Trial Outcomes & Findings for Single Dose Pravastatin Pharmacokinetics in Pediatric Peritoneal Dialysis Patients (NCT NCT00571194)
NCT ID: NCT00571194
Last Updated: 2017-03-15
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
7 participants
Primary outcome timeframe
24 hours
Results posted on
2017-03-15
Participant Flow
Participant milestones
| Measure |
Pravastatin
Study drug given and have levels done to measure pharmacokinetics.
|
|---|---|
|
Overall Study
STARTED
|
7
|
|
Overall Study
COMPLETED
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Single Dose Pravastatin Pharmacokinetics in Pediatric Peritoneal Dialysis Patients
Baseline characteristics by cohort
| Measure |
A Single-Dose Pilot Study
n=7 Participants
Study drug given and have levels done to measure pharmacokinetics
|
|---|---|
|
Age, Categorical
<=18 years
|
7 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 hoursPopulation: Data was not collected
Outcome measures
Outcome data not reported
Adverse Events
A Single-Dose Pilot Study
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place