N/A
N=908
Samsca Post Marketing Surveillance Study
Hypervolemic and Euvolemic Hyponatremia
Bottom Line
View on ClinicalTrials.gov: NCT02722863 ↗Enrolled (actual)
908
Serious AEs
1.5%
Results posted
Mar 2020
Primary outcome: Primary: Safety Measure — 17.37 percentage of AE
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Korea Otsuka Pharmaceutical Co., Ltd.
- Primary completion
- Jun 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety Measure |
17.37 | — |
| SECONDARY Change of the Serum Sodium Level(mEq/L) at the First Visit and Day 4 After the First Visit |
123.78; 134.83 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study :
- 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
- Subjects presenting with any of the following will not be included in the study:
- 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
- Hypernatremia patients
- Women who are pregnant or possibly pregnant and lactation
- Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption Investigators will refer to the product market authorization (label) for exclusion criteria.
Data sourced from ClinicalTrials.gov (NCT02722863). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.