Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03962101
Recruitment Status : Recruiting
First Posted : May 23, 2019
Last Update Posted : May 23, 2019
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Co., Ltd.

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 8 mg Drug: OPC-61815 injection 16 mg Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel 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
Estimated Study Start Date : June 2019
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: OPC-61815 injection 8 mg
Intravenous administration of OPC-61815 at 8 mg once daily for a maximum of 5 days
Drug: OPC-61815 injection 8 mg
once daily for a maximum of 5 days

Experimental: OPC-61815 injection 16 mg
Intravenous administration of OPC-61815 at 16 mg once daily for a maximum of 5 days
Drug: OPC-61815 injection 16 mg
once daily for a maximum of 5 days




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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03962101


Contacts
Layout table for location contacts
Contact: Drug Information Center +81-3-6361-7314

Locations
Layout table for location information
Japan
Gifu Prefectural General Medical Center Recruiting
Gifu, Japan
Sponsors and Collaborators
Otsuka Pharmaceutical Co., Ltd.
Investigators
Layout table for investigator information
Study Director: Osamu Sato Otsuka Pharmaceutical Co., Ltd.

Layout table for additonal information
Responsible Party: Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT03962101     History of Changes
Other Study ID Numbers: 263-102-00004
First Posted: May 23, 2019    Key Record Dates
Last Update Posted: May 23, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Failure
Heart Diseases
Cardiovascular Diseases