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Samsca Post-marketing General Drug Use-results Survey in Patients With Hyponatremia in SIADH

NCT04790175 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2026-06-22

No results posted yet for this study

Summary

The purpose of this study is to confirm the safety of tolvaptan in patients with hyponatremia in syndrome of inappropriate antidiuretic hormone secretion (SIADH) in Japan

Conditions

  • Antidiuretic Hormone, Inappropriate Secretion

Interventions

DRUG

Tolvaptan (SAMSCA)

The usual adult dose of SAMSCA is 7.5 mg of tolvaptan once daily administered orally, increased stepwise to 60 mg daily until a desirable level of serum sodium concentration is achieved.

Sponsors & Collaborators

  • Otsuka Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Yasuhiko Fukuta, PhD · Otsuka Pharmaceutical Co., Ltd.

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-29
Primary Completion
2026-01-19
Completion
2030-01-31
FDA Drug
Yes

Countries

  • Japan

Study Locations

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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 NCT04790175 on ClinicalTrials.gov