Samtasu Post-marketing General Drug Use-results Survey in Patients with Volume Overload in Heart Failure.
NCT05712746 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1600
Last updated 2025-03-21
Summary
To confirm the safety of tolvaptan sodium phosphate in patients with volume overload in heart failure.
Conditions
Interventions
- DRUG
-
Samtasu for I.V. infusion
Drug: 8 mg/vial or 16mg/vial Dosage and Administration: The usual adult dosage of tolvaptan sodium phosphate is 16 mg once daily and intravenously infused over 1 hour.
Sponsors & Collaborators
-
Otsuka Pharmaceutical Co., Ltd.
lead INDUSTRY
Principal Investigators
-
Yasuhiko Fukuta, PhD · Otsuka Pharmaceutical Co., Ltd.
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-03-03
- Primary Completion
- 2025-11-30
- Completion
- 2026-05-31
Countries
- Japan
Study Locations
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