drugset / Trial / NCT03255226

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

NCT03255226

Phase 3 Completed 60 enrolled Otsuka Pharmaceutical Co., Ltd.
NaSingle-groupOpen-labelTreatment

Summary

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

Timeline

Start
2018-03-07
Primary completion
2021-07-11
Completion
2021-07-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Tolvaptan Small molecule 1 %
Subject Tolvaptan Small molecule 15 mg