A Dose-ranging Trial of OPC-131461 in Cardiac Edema (CHF)

JRCT ID: jRCT2071220069

Registered date:22/11/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Cardiac Edema (CHF)
• Date of first enrollment: 10/01/2023
• Target sample size: 155
• Study type: Interventional
• Intervention(s): once-daily oral administration of 1, 2, 5, or 10 mg/day of OPC-131461

Outcome(s)

Primary Outcome

Change in body weight from baseline to last assessment time point (the day after investigational
medicinal product [IMP] administration) by Day 8

Secondary Outcome

Change in body weight from baseline to last assessment time point (the day after IMP administration) by Day 15
Safety:Adverse events
Pharmacodynamic endpoint:Urine volume/fluid intake/fluid balance
Pharmacokinetic endpoint:Plasma concentrations and PK parameters of OPC-131461 and its metabolites

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 89age old
• Gender: Both

Include criteria

1)Subjects with CHF with lower limb edema, pulmonary congestion, or jugular venous distension due to volume overload.
2)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
3)Subjects who were currently hospitalized or who are able to be hospitalized

Exclude criteria

1.Subjects with acute heart failure
2.Subjects with an assisted circulation device
3.Subjects who cannot sense thirst or who have difficulty in ingesting water

Related Information

• Primary Sponsor: Tsunoda Takeshi