NCT03255226

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Otsuka Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 6 Months – 14 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Pediatric Congestive Heart Failure (CHF) Patients With Volume Overload

Interventions

Type	Name	Description
DRUG	Tolvaptan	Tolvaptan 1% granules or tolvaptan 15 mg tablet with water once daily.

Timeline

• Start date: 2018-03-07
• Primary completion: 2021-07-11
• Completion: 2021-07-15
• First posted: 2017-08-21
• Last updated: 2024-08-23
• Results posted: 2024-08-23

Locations

1 site across 1 country: Japan