Double blind placebo controlled dose ranging study of the efficacy and safety of celivarone at 50, 100, or 300 mb once daily with amiodarone as calibrator for the prevention of ICD interventions or death.
Description of Research
The purpose of this study is to measure the effects of 3 doses of celivarone (50, 100 and 300 mg) for the prevention of death or “firing” of ICD (called ICD interventions) caused by ventricular arrhythmias (irregular heart beats in the lower chamber of the heart). Celivarone is an investigational drug. An investigational drug is one that is not approved by the Unites States Food and Drug Administration (FDA).
For participants who have an implantable cardioverter defibrillator (ICD). This device has been implanted to
protect the patient from the risk of cardiac arrest (heart attack) due to an irregular heart beat that starts in the lower part of the heart. The device monitors the heart and when it beats irregularly or too fast, it gives the patient either mild or high energy electrical shocks to put heart beat back in to a regular rhythm.