Samsca PMS in ADPKD Patients
NCT03406286 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 2067
Last updated 2025-07-24
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
- Safety
Interventions
- DRUG
-
Tolvaptan
Sponsors & Collaborators
-
Korea Otsuka Pharmaceutical Co., Ltd.
lead INDUSTRY
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-07-19
- Primary Completion
- 2024-12-31
- Completion
- 2024-12-31
Countries
- South Korea
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