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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
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
Conditions
Interventions
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).
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