Trials / Terminated
TerminatedNCT01464476
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)
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
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 240 (actual)
- Sponsor
- Forest Laboratories · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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 Implantable Cardioverter Defibrillators (ICDs)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Azimilide Dihydrochloride | Azimilide 75 mg. Once daily, oral administration |
| DRUG | Placebo | Dose-matched placebo. Once daily, oral administration |
Timeline
- Start date
- 2011-11-01
- Primary completion
- 2013-05-01
- Completion
- 2013-06-01
- First posted
- 2011-11-03
- Last updated
- 2013-05-06
Locations
138 sites across 13 countries: United States, Belgium, Canada, Czechia, Denmark, France, Germany, Israel, Italy, Netherlands, Poland, Spain, Sweden
Source: ClinicalTrials.gov record NCT01464476. Inclusion in this directory is not an endorsement.