Samsca Post Marketing Surveillance Study

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

908 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-07-09

Study Completion Date

2017-06-15

Brief Summary

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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.

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Detailed Description

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This study will be conducted as a prospective, single-arm, multicenter study. Findings on examination, diagnosis, opinions and observations implemented as per general medical practice during the observational period will be documented in the case report forms by the investigators or responsible staffs at the institution since the surveillance is an observational study.

Conditions

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Hypervolemic and Euvolemic Hyponatremia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

1. 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
2. Patients who are prescribed Samsca® treatment as per investigator's medical judgment
3. Patients who gave written authorization to use their personal and health data

Exclusion Criteria

* Subjects presenting with any of the following will not be included in the study:

1. Patients who have been treated with Samsca®
2. Patients with known or suspected hypersensitivity to tolvaptan or to any ingredient of the drug
3. Patients requiring urgent intervention to raise serum sodium acutely.
4. Inability of the patient to sense or appropriately respond to thirst.
5. Hypovolemic hyponatremia
6. Concomitant use of strong CYP3A inhibitors
7. Anuric patients
8. Volume depletion patients
9. Hypernatremia patients
10. Women who are pregnant or possibly pregnant and lactation

Eligible Sex

ALL

Accepts Healthy Volunteers

No