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

Otsuka Pharmaceutical Co., Ltd.157 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

157

Conditions

Cardiac Edema (CHF)

Interventions

OPC 131461 10mg groupDRUG

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

OPC 131461 5mg groupDRUG

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

OPC 131461 2mg groupDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 89 Years

Medical Language ↔ Plain English

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

Locations (1)

Harasanshin Hospital

Fukuoka, Japan

Outcomes

Primary Outcomes

Change in Body Weight From Baseline to Last Assessment Time Point (the Day After IMP Administration) by Day 8

Calculate the change in body weight from the baseline up to Day 8 (kg)

Time frame: Baseline, Day 8

Secondary Outcomes

Change in Body Weight From Baseline to Last Assessment Time Point (the Day After IMP Administration) by Day 15

Calculate the percentage change in body weight from the baseline up to last assessment time point (the day after IMP administration) by Day 15 （％）

Time frame: Baseline, Day15

Improvement of or Change in Congestive Findings ( Lower Limb Edema ) From Baseline to Last Assessment Time Point (the Day of IMP Administration) by Day 7

The tibial margins or acrotarsia in a sitting position will be examined to assess the severity of edema according to the criteria in 0 : Absent, No pitting observed at all, 1:Mild,Slight pitting observed, 2:Moderate, Pitting observed, 3 : Severe,Apparent edema. Improvement rates (percentages of subjects who have symptoms at baseline and show markedly improved or improved after IMP administration) and resolution rates (percentages of subjects who have symptoms at baseline and no symptoms after IMP administration) at the last assessment time point (the day of IMP administration) by Day 7.

Time frame: Baseline, Day7

Improvement of or Change in Congestive Findings ( Pulmonary Congestion ) From Baseline to Last Assessment Time Point (the Day of IMP Administration) by Day 7

The severity of pulmonary congestion will be determined according to the criteria in 0 : Absent, No congestion, 1:Mild,Pulmonary venous congestion, 2:Moderate, Interstitial pulmonary edema, 3 : Severe, Alveolar pulmonary edema. Improvement rates (percentages of subjects who have symptoms at baseline and show markedly improved or improved after IMP administration) and resolution rates (percentages of subjects who have symptoms at baseline and no symptoms after IMP administration) at the last assessment time point (the day of IMP administration) by Day 7.

Data from ClinicalTrials.gov

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