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Completed

NCT Number: NCT05615363

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

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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Key information

Conditions

Cardiac Edema (CHF) Cardiovascular Diseases Edema Edema, Cardiac Heart Diseases Heart Failure Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Harasanshin Hospital

Fukuoka, Japan

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

OPC 131461 10mg group

Drug

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

OPC 131461 5mg group

Drug

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

OPC 131461 2mg group

Drug

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

OPC 131461 1mg group

Drug

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

Placebo

Drug

Placebo tablet，once-daily oral administration for 14 days

Primary outcomes

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

    Time frame: Baseline, Day 8

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

Secondary outcomes

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

    Time frame: Baseline, Day15

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

  2. 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

    Time frame: Baseline, Day7

    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.

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

    Time frame: Baseline, Day7

    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.

Sponsors and collaborators

Lead sponsor

Otsuka Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 14, 2022
Registry last updated
Oct 20, 2025

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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