Arrhythmia
Conditions
Keywords
Arrhythmia
Brief summary
The purpose of this study is to learn if combination therapy with amiodarone and ranolazine (an approved drug for chest pain) can help prevent arrhythmias.
Interventions
DRUGAmiodarone Plus Ranolazine
Ranolazine 500mg by mouth twice daily
DRUGAmiodarone with Placebo
stabel dose of amiodarone as prescribed by cardiologist
Sponsors
Gilead Sciences
Hartford Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients with an ICD who were on a stable dose of amiodarone for the past 60 days
Exclusion criteria
* Patients with a life expectancy of less than 6 months * Patients with moderate or severe hepatic impairment (Child-Pugh Classes B or C) or requiring hemodialysis. * Pregnancy or lactation. * Treatment with potent CYP3A inhibitors, including ketoconazole, itraconazole, clarithromycin, nefazodone, nelfinavir, indinavir, and saquinavir * Treatment with CYP3A inducers, including rifampin, rifabutin, rifapentine, phenobarbital, phenytoin, carbamazepine, and St. John's wort.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetic Parameter Estimates | 12 hours | Absorption, Peak concentration, time to peak concentration, clearance, area under the curve |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Electrocardiogram (ECG) | 12 hours | The QT/QTc interval and other ECG parameters |
Countries
United States
Outcome results
None listed