A Dose-ranging Trial of OPC-131461 in Cardiac Edema (CHF)
- Conditions
- Cardiac Edema (CHF)
- Registration Number
- JPRN-jRCT2071220069
- Lead Sponsor
- Matsumaru Takehisa
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 155
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in body weight from baseline to last assessment time point (the day after investigational<br>medicinal product [IMP] administration) by Day 8
- Secondary Outcome Measures
Name Time Method Change in body weight from baseline to last assessment time point (the day after IMP administration) by Day 15<br>Safety:Adverse events<br>Pharmacodynamic endpoint:Urine volume/fluid intake/fluid balance<br>Pharmacokinetic endpoint:Plasma concentrations and PK parameters of OPC-131461 and its metabolites