NCT00035464

Efficacy and Safety of Azimilide in the Prophylactic Treatment of Patients

Completed Phase 3 Last updated 30 September 2011

What this trial tests

Phase 3 trial testing Azimilide Dihydrochloride in Atrial Fibrillation in 431 participants. Completed in 1 January 2004.

Timeline

1 December 2000

Primary endpoint
1 January 2004

1 January 2004

Quick facts

Lead sponsor	Forest Laboratories
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	431
Start date	1 December 2000
Primary completion	1 January 2004
Estimated completion	1 January 2004
Sites	103 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

18 and older, 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.

• To prolong the tachycardia-free period in patients
  Time frame: 6 months

Sponsor's own description

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.

Publications & conference data

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