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

SexALL

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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
✕. Anuric patients
✕. Volume depletion patients

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