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)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
240
Azimilide 75 mg. Once daily, oral administration
Dose-matched placebo. Once daily, oral administration
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
Time to first cardiovascular event
Time to first unplanned cardiovascular hospitalization, unplanned cardiovascular emergency department visit, or cardiovascular death in patients with an Implantable Cardioverter Defibrillator (ICD)
Time frame: 365 days
Time to first all-cause shock by the ICD
Time to first all-cause shock initiated by the Implantable Cardioverter Defibrillator
Time frame: 365 days
Time to first unplanned physician-office visit.
Time to the first unplanned physician-office visit.
Time frame: 365 days
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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
...and 128 more locations