Arrhythmia
Conditions
Keywords
Arrhythmia, antiarrhythmic, programmed electrical stimulation
Brief summary
The purpose of this study is to learn the effects of a test drug on heart rhythms, which may become life-threatening if left untreated, and to provide data to see if the drug is well tolerated and safe.
Interventions
Sponsors
Wyeth is now a wholly owned subsidiary of Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with or without ICDs (implantable cardioverter defibrillators) * Patients undergoing an electrophysiology study for evaluation of ventricular rhythm * Patients with a history of heart disease
Exclusion criteria
* Patients with uncontrolled blood pressure * Patients with certain cardiac risk factors * Patients with significant kidney or liver problems
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The measure to determine the effect of the intervention will be whether abnormally fast heart rhythm can be induced after test drug is administered. | — |
Secondary
| Measure | Time frame |
|---|---|
| This study takes place within 24 hours, and looks at whether the test article makes a difference in inducing the abnormally fast heart rhythm during a 24 hour observational period. | — |
Countries
Canada, United States
Outcome results
None listed