Samsca Post Marketing Surveillance Study

Completed

• Conditions: Hypervolemic and Euvolemic Hyponatremia

• Registration Number: NCT02722863
• Lead Sponsor: Korea Otsuka Pharmaceutical Co., Ltd.

Brief 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.

Detailed Description

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.

Study Timeline

• Study Start: 2013-07-09
• Study First Submitted: 2016-03-18
• Study First Submitted QC: 2016-03-23
• Study First Posted: 2016-03-30
• Primary Completion: 2017-06-15
• Study Completion: 2017-06-15
• Results First Submitted: 2019-01-31
• Status Verified: 2020-02
• Results First Submitted QC: 2020-02-23
• Last Update Submitted: 2020-02-23
• Results First Posted: 2020-03-06
• Last Update Posted: 2020-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 908

Inclusion Criteria

• Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study :

  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
  4. 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:

  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
  11. 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety Measure	4days	Adverse Events (AEs)

Secondary Outcome Measures

Name	Time	Method
Change of the Serum Sodium Level(mEq/L) at the First Visit and Day 4 After the First Visit	Follow-up at least 4 days after first Samsca® dose	In the efficacy analysis set, mean change of serum sodium level (mEq/L)on the 4th day compared to the first visit

Trial Locations

Locations (4)

Daegu Catholic University Medical Center; 🇰🇷 Daegu, Korea, Republic of

Chungnam National University Hospital; 🇰🇷 Daejeon, Korea, Republic of

Bong Seng Hospital; 🇰🇷 Busan, Korea, Republic of

Chung-Ang University Hospital; 🇰🇷 Seoul, Korea, Republic of