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临床试验/EUCTR2015-004445-10-Outside-EU/EEA
EUCTR2015-004445-10-Outside-EU/EEA进行中(未招募)1 期

A Multicenter, Open-label, Single-dose Study to Evaluate the Pharmacokinetics of Valsartan in Japanese Pediatric Patients 6 to 14 Years of Age.

ovartis Pharmaceuticals0 个研究点目标入组 12 人开始时间: 2016年6月7日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
12

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • apanese pediatric patients with hypertension, chronic kidney disease, or nephrotic syndrome
  • Are the trial subjects under 18? yes
  • Number of subjects for this age range: 12
  • F.1.2 Adults (18-64 years) no
  • F.1.2.1 Number of subjects for this age range
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • GFR < 30 mL/min/1.73 m2
  • Inability to safely tolerate the temporary discontinuation of concomitant antihypertensive medications (expect amlodipine or atenolol) from 24 hours prior to study drug administration to study completion.
  • Inability to safely tolerate the temporary discontinuation of any drug known or suspected to effect hepatic or renal clearance capacity from 24 hours prior to study drug administration to study completion (this includes drugs that are known to cause induction or inhibition of hepatic enzymes).

研究者

发起方
ovartis Pharmaceuticals

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