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| ID | Type | Description | Link |
|---|---|---|---|
| JapicCTI-184234 | Other Identifier | Japic |
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To confirm the non-inferiority of OPC-61815 16-mg injection to tolvaptan 15-mg tablet using as the primary endpoint the change in body weight following 5-day intravenous administration of OPC-61815 16-mg injection or 5-day oral administration of tolvaptan 15-mg tablet to CHF patients with volume overload despite having received diuretics other than vasopressin antagonists
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OPC-61815 injection 16 mg | Experimental | Once daily for 5 days placebo tablet will be orally administered, followed immediately by intravenous administration of OPC-61815 at 16 mg |
|
| Tolvaptan tablet 15mg | Active Comparator | Once daily for 5 days tolvaptan 15-mg tablet will be orally administered, followed immediately by 1-hour intravenous administration of placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OPC-61815 | Drug | Once daily for 5 days placebo tablet will be orally administered, followed immediately by intravenous administration of OPC-61815 at 16 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Body Weight | Change in body weight from baseline (before investigational medicinal product [IMP] administration on Day 1) at time of final IMP administration (day after final IMP administration). A negative change from baseline indicates improvement. | Baseline, Day 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement Rate for Lower Limb Edema and Pulmonary Congestion | The improvement rate was defined as the percentage of subjects in whom the symptom was present at baseline and it markedly improved or improved after IMP administration. Improvement category is a 4-point scale below:
| Baseline, Day 6 |
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Inclusion Criteria:
Patients who are currently on treatment with any of the following diuretics
Patients with congestive heart failure in whom lower limb edema, pulmonary congestion, and/or jugular venous distension due to volume overload is present
Patients who are currently hospitalized or who are able to be hospitalized during the trial
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Osamu Sato | Otsuka Pharmaceutical Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saiseikai Kumamoto Hospital | Kumamoto | 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.
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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 https://clinical-trials.otsuka.com/contact-us
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| ID | Title | Description |
|---|---|---|
| FG000 | OPC-61815 Injection 16 mg | Once daily for 5 days placebo tablet will be orally administered, followed immediately by intravenous administration of OPC-61815 at 16 mg. |
| FG001 | Tolvaptan Tablet 15mg | Once daily for 5 days tolvaptan 15-mg tablet will be orally administered, followed immediately by 1-hour intravenous administration of placebo. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | OPC-61815 Injection 16 mg | Once daily for 5 days placebo tablet will be orally administered, followed immediately by intravenous administration of OPC-61815 at 16 mg. |
| BG001 | Tolvaptan Tablet 15mg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 From Baseline in Body Weight | Change in body weight from baseline (before investigational medicinal product [IMP] administration on Day 1) at time of final IMP administration (day after final IMP administration). A negative change from baseline indicates improvement. | Full Analysis Set: subjects who received at least one dose of IMP and had at least one postbaseline weight measurement | Posted | Least Squares Mean | 95% Confidence Interval | kg | Baseline, Day 6 |
|
Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least one dose of IMP were included in the safety analysis.
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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 | OPC-61815 Injection 16 mg | Once daily for 5 days placebo tablet will be orally administered, followed immediately by intravenous administration of OPC-61815 at 16 mg. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA Ver. 23.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Ver. 23.0 | 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 | Mar 27, 2020 | Jul 8, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 14, 2020 | Jul 8, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000077602 | Tolvaptan |
| ID | Term |
|---|---|
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Tolvaptan Tab 15 MG | Drug | Once daily for 5 days tolvaptan 15-mg tablet will be orally administered, followed immediately by 1-hour intravenous administration of placebo |
|
| Change From Baseline in Jugular Venous Distension and Hepatomegaly |
| Baseline, Day 6 |
| Percentage of Subjects Who Achieve Resolution of Pulmonary Rales and Third Cardiac Sound | Percentage of subjects in whom the symptom was present at baseline and disappeared after IMP administration was provided.
| Baseline, Day 6 |
| Improvement Rate for New York Heart Association (NYHA) Classification | NYHA classification assesses the severity of heart failure based on subjective symptoms as follows. Class I: No limitations of physical activity. Ordinary physical activity caused no undue fatigue, palpitation, dyspnea or anginal pain. Class II: Slight limitation of physical activity, comfortable at rest. Ordinary physical activity resulted in fatigue, palpitation, dyspnea or anginal pain. Class III: Marked limitation of physical activity, comfortable at rest. Less than ordinary physical activity caused fatigue, palpitation, dyspnea or anginal pain. Class IV: Inability to carry on any physical activity without discomfort. heart failure or anginal syndrome may have been present even at rest. If any physical activity was undertaken, discomfort was increased. Of the subjects with Class II or higher at baseline, the percentage of subjects whose NYHA classification stage at the time of final IMP administration improved by 1 or more grades was provided. | Baseline, Day 6 |
| Protocol Violation |
|
| Physician Decision |
|
Once daily for 5 days tolvaptan 15-mg tablet will be orally administered, followed immediately by 1-hour intravenous administration of placebo.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
Once daily for 5 days tolvaptan 15-mg tablet will be orally administered, followed immediately by 1-hour intravenous administration of placebo.
|
|
| Secondary | Improvement Rate for Lower Limb Edema and Pulmonary Congestion | The improvement rate was defined as the percentage of subjects in whom the symptom was present at baseline and it markedly improved or improved after IMP administration. Improvement category is a 4-point scale below:
| Full Analysis Set: subjects who received at least one dose of IMP and had at least one postbaseline weight measurement were included in the full analysis. "Number Analyzed" = number of subjects with baseline symptoms. | Posted | Number | percentage of participants | Baseline, Day 6 |
|
|
|
| Secondary | Change From Baseline in Jugular Venous Distension and Hepatomegaly |
| Subjects with baseline values in the Full Analysis Set | Posted | Least Squares Mean | 95% Confidence Interval | cm | Baseline, Day 6 |
|
|
|
| Secondary | Percentage of Subjects Who Achieve Resolution of Pulmonary Rales and Third Cardiac Sound | Percentage of subjects in whom the symptom was present at baseline and disappeared after IMP administration was provided.
| Full Analysis Set: subjects who received at least one dose of IMP and had at least one postbaseline weight measurement were included in the full analysis. "Number Analyzed" = number of subjects with baseline symptoms. | Posted | Number | percentage of participants | Baseline, Day 6 |
|
|
|
| Secondary | Improvement Rate for New York Heart Association (NYHA) Classification | NYHA classification assesses the severity of heart failure based on subjective symptoms as follows. Class I: No limitations of physical activity. Ordinary physical activity caused no undue fatigue, palpitation, dyspnea or anginal pain. Class II: Slight limitation of physical activity, comfortable at rest. Ordinary physical activity resulted in fatigue, palpitation, dyspnea or anginal pain. Class III: Marked limitation of physical activity, comfortable at rest. Less than ordinary physical activity caused fatigue, palpitation, dyspnea or anginal pain. Class IV: Inability to carry on any physical activity without discomfort. heart failure or anginal syndrome may have been present even at rest. If any physical activity was undertaken, discomfort was increased. Of the subjects with Class II or higher at baseline, the percentage of subjects whose NYHA classification stage at the time of final IMP administration improved by 1 or more grades was provided. | Full Analysis Set: subjects who received at least one dose of IMP and had at least one postbaseline weight measurement were included in the full analysis. "Overall Number of Participants Analyzed" = number of subjects with a baseline of class II or more. | Posted | Number | percentage of participants | Baseline, Day 6 |
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| 0 |
| 149 |
| 6 |
| 149 |
| 61 |
| 149 |
| EG001 | Tolvaptan Tablet 15mg | Once daily for 5 days tolvaptan 15-mg tablet will be orally administered, followed immediately by 1-hour intravenous administration of placebo. | 0 | 145 | 5 | 145 | 57 | 145 |
| Cardiac failure | Cardiac disorders | MedDRA Ver. 23.0 | Non-systematic Assessment |
|
| Cardiac failure acute | Cardiac disorders | MedDRA Ver. 23.0 | Non-systematic Assessment |
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| Coronary artery stenosis | Cardiac disorders | MedDRA Ver. 23.0 | Non-systematic Assessment |
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| Sinus node dysfunction | Cardiac disorders | MedDRA Ver. 23.0 | Non-systematic Assessment |
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| Ventricular tachycardia | Cardiac disorders | MedDRA Ver. 23.0 | Non-systematic Assessment |
|
| Gastric antral vascular ectasia | Gastrointestinal disorders | MedDRA Ver. 23.0 | Non-systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA Ver. 23.0 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA Ver. 23.0 | Non-systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA Ver. 23.0 | Non-systematic Assessment |
|
| General infarction | Nervous system disorders | MedDRA Ver. 23.0 | Non-systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA Ver. 23.0 | Non-systematic Assessment |
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| Ventricular tachycardia | Cardiac disorders | MedDRA Ver. 23.0 | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA Ver. 23.0 | Non-systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA Ver. 23.0 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA Ver. 23.0 | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA Ver. 23.0 | Non-systematic Assessment |
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| Thirst | General disorders | MedDRA Ver. 23.0 | Non-systematic Assessment |
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| Blood potassium increased | Investigations | MedDRA Ver. 23.0 | Non-systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA Ver. 23.0 | Non-systematic Assessment |
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| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA Ver. 23.0 | Non-systematic Assessment |
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| Hypernatraemia | Metabolism and nutrition disorders | MedDRA Ver. 23.0 | Non-systematic Assessment |
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| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA Ver. 23.0 | Non-systematic Assessment |
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| Renal impairment | Renal and urinary disorders | MedDRA Ver. 23.0 | Non-systematic Assessment |
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| Eczema | Skin and subcutaneous tissue disorders | MedDRA Ver. 23.0 | Non-systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA Ver. 23.0 | Non-systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA Ver. 23.0 | Non-systematic Assessment |
|
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| Pulmonary Congestion |
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| Hepatomegaly |
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| Third Cardiac Sound |
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