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Efficacy and Safety of Azimilide for the Treatment of Patients With Atrial Fibrillation
This study has been completed.
First Received: May 3, 2002   Last Updated: July 17, 2009   History of Changes
Sponsor: Procter and Gamble
Information provided by: Procter and Gamble
ClinicalTrials.gov Identifier: NCT00035477
  Purpose

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.


Condition Intervention Phase
Atrial Fibrillation
Drug: Azimilide Dihydrochloride
Drug: Placebo
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Efficacy and Safety of Azimilide for the Treatment of Patients With Atrial Fibrillation

Resource links provided by NLM:


Further study details as provided by Procter and Gamble:

Primary Outcome Measures:
  • Prolong the time from start of teh efficacy period to the first symptomatic or asymptomatic event fo AFIB, etc [ Time Frame: six months ] [ Designated as safety issue: No ]

Enrollment: 446
Study Start Date: September 2000
Study Completion Date: October 2003
Primary Completion Date: October 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Placebo Comparator
placebo tablets in hospital and placebo tablets outpatient
Drug: Placebo
placebo tablets once a day for 3 days in hospital and placebo tablets once a day for 6 months as outpatient
2: Experimental
Azimilide tablets in hospital and azimilide tablets outpatient
Drug: 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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00035477

  Hide Study Locations
Locations
United States, Alabama
The Heart Group, PC
Mobile, Alabama, United States, 36608
United States, Arizona
University Medical Center
Tucson, Arizona, United States, 85742
United States, California
Inland Clinical Research
Riverside, California, United States, 92501
San Diego Cardiovascular Research Associates
Encinitas, California, United States, 92024
La Mesa Cardiac Center, a Medical Group
La Mesa, California, United States, 91942
Cardiovascular Associates of Penisula
Burlingame, California, United States, 94010
LAC + USC Medical Center
Los Angeles, California, United States, 90033
ARI Clinical Trials
Redondo Beach, California, United States, 90277
Merced Heart Associates
Merced, California, United States, 95340
Good Samaritan Hospital
Los Angeles, California, United States, 90017
Cardiology Section, West Los Angeles VA Hospital
Los Angeles, California, United States, 90073
Sutter Gould Medical Foundation
Modesto, California, United States, 95335
Cardiology Associates
San Diego, California, United States, 92120
Regional Cardiology Assoc.
Sacramento, California, United States, 95819
United States, Colorado
Western Cardiology Assoc.
Denver, Colorado, United States, 80218
United States, Connecticut
Hartford Hospital
Hartford, Connecticut, United States, 06102
United States, District of Columbia
The George Washington University MFA
Washington, District of Columbia, United States, 20037
United States, Florida
Lakeland Regional Medical
Lakeland, Florida, United States, 33805
Cardiology Reasearch Assiocates
Ormond Beach, Florida, United States, 32174
Cardiology Consultants
Daytona Beach, Florida, United States, 32114
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States, 32216
Florida Cardiology
Orlando, Florida, United States, 32803
C/O Research Office Attn: Cardiovascular Research Dept.
Fort Lauderdale, Florida, United States, 33316
Khalid Hasan Sheikh 80 Fortenberry Road
Merritt Island, Florida, United States, 32952
United States, Georgia
VA Medical Center
Decatur, Georgia, United States, 30033
United States, Illinois
Advocate Christ Medical Center
Oak Lawn, Illinois, United States, 60453
Elgin Cardiology Associates
Elgin, Illinois, United States, 60120
United States, Indiana
Heart Center Medical Group
Ft. Wayne, Indiana, United States, 46804
The Care Group
Indianapolis, Indiana, United States, 46260
United States, Kentucky
Louisville Cardiology Medical Group, P.S.C.
Louisville, Kentucky, United States, 40207
University of Louisville-Cardiology
Louisville, Kentucky, United States, 40202
United States, Louisiana
Cardiovascular Institute of the South
Houma, Louisiana, United States, 70360
Cardiovascular Instiute of the South
Morgan City, Louisiana, United States, 70380
Richard Gilmore 501 S. Ryan Street
Lake Charles, Louisiana, United States, 70601
Tulane University
New Orleans, Louisiana, United States, 70112
United States, Maine
Androscoggin Cardiology Associates Research
Auburn, Maine, United States, 04201
Maine Medical Center
Portland, Maine, United States, 04102
United States, Massachusetts
University of Massachusett
Worcester, Massachusetts, United States, 01655
United States, Michigan
Thoracic & Cardiovascular Healthcare Foundation
Lansing, Michigan, United States, 48910
Riverside Osteopathic Hospital
Trenton, Michigan, United States, 48183
United States, Minnesota
St. Paul Heart Clinic
St. Paul, Minnesota, United States, 55102
VA Medical Center Therapeutic Section
Minneapolis, Minnesota, United States, 55417
Regional Heart Center
Duluth, Minnesota, United States, 55805
United States, North Carolina
Duke Medical Center
Durham, North Carolina, United States, 27710
United States, North Dakota
Altru Health System Research Center
Grand Forks, North Dakota, United States, 58201
United States, Ohio
University Hospitals of Cleveland
Cleveland, Ohio, United States, 44106
Lindner Clinical Trial Ctr.
Cincinnati, Ohio, United States, 45219
United States, Oregon
Oregon Health Sciences University
Portland, Oregon, United States, 97201
Hillsboro Cardiology
Hillsboro, Oregon, United States, 97123
United States, Pennsylvania
Cardiology Foundation of Lankenau
Wynnewood, Pennsylvania, United States, 19096
Cardiovascular and Critical Care Associates, P.C.
Pittsburgh, Pennsylvania, United States, 15224
The Pavillion
Jenkintown, Pennsylvania, United States, 19046
Heart Care Group PC
Allentown, Pennsylvania, United States, 18106
UPHS/Presbyterian Medical Center
Philadelphia, Pennsylvania, United States, 19104
Tri-State Medical Group Cardiology
Beaver, Pennsylvania, United States, 15009
Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
United States, South Carolina
Charleston Cardiology
Charleston, South Carolina, United States, 29403
United States, Tennessee
Stern Cardiovascular Center Research Department
Memphis, Tennessee, United States, 38120
United States, Texas
Heart and Vascular Inst. of Texas, PA
San Antonio, Texas, United States, 78217
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Methodist Hospital
Houston, Texas, United States, 77030
United States, Virginia
Riverside Regional Medical Center
Newport News, Virginia, United States, 23601
United States, Washington
FHS Research
Tacoma, Washington, United States, 98405
Daniel Gottlieb 16259 Sylvester Road SW Suite 401
Seattle, Washington, United States, 98166
United States, Wisconsin
Wisconsin Center for Clinical Research
Milwaukee, Wisconsin, United States, 53251
Beloit Clinic, SC
Beloit, Wisconsin, United States, 53511
University of Wisconsin Madison
Madison, Wisconsin, United States, 53792
Dean/Riverview Clinic
Janesville, Wisconsin, United States, 53547
Wisconsin Center for Clinical Research
Elkhorn, Wisconsin, United States, 53121
Canada, Alberta
Rockyview General Hospital CV Lab Research
Calgary, Alberta, Canada, T2V 1P9
University of Calgary
Calgary, Alberta, Canada, T2N 4N1
Canada, British Columbia
Cardiology Research St. Paul's Hospital
Vancouver, British Columbia, Canada, V6Z 1Y6
Canada, Manitoba
Health Sciences Centre
Winnipeg, Manitoba, Canada, R3E0Z3
Canada, Ontario
Hamilton Health Sciences Crop
Hamilton, Ontario, Canada, L8L 2X2
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
University of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y 4W7
Neureka Research Corporation
Sudbury, Ontario, Canada, P3E6B4
Cardiac Investigation Unit
London, Ontario, Canada, N6A 5A5
Canada, Quebec
Recherche Cardiologie
Montreal, Quebec, Canada, H2L4M1
Hospital Sacre-Coeur de Montreal
Montreal, Quebec, Canada, H4J1C5
Quebec Heart Institute
Sainte-Foy, Quebec, Canada, G1V4G5
Montreal Heart Institute
Montreal, Quebec, Canada, H1T1C8
Sponsors and Collaborators
Procter and Gamble
Investigators
Study Director: Preston M Dunnmon, MD Procter and Gamble
  More Information

No publications provided

Responsible Party: Procter & Gamble Pharmaceuticals ( Preston M Dunnmon, MD )
Study ID Numbers: 2000038
Study First Received: May 3, 2002
Last Updated: July 17, 2009
ClinicalTrials.gov Identifier: NCT00035477     History of Changes
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Heart Diseases
Molecular Mechanisms of Pharmacological Action
Calcium Channel Blockers
Cardiovascular Agents
Pharmacologic Actions
Azimilide
Membrane Transport Modulators
Pathologic Processes
Therapeutic Uses
Cardiovascular Diseases
Atrial Fibrillation
Anti-Arrhythmia Agents
Arrhythmias, Cardiac

ClinicalTrials.gov processed this record on November 27, 2009