Safety Trial of OPC-61815 Injection in Patients With Congestive Heart Failure Who Have Difficulty With or Are Incapable of Oral Intake
Primary Purpose
Congestive Heart Failure
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
OPC-61815 injection
Sponsored by
About this trial
This is an interventional treatment trial for Congestive Heart Failure
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)
Sites / Locations
- Gifu Prefectural General Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
OPC-61815 injection
Arm 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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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
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
Full Information
NCT ID
NCT03962101
First Posted
April 18, 2019
Last Updated
August 9, 2021
Sponsor
Otsuka Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03962101
Brief Title
Safety Trial of OPC-61815 Injection in Patients With Congestive Heart Failure 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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
June 17, 2019 (Actual)
Primary Completion Date
June 30, 2020 (Actual)
Study Completion Date
June 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Otsuka Pharmaceutical Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congestive Heart Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
OPC-61815 injection
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
OPC-61815 injection
Intervention 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.
Primary Outcome Measure Information:
Title
Percentage of Subjects With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs
Description
"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.
Time Frame
From the start of IMP administration (Day 1) up to 15 days
Secondary Outcome Measure Information:
Title
Change From Baseline in Body Weight
Description
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.
Time Frame
Baseline, Day after final IMP administration
Title
Improvement Rate for Lower Limb Edema
Description
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
Time Frame
Baseline, Day after final IMP administration
Title
Improvement Rate for Pulmonary Congestion
Description
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
Time Frame
Baseline, Day after final IMP administration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Takehisa Matsumaru
Organizational Affiliation
Otsuka Pharmaceutical Co., Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Gifu Prefectural General Medical Center
City
Gifu
Country
Japan
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Safety Trial of OPC-61815 Injection in Patients With Congestive Heart Failure Who Have Difficulty With or Are Incapable of Oral Intake
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