NCT00035477

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

Completed Phase 3 Last updated 30 September 2011

What this trial tests

Phase 3 trial testing Azimilide Dihydrochloride in Atrial Fibrillation in 446 participants. Completed in 1 October 2003.

Timeline

1 September 2000

Primary endpoint
1 October 2003

1 October 2003

Quick facts

Lead sponsor	Forest Laboratories
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	446
Start date	1 September 2000
Primary completion	1 October 2003
Estimated completion	1 October 2003
Sites	82 locations across United States, Canada

Drugs / interventions tested

• Azimilide Dihydrochloride — full drug profile →
• Placebo

Conditions studied

• Atrial Fibrillation — all drugs for Atrial Fibrillation →

Sponsor

Forest Laboratories — full company profile →

Who can join

Adults 18 to 80, any sex, with Atrial Fibrillation. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

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

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.