Status:
COMPLETED
A Study To Investigate The Effects Of End Stage Renal Disease And Hemodialysis On The Pharmacokinetics Of Ropinirole
Lead Sponsor:
GlaxoSmithKline
Conditions:
Restless Legs Syndrome
Eligibility:
All Genders
18-79 years
Phase:
PHASE1
Brief Summary
This study will investigate the effects of severe renal impairment and hemodialysis on the characteristics of the drug, ropinirole.
Eligibility Criteria
Inclusion
- Inclusion:
- Patients and subjects between 18-79 years old.
- End stage renal patients who are consistently receiving dialysis for a minimum of 3.5 hours, three times per week, with hemodialysis blood flow rates of \>200mL/min may be eligible to enter the study.
- Patients must also have systolic blood pressure 100-190mmHg and diastolic blood pressure \<120mmHg.
- Healthy subjects must have systolic blood pressure 100-150mmHg.
- Exclusion:
- Female subjects who are pregnant and/or breast-feeding must not participate in this study.
Exclusion
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2006
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00422994
Start Date
April 1 2006
End Date
December 1 2006
Last Update
October 26 2016
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
GSK Investigational Site
Minneapolis, Minnesota, United States, 55404
2
GSK Investigational Site
London, United Kingdom, SW17 0QT