drugset
drugset / Trial / NCT01114828

A Study to Investigate Pharmacodynamics and Pharmacokinetics of OPC-41061 in Patients With Hepatic Edema

NCT01114828 ↗

Phase 3 Completed 40 enrolled Otsuka Pharmaceutical Co., Ltd.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

OPC-41061 at 3.75 mg/day or 7.5 mg/day will be orally administered once daily for 7 days to cirrhosis patients with ascites despite having received treatment with conventional diuretics and pharmacodynamics, pharmacokinetics, efficacy, and safety will be investigated.

Timeline

Start
2010-02
Primary completion
2011-10
Completion
2011-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Tolvaptan Small molecule 3.75 mg Oral
Subject Tolvaptan Small molecule 7.5 mg Oral

Indications

cirrhosis of liver