A Study To Investigate The Effects Of End Stage Renal Disease And Hemodialysis On The Pharmacokinetics Of Ropinirole

Phase 1

Completed

• Conditions: Restless Legs Syndrome

• Registration Number: NCT00422994
• Lead Sponsor: GlaxoSmithKline

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-04
• Primary Completion: 2006-12
• Study Completion: 2006-12
• Study First Submitted: 2007-01-12
• Study First Submitted QC: 2007-01-12
• Study First Posted: 2007-01-17
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-24
• Last Update Posted: 2016-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
Vital Signs: Each visit
Adverse Events: each visit
ECG: every other visit
Clinical laboratory: every other visit

Trial Locations

Locations (1)

GSK Investigational Site; 🇬🇧 London, United Kingdom