Clinical Pharmacology Trial to Investigate the Dose of OPC-61815 Injection Equivalent to Tolvaptan 15-mg Tablet in Patients With Congestive Heart Failure
Congestive Heart Failure
About this trial
This is an interventional treatment trial for Congestive Heart Failure
Eligibility Criteria
Inclusion Criteria:
Subjects who are currently on treatment with any of the following diuretics
- Loop diuretics equivalent to furosemide tablet or fine granules at a dose of 40 mg/day or higher
- Concomitant use of a loop diuretic and a thiazide diuretic (including thiazide analogs) at any dose
- Concomitant use of a loop diuretic and an aldosterone antagonist or potassium-sparing diuretic agent at any dose
- Subjects with congestive heart failure in whom lower limb edema, pulmonary congestion, and/or jugular venous distension due to volume overload is present
- Subjects who are currently hospitalized or who are able to be hospitalized during the trial
Exclusion Criteria:
- Subjects with acute heart failure
- Subjects with a history of hypersensitivity to any of ingredients of OPC-61815 or tolvaptan
- Subjects who are unable to sense thirst or who have difficulty with fluid intake
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Experimental
Experimental
Experimental
Active Comparator
OPC-61815 injection 2mg
OPC-61815 injection 4mg
OPC-61815 injection 8mg
OPC-61815 injection 16mg
Tolvaptan tablet 15mg
Once daily for 5 days placebo tablet will be orally administered, followed immediately by intravenous administration of OPC-61815 at 2 mg.
Once daily for 5 days placebo tablet will be orally administered, followed immediately by intravenous administration of OPC-61815 at 4 mg.
Once daily for 5 days placebo tablet will be orally administered, followed immediately by intravenous administration of OPC-61815 at 8 mg.
Once daily for 5 days placebo tablet will be orally administered, followed immediately by intravenous administration of OPC-61815 at 16 mg.
Once daily for 5 days tolvaptan 15-mg tablet will be orally administered, followed immediately by 1-hour intravenous administration of placebo.