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

NCT05615363 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 157

Last updated 2025-10-17

Study results available
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Summary

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

Conditions

  • Cardiac Edema (CHF)

Interventions

DRUG

OPC 131461 10mg group

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

DRUG

OPC 131461 5mg group

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

DRUG

OPC 131461 2mg group

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

DRUG

OPC 131461 1mg group

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

DRUG

Placebo

Placebo tablet，once-daily oral administration for 14 days

Sponsors & Collaborators

  • Otsuka Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Takeshi Tsunoda · Otsuka Pharmaceutical Co., Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-10
Primary Completion
2024-10-21
Completion
2024-10-21

Countries

  • Japan

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05615363 on ClinicalTrials.gov