NCT01507727Unknown2 期
A Multicenter, Randomized, Double-blind, Placebo-controlled (Standard Therapy + Placebo) Study to Evaluate the Efficacy and Safety of the Tolvaptan Tablets in Patients With Non-hypovolemic Non-acute Hyponatremia
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 240
- 试验地点
- 3
- 主要终点
- The change of average daily Area Under the Curve (AUC) of serum sodium by day 4 and 7 comparing with baseline serum sodium level within the double-blind therapy period
研究概览
简要总结
This drug has been developed to treat Hyponatremia. The primary purpose of this study is to verify the efficacy and safety of seven-day repeated oral administration of tolvaptan at 15, 30, and 60 mg or placebo in patients with Non-hypovolemic Non-acute Hyponatremia secondary to Congestive Heart Failure (CHF), hepatic cirrhosis or Syndrome of Inappropriate Antidiuretic Hormone (SIADH), despite receiving standard therapy. This study is being conducted in China.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Drug: Tolvaptan
Experimental
干预措施: Tolvaptan (Drug)
Drug: Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
The change of average daily Area Under the Curve (AUC) of serum sodium by day 4 and 7 comparing with baseline serum sodium level within the double-blind therapy period
时间窗: 4 and 7 days
次要结局
- Percentage of patients with normalized serum sodium at Day 4(4 day)
- Percentage of patients with normalized serum sodium at Day 7(7 day)
- Time to first normalization in serum sodium(up to 7 days)
- Change from baseline in serum sodium at Day 4(4 day)
- Change from baseline in serum sodium at Day 7(7 day)
- Percentage of patients requiring fluid restriction at any time during the double-blind therapy period of the study(up to 7 days)
- 24-hour urine output(day 1, day 2, day 3, day 4, day 5, day 6 and day 7)
- Change from baseline in body weight (hypervolemic patients only)(day 1, day 2, day 3, day 4, day 5, day 6 and day 7)
- Fluid balance (hypervolemic patients only)(day 1, day 2, day 3, day 4, day 5, day 6 and day 7)
- The percentage of patients who are designated as treatment failure due to the need for saline infusion, with or without fluid restriction(up to 7 days)
- For CHF patients, improvement of symptoms and relevant physical examination measures(day 1, day 2, day 3, day 4, day 5, day 6 and day 7)
- For hepatic edema patients, improvement of symptoms and relevant physical examination measures or ultrasound test findings(day 1, day 2, day 3, day 4, day 5, day 6 and day 7)
研究者
研究点 (3)
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