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

PHASE3CompletedINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

March 7, 2018

Primary Completion Date

July 11, 2021

Study Completion Date

July 15, 2021

Conditions
Pediatric Congestive Heart Failure (CHF) Patients With Volume Overload
Interventions
DRUG

Tolvaptan

Tolvaptan 1% granules or tolvaptan 15 mg tablet with water once daily.

Trial Locations (1)

Unknown

Kanto Region

All Listed Sponsors
lead

Otsuka Pharmaceutical Co., Ltd.

INDUSTRY