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ENROLLING BY INVITATION
NCT06863987
PHASE3

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

Sponsor: Shandong New Time Pharmaceutical Co., LTD

View on ClinicalTrials.gov

Summary

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

Official title: 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

Key Details

Gender

All

Age Range

6 Years - 17 Years

Study Type

INTERVENTIONAL

Enrollment

342

Start Date

2025-02-05

Completion Date

2027-12

Last Updated

2025-03-07

Healthy Volunteers

No

Interventions

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.

Locations (1)

Shandong New Time Pharmaceutical Co.LTD,

Linyi, Shandong, China