Overview

Efficacy and Safety Evaluation of Azimilide Dihydrochloride in Patients With Implantable Cardioverter Defibrillators

Status:
Completed
Trial end date:
2004-04-01
Target enrollment:
Participant gender:
Summary
Implantable cardioverter defibrillators (ICDs) have been developed to treat ventricular tachycardia or fibrillation (abnormal heart rhythms) by electrical shock or by pacing the heart. ICD therapy is established as highly effective for stopping life-threatening arrhythmias, but it does not preclude the use of anti-arrhythmic drugs for prevention and to decrease the frequency of ICD shocks. The safety and effectiveness of oral azimilide dihydrochloride in reducing the frequency of ICD shocks has been investigated previously in a placebo-controlled study in patients with ICDs. These results need to be confirmed in this larger double-blind, placebo-controlled study with approximately 600 patients.
Phase:
Phase 3
Details
Lead Sponsor:
Forest Laboratories
Treatments:
Azimilide