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| ID | Type | Description | Link |
|---|---|---|---|
| JapicCTI-111621 | Other Identifier | JAPIC |
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One tolvaptan 15 mg tablet or placebo tablet will be orally administered once daily in the morning for up to 14 days to heart failure patients with volume overload that does not show adequate response to other diuretics such as loop diuretics in order to investigate the effect of tolvaptan on the mid- to long-term prognosis of the target population. The efficacy of tolvaptan during the treatment period will also be investigated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tolvaptan | Experimental | 15 mg |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tolvaptan | Drug | Once-daily oral administration of one tolvaptan 15 mg tablet in the morning |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Cummulative Incidence of Events at Week 26 | From start day of IMP administration to final day of follow up period, 1) and 2) below were defined as event
| Week 26 |
| Mortality （Number of Death） | Statistical comparison was not done. | Week26 |
| Body Weight | The comparison of the average of amount of change from baseline. Statistical comparison was not done. | Day15 |
| Number of Subjects Whose Lower Limb Edema Severity Grading Improved by One or More Grade | Of the subjects who had lower limb edema at baseline, the number of subjects whose lower limb edema severity grading. Statistical comparison was not done. | Day15 |
| Jugular Venous Distension | The comparison of the average of amount of change from baseline. Statistical comparison was not done. | Day15 |
| Change in Liver Size From Baseline | The comparison of the average of amount of change from baseline. Statistical comparison was not done． | Day15 |
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Inclusion Criteria:
Exclusion Criteria:
Patients with a history of hypersensitivity to any ingredient of the drug or to tolvaptan analogues (e.g., mozavaptan hydrochloride)
Patients with anuria
Patients who cannot sense thirst or who have difficulty with fluid intake
Patients with hypernatremia (serum sodium concentration > institutional upper limit of normal) 5) Female patients who are pregnant, possibly pregnant, or nursing
Patients judged by the investigator or subinvestigator to be inappropriate for inclusion in the trial due to any of the following conditions or symptoms:
Patients with suspected hypovolemia
Patients with an implanted circulatory support device
Patients in whom acute cardiac infarction occurred within 30 days prior to the screening examination
Patients who participated in any other clinical trial or postmarketing clinical trial within 30 days prior to the date of informed consent for the present trial
Patients who received tolvaptan within 26 weeks prior to the date of informed consent
Patients who are otherwise judged by the investigator or sub-investigator to be inappropriate for inclusion in the trial
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chube Region | Japan | |||||
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| ID | Title | Description |
|---|---|---|
| FG000 | Tolvaptan | 15 mg Tolvaptan: Once-daily oral administration of one tolvaptan 15 mg tablet in the morning |
| FG001 | Placebo | Placebo Placebo of tolvaptan: Once-daily oral administration of one placebo tablet in the morning |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Tolvaptan | 15 mg Tolvaptan: Once-daily oral administration of one tolvaptan 15 mg tablet in the morning |
| BG001 | Placebo | Placebo Placebo of tolvaptan: Once-daily oral administration of one placebo tablet in the morning |
| 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 | Cummulative Incidence of Events at Week 26 | From start day of IMP administration to final day of follow up period, 1) and 2) below were defined as event
| Posted | Number | Percentage of events at 26 weeks | Week 26 |
|
26 weeks
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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 | Tolvaptan | 15 mg Tolvaptan: Once-daily oral administration of one tolvaptan 15 mg tablet in the morning |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac failure | Cardiac disorders | MedDRA/J Ver.16.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA/J Ver.16.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Research and Development | Otsuka Pharmaceutical Co., Ltd | +81-3-6361-7366 |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D004487 | Edema |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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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| Placebo of tolvaptan |
| Drug |
Once-daily oral administration of one placebo tablet in the morning |
|
| Pulmonary Rales |
Of the subjects who had pulmonary rales at baseline, the number of subjects whose symptom was resolved at completion of treatment. Statistical comparison was not done. |
| Day15 |
| Third Heart Sound | Of the subjects who had third heart sound at baseline, the number of subjects whose symptom was resolved at completion of treatment. Statistical comparison was not done. | Day15 |
| Cardiothoracic Ratio | Investigator majored Thoracic length and Cardiac length from chest X-ray. Cardiothoracic Ratio was calculated from Cardiac length/Thoracic length*100. Lowering of Cardiothoracic Ratio suggests recovery from heart congestion. The comparison of the average of amount of change from baseline. Statistical comparison was not done. | Day15 |
| Pulmonary Congestion | Of the subjects who had pulmonary congestion at baseline, the number of subjects whose pulmonary congestion severity grading showed an improvement of one grade or more (eg, moderate to mild) at completion of treatment. Statistical comparison was not done. | Day15 |
| Plasma Brain Natriuretic Peptide (BNP) Concentration | The comparison of the average of amount of change from baseline. Statistical comparison was not done. | Day15 |
| Dypnea | Of the subjects who had dyspnoea at baseline, the number of subjects whose symptom was resolved at completion of treatment. Statistical comparison was not done. | Day15 |
| Number of Subjects Whose New York Heart Association (NYHA) Classification Improved by One More Grade From Baseline | New York Heart Association (NYHA) Classification is below ClassI：No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea (shortness of breath). ClassII：Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea (shortness of breath). ClassIII：Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea. ClassIV：Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases. | The day after last IMP administration and Baseline |
| Chushikoku Region |
| Japan |
| Hokkaido Region | Japan |
| Hokuriku Region | Japan |
| Kansai Region | Japan |
| Kanto Region | Japan |
| Kyushu Region | Japan |
| Tohoku Region | Japan |
| Deviation of exclusion criteria |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Placebo Placebo of tolvaptan: Once-daily oral administration of one placebo tablet in the morning |
|
|
| Primary | Mortality （Number of Death） | Statistical comparison was not done. | Posted | Number | participants | Week26 |
|
|
|
| Primary | Body Weight | The comparison of the average of amount of change from baseline. Statistical comparison was not done. | Posted | Mean | Standard Deviation | kg | Day15 |
|
|
|
| Primary | Number of Subjects Whose Lower Limb Edema Severity Grading Improved by One or More Grade | Of the subjects who had lower limb edema at baseline, the number of subjects whose lower limb edema severity grading. Statistical comparison was not done. | Posted | Number | participants | Day15 |
|
|
|
| Primary | Jugular Venous Distension | The comparison of the average of amount of change from baseline. Statistical comparison was not done. | Posted | Mean | Standard Deviation | cm | Day15 |
|
|
|
| Primary | Change in Liver Size From Baseline | The comparison of the average of amount of change from baseline. Statistical comparison was not done． | Posted | Mean | Standard Deviation | cm | Day15 |
|
|
|
| Primary | Pulmonary Rales | Of the subjects who had pulmonary rales at baseline, the number of subjects whose symptom was resolved at completion of treatment. Statistical comparison was not done. | Posted | Number | participants | Day15 |
|
|
|
| Primary | Third Heart Sound | Of the subjects who had third heart sound at baseline, the number of subjects whose symptom was resolved at completion of treatment. Statistical comparison was not done. | Posted | Number | participants | Day15 |
|
|
|
| Primary | Cardiothoracic Ratio | Investigator majored Thoracic length and Cardiac length from chest X-ray. Cardiothoracic Ratio was calculated from Cardiac length/Thoracic length*100. Lowering of Cardiothoracic Ratio suggests recovery from heart congestion. The comparison of the average of amount of change from baseline. Statistical comparison was not done. | Posted | Mean | Standard Deviation | Percentage | Day15 |
|
|
|
| Primary | Pulmonary Congestion | Of the subjects who had pulmonary congestion at baseline, the number of subjects whose pulmonary congestion severity grading showed an improvement of one grade or more (eg, moderate to mild) at completion of treatment. Statistical comparison was not done. | Posted | Number | participants | Day15 |
|
|
|
| Primary | Plasma Brain Natriuretic Peptide (BNP) Concentration | The comparison of the average of amount of change from baseline. Statistical comparison was not done. | Posted | Mean | Standard Deviation | pg/mL | Day15 |
|
|
|
| Primary | Dypnea | Of the subjects who had dyspnoea at baseline, the number of subjects whose symptom was resolved at completion of treatment. Statistical comparison was not done. | Posted | Number | participants | Day15 |
|
|
|
| Primary | Number of Subjects Whose New York Heart Association (NYHA) Classification Improved by One More Grade From Baseline | New York Heart Association (NYHA) Classification is below ClassI：No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea (shortness of breath). ClassII：Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea (shortness of breath). ClassIII：Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea. ClassIV：Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases. | Posted | Number | participants | The day after last IMP administration and Baseline |
|
|
|
| 24 |
| 50 |
| 31 |
| 50 |
| EG001 | Placebo | Placebo Placebo of tolvaptan: Once-daily oral administration of one placebo tablet in the morning | 22 | 50 | 7 | 50 |
| Acute Cardiac Failure | Cardiac disorders | MedDRA/J Ver.16.0 | Systematic Assessment |
|
| Congestive Cardiac Failure | Cardiac disorders | MedDRA/J Ver.16.0 | Systematic Assessment |
|
| Ventricular Tachycardia | Cardiac disorders | MedDRA/J Ver.16.0 | Systematic Assessment |
|
| Cataract | Eye disorders | MedDRA/J Ver.16.0 | Systematic Assessment |
|
| Diabetic retina edema | Eye disorders | MedDRA/J Ver.16.0 | Systematic Assessment |
|
| Inguinal hernia | Gastrointestinal disorders | MedDRA/J Ver.16.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA/J Ver.16.0 | Systematic Assessment |
|
| Large intestine polyp | Gastrointestinal disorders | MedDRA/J Ver.16.0 | Systematic Assessment |
|
| Fever | General disorders | MedDRA/J Ver.16.0 | Systematic Assessment |
|
| Rhinopharyngitis | Infections and infestations | MedDRA/J Ver.16.0 | Systematic Assessment |
|
| Pneumoria | Infections and infestations | MedDRA/J Ver.16.0 | Systematic Assessment |
|
| C-reactive protein increased | Investigations | MedDRA/J Ver.16.0 | Systematic Assessment |
|
| Occult blood positive | Investigations | MedDRA/J Ver.16.0 | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA/J Ver.16.0 | Systematic Assessment |
|
| Embolic stroke | Nervous system disorders | MedDRA/J Ver.16.0 | Systematic Assessment |
|
| Loss of consciousness | Nervous system disorders | MedDRA/J Ver.16.0 | Systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA/J Ver.16.0 | Systematic Assessment |
|
| Renal failure chronic | Renal and urinary disorders | MedDRA/J Ver.16.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA/J Ver.16.0 | Systematic Assessment |
|
| Thirst | General disorders | MedDRA/J Ver.16.0 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA/J Ver.16.0 | Systematic Assessment |
|
| Blood potassium increased | Investigations | MedDRA/J Ver.16.0 | Systematic Assessment |
|
| Blood sodium increased | Investigations | MedDRA/J Ver.16.0 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA/J Ver.16.0 | Systematic Assessment |
|
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