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临床试验/NL-OMON30613
NL-OMON30613已完成3 期

A Phase 3, Multi-center, Double-blind, Placebo-controlled, Parallel-arm Trial to Determine Long-term Safety and Efficacy of Oral Tolvaptan Tablet Regimens in Adult Subjects with Autosomal Dominant Polycystic Kidney Disease - Fase III trial in adult subjects with ADPKD

Otsuka America Pharmaceutical0 个研究点目标入组 70 人开始时间: 待定最近更新:
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适应症

试验速览

阶段
3 期
状态
已完成
入组人数
70
研究概览入排标准研究者记录与标识符相似试验

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
18 至 99（—）

入选标准

  • •*GFR estimated at >= 60mL/min
  • •*Expected rapidly progressive kidney growth (total volume >=750cc) by Magnetic Resonance Imaging (MRI) at randomization

排除标准

  • •* Safety contraindications including: non-compliance with therapies, insufficient or no reproductive precautions, unawareness of thirst, severe allergic reactions to compounds with similar chemical structure
  • •* Contraindications to or interference with MRI assessments
  • •* Concurrent conditions or taking therapies likely to confound endpoint assessments or prevent completion of the trial.

研究者

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