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Completed Phase 3 Interventional

Efficacy and Safety of Azimilide in the Prophylactic Treatment of Patients With Atrial Fibrillation.

ClinicalTrials.gov ID: NCT00035464

Public ClinicalTrials.gov record NCT00035464. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 14, 2026, 4:07 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Efficacy and Safety of Azimilide in the Prophylactic Treatment of Patients

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT00035464
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Forest Laboratories
Industry
Enrollment
431 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Nov 30, 2000
Primary completion
Dec 31, 2003
Completion
Dec 31, 2003
Last update posted
Oct 2, 2011

2000 – 2004

United States locations

U.S. sites
88
U.S. states
34
U.S. cities
82
Facility City State ZIP Site status
Cardiovascular Assoc. PC Birmingham Alabama 35213
The Heart Group, PC Mobile Alabama 36608
Southern Arizona VA Health Care System, Section of Cardiology (1-111C) Tucson Arizona 85723
University Medical Center Tucson Arizona 85742
University of Arkansas Medical Center Little Rock Arkansas 72205
Cardiovascular Associates of Penisula Burlingame California 94010
Capitol Interventional Cardiology Carmichael California 95608
VA Central California Health Care System Fresno California 93703
Valley Research Fresno California 93720
Grass Valley Cardiology Grass Valley California 95945
San Diego Cardiovascular Associates La Jolla California 92037
Good Samaritan Hospital Los Angeles California 90017
LAC+USC Medical Center Los Angeles California 90033
Cardiology Section, West Los Angeles VA Hospital Los Angeles California 90073
Merced Heart Associates Merced California 95340
Sutter Gould Medical Foundation Modesto California 95355
ARI Clinical Trials Redondo Beach California 90277
Regional Cardiology Assoc. Sacramento California 95819
Sacramento Heart and Vascular Medical Associates Sacramento California 95825
Cardiology Associates San Diego California 92120
Aurora Denver Cardiology Aurora Colorado 80012
Western Cardiology Assoc. Denver Colorado 80218
Hartford Hospital Hartford Connecticut 06102
The George Washington University MFA Washington D.C. District of Columbia 20037
Cardiology Consultants Daytona Beach Florida 32114
C/O Research Office Attn: Cardiovascular Research Dept. Fort Lauderdale Florida 33316
SW Florida Heart Group/Health Park Medical Center Fort Myers Florida 33919
Jacksonville Center for Clinical Research Jacksonville Florida 32216
Watson Clinic, LLP Lakeland Florida 33805
Khalid Hassan Sheikh 80 Fontenberry Road Merritt Island Florida 32952
Florida Cardiology Orlando Florida 32803
Cardiology Research Assiocates Ormond Beach Florida 32174
VA Medical Center Decatur Georgia 30033
Mount Sinal Hospital Medical Center Chicago Illinois 60608
Elgin Cardiology Associates Elgin Illinois 60120
Illinois Heart & Lung Research Center, SC Normal Illinois 61761-3587
The Center for Advanced Cardiology Park Ridge Illinois 60068
Heart Center Medical Group Fort Wayne Indiana 46804
The Care Group Indianapolis Indiana 46260-1919
Professional Research Network of Kansas Wichita Kansas 67203
University of Louisville-Cardiology Louisville Kentucky 40202
Louisville Cardiology Medical Group, P.S.C Louisville Kentucky 40207
Cardiovascular Institute of the South Houma Louisiana 70360
Richard Gilmore, MD 501 S Ryan Street Lake Charles Louisiana 70601
Cardiovascular of the South Morgan City Louisiana 70380
Cardiovascular Institute of the South New Iberia Louisiana 70560
Tulane University New Orleans Louisiana 70112
Medical Research Institute Slidell Louisiana 70458
Cardiovascular Institute of the South Thibodaux Louisiana 70301
Maine Medical Center Portland Maine 04102
Boston Medical Center Boston Massachusetts 02118
University of Massachusett Worcester Massachusetts 01655
Thoracic & Cardiovascular Healthcare Foundation Lansing Michigan 48910
Nisus Research Petoskey Michigan 49770
Riverside Osteopathic Hospital Trenton Michigan 48183
Regional Heart Center Duluth Minnesota 55802
Fairview Range Regional Health Services Hibbing Minnesota 55746
VA Medical Center Therapeutic Section Minneapolis Minnesota 55417
St. Patrick Hosp/Western Mt. Clinic Cardiology Missoula Montana 59802
Internal Medical Associates Grand Island Nebraska 68803
William Olney, MD 21 Whitehall Rd, Suite 200 Rochester New Hampshire 03867
Cardiology & Int. Medicine Williamsville New York 14221
Duke Medical Center Durham North Carolina 27710
Altru Health System Research Center Grand Forks North Dakota 58201
Lindner Clinical Trial Ctr. Cincinnati Ohio 45219
University Hospitals of Cleveland Cleveland Ohio 44106-5038
MidWest Cardiology Research Foundation Columbus Ohio 43214
Oklahoma Foundation for Cardiovascular Research Oklahoma City Oklahoma 73104
Hillsboro Cardiology Hillsboro Oregon 97123
Oregon Health Sciences University Portland Oregon 97201
Heart Care Group PC Allentown Pennsylvania 18106-0880
Tri-State Medical Group Cardiology Beaver Pennsylvania 15009
Milton S. Hershey Medical Center Hershey Pennsylvania 17033-0850
The Pavillion Jenkintown Pennsylvania 19046
UPHS/Presbyterian Medical Center Philadelphia Pennsylvania 19104
Cardiovascular and Critical Care Associates, P.C. Pittsburgh Pennsylvania 15224
Charleston Cardiology Charleston South Carolina 29403
Stern Cardiovascular Center Research Department Memphis Tennessee 38120
UT Southwestern Medical Center Dallas Texas 75390-9047
Methodist Hospital Houston Texas 77030
Heart and Vascular Inst. of Texas, PA San Antonio Texas 78217
MedSource, Inc Chesapeake Virginia 23321
Riverside Regional Medical Center Newport News Virginia 23601
Daniel Gottlieb, MD 16259 Sylvester Road SW, Suite 401 Seattle Washington 95165
Beloit Clinic, SC Beloit Wisconsin 53511
Dean/Riverview Clinic Janesville Wisconsin 53547-0551
University of Wisconsin Madison Madison Wisconsin 53792
Marshfield Clinic Marshfield Wisconsin 54449

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 15 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00035464, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Oct 2, 2011 · Synced Sep 14, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00035464 live on ClinicalTrials.gov.

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