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

Phase 3

Completed

Brief 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.

Recruitment & Eligibility

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)

Arm && Interventions

Group	Intervention	Description
OPC-61815 injection	OPC-61815 injection	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.

Primary Outcome Measures

Name	Time	Method
Percentage of Subjects With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs	From the start of IMP administration (Day 1) up to 15 days	"An AE is defined as any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. A serious AE (SAE) is an AE that leads to death, is life-threatening, results in persistent or significant disability/incapacity, requires in-patient or prolonged hospitalization, results in a congenital anomaly/birth defect, or any other important medical event which is medically significant. A TEAE is an AE that occurs only after a subject has received IMP.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Body Weight	Baseline, Day after final IMP administration	Change in body weight from baseline (before IMP administration on Day 1) at time of final IMP administration (day after final IMP administration). A negative change from baseline indicates improvement.
Improvement Rate for Lower Limb Edema	Baseline, Day after final IMP administration	The improvement rate was defined as the percentage of subjects in whom a symptom was present at baseline and then markedly improved or improved after IMP administration. Improvement category is a 4-point scale below: * Markedly improved * Improved * Unchanged * Deteriorated
Improvement Rate for Pulmonary Congestion	Baseline, Day after final IMP administration	The improvement rate was defined as the percentage of subjects in whom a symptom was present at baseline and then markedly improved or improved after IMP administration. Improvement category is a 4-point scale below: * Markedly improved * Improved * Unchanged * Deteriorated