Trials / Completed
CompletedNCT02722863
Samsca Post Marketing Surveillance Study
Post Marketing Surveillance Study of Safety and Efficacy of Samsca® Tablets Under the "New Drug Re-Examination"
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 908 (actual)
- Sponsor
- Korea Otsuka Pharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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.
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
Timeline
- Start date
- 2013-07-09
- Primary completion
- 2017-06-15
- Completion
- 2017-06-15
- First posted
- 2016-03-30
- Last updated
- 2020-03-06
- Results posted
- 2020-03-06
Locations
4 sites across 1 country: South Korea
Source: ClinicalTrials.gov record NCT02722863. Inclusion in this directory is not an endorsement.