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

Tracking Information

First Received Date ^ICMJE

January 12, 2007

Last Updated Date

February 19, 2009

Start Date ^ICMJE

April 2006

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00422994 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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)

Brief Summary

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

Detailed Description

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Diagnostic, Non-Randomized, Open Label, Parallel Assignment, Pharmacokinetics Study

Condition ^ICMJE

End Stage Renal Disease

Intervention ^ICMJE

Drug: ropinirole dosing for up to 28 days

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 79 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00422994

Responsible Party

Study Director, GSK

Study ID Numbers ^ICMJE

RRL103628

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

GSK Clinical Trials, MBChB, MFPM

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

February 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP