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NCT05615363
A Dose-ranging Trial of OPC-131461 in Cardiac Edema (Congestive Heart Failure [CHF])
Conditions: Cardiac Edema (CHF)
Sex: All
Ages: 18 Years – 85 Years
Phase: PHASE2
Enrollment: 155
Sponsor: Otsuka Pharmaceutical Co., Ltd.
Location: Japan
Summary
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 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 therapiesLoop diuretics at a dosage equivalent to 40 mg/day or more of furosemide tablet/fine granuleConcomitant administration of a loop diuretic and a thiazide diuretic (including similar drugs) at any dosesConcomitant administration of a loop diuretic and a mineralocorticoid receptor antagonist or potassium-sparing diuretic at any dosesSubjects who were currently hospitalized or who are able to be hospitalizedExclusion Criteria:Subjects with acute heart failureSubjects with an assisted circulation deviceSubjects who cannot sense thirst or who have difficulty in ingesting water
Source: ClinicalTrials.gov (NCT05615363). StuddyBuddy aggregates publicly available trial information.