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)

Forest Laboratories

Status and phase

Terminated

Phase 3

Conditions

Arrhythmias, Cardiac

Cardiovascular Diseases

Implantable Cardioverter Defibrillator

Heart Diseases

Treatments

Drug: Azimilide Dihydrochloride

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01464476

AZM-MD-302

Details and patient eligibility

About

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)

Enrollment

240 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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