Study:
Efficacy and Safety Evaluation of Azimilide Dihydrochloride in Patients With Implantable Cardioverter Defibrillators
Rationale:
n/a
Purpose:
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.
Study Status: Completed
Recruiting:
n/a
| Condition |
Intervention |
Phase |
|
Arrhythmia |
Drug: Azimilide Dihydrochloride
Drug: placebo
Drug: Azimilide Dihydrochloride |
Phase 3 |
Verified by
Forest Laboratories
September, 2011
Sponsored by: Forest Laboratories
Information provided by: Forest Laboratories
ClinicalTrials.gov identifier: NCT00035490
Study Type: Interventional
Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Cleveland Clinic Foundation
Cleveland, Ohio 44195
United States
Jose M Brum, MD., Study Director