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| ID | Type | Description | Link |
|---|---|---|---|
| jRCT | Registry Identifier | jRCT2071220069 |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OPC 131461 10mg group | Experimental | OPC-131461 5 mg tablet ｘ 2 |
|
| OPC 131461 5mg group | Experimental | OPC-131461 5 mg tablet and placebo tablet |
|
| OPC 131461 2mg group | Experimental | OPC-131461 1 mg tablet ｘ 2 |
|
| OPC 131461 1mg group | Experimental | OPC-131461 1 mg tablet and placebo tablet |
|
| Placebo | Placebo Comparator | Placebo tablet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OPC 131461 10mg group | Drug | OPC-131461 5 mg tablet x 2，once-daily oral administration for 14 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 （％） | 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 |
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Inclusion Criteria:
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
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Takeshi Tsunoda | Otsuka Pharmaceutical Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harasanshin Hospital | Fukuoka | Japan |
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.
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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Material A | OPC 131461 10mg group |
| FG001 | Material B | OPC 131461 5mg group |
| FG002 | Material C | OPC 131461 2mg group |
| FG003 | Material D | OPC 131461 1mg group |
| FG004 | Placebo | Placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety analysis set, which included all randomized patients who received ≥1 dose of the study medication.
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| ID | Title | Description |
|---|---|---|
| BG000 | Material A | OPC 131461 10mg group |
| BG001 | Material B | OPC 131461 5mg group |
| BG002 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | 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. | Posted | Least Squares Mean | 95% Confidence Interval | kg | Baseline, Day 8 |
|
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.
All AEs will be coded by system organ class and MedDRA preferred term. The incidence of the following events will be summarized by treatment group. If the same event occurs more than once in the same subject, the higher severity will be used. TEAEs related to the IMP will be tabulated similarly.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Material A | OPC 131461 10mg group | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA Ver. 27.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA Ver. 27.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Trials | Otsuka Pharmaceutical Co., Ltd. | +81-3-6361-7366 | CL_OPCJ_RDA_Team@otsuka.jp |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 27, 2023 | Sep 29, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 27, 2024 | Sep 29, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D004489 | Edema, Cardiac |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D004487 | Edema |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D044382 | Population Groups |
| ID | Term |
|---|---|
| D003710 | Demography |
| D011154 | Population Characteristics |
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| OPC 131461 5mg group | Drug | OPC-131461 5 mg tablet and placebo tablet，once-daily oral administration for 14 days |
|
| OPC 131461 2mg group | Drug | OPC-131461 1 mg tablet x 2，once-daily oral administration for 14 days |
|
| OPC 131461 1mg group | Drug | OPC-131461 1 mg tablet and placebo tablet，once-daily oral administration for 14 days |
|
| Placebo | Drug | Placebo tablet，once-daily oral administration for 14 days |
|
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. |
| 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. | Baseline, Day7 |
| Physician Decision |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Material C |
OPC 131461 2mg group |
| BG003 | Material D | OPC 131461 1mg group |
| BG004 | Placebo | Placebo |
| BG005 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Material C |
OPC 131461 2mg group |
| OG003 | Material D | OPC 131461 1mg group |
| OG004 | Placebo | Placebo |
|
|
| Secondary | 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 （％） | 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. | Posted | Least Squares Mean | 95% Confidence Interval | kg | Baseline, Day15 |
|
|
|
| Secondary | 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. | 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. | Posted | Count of Participants | Participants | Baseline, Day7 |
|
|
|
| Secondary | 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. | 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. | Posted | Count of Participants | Participants | Baseline, Day7 |
|
|
|
| 31 |
| 0 |
| 31 |
| 11 |
| 31 |
| EG001 | Material B | OPC 131461 5mg group | 0 | 32 | 2 | 32 | 8 | 32 |
| EG002 | Material C | OPC 131461 2mg group | 0 | 31 | 0 | 31 | 12 | 31 |
| EG003 | Material D | OPC 131461 1mg group | 1 | 33 | 1 | 33 | 14 | 33 |
| EG004 | Placebo | Placebo | 1 | 30 | 1 | 30 | 8 | 30 |
| Arrhythmia | Cardiac disorders | MedDRA Ver. 27.0 | Non-systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA Ver. 27.0 | Non-systematic Assessment |
|
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA Ver. 27.0 | Non-systematic Assessment |
|
| Chondrocalcinosis | Musculoskeletal and connective tissue disorders | MedDRA Ver. 27.0 | Non-systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA Ver. 27.0 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA Ver. 27.0 | Non-systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA Ver. 27.0 | Non-systematic Assessment |
|
| Thirst | General disorders | MedDRA Ver. 27.0 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA Ver. 27.0 | Non-systematic Assessment |
|
| COVID-19 | Infections and infestations | MedDRA Ver. 27.0 | Non-systematic Assessment |
|
| Blood pressure decreased | Investigations | MedDRA Ver. 27.0 | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA Ver. 27.0 | Non-systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA Ver. 27.0 | Non-systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | MedDRA Ver. 27.0 | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA Ver. 27.0 | Non-systematic Assessment |
|
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| D013568 |
| Pathological Conditions, Signs and Symptoms |