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

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Restless Legs Syndrome; End Stage Renal Disease

Intervention: ropinirole dosing for up to 28 days (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, 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: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

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 visit

Vital 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 Investigational Site, London SW17 0QT, United Kingdom

GSK Investigational Site, Minneapolis, Minnesota 55404, United States

Additional Information

Starting date: April 2006
Last updated: May 31, 2012

Page last updated: August 23, 2015

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