NCT01435174|CompletedPhase 4Results
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Sponsor study identifier
interventional
17
1 country
1
Study Start
October 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2013
Actual (reported)Study Completion
March 2013
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2013
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 14, 2011
Actual (reported)September 16, 2011
Actual (reported)October 2011
Date type not reportedThis date has not been verified as actual or estimated.
March 2013
Actual (reported)March 2013
Actual (reported)June 25, 2014
Actual (reported)Pharmacokinetic Parameters of Ranolazine
Peak Plasma Concentration (Cmax) with a 500 mg dose of ranolazine
At hours post-dose: 0, 2, 4, 8, 12, 15, 18, 20, 22, 23, 26, 30, 65
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
Blood samples collected to assess ranolazine plasma and dialysate concentrations.
University of Michigan Hospital
Ann Arbor, Michigan, 48109, United States
Scoville BA, Segal JH, Salama NN, Heung M, Bleske BE, Eyler RF, Mueller BA. Single dose oral ranolazine pharmacokinetics in patients receiving maintenance hemodialysis. Ren Fail. 2019 Nov;41(1):118-125. doi: 10.1080/0886022X.2019.1585371.
Bruce A Mueller, PharmD
University of Michigan
17 participants (actual enrollment reported by the registry).
First Submitted
September 14, 2011
First Posted
September 16, 2011
Study Start
October 2011
Date type not reportedThis date has not been verified as actual or estimated.
Calculation of a QT interval will be performed throughout subject participation.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
March 2013
Actual (reported)Study Completion
March 2013
Actual (reported)Last Updated
October 16, 2017
Results First Posted
June 25, 2014
Record last verified: 2017-09
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Source: ClinicalTrials.gov.
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