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

NCT05615363 | Completed Phase 2 Results

• 2 other identifiers: 351-102-00004jRCT
• Study Type: interventional
• Target: 157
• Locations: 1 country
• Sites: 1

Brief 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)

Outcome Measures

Primary Outcomes (1)

• 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)

  Baseline, Day 8

Secondary Outcomes (3)

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

  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

  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

  Baseline, Day7

Study Arms (5)

OPC 131461 10mg group

EXPERIMENTAL

OPC-131461 5 mg tablet ｘ 2

Drug: OPC 131461 10mg group

OPC 131461 5mg group

EXPERIMENTAL

OPC-131461 5 mg tablet and placebo tablet

Drug: OPC 131461 5mg group

OPC 131461 2mg group

EXPERIMENTAL

OPC-131461 1 mg tablet ｘ 2

Drug: OPC 131461 2mg group

OPC 131461 1mg group

EXPERIMENTAL

OPC-131461 1 mg tablet and placebo tablet

Drug: OPC 131461 1mg group

Placebo

PLACEBO COMPARATOR

Placebo tablet

Drug: Placebo

Interventions

OPC 131461 10mg group DRUG

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

OPC 131461 10mg group

OPC 131461 5mg group DRUG

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

OPC 131461 5mg group

OPC 131461 2mg group DRUG

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

OPC 131461 2mg group

OPC 131461 1mg group DRUG

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

OPC 131461 1mg group

Placebo DRUG

Placebo tablet，once-daily oral administration for 14 days

Placebo

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Otsuka Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Harasanshin Hospital

Fukuoka, Japan

Location

MeSH Terms

Conditions

Edema, Cardiac; Heart Failure

Interventions

Population Groups

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Edema; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Results Point of Contact

• Title: Director of Clinical Trials
• Organization: Otsuka Pharmaceutical Co., Ltd.

CL_OPCJ_RDA_Team@otsuka.jp

+81-3-6361-7366

Study Officials

• Takeshi Tsunoda

  Otsuka Pharmaceutical Co., Ltd.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2022
• First Posted: November 14, 2022
• Study Start: January 10, 2023
• Primary Completion: October 21, 2024
• Study Completion: October 21, 2024
• Last Updated: October 20, 2025
• Results First Posted: October 20, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be available after marketing approval in global markets, or beginning 1-3 years following article Publication. There is no end date to the availability of the data.
• Access Criteria: Otsuka will share data on an Otsuka-owned remotely accessible data sharing platform with Python and R analytical software. Research requests should be directed to clinicaltransparency@Otsuka-us.com.

Locations

JP (1)