NCT00752596CompletedPhase 2
Compassionate Use Study to Assess the Long Term Safety of 125 mg Per Day of Oral Azimilide Dihydrochloride in One Patient Following Termination of the SHIELD Open-label Study 2001060
Forest Laboratories1 site in 1 country1 target enrollmentStarted: September 2005Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 1
- Locations
- 1
- Primary Endpoint
- There was no outcome measure in this compassionate use
Study Overview
Brief Summary
This is an open-label, long term compassionate use study of 125 mg per day of azimilide 2HCl in a patient who completed two other protocols (2000098 and 2001060.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •No inclusion criteria as the patient to be included is this compassionate use protocol is currently receiving azimilide therapy
Exclusion Criteria
- •Currently taking Class I or other Class III antiarrhythmic drug or other drugs that may prolong QT interval.
- •Is unwilling or unable to give or understand informed consent.
Arms & Interventions
1
Experimental
1 tablet of 125 mg/day of azimilide 2HCl, oral
Intervention: Azimilide 2HCl (Drug)
Outcomes
Primary Outcomes
There was no outcome measure in this compassionate use
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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