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)

Study Overview
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Brief Summary
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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)

Official Title
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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

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

Intervention / Treatment
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* Drug: Azimilide Dihydrochloride
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Azimilide<br>Azimilide 75 mg film coated tablets | Drug: Azimilide Dihydrochloride<br>* Azimilide 75 mg. Once daily, oral administration<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Dose-matched placebo. Once daily, oral administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first cardiovascular event | Time to first unplanned cardiovascular hospitalization, unplanned cardiovascular emergency department visit, or cardiovascular death in patients with an Implantable Cardioverter Defibrillator (ICD) | 365 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first all-cause shock by the ICD | Time to first all-cause shock initiated by the Implantable Cardioverter Defibrillator | 365 days | 
| Time to first unplanned physician-office visit. | Time to the first unplanned physician-office visit. | 365 days |