Clinical trial
Samsca Post-marketing General Drug Use-results Survey in Patients With Hyponatremia in Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH) in Japan
Name
156-101-00348
Description
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
Trial arms
Trial start
2021-03-29
Estimated PCD
2028-08-01
Trial end
2030-01-01
Status
Recruiting
Treatment
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.
Size
300
Primary endpoint
Safety Information (Adverse Event)
90 days from the initiation of tolvaptan treatment
Safety Information (Special Situations)
90 days from the initiation of tolvaptan treatment
Safety Information (Number of off-Label Use)
90 days from the initiation of tolvaptan treatment
Safety Information (Serious Adverse Event)
90 days from the initiation of tolvaptan treatment
Safety Information (Non-serious Adverse Events)
90 days from the initiation of tolvaptan treatment
Eligibility criteria
Inclusion Criteria:
* Subjects with a definite diagnosis of SIADH in reference to "Diagnostic and Treatment Manual of the Hypersecretion of Vasopressin (SIADH), Revised in 2018"
Exclusion Criteria:
-
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 300, 'type': 'ESTIMATED'}}
Updated at
2023-11-02
1 organization
1 product
2 indications
Organization
Otsuka PharmaceuticalProduct
TolvaptanIndication
VasopressinIndication
Inappropriate Secretion