clinical trial · NCT03406286
Samsca PMS in ADPKD Patients
Korea Otsuka Pharmaceutical Co., Ltd.·—·completed·n = 2,067
SafetyTolvaptan
brief 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.
started
Jul 19, 2016
primary completion
Dec 1, 2024
completion
Dec 1, 2024
last updated
Jul 24, 2025
official title
Post-Marketing Surveillance(PMS) of Safety and Efficacy of Samsca® Tablets in Korean Patients With ADPKD
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol