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 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.