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

• Status: Recruiting
• Trial end date: 2024-03-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Otsuka Pharmaceutical Co., Ltd.

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