Trial · NCT03255226
Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics Study of Tolvaptan in Pediatric Congestive Heart Failure (CHF) Patients With Volume Overload
NCT03255226, Phase 3, Completed, Otsuka Pharmaceutical Co., Ltd.; results first posted 2024-08-23
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics Study of Tolvaptan in Pediatric Congestive Heart Failure (CHF) Patients With Volume Overload. Trials, record NCT03255226. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03255226
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics Study of Tolvaptan in Pediatric Congestive Heart Failure (CHF) Patients With Volume Overload
- NCT number
- NCT03255226
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 60 participants, actual
- Lead sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Conditions
- Pediatric Congestive Heart Failure (CHF) Patients With Volume Overload
- Interventions
- Tolvaptan
- First posted
- 2017-08-21
- Last updated
- 2024-08-23
- Results first posted
- 2024-08-23
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentages of Subjects Whose Was Decreased by 1.7% or More Body Weight From Baseline | Day after Day 3 at evaluation dose | 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. |
| Secondary | Change Rate From Baseline in Daily Urine Volume | Baseline, Day1, Day2 and Day3 of administration at evaluation dose | 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 |
| Secondary | Percent Changes From Baseline in Body Weight (kg) | Day after Day 3 at evaluation dose | 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 |
| Secondary | Improvement Rates of Lower Limb Edema | Day after Day 3 at evaluation dose | 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: * Markedly improved * Improved * Unchanged * Deteriorated |
| Secondary | Improvement Rates of Pulmonary Congestion | Day after Day 3 at evaluation dose | 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: * Markedly improved * Improved * Unchanged * Deteriorated |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentages of Subjects Whose Was Decreased by 1.7% or More Body Weight From Baseline | Day after Day 3 at evaluation dose | percentage of participants | NUMBER | |
| SECONDARY | Change Rate From Baseline in Daily Urine Volume | Baseline, Day1, Day2 and Day3 of administration at evaluation dose | 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. | percentage of urine volume (mL) | MEAN |
| SECONDARY | Percent Changes From Baseline in Body Weight (kg) | Day after Day 3 at evaluation dose | percentage of body weight (kg) | MEAN | |
| SECONDARY | Improvement Rates of Lower Limb Edema | Day after Day 3 at evaluation dose | 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. | percentage of participants | NUMBER |
| SECONDARY | Improvement Rates of Pulmonary Congestion | Day after Day 3 at evaluation dose | 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. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group7
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentages of Subjects Whose Was Decreased by 1.7% or More Body Weight From Baseline | Tolvaptan | 22.8 | 95% Confidence Interval 12.7 to 35.8 | percentage of participants | |
| Change Rate From Baseline in Daily Urine Volume | Tolvaptan | Day 1 | 53.1 | Standard Deviation 52.9 | percentage of urine volume (mL) |
| Change Rate From Baseline in Daily Urine Volume | Tolvaptan | Day 2 | 47.8 | Standard Deviation 43.3 | percentage of urine volume (mL) |
| Change Rate From Baseline in Daily Urine Volume | Tolvaptan | Day 3 | 45.8 | Standard Deviation 29.3 | percentage of urine volume (mL) |
| Percent Changes From Baseline in Body Weight (kg) | Tolvaptan | -0.371 | Standard Deviation 2.470 | percentage of body weight (kg) | |
| Improvement Rates of Lower Limb Edema | Tolvaptan | 68.6 | 95% Confidence Interval 50.7 to 83.1 | percentage of participants | |
| Improvement Rates of Pulmonary Congestion | Tolvaptan | 51.6 | 95% Confidence Interval 33.1 to 69.8 | percentage of participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Tolvaptan | 60 | |
| Overall Study | COMPLETED | Tolvaptan | 46 | |
| Overall Study | NOT COMPLETED | Tolvaptan | 14 |
Source ClinicalTrials.gov
Adverse events30
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Tolvaptan | 2 | 60 | |
| other | Neutropenia | Blood and lymphatic system disorders | Tolvaptan | 1 | 60 | |
| other | Cardiovascular insufficiency | Cardiac disorders | Tolvaptan | 1 | 60 | |
| other | Erythema of eyelid | Eye disorders | Tolvaptan | 1 | 60 | |
| other | Abdominal pain | Gastrointestinal disorders | Tolvaptan | 1 | 60 | |
| other | Constipation | Gastrointestinal disorders | Tolvaptan | 2 | 60 | |
| other | Dry mouth | Gastrointestinal disorders | Tolvaptan | 2 | 60 | |
| other | Nausea | Gastrointestinal disorders | Tolvaptan | 1 | 60 | |
| other | Vomitng | Gastrointestinal disorders | Tolvaptan | 2 | 60 | |
| other | Gastrointestinal hypomotility | Gastrointestinal disorders | Tolvaptan | 1 | 60 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tolvaptan | 0 | 60 |
| Total, other adverse events | Tolvaptan | 25 | 60 |
| Total, serious adverse events | Tolvaptan | 1 | 60 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03255226
GET https://conductscience.org/api/trials/v1/NCT03255226/events?page=2