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

Study Overview
=================
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.

Official Title
-----------------
A Multicenter, Open-label, Uncontrolled Clinical Trial to Confirm the Tolerability of OPC-61815 in Patients With Congestive Heart Failure Who Have Difficulty With or Are Incapable of Oral Intake

Conditions
-----------------
Congestive Heart Failure

Intervention / Treatment
-----------------
* Drug: OPC-61815 injection


Participation Criteria
=================
Eligibility 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)

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OPC-61815 injection<br>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. | Drug: OPC-61815 injection<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Subjects With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs | 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. | From the start of IMP administration (Day 1) up to 15 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Body Weight | 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. | Baseline, Day after final IMP administration | 
| Improvement Rate for Lower Limb Edema | 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 | Baseline, Day after final IMP administration | 
| Improvement Rate for Pulmonary Congestion | 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 | Baseline, Day after final IMP administration |