Trial Outcomes & Findings for The Effect of Atorvastatin on Endothelial Cell Dysfunction in Chronic Kidney Disease (NCT NCT02133534)

NCT ID: NCT02133534

Last Updated: 2014-07-03

Results Overview

Improvement of endothelial cell (EC) dysfunction will be assessed by improved counts of endothelial progenitor cells.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

1 participants

Primary outcome timeframe

baseline, 30 days

Results posted on

2014-07-03

Participant Flow

Participant milestones

Participant milestones
Measure
Atorvastatin
Subjects will be treated with atorvastatin 10 mg/day for 30 days. The study team will obtain one blood and urine sample at baseline prior to starting atorvastatin therapy, and again after 30 days of drug therapy. The study team will do ultrasound imaging of the arm in which a probe will be placed over the blood vessels to measure the diameter of the artery and how this changes after a blood pressure cuff is inflated and then deflated. Subjects will take one nitroglycerine tablet during the ultrasound imaging. Atorvastatin
Overall Study
STARTED
1
Overall Study
COMPLETED
1
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Effect of Atorvastatin on Endothelial Cell Dysfunction in Chronic Kidney Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Atorvastatin
n=1 Participants
Subjects will be treated with atorvastatin 10 mg/day for 30 days. The study team will obtain one blood and urine sample at baseline prior to starting atorvastatin therapy, and again after 30 days of drug therapy. The study team will do ultrasound imaging of the arm in which a probe will be placed over the blood vessels to measure the diameter of the artery and how this changes after a blood pressure cuff is inflated and then deflated. Subjects will take one nitroglycerine tablet during the ultrasound imaging. Atorvastatin
Age, Customized
Greater than 18 Years
1 participants
n=5 Participants
Sex: Female, Male
Female
1 Participants
n=5 Participants
Sex: Female, Male
Male
0 Participants
n=5 Participants
Region of Enrollment
United States
1 participants
n=5 Participants

PRIMARY outcome

Timeframe: baseline, 30 days

Population: Early termination because of insufficient accrual. With only one study participant, data could not be analyzed.

Improvement of endothelial cell (EC) dysfunction will be assessed by improved counts of endothelial progenitor cells.

Outcome measures

Outcome data not reported

Adverse Events

Atorvastatin

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

Research Practice Manager

Duke University Medical Center

Phone: 919 681 6819

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place