Cardiac Edema (CHF)Phase 2NCT05615363

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

A Phase 2 study testing OPC 131461 10mg group, OPC 131461 5mg group and OPC 131461 2mg group in people with Cardiac Edema (CHF), run by Otsuka Pharmaceutical Co., Ltd. at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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 Read more about this study

Who is it for?: Ages 18 to 89 years
Conditions the study is for: Cardiac Edema (CHF)
What is being tested?: OPC 131461 10mg group, OPC 131461 5mg group and OPC 131461 2mg group
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 157 participants
Where: 1 siteJapan
Study dates: 10 Jan 2023to 21 Oct 2024
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 to 89 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Japan1 site

Harasanshin Hospital
Fukuoka

Other trials in Japan

About this study

Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Doseranging Trial of OPC-131461 in Cardiac Edema (Congestive Heart Failure [CHF])

Conditions: Cardiac Edema (CHF)
Being tested: OPC 131461 10mg group, OPC 131461 5mg group, OPC 131461 2mg group, OPC 131461 1mg group, Placebo
Medical subject headings: Edema, Cardiac, Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

OPC 131461 10mg groupDrug
OPC-131461 5 mg tablet x 2，once-daily oral administration for 14 days
OPC 131461 5mg groupDrug
OPC-131461 5 mg tablet and placebo tablet，once-daily oral administration for 14 days
OPC 131461 2mg groupDrug
OPC-131461 1 mg tablet x 2，once-daily oral administration for 14 days
OPC 131461 1mg groupDrug
OPC-131461 1 mg tablet and placebo tablet，once-daily oral administration for 14 days
PlaceboDrug
Placebo tablet，once-daily oral administration for 14 days

Study groups in NCT05615363
Study group	Role	What they receive
OPC 131461 10mg group	Experimental	OPC-131461 5 mg tablet ｘ 2 Receives: Drug: OPC 131461 10mg group
OPC 131461 5mg group	Experimental	OPC-131461 5 mg tablet and placebo tablet Receives: Drug: OPC 131461 5mg group
OPC 131461 2mg group	Experimental	OPC-131461 1 mg tablet ｘ 2 Receives: Drug: OPC 131461 2mg group
OPC 131461 1mg group	Experimental	OPC-131461 1 mg tablet and placebo tablet Receives: Drug: OPC 131461 1mg group
Placebo	Placebo comparator	Placebo tablet Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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)
Measured: 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
Calculate the percentage change in body weight from the baseline up to last assessment time point (the day after IMP administration) by Day 15 （％）
Measured: 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
The tibial margins or acrotarsia in a sitting position will be examined to assess the severity of edema according to the criteria in 0 : Absent, No pitting observed at all, 1:Mild,Slight pitting observed, 2:Moderate, Pitting observed, 3 : Severe,Apparent edema.
Improvement rates (percentages of subjects who have symptoms at baseline and show markedly improved or improved after IMP administration) and resolution rates (percentages of subjects who have symptoms at baseline and no symptoms after IMP administration) at the last assessment time point (the day of IMP administration) by Day 7.
Measured: 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
The severity of pulmonary congestion will be determined according to the criteria in 0 : Absent, No congestion, 1:Mild,Pulmonary venous congestion, 2:Moderate, Interstitial pulmonary edema, 3 : Severe, Alveolar pulmonary edema.
Improvement rates (percentages of subjects who have symptoms at baseline and show markedly improved or improved after IMP administration) and resolution rates (percentages of subjects who have symptoms at baseline and no symptoms after IMP administration) at the last assessment time point (the day of IMP administration) by Day 7.
Measured: Baseline, Day7

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Jan 202321 Oct 2024

First posted14 Nov 2022
Study start10 Jan 2023
Primary completion21 Oct 2024
Study completion21 Oct 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Cardiac Edema (CHF)Studies of the same condition, open and under way.
More trials run by Otsuka Pharmaceutical Co., Ltd.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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 157 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05615363
Sponsor's protocol ID: 351-102-00004
Other IDs: jRCT
Status last verified: Oct 2024
First submitted: 7 Nov 2022
Last updated: 20 Oct 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingObservational study
Hemodynamic Evaluation of Left Atrial Pressure in Relationship to Pulmonary Capillary Wedge Pressure in Cardio Thoracic Patients
Cardiogenic Shock, Pulmonary Edema Cardiac Cause
RecruitingPhase 4
DECONGEST-AHF: Vasodilatation or Loop Diuretics in Acute Heart Failure
Pulmonary Edema, Congestive Heart Failure
Not yet recruitingPhase 4
A Phase IV, Two-part, Open-label Study Assessing the Pharmacokinetics, Safety and Pharmacodynamics of Spironolactone Oral Suspension in Pediatric Patients
Edema Due to Heart Failure or Cirrhosis
RecruitingObservational study
Sensor-based Congestion ALert for Events in Peritoneal Dialysis (SCALE-PD)
Kidney Disease, Peritoneal Dialysis (PD)
Recruiting
The HEARTFELT Study
Heart Failure, Chronic Heart Failure

All Cardiac Edema (CHF) trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Doseranging Trial of OPC-131461 in Cardiac Edema (Congestive Heart Failure [CHF])
ClinicalTrials.gov ID: NCT05615363
Acronym / sponsor ID: 351-102-00004
Conditions: Cardiac Edema (CHF)
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 157 participants (actual)
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Study start: 10 Jan 2023 (actual)
Primary completion: 21 Oct 2024 (actual)
Study completion: 21 Oct 2024 (actual)
First posted: 14 Nov 2022 (actual)
Results: Posted 20 Oct 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 5

Arm	Type	Receives
OPC 131461 10mg group	Experimental	Drug: OPC 131461 10mg groupOPC-131461 5 mg tablet ｘ 2
OPC 131461 5mg group	Experimental	Drug: OPC 131461 5mg groupOPC-131461 5 mg tablet and placebo tablet
OPC 131461 2mg group	Experimental	Drug: OPC 131461 2mg groupOPC-131461 1 mg tablet ｘ 2
OPC 131461 1mg group	Experimental	Drug: OPC 131461 1mg groupOPC-131461 1 mg tablet and placebo tablet
Placebo	Placebo comparator	Drug: PlaceboPlacebo tablet

Who may qualify

Ages: 18 to 89 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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
Subjects who were currently hospitalized or who are able to be hospitalized

Key exclusion criteria (3 listed)

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

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 131461 10mg groupOPC-131461 5 mg tablet x 2，once-daily oral administration for 14 days	Drug	OPC 131461 10mg group
OPC 131461 5mg groupOPC-131461 5 mg tablet and placebo tablet，once-daily oral administration for 14 days	Drug	OPC 131461 5mg group
OPC 131461 2mg groupOPC-131461 1 mg tablet x 2，once-daily oral administration for 14 days	Drug	OPC 131461 2mg group
OPC 131461 1mg groupOPC-131461 1 mg tablet and placebo tablet，once-daily oral administration for 14 days	Drug	OPC 131461 1mg group
PlaceboPlacebo tablet，once-daily oral administration for 14 days	Drug	Placebo

Primary outcome

Change in Body Weight From Baseline to Last Assessment Time Point (the Day After IMP Administration) by Day 8
Time frame: Baseline, Day 8
Calculate the change in body weight from the baseline up to Day 8 (kg)

3 secondary outcomes

Change in Body Weight From Baseline to Last Assessment Time Point (the Day After IMP Administration) by Day 15
Time frame: 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
Time frame: 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
Time frame: Baseline, Day7

Results and safety

Results posted to the registry on 20 Oct 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Material A	31	27
Material B	32	28
Material C	31	22
Material D	33	29
Placebo	30	25

Primary outcome: Change in Body Weight From Baseline to Last Assessment Time Point (the Day After IMP Administration) by Day 8

Time frame: Baseline, Day 8. Least squares mean (95% Confidence Interval). Unit: kg

Measure	Material A n = 31	Material B n = 32	Material C n = 31	Material D n = 33	Placebo n = 30
Value	-1.96 (-2.50 to -1.42)	-1.74 (-2.28 to -1.20)	-1.4 (-1.94 to -0.85)	-1.84 (-2.36 to -1.31)	-1.17 (-1.72 to -0.62)

Population analysed: The full analysis set includes all subjects who have been administered at least one treatment of the IMP, and for whom efficacy data after IMP administration are available.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were monitored from signing of the informed consent form until follow-up for up to 10 - 14 days after the last dose of study medication.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Material A	0 of 31 (0%)	11 of 31 (35.5%)	0 of 31
Material B	2 of 32 (6.3%)	8 of 32 (25%)	0 of 32
Material C	0 of 31 (0%)	12 of 31 (38.7%)	0 of 31
Material D	1 of 33 (3%)	14 of 33 (42.4%)	1 of 33
Placebo	1 of 30 (3.3%)	8 of 30 (26.7%)	1 of 30

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal.

Related trials for Cardiac Edema (CHF)

Not yet recruitingObservational study
Hemodynamic Evaluation of Left Atrial Pressure in Relationship to Pulmonary Capillary Wedge Pressure in Cardio Thoracic Patients
Cardiogenic Shock, Pulmonary Edema Cardiac Cause
RecruitingPhase 4
DECONGEST-AHF: Vasodilatation or Loop Diuretics in Acute Heart Failure
Pulmonary Edema, Congestive Heart Failure
Not yet recruitingPhase 4
A Phase IV, Two-part, Open-label Study Assessing the Pharmacokinetics, Safety and Pharmacodynamics of Spironolactone Oral Suspension in Pediatric Patients
Edema Due to Heart Failure or Cirrhosis
RecruitingObservational study
Sensor-based Congestion ALert for Events in Peritoneal Dialysis (SCALE-PD)
Kidney Disease, Peritoneal Dialysis (PD)
Recruiting
The HEARTFELT Study
Heart Failure, Chronic Heart Failure

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.

Takeshi Tsunoda study director

Otsuka Pharmaceutical Co., Ltd.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing OPC 131461 10mg group, OPC 131461 5mg group and OPC 131461 2mg group in people with Cardiac Edema (CHF), run by Otsuka Pharmaceutical Co., Ltd. at 1 site in Japan.

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 6 inclusion and 3 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: finished, as of the sponsor's last update on 20 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Yes. Results are posted in the registry (first posted 20 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change in Body Weight From Baseline to Last Assessment Time Point (the Day After IMP Administration) by Day 8 (time frame: Baseline, Day 8). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05615363.

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 20 Oct 2025.