Samsca PMS in ADPKD Patients

NCT03406286 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 2067

Last updated 2025-07-24

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03406286 on ClinicalTrials.gov