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出境医 / 临床实验 / Safety Trial of OPC-61815 Injection in Patients With Congestive Heart Failure Who Have Difficulty With or Are Incapable of Oral Intake

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

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.

Condition or disease Intervention/treatment Phase
Congestive Heart Failure Drug: OPC-61815 injection Phase 3

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : June 17, 2019
Actual Primary Completion Date : June 30, 2020
Actual Study Completion Date : June 30, 2020
Arms and Interventions
Arm Intervention/treatment
Experimental: 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.
 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.
Outcome Measures
Primary Outcome Measures :
  1. Incidence of Adverse events(AEs) [ Time Frame: Screening period to Follow-up period, up to 16 days ]

Secondary Outcome Measures :
  1. Change from baseline in Body weight [ Time Frame: Baseline and 5 days after dosing ]
  2. Make the shift table how lower limb edema is improved from Baseline, to 2, 3, 4, 5 days after dosing. [ Time Frame: Baseline and 2, 3, 4, 5 days after dosing ]
  3. Make the shift table how pulmonary congestion is improved from Baseline, to 2, 3, 4, 5 days after dosing. [ Time Frame: Baseline and 2, 3, 4, 5 days after dosing ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations

Locations
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Japan
Gifu Prefectural General Medical Center
Gifu, Japan
Sponsors and Collaborators
Otsuka Pharmaceutical Co., Ltd.
Investigators
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Study Director: Takehisa Matsumaru Otsuka Pharmaceutical Co., Ltd.
Tracking Information
First Submitted Date  ICMJE April 18, 2019
First Posted Date  ICMJE May 23, 2019
Last Update Posted Date November 18, 2020
Actual Study Start Date  ICMJE June 17, 2019
Actual Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 22, 2019) 		Incidence of Adverse events(AEs) [ Time Frame: Screening period to Follow-up period, up to 16 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 22, 2019)
  • Change from baseline in Body weight [ Time Frame: Baseline and 5 days after dosing ]
  • Make the shift table how lower limb edema is improved from Baseline, to 2, 3, 4, 5 days after dosing. [ Time Frame: Baseline and 2, 3, 4, 5 days after dosing ]
  • Make the shift table how pulmonary congestion is improved from Baseline, to 2, 3, 4, 5 days after dosing. [ Time Frame: Baseline and 2, 3, 4, 5 days after dosing ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety Trial of OPC-61815 Injection in Patients With Congestive Heart Failure Who Have Difficulty With or Are Incapable of Oral Intake
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Congestive Heart Failure
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: 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: Drug: OPC-61815 injection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 16, 2020) 		45
Original Estimated Enrollment  ICMJE
 (submitted: May 22, 2019) 		40
Actual Study Completion Date  ICMJE June 30, 2020
Actual Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03962101
Other Study ID Numbers  ICMJE 263-102-00004
JapicCTI-194715 ( Other Identifier: JapicCTI )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Otsuka Pharmaceutical Co., Ltd.
Study Sponsor  ICMJE Otsuka Pharmaceutical Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Takehisa Matsumaru Otsuka Pharmaceutical Co., Ltd.
PRS Account Otsuka Pharmaceutical Co., Ltd.
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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