Trial Outcomes & Findings for Pharmacokinetics of Single-Dose Oral Ranolazine in Hemodialysis Patients (NCT NCT01435174)
NCT ID: NCT01435174
Last Updated: 2017-10-16
Results Overview
Peak Plasma Concentration (Cmax) with a 500 mg dose of ranolazine
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
17 participants
Primary outcome timeframe
At hours post-dose: 0, 2, 4, 8, 12, 15, 18, 20, 22, 23, 26, 30, 65
Results posted on
2017-10-16
Participant Flow
Participant milestones
| Measure |
Ranolazine
End-stage renal disease patients receiving a single-dose of ranolazine and a concomitant hemodialysis session.
Ranolazine: A single dose of two oral ranolazine extended release 500 mg tablets
Pharmacokinetic Blood and Dialysate Sampling: Blood samples collected to assess ranolazine plasma and dialysate concentrations.
QT Interval: Calculation of a QT interval will be performed throughout subject participation.
|
|---|---|
|
Overall Study
STARTED
|
17
|
|
Overall Study
COMPLETED
|
8
|
|
Overall Study
NOT COMPLETED
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pharmacokinetics of Single-Dose Oral Ranolazine in Hemodialysis Patients
Baseline characteristics by cohort
| Measure |
Ranolazine
n=17 Participants
End-stage renal disease patients receiving a single-dose of ranolazine and a concomitant hemodialysis session.
Ranolazine: A single dose of two oral ranolazine extended release 500 mg tablets
Pharmacokinetic Blood and Dialysate Sampling: Blood samples collected to assess ranolazine plasma and dialysate concentrations.
QT Interval: Calculation of a QT interval will be performed throughout subject participation.
|
|---|---|
|
Age, Continuous
|
33 years
n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At hours post-dose: 0, 2, 4, 8, 12, 15, 18, 20, 22, 23, 26, 30, 65Peak Plasma Concentration (Cmax) with a 500 mg dose of ranolazine
Outcome measures
| Measure |
Ranolazine
n=8 Participants
End-stage renal disease patients receiving a single-dose of ranolazine and a concomitant hemodialysis session.
Ranolazine: A single dose of two oral ranolazine extended release 500 mg tablets
Pharmacokinetic Blood and Dialysate Sampling: Blood samples collected to assess ranolazine plasma and dialysate concentrations.
QT Interval: Calculation of a QT interval will be performed throughout subject participation.
|
|---|---|
|
Pharmacokinetic Parameters of Ranolazine
|
0.65 mcg/mL
Standard Deviation 0.27
|
Adverse Events
Ranolazine
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ranolazine
n=8 participants at risk
End-stage renal disease patients receiving a single-dose of ranolazine and a concomitant hemodialysis session.
Ranolazine: A single dose of two oral ranolazine extended release 500 mg tablets
Pharmacokinetic Blood and Dialysate Sampling: Blood samples collected to assess ranolazine plasma and dialysate concentrations.
QT Interval: Calculation of a QT interval will be performed throughout subject participation.
|
|---|---|
|
Cardiac disorders
Elevated Potassium with EKG Changes
|
12.5%
1/8
|
Other adverse events
Adverse event data not reported
Additional Information
Bruce A. Mueller
University of Michigan College of Pharmacy
Phone: 7346154578
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place