Clinical trial NCT03255226: Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics Study of Tolvaptan in Pediatric Congestive Heart Failure (CHF) Patients With Volume Overload
Official title: A Multicenter, Open-labeled, Dose-defining Trial to Investigate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Tolvaptan in Pediatric Congestive Heart Failure (CHF) Patients With Volume Overload
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pediatric Congestive Heart Failure (CHF) Patients With Volume Overload
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2017-08-21
Enrollment: 60
Sex: ALL
Minimum age (years): 6
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To determine the efficacy, safety, and dose and regimen of tolvaptan in pediatric CHF patients with volume overload


Eligibility criteria: 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

  * Furosemide (oral administration) ≥0.5 mg/kg/day. Azosemide 30 mg and torasemide 4 mg will be calculated as equivalent to furosemide 20 mg.
  * Hydrochlorothiazide ≥2 mg/kg/day
  * Trichlormethiazide ≥0.05 mg/kg/day
  * Spironolactone ≥ 1 mg/kg/day
* 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:

* Patients whose volume overload status shows improvement during the screening period or pretreatment observation period
* Patients who are unable to drink fluid (including patients who are unable to sense thirst)
* Patients whose circulatory blood flow is suspected to be decreased
* Patients with an assisted circulation apparatus
* Patients with hypernatremia (serum or blood sodium concentration exceeding 145 mEq/L) others

Primary outcomes:
measure: Percentages of Subjects Whose Was Decreased by 1.7% or More Body Weight From Baseline
timeFrame: Day after Day 3 at evaluation dose
Secondary outcomes:
measure: Change Rate From Baseline in Daily Urine Volume
timeFrame: Baseline, Day1, Day2 and Day3 of administration at evaluation dose
measure: Percent Changes From Baseline in Body Weight (kg)
timeFrame: Day after Day 3 at evaluation dose
measure: Improvement Rates of Lower Limb Edema
timeFrame: Day after Day 3 at evaluation dose
measure: Improvement Rates of Pulmonary Congestion
timeFrame: Day after Day 3 at evaluation dose
Other outcomes:
Locations:
city: Kanto Region
country: Japan
Study officials:
affiliation: Otsuka Pharmaceutical Co., Ltd.
name: Takehisa Matsumaru, Mr
role: STUDY_DIRECTOR
References: