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

Congestive Heart Failure Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03962101
• Other study ID #: 263-102-00004
• Secondary ID: JapicCTI-194715
• Status: Completed
• Phase: Phase 3
• Start date: June 17, 2019
• Est. completion date: June 30, 2020

Study information

• Verified date: August 2021
• Source: Otsuka Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: June 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 85 Years

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)

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Japan	Gifu Prefectural General Medical Center	Gifu

Sponsors (1)

Lead Sponsor	Collaborator
Otsuka Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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