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

NCT06863987 · Status: ENROLLING_BY_INVITATION · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 342

Last updated 2025-03-07

No results posted yet for this study

Summary

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

Conditions

  • Essential Hypertension

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.

Sponsors & Collaborators

  • Shandong New Time Pharmaceutical Co., LTD

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-05
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06863987 on ClinicalTrials.gov