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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) (SHIELD-2)

This study has been terminated.
Information provided by (Responsible Party):
Forest Laboratories Identifier:
First received: November 1, 2011
Last updated: May 2, 2013
Last verified: May 2013
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)

Condition Intervention Phase
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Implantable Cardioverter Defibrillator
Drug: Azimilide Dihydrochloride
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Forest Laboratories:

Primary Outcome Measures:
  • Time to first cardiovascular event [ Time Frame: 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:
  • Time to first all-cause shock by the ICD [ Time Frame: 365 days ]
    Time to first all-cause shock initiated by the Implantable Cardioverter Defibrillator

  • Time to first unplanned physician-office visit. [ Time Frame: 365 days ]
    Time to the first unplanned physician-office visit.

Enrollment: 240
Study Start Date: November 2011
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Azimilide
Azimilide 75 mg film coated tablets
Drug: Azimilide Dihydrochloride
Azimilide 75 mg. Once daily, oral administration
Placebo Comparator: Placebo Drug: Placebo
Dose-matched placebo. Once daily, oral administration


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01464476

  Show 138 Study Locations
Sponsors and Collaborators
Forest Laboratories
Study Director: David B Bharucha, MD, PhD Forest Laboratories
  More Information

Responsible Party: Forest Laboratories Identifier: NCT01464476     History of Changes
Other Study ID Numbers: AZM-MD-302
Study First Received: November 1, 2011
Last Updated: May 2, 2013

Additional relevant MeSH terms:
Cardiovascular Diseases
Heart Diseases
Arrhythmias, Cardiac
Disease Attributes
Pathologic Processes
Anti-Arrhythmia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action processed this record on May 24, 2017