Trial | NCT00035477  Report issue

Official Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    azimilide ...

  • Study Participants

    446
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 Started
Sep 30
2000
Primary Completion
Oct 31
2003
Study Completion
Oct 31
2003
Last Update
Oct 03
2011
Estimate

Drug Azimilide Dihydrochloride

125 mg azimilide tablets once a day for 3 days in hospital and 125 mg azimilide tablets once a day for 6 months as outpatient

Drug Placebo

placebo tablets once a day for 3 days in hospital and placebo tablets once a day for 6 months as outpatient

1 Placebo Comparator

placebo tablets in hospital and placebo tablets outpatient

2 Experimental

Azimilide tablets in hospital and azimilide tablets outpatient

Criteria 

Inclusion criteria:

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.

Exclusion criteria:

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
No Results Posted