临床试验/NCT00422994

NCT00422994已完成1 期

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)

GlaxoSmithKline2 个研究点分布在 2 个国家目标入组 48 人开始时间: 2006年4月1日最近更新: 2016年10月26日

适应症

试验速览

阶段: 1 期
状态: 已完成
发起方: GlaxoSmithKline
入组人数: 48
试验地点: 2
主要终点: SK&F-104557 and SK&F-89124 blood levels over 24 hours at Weeks 1 & 3 for all subjects.

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Parallel
主要目的: Diagnostic
盲法: None

入排标准

年龄范围: 18 Years 至 79 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 是

入选标准

•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.

排除标准

•Female subjects who are pregnant and/or breast-feeding must not participate in this study.

结局指标

主要结局

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.

次要结局

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

研究者

发起方

GlaxoSmithKline

申办方类型

Industry

责任方

Sponsor

研究点 (2)

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