Efficacy and Safety of Azimilide in the Prophylactic Treatment of Patients With Atrial Fibrillation.
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|ClinicalTrials.gov Identifier: NCT00035464|
Recruitment Status : Completed
First Posted : May 6, 2002
Last Update Posted : October 3, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Atrial Fibrillation||Drug: Azimilide Dihydrochloride Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||431 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Efficacy and Safety of Azimilide in the Prophylactic Treatment of Patients|
|Study Start Date :||December 2000|
|Actual Primary Completion Date :||January 2004|
|Actual Study Completion Date :||January 2004|
Placebo Comparator: 1
placebo tablets, twice a day for 6 months
125 mg azimilide tablets
Drug: Azimilide Dihydrochloride
125 mg azimilide tablets, twice a day for 6 months
- To prolong the tachycardia-free period in patients [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00035464
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|Study Director:||Martin Phillips, MD||Procter and Gamble|