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Completed

NCT Number: NCT00422994

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.

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Key information

Conditions

Restless Legs Syndrome Dyssomnias Mental Disorders Nervous System Diseases Parasomnias Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

GSK Investigational Site, London, United Kingdom

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ropinirole dosing for up to 28 days

Drug

Primary outcomes

  1. SK&F-104557 and SK&F-89124 blood levels over 24 hours at Weeks 1 & 3 for all subjects.

  2. SK&F-104557 and SK&F-89124 blood levels at beginning, middle, & end of hemodialysis period when "on dialysis" & "off dialysis" in patients.

Secondary outcomes

  1. ECG: every other visit

  2. Vital Signs: Each visit

  3. Adverse Events: each visit

  4. Clinical laboratory: every other visit

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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)

Important dates

Study start
2006
Primary completion
2006
Study completion
2006
First posted
Jan 17, 2007
Registry last updated
Oct 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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