Please sign in to follow a disease.
Japanese study monitors safety of samsca for SIADH patients
NCT ID NCT04790175
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tracks the safety of the drug Samsca (tolvaptan) in 300 Japanese patients with low sodium levels caused by SIADH. Researchers will record any side effects or special situations that occur during routine use. The goal is to confirm the drug's safety in real-world settings.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Tolvaptan (Samsca)
- What this could lead to
- If successful, this study will confirm that Samsca is safe for treating low sodium in SIADH patients in Japan, supporting its continued use.
- What could go wrong
- This is an observational safety study, not a test of how well the drug works. It may not lead to new treatments or change current practice.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
-
About 300 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Mar 2021
- Expected to finish
-
Jan 2030
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Patients in Japan with hyponatremia in SIADH who are planned to be newly started on Samsca therapy
- Ages
-
Children (under 18), adults (18 to 64) and older adults (65 and over)
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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: \-
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Antidiuretic hormone, inappropriate secretion are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Pharmacovigilance Department
Osaka, Osaka, 540-0021, Japan