Samsca Post Marketing Surveillance Study (Samsca PMS)

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

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.

Study Overview

• Status: Completed
• Conditions: Hypervolemic and Euvolemic Hyponatremia

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 Type: Observational
• Enrollment (Actual): 908

Contacts and Locations

Study Locations

• Korea, Republic of
  • Busan, Korea, Republic of, 47889
    • Bong Seng Hospital
  • Daegu, Korea, Republic of, 42472
    • Daegu Catholic University Medical Center
  • Daejeon, Korea, Republic of, 35015
    • Chungnam National University Hospital
  • Seoul, Korea, Republic of, 06973
    • Chung-Ang University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The treatment of clinically significant hypervolemic and euvolemic hyponatremia [serum sodium < 125 mEq/L or hyponatremia that is symptomatic and has resisted correction with fluid restriction], including patients with heart failure, cirrhosis, Syndrome of Inappropriate Antidiuretic Hormone (SIADH) and etc.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Measure	Adverse Events (AEs)	4days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Korea Otsuka Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): July 9, 2013
• Primary Completion (Actual): June 15, 2017
• Study Completion (Actual): June 15, 2017

Study Registration Dates

• First Submitted: March 18, 2016
• First Submitted That Met QC Criteria: March 23, 2016
• First Posted (Estimate): March 30, 2016

Study Record Updates

• Last Update Posted (Actual): March 6, 2020
• Last Update Submitted That Met QC Criteria: February 23, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Water-Electrolyte Imbalance; Hyponatremia
• Other Study ID Numbers: 156-KOA-1201n

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided