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

PHASE3Enrolling by invitationINTERVENTIONAL
Enrollment

342

Participants

Timeline

Start Date

February 5, 2025

Primary Completion Date

December 31, 2027

Study Completion Date

December 31, 2027

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."

Trial Locations (1)

Unknown

Shandong New Time Pharmaceutical Co.LTD,, Linyi

All Listed Sponsors
lead

Shandong New Time Pharmaceutical Co., LTD

INDUSTRY