WithdrawnNCT06795399Updated Apr 17, 2026

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

A Phase 2 interventional study of OPC-131461 and Placebo in Heart Failure, sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc.. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-17.

Sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc. · Phase 2, Interventional, and Treatment

Why this study was withdrawn

No sites were initiated, no sites were activated, no patients were enrolled in this study.

Phase: Phase 2
Study type: Interventional
Enrollment: 0
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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.

Read the detailed description

Each participant in this trial is expected to participate in the following periods of the trial:

Screening/qualification period: up to 48 hours (2 days)
Double-blind treatment period: 30 days
Safety follow-up period: 7 days
Vital status follow-up period: 6 months

Eligible participants will be randomized to receive the study drug (1 of 2 dose levels [5 milligrams (mg) or 10 mg] of OPC-131461 tablets or placebo) in a 1:1:1 ratio.

Overall, the trial duration is expected to be approximately 210 days (7 months).

Conditions studied

Heart Failure

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Heart Failure 5,701

In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

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Lead sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc. is the lead sponsor of 289 studies on the registry; 18 are open to participants now.

Of its 104 completed or terminated interventional studies of FDA-regulated products, 69 (66%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

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).

Exclusion criteria

Exclusion Criteria:

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.

Note: Other protocol-specified inclusion and exclusion criteria may apply.

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 0 participants (actual)

Study arms

Experimental
OPC-131461 5 mg
Participants will receive OPC-131461 5 mg, orally, once daily for 30 days.
Drug: OPC-131461
Experimental
OPC-131461 10 mg
Participants will receive OPC-131461 10 mg, orally, once daily for 30 days.
Drug: OPC-131461
Placebo comparator
Placebo
Participants will receive OPC-131461 matched placebo, orally, once daily for 30 days.
Drug: Placebo

Interventions

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

What researchers measure

Primary outcomes

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.
Time frame: Baseline, Day 31

Secondary outcomes

Proportional Change From Baseline in Serum Concentration of NT-proBNP at Days 8 and 15
Proportional change from baseline in serum concentration of NT-proBNP is defined as the ratio of NT-proBNP at Day 8 over baseline and at Day 15 over baseline.
Time frame: Baseline, Days 8 and 15
Time to First Heart Failure (HF) Rehospitalization
Time frame: From first dose of study drug up to end of treatment period (up to 30 days)
Time to First Urgent HF Outpatient Visit
Time frame: From first dose of study drug up to end of treatment period (up to 30 days)
Time to Cardiovascular (CV) Death
Time frame: From first dose of study drug up to end of treatment period (up to 30 days)
Composite Endpoint Defined by the Win Ratio
A hierarchical composite of CV death, number of HF rehospitalizations, number of urgent HF outpatient visits, time to first HF rehospitalization or urgent HF outpatient visit, and change from baseline in Kansas City Cardiomyopathy Questionnaire - 23 items (KCCQ-23) Total Symptom Score (difference larger or equal to 5) will be analyzed using the Win ratio method.
Time frame: From the first dose of the study drug up to end of treatment period (up to 30 days)
Change From Baseline in Kansas City Cardiomyopathy Questionnaire - 23 items (KCCQ-23) Clinical Summary Score
The KCCQ-23 is a questionnaire consisting of 23 items to measure health status, symptoms, and quality of life in participants with heart failure. The KCCQ-23 consists of the following domains: Physical Limitation, Symptoms, Self-efficacy and knowledge, Quality of Life, Social Limitation. A functional status score is calculated from physical limitations and symptoms. The clinical summary score is derived from the functional status score, quality of life, and social limitations domains and range from 0-100. A higher score indicates fewer symptoms and better physical functioning, reflecting improved overall clinical status.
Time frame: Up to 31 days
Change From Baseline in KCCQ-23 Total Symptom Score
The KCCQ-23 is a questionnaire consisting of 23 items to measure health status, symptoms, and quality of life in participants with heart failure. The KCCQ-23 consists of the following domains: Physical Limitation, Symptoms, Self-efficacy and knowledge, Quality of Life, Social Limitation. The total symptom score combines responses from the symptom frequency and symptom burden domains. Score ranges from 0-100, where higher scores indicate fewer symptoms and a better symptom experience.
Time frame: Up to 31 days
Change From Baseline in KCCQ-23 Physical Limitations Score
The KCCQ-23 is a questionnaire consisting of 23 items to measure health status, symptoms, and quality of life in participants with heart failure. The KCCQ-23 consists of the following domains: Physical Limitation, Symptoms, Self-efficacy and knowledge, Quality of Life, Social Limitation. The Physical Limitation Score will assess the impact of HF on participants' ability to perform physical activities. Scores range from 0-100, with higher scores reflecting fewer physical limitations and better functional capacity.
Time frame: Up to 31 days
Change From Baseline in Body Weight
Time frame: Up to 37 days
Change From Baseline in EVEREST Congestion Score
The EVEREST Congestion Score will assess the severity of congestion in participants with HF. The score includes clinical signs and symptoms such as edema, dyspnea, orthopnea, jugular vein distention, rales, and fatigue. The total score ranges from 0-18, with a higher score indicating greater severity of congestion and a lower score reflecting less congestion and improvement in symptoms.
Time frame: Up to 37 days
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR)
Time frame: Up to 37 days
Number of Participants With Serum Electrolyte Abnormalities
Time frame: Up to 37 days
Number of Participants With Hypotension/Orthostatic Hypotension and Related Treatment-emergent Adverse Events (TEAEs) of Syncope and Presyncope
Time frame: Up to 37 days
Number of Participants With Major and Minor Bleeding Events
Time frame: Up to 37 days

Study locations

No study locations are listed for this record.

References and documents

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Apr 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT06795399
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Responsible party: Sponsor
First posted: Jan 28, 2025
Start date: Apr 30, 2025
Primary completion: May 25, 2025
Completion: May 25, 2025
Last update: Apr 17, 2026

Oversight

Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is withdrawn, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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