CompletedPhase 2

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

Japan157 participantsStarted 2023-01-10

Plain-language 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

Who can participate

Age range18 Years – 89 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Change in Body Weight From Baseline to Last Assessment Time Point (the Day After IMP Administration) by Day 8

Timeframe: Baseline, Day 8

Trial details

NCT IDNCT05615363

SponsorOtsuka Pharmaceutical Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-10-21

Results submitted2025-09-29

View on ClinicalTrials.gov More Cardiac Edema (CHF) trials