Clinical trialNCT00035477CompletedPhase 3Interventional

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

SponsorForest LaboratoriesEnrollment446Atrial Fibrillation

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Preston M Dunnmon, MD
Procter and Gamble
Study Director
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

82 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Canada

Rockyview General Hospital Cv Lab Research
Calgary, Alberta, Canada
University of Calgary
Calgary, Alberta, Canada
Cardiology Research St. Paul'S Hospital
Vancouver, British Columbia, Canada
Health Sciences Centre
Winnipeg, Manitoba, Canada
Neureka Research Corporation
Greater Sudbury, Ontario, Canada
Hamilton Health Sciences Crop
Hamilton, Ontario, Canada
Cardiac Investigation Unit
London, Ontario, Canada
University of Ottawa Heart Institute
Ottawa, Ontario, Canada
St. Michael'S Hospital
Toronto, Ontario, Canada
Hospital Sacre-Coeur de Montreal
Montreal, Quebec, Canada
Montreal Heart Institute
Montreal, Quebec, Canada
Recherche Cardiologie
Montreal, Quebec, Canada
Quebec Heart Institute
Sainte-Foy, Quebec, Canada

United States

the Heart Group, Pc
Mobile, Alabama, United States
University Medical Center
Tucson, Arizona, United States
Cardiovascular Associates of Penisula
Burlingame, California, United States
San Diego Cardiovascular Research Associates
Encinitas, California, United States
la Mesa Cardiac Center, A Medical Group
La Mesa, California, United States
Cardiology Section, West Los Angeles Va Hospital
Los Angeles, California, United States
Good Samaritan Hospital
Los Angeles, California, United States
Lac + Usc Medical Center
Los Angeles, California, United States
Merced Heart Associates
Merced, California, United States
Sutter Gould Medical Foundation
Modesto, California, United States
Ari Clinical Trials
Redondo Beach, California, United States
Inland Clinical Research
Riverside, California, United States
Regional Cardiology Assoc.
Sacramento, California, United States
Cardiology Associates
San Diego, California, United States
Western Cardiology Assoc.
Denver, Colorado, United States
Hartford Hospital
Hartford, Connecticut, United States
the George Washington University Mfa
Washington D.C., District of Columbia, United States
Cardiology Consultants
Daytona Beach, Florida, United States
C/o Research Office Attn: Cardiovascular Research Dept.
Fort Lauderdale, Florida, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
Lakeland Regional Medical
Lakeland, Florida, United States
Khalid Hasan Sheikh 80 Fortenberry Road
Merritt Island, Florida, United States
Florida Cardiology
Orlando, Florida, United States
Cardiology Reasearch Assiocates
Ormond Beach, Florida, United States
Va Medical Center
Decatur, Georgia, United States
Elgin Cardiology Associates
Elgin, Illinois, United States
Advocate Christ Medical Center
Oak Lawn, Illinois, United States

42 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Azimilide DihydrochloridePlacebo

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 30 Sept 2000
Primary completion: 31 Oct 2003
Completion: 31 Oct 2003
Last update posted: 3 Oct 2011
Registered enrollment: 446
Registry id: NCT00035477

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.