A Study To Investigate The Effects Of End Stage Renal Disease And Hemodialysis On The Pharmacokinetics Of Ropinirole
Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Restless Legs Syndrome; End Stage Renal Disease
Intervention: ropinirole dosing for up to 28 days (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s): GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline
Summary
This study will investigate the effects of severe renal impairment and hemodialysis on the
characteristics of the drug, ropinirole.
Clinical Details
Official title: An Open-Label, Parallel-Group, Repeat-Dose Study to Investigate the Effects of End Stage Renal Disease and Haemodialysis on the Pharmacokinetics of Ropinirole (Study RRL103628)
Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Primary outcome: SK&F-104557 and SK&F-89124 blood levels over 24 hours at Weeks 1 & 3 for all subjects.SK&F-104557 and SK&F-89124 blood levels at beginning, middle, & end of hemodialysis period when "on dialysis" & "off dialysis" in patients.
Secondary outcome: ECG: every other visitVital Signs: Each visit Adverse Events: each visit Clinical laboratory: every other visit
Eligibility
Minimum age: 18 Years.
Maximum age: 79 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
GSK Investigational Site, London SW17 0QT, United Kingdom
GSK Investigational Site, Minneapolis, Minnesota 55404, United States
Additional Information
Starting date: April 2006
Last updated: May 31, 2012
|