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

Inclusion Criteria:

1. 6 years old ≤ age ≤ 17 years old, male or female;

2. 18kg ≤ weight ≤ 160kg;

3. Initial diagnosis of essential hypertension or previous history of essentialhypertension at the V1 visit, mean seated systolic blood pressure (MSSBP) and/ormean seated diastolic blood pressure (MSDBP) before the first administration ofmedication (at the V2 visit) at least in the 95th percentile for the same age, sex,and height (with reference to the "Chinese Guidelines for the Prevention and Controlof Hypertension, Revised Edition 2018" for Chinese children aged 3-17 years for eachyear of age, height corresponding blood pressure standard) and meets the criteriafor hypertension medication;

4. Vital organ function meets the following requirements: Blood routine: hemoglobin ≥ 90 g/L, platelet count ≥ 100 × 109 /L, serum potassium ≤ 5.3 mmol/L; Liver function: ALT and AST ≤ 3 × ULN, total bilirubin level (TBIL) ≤ 2 × ULN; Renal function: glomerular filtration rate ≥ 30 mL/min/1.73 m2 (see Appendix 1 for calculation formula);

5. The legal guardian and/or the person himself/herself voluntarily signed the informedconsent form.

Exclusion Criteria:

1. those with confirmed or previous hypertensive emergencies, hypertensivesub-emergencies;

2. Patients with secondary hypertension;

3. Medication adherence <80% and/or >120% during the placebo washout period at the V2visit;

4. Patients with diabetes mellitus judged uncontrollable by the investigator;

5. Persons with associated electrolyte disturbances (e.g., severe hyponatremia);

6. those with a prior history of biliary cirrhosis and cholestasis;

7. persons with a prior history of organ transplantation;

8. patients with known active gastritis, duodenal ulcer or gastric ulcer orgastrointestinal/rectal bleeding within 3 months prior to the first dose;

9. Patients with a history of clinically significant drug/food allergy (within 6 monthsprior to first dose) or history of atopic allergic disease (e.g., asthma, etc.) orknown allergy to valsartan and its excipients or other angiotensin II receptorantagonists (ARBs) and/or angiotensin converting enzyme inhibitors (ACEIs);

10. Persons who are infectious disease screen positive for hepatitis B surface antigenand/or core antibody and test positive for HBV-DNA, hepatitis C virus antibodypositive and test positive for RNA, HIV positive, or syphilis spirochete antibodypositive;

11. Persons who have been treated with any other clinical trial drug/device within 1month prior to the first dose or within 5 half-lives of the trial drug, whichever isshorter;

12. Females with a history of menstruation who have had a positive pregnancy test;

13. Those who may not be able to complete the study for other reasons or those who, inthe opinion of the investigator, are not suitable for inclusion.