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。目标患者入组是5名患者，为期5个月。该研究将分两个阶段进行，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，如果发生并发症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 five patients over a five-month period. The study will be conducted in two phases with an optional third phase: (1) inpatient six-day phase for assessment of baseline characteristics and initiation of therapy, (2)outpatient phase with at least six outpatient evaluations (six anticipated, additional visits may be necessary in the event of a complication), (3) optional 24-hour inpatient evaluation for further pharmacokinetic studies. The GCRC will be used during all phases of evaluation.