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)

NCT00422994 Phase 1 COMPLETED

This study will investigate the effects of severe renal impairment and hemodialysis on the characteristics of the drug, ropinirole.

Details

Lead sponsor	GlaxoSmithKline
Phase	Phase 1
Status	COMPLETED
Enrolment	48
Start date	2006-04
Completion	2006-12

Conditions

• Restless Legs Syndrome

Interventions

• ropinirole dosing for up to 28 days

Primary outcomes

• 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.

Countries

United States, United Kingdom