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

OPC-41061 治疗继发于肝病的低钠血症的试验

• 批准号: 6276473
• 负责人: NATHAN BASS
• 金额: $ 6.43万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-12-01 至 1999-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6276473
• 关键词: benzazepines; clinical research; dosage; hormone inhibitor; hormone receptor; hormone regulation /control mechanism; human subject; human therapy evaluation; hyponatremia; liver disorder chemotherapy; longitudinal human study; placebos; vasopressins

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.

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。