Heart FailurePhase 2NCT06795399
A Proof-of-concept Trial for OPC 131461 in Patients Hospitalized for Worsening Heart Failure
A Phase 2 study testing OPC-131461 in people with Heart Failure, run by Otsuka Pharmaceutical Development & Commercialization, Inc..
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- OPC-131461
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 30 Apr 2025to 25 May 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
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- 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.
About this study
Official title: A Phase 2, Randomized, Double-blind, Placebo-controlled, Proof of Concept Trial for OPC-131461 in Patients Hospitalized for Worsening Heart Failure With Laboratory Evidence of Incomplete Decongestion Following Urgent Decongestive Therapy
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
- Heart Failure
- Being tested
- OPC-131461, Placebo
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OPC-131461Drug
OPC-131461 will be administered as oral tablets.
PlaceboDrug
OPC-131461 matched placebo will be administered as oral tablets.
| Study group | Role | What they receive |
|---|---|---|
| OPC-131461 5 mg | Experimental | Participants will receive OPC-131461 5 mg, orally, once daily for 30 days. Receives: Drug: OPC-131461 |
| OPC-131461 10 mg | Experimental | Participants will receive OPC-131461 10 mg, orally, once daily for 30 days. Receives: Drug: OPC-131461 |
| Placebo | Placebo comparator | Participants will receive OPC-131461 matched placebo, orally, once daily for 30 days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Day 31
Secondary outcomes (14)
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.
Measured: Baseline, Days 8 and 15
Time to First Heart Failure (HF) Rehospitalization
Measured: From first dose of study drug up to end of treatment period (up to 30 days)
Time to First Urgent HF Outpatient Visit
Measured: From first dose of study drug up to end of treatment period (up to 30 days)
Time to Cardiovascular (CV) Death
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 31 days
Change From Baseline in Body Weight
Measured: 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.
Measured: Up to 37 days
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR)
Measured: Up to 37 days
Number of Participants With Serum Electrolyte Abnormalities
Measured: Up to 37 days
Number of Participants With Hypotension/Orthostatic Hypotension and Related Treatment-emergent Adverse Events (TEAEs) of Syncope and Presyncope
Measured: Up to 37 days
Number of Participants With Major and Minor Bleeding Events
Measured: Up to 37 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2025
- Study start30 Apr 2025
- Primary completion25 May 2025
- Study completion25 May 2025
Why it stopped: No sites were initiated, no sites were activated, no patients were enrolled in this study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Otsuka Pharmaceutical Development & Commercialization, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06795399
- Sponsor's protocol ID
- 351-201-00015
- Status last verified
- Apr 2026
- First submitted
- 22 Jan 2025
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-blind, Placebo-controlled, Proof of Concept Trial for OPC-131461 in Patients Hospitalized for Worsening Heart Failure With Laboratory Evidence of Incomplete Decongestion Following Urgent Decongestive Therapy
- ClinicalTrials.gov ID
- NCT06795399
- Acronym / sponsor ID
- 351-201-00015
- Conditions
- Heart Failure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No sites were initiated, no sites were activated, no patients were enrolled in this study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Apr 2025 (actual)
- Primary completion
- 25 May 2025 (actual)
- Study completion
- 25 May 2025 (actual)
- First posted
- 28 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| OPC-131461 5 mg | Experimental | Drug: OPC-131461Participants will receive OPC-131461 5 mg, orally, once daily for 30 days. |
| OPC-131461 10 mg | Experimental | Drug: OPC-131461Participants will receive OPC-131461 10 mg, orally, once daily for 30 days. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive OPC-131461 matched placebo, orally, once daily for 30 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (14 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OPC-131461OPC-131461 will be administered as oral tablets. | Drug | OPC-131461 10 mg, OPC-131461 5 mg |
| PlaceboOPC-131461 matched placebo will be administered as oral tablets. | Drug | Placebo |
Primary outcome
Proportional Change From Baseline in Serum Concentration of NT-proBNP at Day 31
Time frame: Baseline, 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.
14 secondary outcomes
Proportional Change From Baseline in Serum Concentration of NT-proBNP at Days 8 and 15
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
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
Time frame: Up to 31 days
Change From Baseline in KCCQ-23 Total Symptom Score
Time frame: Up to 31 days
Change From Baseline in KCCQ-23 Physical Limitations Score
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
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- Otsuka Clinical Trial Website:Link provided by the sponsor.
- Otsuka Clinical Trial Transparency:Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing OPC-131461 in people with Heart Failure, run by Otsuka Pharmaceutical Development & Commercialization, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportional Change From Baseline in Serum Concentration of NT-proBNP at Day 31 (time frame: Baseline, Day 31). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.