Samsca Post Marketing Surveillance Study

NCT02722863 | Completed Results DMC

• 1 other identifier: 156-KOA-1201n
• Study Type: observational
• Target: 908
• Locations: 1 country
• Sites: 4

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.

Conditions

Hypervolemic and Euvolemic Hyponatremia

Outcome Measures

Primary Outcomes (1)

• Safety Measure

  Adverse Events (AEs)

  4days

Secondary Outcomes (1)

• 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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Korea Otsuka Pharmaceutical Co., Ltd.: lead

Study Sites (4)

Bong Seng Hospital

Busan, 47889, South Korea

Location

Daegu Catholic University Medical Center

Daegu, 42472, South Korea

Location

Chungnam National University Hospital

Daejeon, 35015, South Korea

Location

Chung-Ang University Hospital

Seoul, 06973, South Korea

Location

Results Point of Contact

• Title: Huiyeong,Shim/Associate CTM for LPS & ISS
• Organization: Korea Otsuka Pharmaceutical Co.,Ltd.

hyshim@otsuka.co.kr

02-3287-9220

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2016
• First Posted: March 30, 2016
• Study Start: July 9, 2013
• Primary Completion: June 15, 2017
• Study Completion: June 15, 2017
• Last Updated: March 6, 2020
• Results First Posted: March 6, 2020

Record last verified: 2020-02

Locations

KR (4)