NCT02722863已完成不适用
Post Marketing Surveillance Study of Safety and Efficacy of Samsca® Tablets Under the "New Drug Re-Examination"
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 908
- 试验地点
- 4
- 主要终点
- Safety Measure
研究概览
简要总结
This Post-Marketing Surveillance will be conducted in accordance with the local regulation of New Drug Re-examination. The surveillance will be conducted for 6 years of the re-examination period (01Sep2011~31Aug2017). Each subject will be observed at least for 4 days during the surveillance period.
详细描述
This study will be conducted as a prospective, single-arm, multicenter study. Findings on examination, diagnosis, opinions and observations implemented as per general medical practice during the observational period will be documented in the case report forms by the investigators or responsible staffs at the institution since the surveillance is an observational study.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study :
- •Patients who have hyponatremia in euvolemic or hypervolemic states, defined as serum sodium level < 125 mEq/L or hyponatremia that is symptomatic and has resisted correction with fluid restriction
- •Patients who are prescribed Samsca® treatment as per investigator's medical judgment
- •Patients who gave written authorization to use their personal and health data
- •Patients starting Samsca® treatment after agreement is in place Investigators will refer to the product market authorization (label) for inclusion criteria.
排除标准
- •Subjects presenting with any of the following will not be included in the study:
- •Patients who have been treated with Samsca®
- •Patients with known or suspected hypersensitivity to tolvaptan or to any ingredient of the drug
- •Patients requiring urgent intervention to raise serum sodium acutely.
- •Inability of the patient to sense or appropriately respond to thirst.
- •Hypovolemic hyponatremia
- •Concomitant use of strong CYP3A inhibitors
- •Anuric patients
- •Volume depletion patients
- •Hypernatremia patients
- •Women who are pregnant or possibly pregnant and lactation
- •Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption Investigators will refer to the product market authorization (label) for exclusion criteria.
结局指标
主要结局
Safety Measure
时间窗: 4days
Adverse Events (AEs)
次要结局
- Change of the Serum Sodium Level(mEq/L) at the First Visit and Day 4 After the First Visit(Follow-up at least 4 days after first Samsca® dose)
研究者
研究点 (4)
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