drugset / Trial / NCT03048747

A Multicenter Trial to Investigate the Efficacy and Safety of Tolvaptan in Patients With Hyponatremia in SIADH

NCT03048747

Phase 3 Completed 16 enrolled Otsuka Pharmaceutical Co., Ltd.
NaSingle-groupOpen-labelTreatment

Summary

The objective of this study is to investigate the efficacy and safety of tolvaptan based on the change in serum sodium concentration following administration of tolvaptan oral tablets at 7.5 to 60 mg/day for up to 30 days in patients with hyponatremia in the SIADH.

Timeline

Start
2017-03-02
Primary completion
2019-03-19
Completion
2019-03-19

Drugs

EvaluationDrugModalityDoseRoute
Subject Tolvaptan Small molecule 7.5 mg Oral
Subject Tolvaptan Small molecule 15 mg Oral
Subject Tolvaptan Small molecule 30 mg Oral
Subject Tolvaptan Small molecule 60 mg Oral