TRIAL OF OPC-41061 FOR TREATMENT OF HYPONATREMIA SECONDARY TO LIVER DISORDER

这是一项多中心、随机、双盲、安慰剂对照、剂量范围研究，研究一种非肽抗利尿激素（V2）受体拮抗剂OPC-41061，用于治疗继发性肝病低钠血症。目标患者入组为5例患者，为期5个月。该研究将分为两个阶段，第三阶段是可选的：1)住院6天阶段，评估基线特征和开始治疗；2)门诊阶段，至少进行6次门诊评估（预计6次，即使出现并发症也可能需要额外的访问）；3)可选的24小时住院评估，以进一步进行药代动力学研究。GCRC将在评估的所有阶段使用。

This is a multicenter, randomized, double-blind, placebo-controlled, dose-ranging study of a non-peptide vasopressin (V2) receptor antagonist, OPC-41061, for the treatment of hyponatremia secondary to liver disease. The goal patient enrollment is 5 patients over a 5 month period. The study will be conducted in 2 phases with an optional 3rd phase: 1)inpatient 6 day phase for assessment of baseline characteristics and initiation of therapy 2)outpatient phase with at least 6 outpatient evaluations (6 anticipated, additional visits may be necessary in the even of a complication) 3) optional 24 hour inpatient evaluation for further pharmacokinetic studies. The GCRC will be used during all phases of evaluation.