JPRN-jRCT2080223457已完成3 期
A Multicenter, Uncontrolled, Open-label, Dose-titration Trial to Investigate theEfficacy and Safety of Tolvaptan Tablets in Patients With Hyponatremia inSyndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 16
研究概览
简要总结
Tolvaptan was suggested to be useful for patients with SIADH.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 85age old（—）
- 性别
- All
入选标准
- •Subjects with a definite diagnosis of SIADH in reference to Diagnostic and Treatment Manual of the Hypersecretion of Vasopressin (SIADH), Revised in 2011
- •- Subjects who have been on fluid restriction for at least 7 consecutive days at the time of informed consent and who are showing no improvement of hyponatremia at the time of the screening examination
排除标准
- •Subjects who have transient hyponatremia induced by drug administration
- •- Subjects who are unable to sense thirst or who have difficulty with fluid intake
- •- Subjects with urinary tract obstruction
- •- Subjects who have participated in any other clinical trial within 30 days prior to informed consent
- •- Subjects with serum sodium concentration below 120 mEq/L associated with neurologic impairment, including apathy, confusion, or seizures
研究者
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