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Phase 3 open-label study of OPC-41061 (tolvaptan) for hepatic edema (ascites) in cirrhosis
jRCT2080220951Phase 3
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Start
- Jan 2010
- Modality
- Small Molecules
- Countries
- 1
01
Overview
Phase 3, open-label, single-arm trial of tolvaptan in ascites and Cirrhosis, sponsored by Otsuka Pharmaceutical Co., Ltd. Primary endpoints: Safety of extended 7.5 mg dosing beyond 7 days and Effect of dose escalation to 15 mg.
02
Drugs
tolvaptan
03
Conditions
ascitesCirrhosis
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