Pharmacokinetics of Single-Dose Oral Ranolazine in Hemodialysis Patients
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|ClinicalTrials.gov Identifier: NCT01435174|
Recruitment Status : Completed
First Posted : September 16, 2011
Results First Posted : June 25, 2014
Last Update Posted : October 16, 2017
|Condition or disease||Intervention/treatment||Phase|
|End-stage Renal Disease Cardiovascular Disease||Drug: Ranolazine Procedure: Pharmacokinetic Blood and Dialysate Sampling Procedure: QT Interval||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||17 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pharmacokinetics of Single-Dose Oral Ranolazine in Hemodialysis Patients|
|Study Start Date :||October 2011|
|Actual Primary Completion Date :||March 2013|
|Actual Study Completion Date :||March 2013|
End-stage renal disease patients receiving a single-dose of ranolazine and a concomitant hemodialysis session.
A single dose of two oral ranolazine extended release 500 mg tablets
Other Name: Ranexa
Procedure: Pharmacokinetic Blood and Dialysate Sampling
Blood samples collected to assess ranolazine plasma and dialysate concentrations.
Procedure: QT Interval
Calculation of a QT interval will be performed throughout subject participation.
- Pharmacokinetic Parameters of Ranolazine [ Time Frame: At hours post-dose: 0, 2, 4, 8, 12, 15, 18, 20, 22, 23, 26, 30, 65 ]Peak Plasma Concentration (Cmax) with a 500 mg dose of ranolazine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01435174
|United States, Michigan|
|University of Michigan Hospital|
|Ann Arbor, Michigan, United States, 48109|
|Principal Investigator:||Bruce A Mueller, PharmD||University of Michigan|