| Trial ID: | L1621 |
| Source ID: | NCT00422994
|
| Associated Drug: |
Ropinirole Dosing For Up To 28 Days
|
| Title: |
A Study To Investigate The Effects Of End Stage Renal Disease And Hemodialysis On The Pharmacokinetics Of Ropinirole
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Restless Legs Syndrome
|
| Interventions: |
DRUG: ropinirole dosing for up to 28 days
|
| Outcome Measures: |
Primary: 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: ECG: every other visit|Vital Signs: Each visit|Adverse Events: each visit|Clinical laboratory: every other visit
|
| Sponsor/Collaborators: |
Sponsor: GlaxoSmithKline
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
48
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: DIAGNOSTIC
|
| Start Date: |
2006-04
|
| Completion Date: |
2006-12
|
| Results First Posted: |
|
| Last Update Posted: |
2016-10-26
|
| Locations: |
GSK Investigational Site, Minneapolis, Minnesota, 55404, United States|GSK Investigational Site, London, SW17 0QT, United Kingdom
|
| URL: |
https://clinicaltrials.gov/show/NCT00422994
|
