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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: Completed Phase 4 study, sponsored by University of Michigan.
NCT01435174 is a Phase 4 study that has completed, run by University of Michigan. The registered enrollment target is 17 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Peak Plasma Concentration (Cmax) with a 500 mg dose of ranolazine
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 |
What the finished NCT01435174 record still lists
NCT01435174 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 3 interventions - of which Ranolazine is the first listed.
NCT01435174 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01435174's enrollment target sits among peer trials
17 1854th of 2000 higher than 132 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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