A Study To Investigate The Effects Of End Stage Renal Disease And Hemodialysis On The Pharmacokinetics Of Ropinirole
Information source: GlaxoSmithKline
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: End Stage Renal Disease
Intervention: ropinirole dosing for up to 28 days (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s):
GSK Clinical Trials, MBChB, MFPM, 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: Diagnostic, Non-Randomized, Open Label, Active Control, Parallel Assignment, Pharmacokinetics Study
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 Clinical Trials Call Center, London SW17 0RE, United Kingdom
GSK Clinical Trials Call Center, Minneapolis, Minnesota 55404, United States
Additional Information
Starting date: March 2006
Last updated: January 12, 2007
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