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NCT01435174 · ClinicalTrials.gov registry record · Phase 4
Pharmacokinetics of Single-Dose Oral Ranolazine in Hemodialysis Patients
A Phase 4 study, sponsored by University of Michigan.
- Completed
- Registry status
- Phase 4
- Development phase
- 17
- Enrollment target
NCT01435174 is a Phase 4 study that has completed, run by University of Michigan. The registered enrollment target is 17 participants.
The verdict
NCT01435174, a Phase 4 study, has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 17 participants
- Enrollment target
Study 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.
Interventions
- DRUG Ranolazine
- PROCEDURE Pharmacokinetic Blood and Dialysate Sampling
- PROCEDURE QT Interval
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2011-10 |
| Est. Completion | 2013-03 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01435174
The ClinicalTrials.gov registry entry for NCT01435174 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 17 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Michigan, which has 1,327 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Ranolazine is the first listed.
NCT01435174 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01435174 about?
NCT01435174 is a clinical study titled "Pharmacokinetics of Single-Dose Oral Ranolazine in Hemodialysis Patients". 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 hemo...
What is the current status of trial NCT01435174?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 17 participants. The study started on 2011-10. Estimated completion is 2013-03.
What interventions are being tested in trial NCT01435174?
The interventions under investigation include: Ranolazine (DRUG), Pharmacokinetic Blood and Dialysate Sampling (PROCEDURE), QT Interval (PROCEDURE).
Who is sponsoring clinical trial NCT01435174?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
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