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

NCT ID: NCT03962101

Last Updated: 2021-09-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-17
• Study Completion Date: 2020-06-30

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.

Conditions

Congestive Heart Failure

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

OPC-61815 injection

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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)

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Otsuka Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Takehisa Matsumaru

Role: STUDY_DIRECTOR

Otsuka Pharmaceutical Co., Ltd.

Locations

Gifu Prefectural General Medical Center

Gifu, , Japan

Countries

Japan

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

JapicCTI-194715

Identifier Type: OTHER

Identifier Source: secondary_id

263-102-00004

Identifier Type: -

Identifier Source: org_study_id