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

Phase 3

Completed

• Conditions: Atrial Fibrillation
• Interventions: Drug: Placebo; Drug: Azimilide Dihydrochloride

• Registration Number: NCT00035464
• Lead Sponsor: Forest Laboratories

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2000-12
• Study First Submitted: 2002-05-03
• Study First Submitted QC: 2002-05-03
• Study First Posted: 2002-05-06
• Primary Completion: 2004-01
• Study Completion: 2004-01
• Status Verified: 2011-09
• Last Update Submitted: 2011-09-30
• Last Update Posted: 2011-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 431

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Placebo	Placebo tablets
2	Azimilide Dihydrochloride	125 mg azimilide tablets

Primary Outcome Measures

Name	Time	Method
To prolong the tachycardia-free period in patients	6 months

Trial Locations

Locations (101)

Cardiovascular Assoc. PC; 🇺🇸 Birmingham, Alabama, United States

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

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