Clinical Pharmacology Trial to Investigate the Dose of OPC-61815 Injection Equivalent to Tolvaptan 15-mg Tablet in Patients With Congestive Heart Failure

A Multicenter, Double-blind, Randomized, Active-controlled, Parallel-group Comparison Clinical Pharmacology Trial to Investigate the Dose of OPC-61815 Injection Equivalent to Tolvaptan 15-mg Tablet in Patients With Congestive Heart Failure

The dose for intravenous administration of OPC-61815 achieving tolvaptan exposure equivalent to that for oral administration of tolvaptan 15-mg tablet will be investigated by administering OPC-61815 injection 2 to 16mg or tolvaptan 15-mg oral tablet to subjects with congestive heart failure.

Inclusion Criteria:

1. 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

2. Subjects with congestive heart failure in whom lower limb edema, pulmonary congestion, and/or jugular venous distension due to volume overload is present

3. Subjects who are currently hospitalized or who are able to be hospitalized during the trial

Exclusion Criteria:

1. Subjects with acute heart failure
2. Subjects with a history of hypersensitivity to any of ingredients of OPC-61815 or tolvaptan
3. Subjects who are unable to sense thirst or who have difficulty with fluid intake