Efficacy and Safety Trial of OPC-61815 Injection Compared With Tolvaptan 15-mg Tablet in Patients With Congestive Heart Failure

A Multicenter, Double-blind, Randomized, Active-controlled, Parallel-group, Non-inferiority Trial to Evaluate the Efficacy and Safety of OPC-61815 Injection Compared With Tolvaptan 15-mg Tablet in Patients With Congestive Heart Failure

To confirm the non-inferiority of OPC-61815 16-mg injection to tolvaptan 15-mg tablet using as the primary endpoint the change in body weight following 5-day intravenous administration of OPC-61815 16-mg injection or 5-day oral administration of tolvaptan 15-mg tablet to CHF patients with volume overload despite having received diuretics other than vasopressin antagonists

Inclusion Criteria:

• Patients who are currently on treatment with any of the following diuretics

  1. Loop diuretics equivalent to furosemide tablet or fine granules at a dose of 40 mg/day or higher
  2. Concomitant use of a loop diuretic and a thiazide diuretic (including thiazide analogs) at any dose
  3. Concomitant use of a loop diuretic and an aldosterone antagonist or potassium-sparing diuretic agent at any dose

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

• Patients who are currently hospitalized or who are able to be hospitalized during the trial

Exclusion Criteria:

• Patients with acute heart failure
• Patients who are on a ventricular assist device
• Patients who are unable to sense thirst or who have difficulty with fluid intake