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Completed Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT00035477

Public ClinicalTrials.gov record NCT00035477. 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.

Brief summary

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

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.

Study identification

NCT ID
NCT00035477
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Forest Laboratories
Industry
Enrollment
446 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years to 80 Years
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
Aug 31, 2000
Primary completion
Sep 30, 2003
Completion
Sep 30, 2003
Last update posted
Oct 2, 2011

2000 – 2003

United States locations

U.S. sites
69
U.S. states
27
U.S. cities
66
Facility City State ZIP Site status
The Heart Group, PC Mobile Alabama 36608
University Medical Center Tucson Arizona 85742
Cardiovascular Associates of Penisula Burlingame California 94010
San Diego Cardiovascular Research Associates Encinitas California 92024
La Mesa Cardiac Center, a Medical Group La Mesa California 91942
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 95335
ARI Clinical Trials Redondo Beach California 90277
Inland Clinical Research Riverside California 92501
Regional Cardiology Assoc. Sacramento California 95819
Cardiology Associates San Diego California 92120
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
Jacksonville Center for Clinical Research Jacksonville Florida 32216
Lakeland Regional Medical Lakeland Florida 33805
Khalid Hasan Sheikh 80 Fortenberry Road Merritt Island Florida 32952
Florida Cardiology Orlando Florida 32803
Cardiology Reasearch Assiocates Ormond Beach Florida 32174
VA Medical Center Decatur Georgia 30033
Elgin Cardiology Associates Elgin Illinois 60120
Advocate Christ Medical Center Oak Lawn Illinois 60453
Heart Center Medical Group Fort Wayne Indiana 46804
The Care Group Indianapolis Indiana 46260
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 501 S. Ryan Street Lake Charles Louisiana 70601
Cardiovascular Instiute of the South Morgan City Louisiana 70380
Tulane University New Orleans Louisiana 70112
Androscoggin Cardiology Associates Research Auburn Maine 04201
Maine Medical Center Portland Maine 04102
University of Massachusett Worcester Massachusetts 01655
Thoracic & Cardiovascular Healthcare Foundation Lansing Michigan 48910
Riverside Osteopathic Hospital Trenton Michigan 48183
Regional Heart Center Duluth Minnesota 55805
VA Medical Center Therapeutic Section Minneapolis Minnesota 55417
St. Paul Heart Clinic Saint Paul Minnesota 55102
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
Hillsboro Cardiology Hillsboro Oregon 97123
Oregon Health Sciences University Portland Oregon 97201
Heart Care Group PC Allentown Pennsylvania 18106
Tri-State Medical Group Cardiology Beaver Pennsylvania 15009
Milton S. Hershey Medical Center Hershey Pennsylvania 17033
The Pavillion Jenkintown Pennsylvania 19046
UPHS/Presbyterian Medical Center Philadelphia Pennsylvania 19104
Cardiovascular and Critical Care Associates, P.C. Pittsburgh Pennsylvania 15224
Cardiology Foundation of Lankenau Wynnewood Pennsylvania 19096
Charleston Cardiology Charleston South Carolina 29403
Stern Cardiovascular Center Research Department Memphis Tennessee 38120
UT Southwestern Medical Center Dallas Texas 75390
Methodist Hospital Houston Texas 77030
Heart and Vascular Inst. of Texas, PA San Antonio Texas 78217
Riverside Regional Medical Center Newport News Virginia 23601
Daniel Gottlieb 16259 Sylvester Road SW Suite 401 Seattle Washington 98166
FHS Research Tacoma Washington 98405
Beloit Clinic, SC Beloit Wisconsin 53511
Wisconsin Center for Clinical Research Elkhorn Wisconsin 53121
Dean/Riverview Clinic Janesville Wisconsin 53547
University of Wisconsin Madison Madison Wisconsin 53792
Wisconsin Center for Clinical Research Milwaukee Wisconsin 53251

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 13 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00035477, 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 NCT00035477 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →