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

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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.