NCT00137293TerminatedPhase 2
A Study to Characterize the Acute Electrophysiologic Properties, Safety and Tolerability of GAP-486
Wyeth is now a wholly owned subsidiary of Pfizer7 sites in 2 countries30 target enrollmentStarted: November 1, 2005Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Sponsor
- Enrollment
- 30
- Locations
- 7
- Primary Endpoint
- This study takes place within 24 hours. The measure to determine the effect of the intervention will be the difference in values from the baseline electrophysiology study, and the values obtained after intervention within the test drug.
Study Overview
Brief Summary
The purpose of this study is to learn the effects of a test drug on heart rhythm, and to provide additional data to see if the test drug is well tolerated and safe.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients undergoing an electrophysiology study for evaluation of heart rhythm.
Exclusion Criteria
- •Patients with uncontrolled blood pressure
- •Patients with certain cardiac risk factors
- •Patients with significant kidney or liver problems
Outcomes
Primary Outcomes
This study takes place within 24 hours. The measure to determine the effect of the intervention will be the difference in values from the baseline electrophysiology study, and the values obtained after intervention within the test drug.
Secondary Outcomes
- This study takes place within 24 hours, and looks at the changes in values of electrophysiology studies, before and after administration of test article.
Investigators
Study Sites (7)
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