NCT03962101

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jun 2019

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 18, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 23, 2019

Completed
25 days until next milestone

Study Start

First participant enrolled

June 17, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

September 5, 2021

Completed
Last Updated

September 5, 2021

Status Verified

August 1, 2021

Enrollment Period

1 year

First QC Date

April 18, 2019

Results QC Date

July 15, 2021

Last Update Submit

August 9, 2021

Conditions

Congestive Heart Failure

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Change From Baseline in Body Weight

    Baseline, Day after final IMP administration

  • Improvement Rate for Lower Limb Edema

    Baseline, Day after final IMP administration

  • Improvement Rate for Pulmonary Congestion

    Baseline, Day after final IMP administration

Study Arms (1)

OPC-61815 injection

EXPERIMENTAL

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

Interventions

OPC-61815 injectionDRUG

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.

OPC-61815 injection

Eligibility Criteria

Age20 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gifu Prefectural General Medical Center

Gifu, Japan

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Results Point of Contact

Title
Director of Clinical Trials
Organization
Otsuka Pharmaceutical Co., LTD.
CL_OPCJ_RDA_Team@otsuka.jp
+81-3-6361-7366

Study Officials

  • Takehisa Matsumaru

    Otsuka Pharmaceutical Co., Ltd.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2019

First Posted

May 23, 2019

Study Start

June 17, 2019

Primary Completion

June 30, 2020

Study Completion

June 30, 2020

Last Updated

September 5, 2021

Results First Posted

September 5, 2021

Record last verified: 2021-08

Locations

JP(1)