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Samsca Post-marketing General Drug Use-results Survey in Patients with Hyponatremia in SIADH
Sponsor: Otsuka Pharmaceutical Co., Ltd.
Summary
The purpose of this study is to confirm the safety of tolvaptan in patients with hyponatremia in syndrome of inappropriate antidiuretic hormone secretion (SIADH) in Japan
Official title: Samsca Post-marketing General Drug Use-results Survey in Patients with Hyponatremia in Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH) in Japan
Key Details
Gender
All
Age Range
Any - Any
Study Type
OBSERVATIONAL
Enrollment
300
Start Date
2021-03-29
Completion Date
2030-01
Last Updated
2025-03-24
Healthy Volunteers
No
Interventions
Tolvaptan (SAMSCA)
The usual adult dose of SAMSCA is 7.5 mg of tolvaptan once daily administered orally, increased stepwise to 60 mg daily until a desirable level of serum sodium concentration is achieved.
Locations (1)
Pharmacovigilance Department
Osaka, Osaka, Japan