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Completed

NCT Number: NCT03962101

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

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.

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Key information

Conditions

Congestive Heart Failure Cardiovascular Diseases Heart Diseases Heart Failure

Age range

20 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Gifu Prefectural General Medical Center

Gifu, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

OPC-61815 injection

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.

Primary outcomes

  1. Percentage of Subjects With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs

    Time frame: From the start of IMP administration (Day 1) up to 15 days

    "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 outcomes

  1. Change From Baseline in Body Weight

    Time frame: Baseline, Day after final IMP administration

    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.

  2. Improvement Rate for Lower Limb Edema

    Time frame: Baseline, Day after final IMP administration

    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

  3. Improvement Rate for Pulmonary Congestion

    Time frame: Baseline, Day after final IMP administration

    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

Sponsors and collaborators

Lead sponsor

Otsuka Pharmaceutical Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 23, 2019
Registry last updated
Sep 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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