Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics Study of Tolvaptan in Pediatric Congestive Heart Failure (CHF) Patients With Volume Overload
Study Details
Study Description
Brief Summary
To determine the efficacy, safety, and dose and regimen of tolvaptan in pediatric CHF patients with volume overload
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Tolvaptan Tolvaptan 1% granules or tolvaptan 15 mg tablet with water once daily. |
Drug: Tolvaptan
Tolvaptan 1% granules or tolvaptan 15 mg tablet with water once daily.
|
Outcome Measures
Primary Outcome Measures
- Ratio of subject whom the body weight is decreased from baseline [-day1, day4]
Ratio of subject whom the body weight is decreased by 1.7% or more from the baseline.
Secondary Outcome Measures
- Change the amount of daily urine volume from baseline [-day1 to day9]
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Kanto Region | Japan |
Sponsors and Collaborators
- Otsuka Pharmaceutical Co., Ltd.
Investigators
- Study Director: Hiroaki Ono, Mr, Otsuka Pharmaceutical Co., Ltd.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 156-102-00123
- JapicCTI-173674