Samsca Post Marketing Surveillance Study

Hypervolemic and Euvolemic Hyponatremia Clinical Trial

— Samsca PMS  

Official title:

Post Marketing Surveillance Study of Safety and Efficacy of Samsca® Tablets Under the "New Drug Re-Examination"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02722863
• Other study ID #: 156-KOA-1201n
• Status: Completed
• Start date: July 9, 2013
• Est. completion date: June 15, 2017

Study information

• Verified date: February 2020
• Source: Korea Otsuka Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 908
• Est. completion date: June 15, 2017
• Est. primary completion date: June 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Hypervolemic and Euvolemic Hyponatremia
• Hyponatremia

Locations

Country	Name	City	State
Korea, Republic of	Bong Seng Hospital	Busan
Korea, Republic of	Daegu Catholic University Medical Center	Daegu
Korea, Republic of	Chungnam National University Hospital	Daejeon
Korea, Republic of	Chung-Ang University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Korea Otsuka Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety Measure	Adverse Events (AEs)	4days
Secondary	Change of the Serum Sodium Level(mEq/L) at the First Visit and Day 4 After the First Visit	In the efficacy analysis set, mean change of serum sodium level (mEq/L)on the 4th day compared to the first visit	Follow-up at least 4 days after first Samsca® dose