drugset / Trial / NCT01435174

Pharmacokinetics of Single-Dose Oral Ranolazine in Hemodialysis Patients

NCT01435174

Phase 4 Completed 17 enrolled University of Michigan Gilead Sciences · collab
NaSingle-groupOpen-labelTreatment

Summary

End-stage renal disease (ESRD) patients often develop cardiovascular complications, and cardiovascular disease is the leading cause of death in this population. Ranolazine's ability to treat angina without reducing heart rate or blood pressure makes it an important option for ESRD patients. The hemodialysis clearance of ranolazine is unknown. A single-dose pharmacokinetic study is needed to characterize ranolazine and its metabolites in ESRD patients on and off hemodialysis. Results of the proposed study will provide initial dosing estimates for a follow-up, multiple-dose pharmacokinetic study in this population.

Timeline

Start
2011-10
Primary completion
2013-03
Completion
2013-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Ranolazine Small molecule 500 mg Oral
Subject Ranolazine Small molecule 1000 mg Oral