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| ID | Type | Description | Link |
|---|---|---|---|
| JapicCTI-173674 | Other Identifier | Japic |
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To determine the efficacy, safety, and dose and regimen of tolvaptan in pediatric CHF patients with volume overload
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tolvaptan | Experimental | Tolvaptan 1% granules or tolvaptan 15 mg tablet with water once daily. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tolvaptan | Drug | Tolvaptan 1% granules or tolvaptan 15 mg tablet with water once daily. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentages of Subjects Whose Was Decreased by 1.7% or More Body Weight From Baseline | The primary endpoint of this trial was the percentage of subjects whose body weight on the day after the third day of treatment with tolvaptan at the evaluation dose (the third day of administration at the evaluation dose) was decreased by 1.7% or more from the weight measured before breakfast (baseline) on the first day of the treatment period (the initial tolvaptan administration day), under the condition that the mean daily urine volume for the 3 days of treatment with tolvaptan at the evaluation dose was higher than the daily urine volume for the pretreatment observation period. The percentage of subjects as well as the exact 95% confidence interval (CI) based on binomial distribution were calculated. | Day after Day 3 at evaluation dose |
| Measure | Description | Time Frame |
|---|---|---|
| Change Rate From Baseline in Daily Urine Volume | Daily urine volume was measured for the time interval starting at urination (an instruction to urinate) after breakfast and ending at complete urination immediately before administration on the following day. Baseline was 100% and the change rate was calculated like this. Percent change (%) = ([daily urine volume on the Day1, Day2 and Day3 of the tolvaptan at the evaluation dose] - [daily urine volume on baseline] ) / [daily urine volume on baseline] ×100 |
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Inclusion Criteria:
Patients with volume overload despite having received any of the following diuretic therapies in whom sufficient effects cannot be expected even if the dose of the diuretics is increased or in whom the investigator or subinvestigator judges that increasing the dose of the diuretics is difficult due to concerns regarding electrolyte abnormalities or other side effects
Patients capable of complaining of thirst. Patients unable to complain of thirst due to their young age can also be enrolled in the trial if strict management of fluid intake and excretion is conducted. However, even if such fluid management is possible, the patients in whom the investigator or subinvestigator judges that tolvaptan cannot be safely administered are to be excluded
Patients who can be hospitalized from at least 3 days before start of tolvaptan administration until 2 days after the final administration.
others
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Takehisa Matsumaru, Mr | Otsuka Pharmaceutical Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kanto Region | 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 | Tolvaptan | Tolvaptan 1% granules or tolvaptan 15 mg tablet with water once daily. Tolvaptan: Tolvaptan 1% granules or tolvaptan 15 mg tablet with water once daily. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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 | Feb 3, 2021 | Jun 27, 2022 |
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| Baseline, Day1, Day2 and Day3 of administration at evaluation dose |
| Percent Changes From Baseline in Body Weight (kg) | Percent change from baseline in body weight (kg) on the day after the third day of treatment with tolvaptan at the evaluation dose was evaluated. For body weight measured on the day after the third day of administration at the evaluation dose, their percent changes from baseline (before the start of tolvaptan administration on the first day of the treatment period) mean and standard deviation (SD) were calculated. Baseline was 100% and the change rate was alculated like this. Percent change (%) = ([body weight on the day after the third day of treatment with tolvaptan at the evaluation dose] - [body weight on baseline] ) / [body weight on baseline] ×100 | Day after Day 3 at evaluation dose |
| Improvement Rates of Lower Limb Edema | The improvement rate was defined as the percentage of subjects in whom a symptom was present at baseline and then markedly improved or improved after IMP administration. Improvement category is a 4-point scale below:
| Day after Day 3 at evaluation dose |
| Improvement Rates of Pulmonary Congestion | The improvement rate was defined as the percentage of subjects in whom a symptom was present at baseline and then markedly improved or improved after IMP administration. Improvement category is a 4-point scale below:
| Day after Day 3 at evaluation dose |
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| NOT COMPLETED |
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The FAS included 59 of 60 subjects (98.3%) who received the IMP. One subject was excluded from the FAS because the subject received the IMP at least once, and discontinued the trial before the daily urine volume data on Day 1 were obtained.
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| ID | Title | Description |
|---|---|---|
| BG000 | Tolvaptan | Tolvaptan 1% granules or tolvaptan 15 mg tablet with water once daily. Tolvaptan: Tolvaptan 1% granules or tolvaptan 15 mg tablet with water once daily. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | Percentages of Subjects Whose Was Decreased by 1.7% or More Body Weight From Baseline | The primary endpoint of this trial was the percentage of subjects whose body weight on the day after the third day of treatment with tolvaptan at the evaluation dose (the third day of administration at the evaluation dose) was decreased by 1.7% or more from the weight measured before breakfast (baseline) on the first day of the treatment period (the initial tolvaptan administration day), under the condition that the mean daily urine volume for the 3 days of treatment with tolvaptan at the evaluation dose was higher than the daily urine volume for the pretreatment observation period. The percentage of subjects as well as the exact 95% confidence interval (CI) based on binomial distribution were calculated. | Posted | Number | 95% Confidence Interval | percentage of participants | Day after Day 3 at evaluation dose |
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| Secondary | Change Rate From Baseline in Daily Urine Volume | Daily urine volume was measured for the time interval starting at urination (an instruction to urinate) after breakfast and ending at complete urination immediately before administration on the following day. Baseline was 100% and the change rate was calculated like this. Percent change (%) = ([daily urine volume on the Day1, Day2 and Day3 of the tolvaptan at the evaluation dose] - [daily urine volume on baseline] ) / [daily urine volume on baseline] ×100 | The FAS included 59 of 60 subjects (98.3%) who received the IMP. One subject was excluded from the FAS because the subject received the IMP at least once, and discontinued the trial before the daily urine volume data on Day 1 were obtained. | Posted | Mean | Standard Deviation | percentage of urine volume (mL) | Baseline, Day1, Day2 and Day3 of administration at evaluation dose |
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| Secondary | Percent Changes From Baseline in Body Weight (kg) | Percent change from baseline in body weight (kg) on the day after the third day of treatment with tolvaptan at the evaluation dose was evaluated. For body weight measured on the day after the third day of administration at the evaluation dose, their percent changes from baseline (before the start of tolvaptan administration on the first day of the treatment period) mean and standard deviation (SD) were calculated. Baseline was 100% and the change rate was alculated like this. Percent change (%) = ([body weight on the day after the third day of treatment with tolvaptan at the evaluation dose] - [body weight on baseline] ) / [body weight on baseline] ×100 | Posted | Mean | Standard Deviation | percentage of body weight (kg) | Day after Day 3 at evaluation dose |
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| Secondary | Improvement Rates of Lower Limb Edema | The improvement rate was defined as the percentage of subjects in whom a symptom was present at baseline and then markedly improved or improved after IMP administration. Improvement category is a 4-point scale below:
| The FAS included 59 of 60 subjects (98.3%) who received the IMP. One subject was excluded from the FAS because the subject received the IMP at least once, and discontinued the trial before the daily urine volume data on Day 1 were obtained. Number of subjects with lower libm edema at baseline was 35. | Posted | Number | 95% Confidence Interval | percentage of participants | Day after Day 3 at evaluation dose |
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| Secondary | Improvement Rates of Pulmonary Congestion | The improvement rate was defined as the percentage of subjects in whom a symptom was present at baseline and then markedly improved or improved after IMP administration. Improvement category is a 4-point scale below:
| The FAS included 59 of 60 subjects (98.3%) who received the IMP. One subject was excluded from the FAS because the subject received the IMP at least once, and discontinued the trial before the daily urine volume data on Day 1 were obtained. Number of subjects with pulmonary conjestion at baseline was 31. | Posted | Number | 95% Confidence Interval | percentage of participants | Day after Day 3 at evaluation dose |
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Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 16 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 | Tolvaptan | Tolvaptan 1% granules or tolvaptan 15 mg tablet with water once daily. Tolvaptan: Tolvaptan 1% granules or tolvaptan 15 mg tablet with water once daily. | 0 | 60 | 1 | 60 | 25 | 60 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac failure chronic | Cardiac disorders | MedDRA Ver. 24.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Ver. 24.0 | Non-systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA Ver. 24.0 | Non-systematic Assessment |
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| Cardiovascular insufficiency | Cardiac disorders | MedDRA Ver. 24.0 | Non-systematic Assessment |
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| Erythema of eyelid | Eye disorders | MedDRA Ver. 24.0 | Non-systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA Ver. 24.0 | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA Ver. 24.0 | Non-systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA Ver. 24.0 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA Ver. 24.0 | Non-systematic Assessment |
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| Vomitng | Gastrointestinal disorders | MedDRA Ver. 24.0 | Non-systematic Assessment |
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| Gastrointestinal hypomotility | Gastrointestinal disorders | MedDRA Ver. 24.0 | Non-systematic Assessment |
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| Anal erythema | Gastrointestinal disorders | MedDRA Ver. 24.0 | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA Ver. 24.0 | Non-systematic Assessment |
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| Thirst | General disorders | MedDRA Ver. 24.0 | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA Ver. 24.0 | Non-systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA Ver. 24.0 | Non-systematic Assessment |
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| Bacterial infection | Infections and infestations | MedDRA Ver. 24.0 | Non-systematic Assessment |
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| Blood pressure increased | Investigations | MedDRA Ver. 24.0 | Non-systematic Assessment |
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| Blood pressure systolic decreased | Investigations | MedDRA Ver. 24.0 | Non-systematic Assessment |
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| Hepatic enzyme increased | Investigations | MedDRA Ver. 24.0 | Non-systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA Ver. 24.0 | Non-systematic Assessment |
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| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA Ver. 24.0 | Non-systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA Ver. 24.0 | Non-systematic Assessment |
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| Polydipsia | Metabolism and nutrition disorders | MedDRA Ver. 24.0 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA Ver. 24.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA Ver. 24.0 | Non-systematic Assessment |
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| Renal impairment | Renal and urinary disorders | MedDRA Ver. 24.0 | Non-systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Ver. 24.0 | Non-systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA Ver. 24.0 | Non-systematic Assessment |
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| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA Ver. 24.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Trials | Otsuka Pharmaceutical Co., Ltd. | +81363617366 | CL_OPCJ_RDA_Team@otsuka.jp |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 8, 2021 | Jun 27, 2022 | SAP_001.pdf |
| 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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| 7 years to less than 15 years |
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