the effects of amiodarone, sotalol, and placebo in maintaining sinus rhythm in patients with atrial fibrillation converted to sinus rhythm

5. Efficacy and Safety of Azimilide for the Treatment of Patients With Atrial Fibrillation

Related Studies:

Other Atrial Fibrillation Clinical Trials
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Efficacy and Safety of Azimilide for the Treatment of Patients With Atrial Fibrillation

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