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Search / Trial NCT05615363

A Dose-ranging Trial of OPC-131461 in Cardiac Edema (Congestive Heart Failure [CHF])

Launched by OTSUKA PHARMACEUTICAL CO., LTD. · Nov 7, 2022

Trial Information

Current as of October 03, 2025

Completed

Keywords

ClinConnect Summary

No description provided

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Subjects with CHF with lower limb edema, pulmonary congestion, or jugular venous distension due to volume overload.
  • Subjects undergoing any of the following diuretic therapies
  • Loop diuretics at a dosage equivalent to 40 mg/day or more of furosemide tablet/fine granule
  • Concomitant administration of a loop diuretic and a thiazide diuretic (including similar drugs) at any doses
  • Concomitant administration of a loop diuretic and a mineralocorticoid receptor antagonist or potassium-sparing diuretic at any doses
  • Subjects who were currently hospitalized or who are able to be hospitalized
  • Exclusion Criteria:
  • Subjects with acute heart failure
  • Subjects with an assisted circulation device
  • Subjects who cannot sense thirst or who have difficulty in ingesting water

About Otsuka Pharmaceutical Co., Ltd.

Otsuka Pharmaceutical Co., Ltd. is a global healthcare company headquartered in Tokyo, Japan, dedicated to the research, development, and commercialization of innovative pharmaceuticals and nutraceuticals. Founded in 1964, Otsuka focuses on addressing unmet medical needs across various therapeutic areas, including psychiatry, neurology, oncology, and cardiovascular health. With a commitment to advancing healthcare through scientific innovation, Otsuka leverages its expertise in drug development and strategic partnerships to deliver groundbreaking therapies that improve patients' quality of life. The company's dedication to sustainability and ethical practices underscores its mission to contribute positively to global health.

Locations

Fukuoka, Japan

Patients applied

0 patients applied

Trial Officials

Takeshi Tsunoda

Study Director

Otsuka Pharmaceutical Co., Ltd.

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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