Safety Trial of OPC-61815 Injection in Patients With Congestive Heart Failure Who Have Difficulty With or Are Incapable of Oral Intake

• Status: Completed
• Trial end date: 2020-06-30
• Target enrollment: 0
• Participant gender: All

Summary

To confirm the tolerability of intravenous administration of OPC-61815 at 8 or 16 mg once daily for a maximum of 5 days to CHF patients with volume overload despite having received diuretics (injection) other than vasopressin antagonists and who have difficulty with or are incapable of oral intake.

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

Details

• Lead Sponsor: Otsuka Pharmaceutical Co., Ltd.

Criteria

Inclusion Criteria:

• Patients receiving loop diuretic injection at a dose equivalent to furosemide 20 mg/day or higher

• CHF patients in whom lower limb edema, pulmonary congestion, and/or jugular venous distension due to volume overload is present

• Patients who are judged by the investigator or subinvestigator to have difficulty or be incapable of oral intake, including patients who are judged by the investigator or subinvestigator to require nothing by mouth(NPO) management

• Patients who are currently hospitalized or who are capable of being hospitalized from the time of informed consent until the end of the treatment period

• Patients who are capable of giving informed consent

Exclusion Criteria:

• Patients who are on a ventricular assist device

• Patients who have difficulty with spontaneous respiration or who have been on tracheal intubation under sedative therapy

• Patients with severe disturbed consciousness (ie, coma or stupor)