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

• Status: Completed
• Trial end date: 2020-07-29
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Otsuka Pharmaceutical Co., Ltd.
• Treatments: Tolvaptan

Criteria

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