NCT03406286已完成不适用
Post-Marketing Surveillance(PMS) of Safety and Efficacy of Samsca® Tablets in Korean Patients With ADPKD
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,067
- 试验地点
- 1
- 主要终点
- The incidence rate and the number of Adverse Events (AE) / Adverse Drug Response (ADR)
研究概览
简要总结
This is a Post-Marketing Surveillance study(PMS) of Samsca® tablets in actual use in cases to slow the progression of cyst development and renal insufficiency in accordance with Korean regulations on Risk Management Plan(RMP) and New Drug Re-examination. This survey is a post-marketing, prospective, single-arm, all-cases survey conducted on approved indication, usage, dosage.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years and older patients with CKD(chronic kidney disease) stage 1 to 4 at initiation of treatment with evidence of rapidly progressing disease.
- •Patients who need to be prescribed by Investigators who got registered in Risk Management Plan.
- •Patients who have agreed and signed on conditions specified in Risk Management Plan.
排除标准
- •Patients with known or suspected hypersensitivity to tolvaptan or chemically related structures such as benzazepines 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(Cytochrome P450, family3, subfamily A) 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
- •Patients who are applicable to permanent discontinuation criteria prior to initiation of Samsca® Tablets
结局指标
主要结局
The incidence rate and the number of Adverse Events (AE) / Adverse Drug Response (ADR)
时间窗: 10 years
All adverse events (AEs) observed during/after the administration will be analyzed as safety assessment. The number of patients and the number of AE, ADR, Serious AE·ADR, Unexpected AE·ADR will be calculated (frequency and percentage).
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Post Marketing Surveillance Study To Observe Safety And Efficacy Of Champix® TabletsSmoking CessationNCT00483002Pfizer3,719
已完成
不适用
Post Marketing Surveillance (PMS) Study to Assess Safety and Efficacy of Micardis in Patients With Essential HypertensionHypertensionNCT02245464Boehringer Ingelheim13,066
撤回
不适用
A Safety and Effectiveness Study of Prolonged Release Tapentadol Hydrochloride Among Filipino Patients With Moderate to Severe Chronic Non-Cancer PainModerate to Severe Chronic Non-cancer PainNCT01719588Janssen Pharmaceutica
已完成
不适用
Lyrica (Pregabalin) Korean Post Marketing Surveillance StudyNeuropathic PainPost-market SurveillanceEpilepsyFibromyalgiaNCT01220180Pfizer's Upjohn has merged with Mylan to form Viatris Inc.4,175
撤回
不适用
A Safety and Effectiveness Study of Immediate Release Tapentadol Hydrochloride Among Filipino Patients With Moderate to Severe Acute Non-Cancer PainModerate to Severe Acute Non-Cancer PainNCT01719601Janssen Pharmaceutica