NCT00035490

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 633 (actual)
• Sponsor: Forest Laboratories · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Arrhythmia

Interventions

Type	Name	Description
DRUG	Azimilide Dihydrochloride	125 mg azimilide, once a day for one year
DRUG	placebo	placebo tablet, once daily for one year
DRUG	Azimilide Dihydrochloride	75 mg azimilide, once a day for one year

Timeline

• Start date: 2001-09-01
• Primary completion: 2004-04-01
• Completion: 2004-04-01
• First posted: 2002-05-06
• Last updated: 2011-10-03

Locations

142 sites across 9 countries: United States, Belgium, Canada, France, Germany, Italy, Netherlands, Poland, Spain