Status:
TERMINATED
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)
Lead Sponsor:
Forest Laboratories
Conditions:
Arrhythmias, Cardiac
Heart Diseases
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 I...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT01464476
Start Date
November 1 2011
End Date
June 1 2013
Last Update
May 6 2013
Active Locations (138)
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1
Forest Investigative Site 053
Birmingham, Alabama, United States, 35211
2
Forest Investigative Site 048
Huntsville, Alabama, United States, 35801
3
Forest Investigative Site 013
Phoenix, Arizona, United States, 85013
4
Forest Investigative Site 110
Los Angeles, California, United States, 99048