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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 Nov 5, 2026, 2:42 AM EST

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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
Dec 2000 (Type not available)
Primary completion
Jan 2004 (Actual)
Completion
Jan 2004 (Actual)
Last update posted
Oct 3, 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 3, 2011 · Synced Nov 5, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00035464 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →