Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics Study of Tolvaptan in Pediatric Congestive Heart Failure (CHF) Patients With Volume Overload
CompletedPhase 3Results postedLast updated 23 August 2024
What this trial tests
Phase 3 trial testing Tolvaptan in Pediatric Congestive Heart Failure (CHF) Patients With Volume Overload in 60 participants. Completed in 15 July 2021.
Adults 6 Months to 14, any sex, with Pediatric Congestive Heart Failure (CHF) Patients With Volume Overload. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentages of Subjects Whose Was Decreased by 1.7% or More Body Weight From BaselinePrimary· 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 perce
Group
Value
95% CI
Tolvaptan
22.8
12.7 – 35.8
Change Rate From Baseline in Daily Urine VolumeSecondary· 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
Day 1
Group
Value
95% CI
Tolvaptan
53.1
± 52.9
Day 2
Group
Value
95% CI
Tolvaptan
47.8
± 43.3
Day 3
Group
Value
95% CI
Tolvaptan
45.8
± 29.3
Percent Changes From Baseline in Body Weight (kg)Secondary· 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
Group
Value
95% CI
Tolvaptan
-0.371
± 2.470
Improvement Rates of Lower Limb EdemaSecondary· 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
Group
Value
95% CI
Tolvaptan
68.6
50.7 – 83.1
Improvement Rates of Pulmonary CongestionSecondary· 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
Group
Value
95% CI
Tolvaptan
51.6
33.1 – 69.8
Adverse events — posted to ClinicalTrials.gov
Time frame: Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 16 days.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Otsuka Pharmaceutical Co., Ltd.
Last refreshed: 23 August 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03255226.