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

Otsuka

Status and phase: Completed; Phase 3

Conditions: Congestive Heart Failure

Treatments: Drug: OPC-61815 injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT03962101

263-102-00004

JapicCTI-194715 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 45 patients

Sex: All

Ages: 20 to 85 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

45 participants in 1 patient group

OPC-61815 injection

Experimental group

Description:

Intravenous administration of OPC-61815 at 8 mg or 16 mg once daily for a maximum of 5 days. Starting with 8mg, increase the dose to 16mg on Day 2 or Day 3, according to the dose escalation criteria.

Treatment:

Drug: OPC-61815 injection