At a glance
ClinicalIndex Comparison RecordN/ACompleted· 908 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Post Marketing Surveillance Study of Safety and Efficacy of Samsca® Tablets Under the "New Drug Re-Examination"
In Brief
An observational study for Hypervolemic and Euvolemic Hyponatremia. Completed, enrolled 908 participants across 4 sites.
Detailed 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.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsHypervolemic and Euvolemic Hyponatremia
CountriesSouth Korea
Collaborators--
Timeline
N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartJul 2013
First PostedMar 2016
Primary CompletionJun 2017
TodayJul 2026
First PostedMar 30, 2016
Enrollment StartJul 9, 2013
Primary CompletionJun 15, 2017
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 10.3 years ago