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

Otsuka Pharmaceutical Co., Ltd.45 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Congestive Heart Failure

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.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 85 Years

Medical Language ↔ Plain English

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)

Locations (1)

Gifu Prefectural General Medical Center

Gifu, Japan

Outcomes

Primary Outcomes

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.

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

Secondary Outcomes

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.

Time frame: Baseline, Day after final IMP administration

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

Time frame: Baseline, Day after final IMP administration

Improvement Rate for Pulmonary Congestion

Time frame: Baseline, Day after final IMP administration

Data from ClinicalTrials.gov

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