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

Completed · Phase 3 · Has a placebo group

Conditions studied: Atrial Fibrillation

In brief

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.

Key facts

Study ID

NCT00035477

Run by

Forest Laboratories

People needed

446

Starts

2000-09-01

Expected to finish

2003-10-01

Last updated by the study team

2011-10-03

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• 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
• Good Samaritan Hospital — Los Angeles, California, United States
• LAC + USC Medical Center — Los Angeles, California, United States
• Cardiology Section, West Los Angeles VA Hospital — 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
• The Heart Group, PC — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.