RecruitingNCT05712746

Samtasu Post-marketing General Drug Use-results Survey in Patients with Volume Overload in Heart Failure.


Sponsor

Otsuka Pharmaceutical Co., Ltd.

Enrollment

1,600 participants

Start Date

Mar 3, 2023

Study Type

OBSERVATIONAL

Conditions

Summary

To confirm the safety of tolvaptan sodium phosphate in patients with volume overload in heart failure.


Eligibility

Min Age: 18 Years

Inclusion Criteria1

  • \-

Exclusion Criteria1

  • patients with a known hypersensitivity to Tolvaptan sodium phosphate or Tolvaptan

Interventions

DRUGSamtasu 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.


Locations(1)

Pharmacovigilance Department

Osaka, Japan

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NCT05712746


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