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

Study Overview
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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

Official Title
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A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Doseranging Trial of OPC-131461 in Cardiac Edema (Congestive Heart Failure [CHF])

Conditions
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Cardiac Edema (CHF)

Intervention / Treatment
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* Drug: OPC 131461 10mg group
* Drug: OPC 131461 5mg group
* Drug: OPC 131461 2mg group
* Drug: OPC 131461 1mg group
* Drug: Placebo


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OPC 131461 10mg group<br>OPC-131461 5 mg tablet ｘ 2 | Drug: OPC 131461 10mg group<br>* OPC-131461 5 mg tablet x 2，once-daily oral administration for 14 days<br>|
| Experimental: OPC 131461 5mg group<br>OPC-131461 5 mg tablet and placebo tablet | Drug: OPC 131461 5mg group<br>* OPC-131461 5 mg tablet and placebo tablet，once-daily oral administration for 14 days<br>|
| Experimental: OPC 131461 2mg group<br>OPC-131461 1 mg tablet ｘ 2 | Drug: OPC 131461 2mg group<br>* OPC-131461 1 mg tablet x 2，once-daily oral administration for 14 days<br>|
| Experimental: OPC 131461 1mg group<br>OPC-131461 1 mg tablet and placebo tablet | Drug: OPC 131461 1mg group<br>* OPC-131461 1 mg tablet and placebo tablet，once-daily oral administration for 14 days<br>|
| Placebo Comparator: Placebo<br>Placebo tablet | Drug: Placebo<br>* Placebo tablet，once-daily oral administration for 14 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in body weight from baseline to last assessment time point (the day after investigational medicinal product [IMP] administration) by Day 8 | The primary endpoint is the change in body weight from baseline (before IMP administration on Day 1) to last assessment time point (the day after IMP administration) by Day 8. | From baseline (before IMP administration on Day 1) to last assessment time point (the day after IMP administration) by Day 8 |