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

Completed · Phase 3 · Has a placebo group

Conditions studied: Atrial Fibrillation

In brief

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.

Key facts

Study ID

NCT00035464

Run by

Forest Laboratories

People needed

431

Starts

2000-12-01

Expected to finish

2004-01-01

Last updated by the study team

2011-10-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• History of symptomatic atrial fibrillation that significantly disrupts the patient's customary daily living activities
• History of congestive heart failure and/or ischemic heart disease
• Sinus rhythm (normal heart rhythm) upon entry to the 30 day screening period for the study
• At least one episode of symptomatic atrial fibrillation during the screening period, with a spontaneous return to sinus rhythm.
• Sinus rhythm immediately prior to dosing

You may not qualify if…

• Previously unsuccessful cardioversions within 60 days of screening period
• 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
• Previously in an azimilide study

Where it is running

• The Heart Group, PC — Mobile, Alabama, United States
• Southern Arizona VA Health Care System, Section of Cardiology (1-111C) — Tucson, Arizona, United States
• University Medical Center — Tucson, Arizona, United States
• University of Arkansas Medical Center — Little Rock, Arkansas, United States
• Cardiovascular Associates of Penisula — Burlingame, California, United States
• Capitol Interventional Cardiology — Carmichael, California, United States
• VA Central California Health Care System — Fresno, California, United States
• Valley Research — Fresno, California, United States
• Grass Valley Cardiology — Grass Valley, California, United States
• San Diego Cardiovascular Associates — La Jolla, 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
• Regional Cardiology Assoc. — Sacramento, California, United States
• Sacramento Heart and Vascular Medical Associates — Sacramento, California, United States
• Cardiology Associates — San Diego, California, United States
• Aurora Denver Cardiology — Aurora, Colorado, 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
• Cardiovascular Assoc. PC — Birmingham, 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.