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:Completed
Conditions:Peripheral Vascular Disease, Cardiology, Hospital
Therapuetic Areas:Cardiology / Vascular Diseases, Other
Healthy:No
Age Range:18 - Any
Updated:3/30/2013
Start Date:November 2011
End Date:August 2014
Contact:Sandra Beaird, PhD
Email:FRXClinTrials@frx.com
Phone:1-800-678-1605

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Phase 3 Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of the Effects of Once Daily Oral Doses of 75 mg Azimilide Dihydrochloride on the Incidence of Cardiovascular Hospitalizations/Emergency Department Visits or Cardiovascular Death in Patients With an Implantable Cardioverter Defibrillator


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)


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
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Baltimore, Maryland 21237
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Albany, New York 12205
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