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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01464476
First Posted: November 3, 2011
Last Update Posted: May 6, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Forest Laboratories
  Purpose
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: Triple (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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01464476


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

Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT01464476     History of Changes
Other Study ID Numbers: AZM-MD-302
First Submitted: November 1, 2011
First Posted: November 3, 2011
Last Update Posted: May 6, 2013
Last Verified: May 2013

Additional relevant MeSH terms:
Cardiovascular Diseases
Heart Diseases
Emergencies
Arrhythmias, Cardiac
Disease Attributes
Pathologic Processes
Azimilide
Anti-Arrhythmia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action