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临床试验/EUCTR2009-016371-30-BE
EUCTR2009-016371-30-BE进行中(未招募)不适用

International, multi-center, study of a twenty-eight week, open-label, titrated oral lixivaptan administration in patients with chronic hyponatremia: extension to studies CK-LX3401, 3405, and 3430 - Ole

Cardiokine Biopharma LLC0 个研究点目标入组 150 人开始时间: 2010年4月27日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
150

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

  • 1.Men and women 18 years of age or older
  • 2.Ability to provide informed consent or assent
  • 3.Prior participation in a lixivaptan hyponatremia trial with evidence of continued need or desire for therapy
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range

排除标准

  • 1.A current medical condition where long-term treatment with an aquaretic agent may present an undue risk to the patient
  • 2.Hyponatremia which is acute, reversible, artifactual or due to conditions not associated with vasopressin excess or likely to respond to aquaretic therapy
  • 3.Hyponatremia due to reversible medical condition or therapy
  • 4.Conditions associated with an independent imminent risk of morbidity and mortality

研究者

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