A Phase 3 interventional study of Azimilide Dihydrochloride and Placebo in Atrial Fibrillation, sponsored by Forest Laboratories. Completed at 103 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-10-03.
Sponsored by Forest Laboratories · Phase 3, Interventional, and Treatment
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.
3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.
This study's enrollment of 431 is above the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Forest Laboratories is the lead sponsor of 165 studies on the registry; none are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
Placebo tablets
Drug: Placebo
125 mg azimilide tablets
Drug: Azimilide Dihydrochloride
125 mg azimilide tablets, twice a day for 6 months
placebo tablets, twice a day for 6 months
To prolong the tachycardia-free period in patients
Time frame: 6 months
Showing the first 100 of 103 sites across 2 countries.
This study is completed, as verified in Sep 2011. You cannot join it, but the record below documents what was studied.
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Forest Laboratories