CompletedNot Applicable

Samsca Post Marketing Surveillance Study

South Korea908 participantsStarted 2013-07-09

Plain-language summary

This Post-Marketing Surveillance will be conducted in accordance with the local regulation of New Drug Re-examination. The surveillance will be conducted for 6 years of the re-examination period (01Sep2011\~31Aug2017). Each subject will be observed at least for 4 days during the surveillance period.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Patients who have hyponatremia in euvolemic or hypervolemic states, defined as serum sodium level \< 125 mEq/L or hyponatremia that is symptomatic and has resisted correction with fluid restriction
. Patients who are prescribed Samsca® treatment as per investigator's medical judgment
. Patients who gave written authorization to use their personal and health data
. Patients starting Samsca® treatment after agreement is in place Investigators will refer to the product market authorization (label) for inclusion criteria.

Exclusion criteria

. Patients who have been treated with Samsca®
. Patients with known or suspected hypersensitivity to tolvaptan or to any ingredient of the drug
. Patients requiring urgent intervention to raise serum sodium acutely.
. Inability of the patient to sense or appropriately respond to thirst.
. Hypovolemic hyponatremia
. Concomitant use of strong CYP3A inhibitors

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Safety Measure

Timeframe: 4days

Trial details

NCT IDNCT02722863

SponsorKorea Otsuka Pharmaceutical Co., Ltd.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2017-06-15

Results submitted2019-01-31

View on ClinicalTrials.gov More Hypervolemic and Euvolemic Hyponatremia trials