A Dose-ranging Trial of OPC-131461 in Cardiac Edema (Congestive Heart Failure [CHF])

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

157 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-10

Study Completion Date

2024-10-21

Brief Summary

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To investigate the dose response in respect of weight decrease following repeated oral administration of OPC-131461 at 1, 2, 5, and 10 mg or placebo in patients with CHF with volume overload despite having received diuretics other than vasopressin antagonists

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Detailed Description

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Conditions

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Cardiac Edema (CHF)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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OPC 131461 10mg group

OPC-131461 5 mg tablet ｘ 2

Group Type EXPERIMENTAL

OPC 131461 10mg group

Intervention Type DRUG

OPC-131461 5 mg tablet x 2，once-daily oral administration for 14 days

OPC 131461 5mg group

OPC-131461 5 mg tablet and placebo tablet

Group Type EXPERIMENTAL

OPC 131461 5mg group

Intervention Type DRUG

OPC-131461 5 mg tablet and placebo tablet，once-daily oral administration for 14 days

OPC 131461 2mg group

OPC-131461 1 mg tablet ｘ 2

Group Type EXPERIMENTAL

OPC 131461 2mg group

Intervention Type DRUG

OPC-131461 1 mg tablet x 2，once-daily oral administration for 14 days

OPC 131461 1mg group

OPC-131461 1 mg tablet and placebo tablet

Group Type EXPERIMENTAL

OPC 131461 1mg group

Intervention Type DRUG

OPC-131461 1 mg tablet and placebo tablet，once-daily oral administration for 14 days

Placebo

Placebo tablet

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo tablet，once-daily oral administration for 14 days

Interventions

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OPC 131461 10mg group

OPC-131461 5 mg tablet x 2，once-daily oral administration for 14 days

Intervention Type DRUG

OPC 131461 5mg group

OPC-131461 5 mg tablet and placebo tablet，once-daily oral administration for 14 days

Intervention Type DRUG

OPC 131461 2mg group

OPC-131461 1 mg tablet x 2，once-daily oral administration for 14 days

Intervention Type DRUG

OPC 131461 1mg group

OPC-131461 1 mg tablet and placebo tablet，once-daily oral administration for 14 days

Intervention Type DRUG

Placebo

Placebo tablet，once-daily oral administration for 14 days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects with CHF with lower limb edema, pulmonary congestion, or jugular venous distension due to volume overload.
* Subjects undergoing any of the following diuretic therapies

* Loop diuretics at a dosage equivalent to 40 mg/day or more of furosemide tablet/fine granule
* Concomitant administration of a loop diuretic and a thiazide diuretic (including similar drugs) at any doses
* Concomitant administration of a loop diuretic and a mineralocorticoid receptor antagonist or potassium-sparing diuretic at any doses
* Subjects who were currently hospitalized or who are able to be hospitalized

Exclusion Criteria

* Subjects with acute heart failure
* Subjects with an assisted circulation device
* Subjects who cannot sense thirst or who have difficulty in ingesting water

Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No