NCT06863987

A Phase III Clinical Study of Valsartan Oral Solution for the Treatment of Hypertension in Children and Adolescents

A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Phase III Study to Evaluate the Efficacy and Safety of Valsartan Oral Solution in Children and Adolescent Hypertensive Patients

• Status: Enrolling By Invitation
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 342 (estimated)
• Sponsor: Shandong New Time Pharmaceutical Co., LTD · Industry
• Sex: All
• Age: 6 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

This study was an randomized, double-Blind, placebo-controlled, multicenter Phase II/III study.

Detailed description

The trial was divided into three parts: a screening period, a treatment period, and an open-label safety observation period, in which the screening period consisted of screening and placebo elution, and the treatment period consisted of the test drug administration period and a randomized placebo withdrawal period.the entire trial process lasts at least 3 months (excluding the screening period).

Conditions

• Essential Hypertension

Interventions

Type	Name	Description
DRUG	Valsartan Oral Solution	Valsartan oral solution, taken by mouth, once daily. It is recommended that the medication be administered at the same time each day (e.g., in the morning). The dose administered is based on the subject's weight at the V1 visit: Halve dose: \<35 kg: 7 mL (equivalent to valsartan 20 mg); * 35 kg: 13 mL (equivalent to valsartan 40 mg). Full dose: \<35 kg: 13 mL (equivalent to valsartan 40 mg); * 35 kg: 27 mL (equivalent to valsartan 80 mg).
DRUG	Placebo	placebo, taken by mouth, once daily. It is recommended that the medication be administered at the same time each day (e.g., in the morning). The dose administered is based on the subject's weight at the V1 visit: Full dose: \<35 kg: 13 mL ; * 35 kg: 27 mL . Placebo dosing during elution phase: \<35 kg: 7 mL; * 35 kg: 13 mL.

Timeline

• Start date: 2025-02-05
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2025-03-07
• Last updated: 2025-03-07

Locations

1 site across 1 country: China