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

NCT ID: NCT00422994

Last Updated: 2016-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2006-12-31

Brief Summary

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

Detailed Description

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Conditions

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Restless Legs Syndrome

Keywords

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end stage renal impairment tolerability ropinirole pharmacokinetics hemodialysis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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ropinirole dosing for up to 28 days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Minneapolis, Minnesota, United States

Site Status

GSK Investigational Site

London, , United Kingdom

Site Status

Countries

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United States United Kingdom

Study Documents

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Document Type: Clinical Study Report

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Document Type: Annotated Case Report Form

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Document Type: Statistical Analysis Plan

View Document

Document Type: Individual Participant Data Set

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Document Type: Study Protocol

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Document Type: Informed Consent Form

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Document Type: Dataset Specification

View Document

Related Links

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https://www.clinicalstudydatarequest.com

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Other Identifiers

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RRL103628

Identifier Type: -

Identifier Source: org_study_id