Trials / Completed
CompletedNCT03406286
Samsca PMS in ADPKD Patients
Post-Marketing Surveillance(PMS) of Safety and Efficacy of Samsca® Tablets in Korean Patients With ADPKD
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 2,067 (actual)
- Sponsor
- Korea Otsuka Pharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a Post-Marketing Surveillance study(PMS) of Samsca® tablets in actual use in cases to slow the progression of cyst development and renal insufficiency in accordance with Korean regulations on Risk Management Plan(RMP) and New Drug Re-examination. This survey is a post-marketing, prospective, single-arm, all-cases survey conducted on approved indication, usage, dosage.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tolvaptan |
Timeline
- Start date
- 2016-07-19
- Primary completion
- 2024-12-01
- Completion
- 2024-12-01
- First posted
- 2018-01-23
- Last updated
- 2025-07-24
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT03406286. Inclusion in this directory is not an endorsement.