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)

Phase 3

Terminated

• Conditions: Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Implantable Cardioverter Defibrillator
• Interventions: Drug: Azimilide Dihydrochloride; Drug: Placebo

• Registration Number: NCT01464476
• Lead Sponsor: Forest Laboratories

Brief 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)

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2011-11-01
• Study First Submitted QC: 2011-11-02
• Study First Posted: 2011-11-03
• Status Verified: 2013-05
• Primary Completion: 2013-05
• Last Update Submitted: 2013-05-02
• Last Update Posted: 2013-05-06
• Study Completion: 2013-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 240

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Azimilide	Azimilide Dihydrochloride	Azimilide 75 mg film coated tablets
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Time to first cardiovascular event	365 days	Time to first unplanned cardiovascular hospitalization, unplanned cardiovascular emergency department visit, or cardiovascular death in patients with an Implantable Cardioverter Defibrillator (ICD)

Secondary Outcome Measures

Name	Time	Method
Time to first all-cause shock by the ICD	365 days	Time to first all-cause shock initiated by the Implantable Cardioverter Defibrillator
Time to first unplanned physician-office visit.	365 days	Time to the first unplanned physician-office visit.

Trial Locations

Locations (138)

Forest Investigative Site 053; 🇺🇸 Birmingham, Alabama, United States

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

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