JPRN-jRCT2080221325未知3 期
A multicenter, open-label extension study to investigate the long-term safety and efficacy of tolvaptan in patients with autosomal dominant polycystic kidney disease (ADPKD) [Extension of Trial 156-04-251]
适应症
试验速览
- 阶段
- 3 期
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 23age old 至 <= 53age old（—）
- 性别
- All
入选标准
- •1) Patients who participated in Trial 156-04-251 in Japan and for whom CRF collection has been completed.
- •2) Patients who completed 3-year repeated administration and who completed the second follow-up visit or patients whose treatment with the trial drug was interupted due to pregnancy and who completed out the second follow-up visit in Trial 156-04-251.
- •3) Patients in whom any adverse events occurring in Trial 156-04-251 were resolved orstabilized and require no further follow-up.
排除标准
- •1) Patients with eGFR of less than 15 mL/min/1.73 m2
- •2) Pregnant, breast-feeding, or possibly pregnant women or women who are planning to become pregnant
- •3) Patients who received any investigational drug other than Tolvaptan within 30 days prior to commencement of administration of tolvaptan
- •4) Any patients who, in the opinion of the principle investigator or subinvestigators, should not participate in the study
研究者
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