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

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

Non Recruiting
18-89 years
All
Phase 2

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Overview

To investigate the dose response in respect of weight decrease following repeated oral administration of OPC-131461 at 1, 2, 5, and 10 mg or placebo in patients with CHF with volume overload despite having received diuretics other than vasopressin antagonists

Eligibility

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

Study details
    Cardiac Edema (CHF)

NCT05615363

Otsuka Pharmaceutical Co., Ltd.

20 August 2025

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