Text Size

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)

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT01464476
First received: November 1, 2011
Last updated: May 2, 2013
Last verified: May 2013
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:

U.S. FDA Resources

Further study details as provided by Forest Laboratories:

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

  • Time to first unplanned physician-office visit. [ Time Frame: 365 days ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01464476

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

No publications provided

Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT01464476     History of Changes
Other Study ID Numbers: AZM-MD-302
Study First Received: November 1, 2011
Last Updated: May 2, 2013
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Belgium: Federal Agency for Medicinal Products and Health Products
Czech Republic: State Institute for Drug Control
Denmark: Danish Health and Medicines Authority
Denmark: The Danish National Committee on Biomedical Research Ethics
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Committee for the Protection of Personnes
France: Conseil National de l'Ordre des Médecins
Germany: Ethics Commission
Germany: Federal Institute for Drugs and Medical Devices
Germany: Federal Office for Radiation Protection
Israel: Israeli Health Ministry Pharmaceutical Administration
Italy: The Italian Medicines Agency
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Netherlands: Medical Ethics Review Committee (METC)
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Sweden: Medical Products Agency

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

ClinicalTrials.gov processed this record on May 22, 2013