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COMPLETEDPhase 1NCT00422994

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

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

Lead sponsor: GlaxoSmithKline•1 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

GlaxoSmithKline

Age

18 - 79 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion 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.

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: October 26, 2016Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE1

Enrollment48

Start dateApr 2006

Last updatedOct 26, 2016

Condition

Restless Legs Syndrome

Locations shown

GSK Investigational Site

Minneapolis, Minnesota

GSK Investigational Site

London

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 26, 2016Data synced to Clareo: May 10, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions