A Proof-of-concept Trial for OPC 131461 in Patients Hospitalized for Worsening Heart Failure

NCT06795399 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: 351-201-00015
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary objective of the study is to compare relative changes in blood N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels after 30 days of treatment in participants with worsening heart failure (WHF), who are treated with either OPC-131461 or placebo.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• Proportional Change From Baseline in Serum Concentration of NT-proBNP at Day 31

  Proportional change from baseline in serum concentration of NT-proBNP is defined as the ratio of NT-proBNP at Day 31 over baseline.

  Baseline, Day 31

Secondary Outcomes (14)

• Proportional Change From Baseline in Serum Concentration of NT-proBNP at Days 8 and 15

  Baseline, Days 8 and 15

• Time to First Heart Failure (HF) Rehospitalization

  From first dose of study drug up to end of treatment period (up to 30 days)

• Time to First Urgent HF Outpatient Visit

  From first dose of study drug up to end of treatment period (up to 30 days)

• Time to Cardiovascular (CV) Death

  From first dose of study drug up to end of treatment period (up to 30 days)

• Composite Endpoint Defined by the Win Ratio

  From the first dose of the study drug up to end of treatment period (up to 30 days)

Study Arms (3)

OPC-131461 5 mg

EXPERIMENTAL

Participants will receive OPC-131461 5 mg, orally, once daily for 30 days.

Drug: OPC-131461

OPC-131461 10 mg

EXPERIMENTAL

Participants will receive OPC-131461 10 mg, orally, once daily for 30 days.

Drug: OPC-131461

Placebo

PLACEBO COMPARATOR

Participants will receive OPC-131461 matched placebo, orally, once daily for 30 days.

Drug: Placebo

Interventions

OPC-131461 DRUG

OPC-131461 will be administered as oral tablets.

OPC-131461 10 mg; OPC-131461 5 mg

Placebo DRUG

OPC-131461 matched placebo will be administered as oral tablets.

Placebo

Eligibility Criteria

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

You may qualify if:

• Diagnosis of HF ≥ 3 months prior to screening.
• Admitted to the hospital with primary diagnosis of WHF and received treatment with intravenous (IV) diuretics.
• Eligible participants will be randomized no earlier than 48 hours and up to 5 days after presentation to the hospital as long as they meet the following definition of stable status: Stable for at least 24 hours, defined by systolic blood pressure (SBP) ≥ 90 millimeters of mercury (mmHg) for preceding 24 hours, no increase in diuretic dose for 24 hours prior to randomization, did not receive IV inotropic or vasodilator (including nitrates) for 24 hours prior to randomization, and no oxygen therapy or mechanical ventilation in the 24 hours prior to randomization
• Left ventricular ejection fraction (LVEF) assessed either during hospitalization for Index Event or within 12 months prior to randomization.
• Has evidence of incomplete decongestion, indicated by NT-proBNP levels \> 750 picograms per milliliter (pg/mL) (or \> 1000 pg/mL if in atrial fibrillation). At hospital sites where NT proBNP test is unavailable at screening: B-type natriuretic peptide (BNP) \> 375 pg/mL (or \> 500 pg/mL if in atrial fibrillation).

You may not qualify if:

• Primary cause of WHF (Index Event) due to valvular heart disease (defined as severe aortic or primary mitral regurgitation, moderate or severe aortic stenosis, any mitral stenosis requiring surgical repair, or active endocarditis), congenital heart disease, hypertrophic obstructive cardiomyopathy, pulmonary embolism, Type I myocardial infarction, infection, severe anemia, exacerbation of chronic obstructive pulmonary disease (COPD), or sustained ventricular tachycardia, or bradycardia with sustained ventricular rate \< 45 beats/minute.
• Duration of hospitalization for Index Event \> 2 weeks at time of screening.
• End-stage HF requiring at the time of screening left ventricular assist device (LVAD), intra-aortic balloon pump (IABP) or any similar mechanical support.
• Cardiac surgery (coronary artery bypass grafting \[CABG\]), percutaneous coronary intervention (PCI), implantation of a cardiac device or cardiac mechanical support implantation within 30 days prior to randomization or planned during the study
• Severely impaired renal function eGFR \< 25 milliliters per minute per 1.73-meter square (mL/min/1.73m\^2).
• History of dialysis or kidney transplant.
• History of cirrhosis or noncirrhotic portal hypertension.
• Severe hyponatremia Sodium (Na) level \< 125 mEq/L (milliequivalents per liter) or hypernatremia Na level \> 145 mEq/L).
• Systolic blood pressure \< 90 mmHg at screening.
• History of or current hepatitis or acquired immunodeficiency syndrome or carriers of hepatitis B surface antigen (HBsAg) and/or hepatitis C antibodies (anti-HCV), or human immunodeficiency virus (HIV) antibodies.
• History of any significant drug allergy or known or suspected hypersensitivity to any component of the study drug.
• Use of any investigational drug within 30 days prior to screening.
• History of serious mental disorders that, in the opinion of the investigator, would exclude the participant from participating in this trial.

Sponsors & Collaborators

• Otsuka Pharmaceutical Development & Commercialization, Inc.: lead

Related Links

• Otsuka Clinical Trial Website:
• Otsuka Clinical Trial Transparency:

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

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

Study Record Dates

• First Submitted: January 22, 2025
• First Posted: January 28, 2025
• Study Start: April 30, 2025
• Primary Completion: May 25, 2025
• Study Completion: May 25, 2025
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share