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)

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Arrhythmias, Cardiac, Heart Diseases, Cardiovascular Diseases, Implantable Cardioverter Defibrillator

In brief

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)

Key facts

Study ID

NCT01464476

Run by

Forest Laboratories

People needed

240

Starts

2011-11-01

Expected to finish

2013-06-01

Last updated by the study team

2013-05-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Forest Investigative Site 048 — Huntsville, Alabama, United States
• Forest Investigative Site 013 — Phoenix, Arizona, United States
• Forest Investigative Site 110 — Los Angeles, California, United States
• Forest Investigative Site 022 — Merced, California, United States
• Forest Investigative Site 060 — Colorado Springs, Colorado, United States
• Forest Investigative Site 090 — Littleton, Colorado, United States
• Forest Investigative Site 041 — Newark, Delaware, United States
• Forest Investigative Site 113 — Hollywood, Florida, United States
• Forest Investigative Site 010 — Jacksonville, Florida, United States
• Forest Investigative Site 035 — Lakeland, Florida, United States
• Forest Investigative Site 044 — Port Charlotte, Florida, United States
• Forest Investigative Site 062 — Rockledge, Florida, United States
• Forest Investigative Site 082 — Safety Harbor, Florida, United States
• Forest Investigative Site 006 — Zephyrhills, Florida, United States
• Forest Investigative Site 123 — Augusta, Georgia, United States
• Forest Investigative Site 092 — Boise, Idaho, United States
• Forest Investigative Site 012 — Bloomington, Indiana, United States
• Forest Investigative Site 068 — Indianapolis, Indiana, United States
• Forest Investigative Site 087 — South Bend, Indiana, United States
• Forest Investigative Site 063 — Houma, Louisiana, United States
• Forest Investigative Site 050 — Auburn, Maine, United States
• Forest Investigative Site 030 — Baltimore, Maryland, United States
• Forest Investigative Site 058 — Baltimore, Maryland, United States
• Forest Investigative Site 052 — Lanham, Maryland, United States
• Forest Investigative Site 053 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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