A Multicenter, Uncontrolled, Open-label, Dose-titration Trial to Investigate the Efficacy and Safety of Tolvaptan Tablets in Patients With Hyponatremia in Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 16
- 主要终点
- Percentage of Subjects With Normalized Serum Sodium Concentration on the Day After Final IMP Administration
研究概览
简要总结
The objective of this study is to investigate the efficacy and safety of tolvaptan based on the change in serum sodium concentration following administration of tolvaptan oral tablets at 7.5 to 60 mg/day for up to 30 days in patients with hyponatremia in the SIADH.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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 of <120 mEq/L associated with neurologic impairment, including apathy, confusion, or seizures
研究组 & 干预措施
Tolvaptan
Tolvaptan tablets at 7.5, 15, 30 (one tablet each), or 60 mg (two 30 mg tablets) will be orally administered once daily after breakfast for up to 30 days.
干预措施: Tolvaptan Oral Tablet (Drug)
结局指标
主要结局
Percentage of Subjects With Normalized Serum Sodium Concentration on the Day After Final IMP Administration
时间窗: Baseline, Day2, Day3, Day4, Day5, Day7, Day14, Day21, Day after final study medication
The percentage of subjects with normalized serum sodium concentration, defined as ≥135 mEq/L, on the day after final IMP administration will be calculated versus the number of subjects with serum sodium concentration of \<135 mEq/L at baseline on Day 1 of the treatment period.
次要结局
- Change in Serum Sodium Concentration(Day2, Day3, Day4, Day5, Day7, Day14, Day21 and the day after final IMP administration)