Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics Study of Tolvaptan in Pediatric Congestive Heart Failure (CHF) Patients With Volume Overload

Inclusion Criteria:

• Patients with volume overload despite having received any of the following diuretictherapies in whom sufficient effects cannot be expected even if the dose of thediuretics is increased or in whom the investigator or subinvestigator judges thatincreasing the dose of the diuretics is difficult due to concerns regardingelectrolyte 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 dueto their young age can also be enrolled in the trial if strict management of fluidintake and excretion is conducted. However, even if such fluid management ispossible, the patients in whom the investigator or subinvestigator judges thattolvaptan cannot be safely administered are to be excluded

• Patients who can be hospitalized from at least 3 days before start of tolvaptanadministration until 2 days after the final administration.

others

Exclusion Criteria:

• Patients whose volume overload status shows improvement during the screening periodor pretreatment observation period

• Patients who are unable to drink fluid (including patients who are unable to sensethirst)

• 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 145mEq/L) others