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Samsca Post Marketing Surveillance Study (Samsca PMS)

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ClinicalTrials.gov Identifier: NCT02722863
Recruitment Status : Completed
First Posted : March 30, 2016
Last Update Posted : August 14, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
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.

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Study Type : Observational
Actual Enrollment : 908 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Post Marketing Surveillance Study of Safety and Efficacy of Samsca® Tablets Under the "New Drug Re-Examination"
Actual Study Start Date : July 9, 2013
Actual Primary Completion Date : June 15, 2017
Actual Study Completion Date : June 15, 2017



Primary Outcome Measures :
  1. The numbers of subjects presenting at least one adverse event/adverse drug reaction, at least one serious adverse event/adverse drug reaction, or at least one unexpected adverse event/adverse drug reaction. [ Time Frame: Follow-up at least 4 days after first Samsca® dose ]
  2. The percentage of subjects presenting at least one adverse event/adverse drug [ Time Frame: Follow-up at least 4 days after first Samsca® dose ]
  3. The incidence rate of subjects presenting at least one adverse event/adverse drug [ Time Frame: Follow-up at least 4 days after first Samsca® dose ]

Secondary Outcome Measures :
  1. The number of subjects who discontinued Samsca® (inc.due to an adverse event) [ Time Frame: Follow-up at least 4 days after first Samsca® dose ]
  2. The percentage of subjects who discontinued Samsca® (inc.due to an adverse event) [ Time Frame: Follow-up at least 4 days after first Samsca® dose ]
  3. Change of the serum sodium level at the first visit and Day 4 after the first visit [ Time Frame: Follow-up at least 4 days after first Samsca® dose ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02722863


Locations
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Korea, Republic of
Bong Seng Hospital
Busan, Korea, Republic of, 47889
Daegu Catholic University Medical Center
Daegu, Korea, Republic of, 42472
Chungnam National University Hospital
Daejeon, Korea, Republic of, 35015
Chung-Ang University Hospital
Seoul, Korea, Republic of, 06973
Sponsors and Collaborators
Korea Otsuka Pharmaceutical Co., Ltd.

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Responsible Party: Korea Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT02722863     History of Changes
Other Study ID Numbers: 156-KOA-1201n
First Posted: March 30, 2016    Key Record Dates
Last Update Posted: August 14, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Hyponatremia
Water-Electrolyte Imbalance
Metabolic Diseases