Efficacy and Safety Study of Azimilide on the Incidence of Cardiovascular Hospitalizations/Emergency Department Visits or Cardiovascular Death in Patients With an Implantable Cardioverter Defibrillator (ICD) (SHIELD-2)

• Status: Terminated
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the efficacy and safety of Azimilide on the incidence of cardiovascular hospitalizations, cardiovascular emergency department visits or cardiovascular death in patients with Implantable Cardioverter Defibrillators (ICDs)

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Forest Laboratories
• Treatments: Azimilide

Criteria

Inclusion Criteria:

• Have an ICD implanted and a history of ventricular tachycardia, ventricular fibrillation, or an appropriate ICD therapy.

• Have a left ventricular ejection fraction <= 0.40

Exclusion Criteria:

• Have New York Heart Association (NYHA) Class IV Congestive Heart Failure (CHF) or have decompensated CHF at the time of randomization;

• Have unstable angina pectoris or a myocardial infarction within 30 days of randomization;

• Have a history of Torsade de Pointes or heart transplantation

• Have chronic atrial fibrillation or atrial fibrillation/flutter, that is not adequately rate controlled in the judgment of the Investigator, at screening;

• Are currently taking systemic Class I or other Class III antiarrhythmic drugs

• Are currently taking systemic drugs that prolong the QT interval

• If female, are currently pregnant or breast feeding, or plan to become pregnant during the course of the study