Cardiac Edema (CHF)
Conditions
Interventions
once-daily oral administration of 1, 2, 5, or 10 mg/day of OPC-131461
Sponsors
Tsunoda Takeshi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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
Exclusion criteria
Exclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in body weight from baseline to last assessment time point (the day after investigational medicinal product [IMP] administration) by Day 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Contacts
Public ContactDrug Information Center
Otsuka Pharmaceutical Co., LTD.
Outcome results
None listed