Hypervolemic and Euvolemic HyponatremiaSamsca PMSNCT02722863
Samsca Post Marketing Surveillance Study
An observational study of Hypervolemic and Euvolemic Hyponatremia, run by Korea Otsuka Pharmaceutical Co., Ltd. at 4 sites in South Korea.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hypervolemic and Euvolemic Hyponatremia
- How many people
- 908 participants
- Where
- 4 sitesSouth Korea
- Study dates
- 9 Jul 2013to 15 Jun 2017
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study :
- 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
- Patients starting Samsca® treatment after agreement is in place Investigators will refer to the product market authorization (label) for inclusion criteria.
Who cannot join
- 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
Show all 12Show fewer
- Concomitant use of strong CYP3A inhibitors
- Anuric patients
- Volume depletion patients
- Hypernatremia patients
- Women who are pregnant or possibly pregnant and lactation
- 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.
Trial locations and contacts
4 sites in 1 country.
South Korea4 sites
Bong Seng Hospital
Busan, 47889
Daegu Catholic University Medical Center
Daegu, 42472
Chungnam National University Hospital
Daejeon, 35015
Chung-Ang University Hospital
Seoul, 06973
About this study
Official title: 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.
Read the 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.
- Conditions
- Hypervolemic and Euvolemic Hyponatremia
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Measure
Adverse Events (AEs)
Measured: 4days
Secondary outcomes (1)
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
Measured: Follow-up at least 4 days after first Samsca® dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2016 (estimated)
- Study start9 Jul 2013
- Primary completion15 Jun 2017
- Study completion15 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hypervolemic and Euvolemic HyponatremiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 908 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korea Otsuka Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02722863
- Sponsor's protocol ID
- 156-KOA-1201n
- Acronym
- Samsca PMS
- Status last verified
- Feb 2020
- First submitted
- 18 Mar 2016
- Last updated
- 6 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Marketing Surveillance Study of Safety and Efficacy of Samsca® Tablets Under the "New Drug Re-Examination"
- ClinicalTrials.gov ID
- NCT02722863
- Acronym / sponsor ID
- Samsca PMS / 156-KOA-1201n
- Conditions
- Hypervolemic and Euvolemic Hyponatremia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 908 participants (actual)
- Lead sponsor
- Korea Otsuka Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 Jul 2013 (actual)
- Primary completion
- 15 Jun 2017 (actual)
- Study completion
- 15 Jun 2017 (actual)
- First posted
- 30 Mar 2016 (estimated)
- Results
- Posted 6 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study :
Key exclusion criteria (12 listed)
- Subjects presenting with any of the following will not be included in the study:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Safety Measure
Time frame: 4days
Adverse Events (AEs)
1 secondary outcome
Change of the Serum Sodium Level(mEq/L) at the First Visit and Day 4 After the First Visit
Time frame: Follow-up at least 4 days after first Samsca® dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypervolemic and Euvolemic Hyponatremia, run by Korea Otsuka Pharmaceutical Co., Ltd. at 4 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety Measure (time frame: 4days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2020.