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

Phase 3

Completed

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

• Registration Number: NCT00035477
• Lead Sponsor: Forest Laboratories

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2000-09
• Study First Submitted: 2002-05-03
• Study First Submitted QC: 2002-05-03
• Study First Posted: 2002-05-06
• Primary Completion: 2003-10
• Study Completion: 2003-10
• Status Verified: 2011-09
• Last Update Submitted: 2011-09-30
• Last Update Posted: 2011-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 446

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 in hospital and placebo tablets outpatient
2	Azimilide Dihydrochloride	Azimilide tablets in hospital and azimilide tablets outpatient

Primary Outcome Measures

Name	Time	Method
Prolong the time from start of teh efficacy period to the first symptomatic or asymptomatic event fo AFIB, etc	six months

Trial Locations

Locations (81)

The Heart Group, PC; 🇺🇸 Mobile, Alabama, United States

University Medical Center; 🇺🇸 Tucson, Arizona, United States

Cardiovascular Associates of Penisula; 🇺🇸 Burlingame, California, United States

San Diego Cardiovascular Research Associates; 🇺🇸 Encinitas, California, United States

La Mesa Cardiac Center, a Medical Group; 🇺🇸 La Mesa, California, United States

Good Samaritan Hospital; 🇺🇸 Los Angeles, California, United States

LAC + USC Medical Center; 🇺🇸 Los Angeles, California, United States

Cardiology Section, West Los Angeles VA Hospital; 🇺🇸 Los Angeles, California, United States

Merced Heart Associates; 🇺🇸 Merced, California, United States

Sutter Gould Medical Foundation; 🇺🇸 Modesto, California, United States

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