CLINICAL TRIALS PROFILE FOR AZIMILIDE

Clinical Trials for Azimilide

Trial ID	Title	Status	Sponsor	Phase	Summary
NCT00035451 ↗	Efficacy and Safety Evaluation of Azimilide or Sotalol vs Placebo for Treatment of Patients With Atrial Fibrillation.	Completed	Forest Laboratories	Phase 3	Atrial fibrillation (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. The double-blind, placebo-controlled phase of this study is designed to evaluate the efficacy and safety of oral azimilide compared with placebo and with sotalol, an antiarrhythmic drug, in maintaining sinus rhythm in patients who require cardioversion (electric shock to correct heart rhythm) to correct 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 first study. The follow-up phase will continue to evaluate the long-term safety of a daily oral dose of azimilide in patients who complete the double-blind, placebo-controlled phase of this study.
NCT00035464 ↗	Efficacy and Safety of Azimilide in the Prophylactic Treatment of Patients With Atrial Fibrillation.	Completed	Forest Laboratories	Phase 3	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.
NCT00035477 ↗	Efficacy and Safety of Azimilide for the Treatment of Patients With Atrial Fibrillation	Completed	Forest Laboratories	Phase 3	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.
NCT00035490 ↗	Efficacy and Safety Evaluation of Azimilide Dihydrochloride in Patients With Implantable Cardioverter Defibrillators	Completed	Forest Laboratories	Phase 3	Implantable cardioverter defibrillators (ICDs) have been developed to treat ventricular tachycardia or fibrillation (abnormal heart rhythms) by electrical shock or by pacing the heart. ICD therapy is established as highly effective for stopping life-threatening arrhythmias, but it does not preclude the use of anti-arrhythmic drugs for prevention and to decrease the frequency of ICD shocks. The safety and effectiveness of oral azimilide dihydrochloride in reducing the frequency of ICD shocks has been investigated previously in a placebo-controlled study in patients with ICDs. These results need to be confirmed in this larger double-blind, placebo-controlled study with approximately 600 patients.

Clinical Trial Conditions for Azimilide

Condition Name

Condition Name
Intervention	Trials
Atrial Fibrillation	3
Arrhythmia	1
Arrhythmias	1
Arrhythmias, Cardiac	1

Condition MeSH

Condition MeSH
Intervention	Trials
Arrhythmias, Cardiac	3
Atrial Fibrillation	3
Heart Failure	1
Heart Diseases	1

Clinical Trial Locations for Azimilide

Trials by Country

Trials by Country
Location	Trials
United States	150
Canada	27
Poland	5
France	4
Belgium	4

Trials by US State

Trials by US State
Location	Trials
Florida	5
Colorado	5
California	5
Arizona	5
Wisconsin	5

Clinical Trial Progress for Azimilide

Clinical Trial Phase

Clinical Trial Phase
Clinical Trial Phase	Trials
Phase 3	6
Phase 2	1
Phase 1	1

Clinical Trial Status

Clinical Trial Status
Clinical Trial Phase	Trials
Completed	7
Terminated	1

Clinical Trial Sponsors for Azimilide

Sponsor Name

Sponsor Name
Sponsor	Trials
Forest Laboratories	8
Warner Chilcott	3

Sponsor Type

Sponsor Type
Sponsor	Trials
Industry	11