Clinical trial NCT06863987: A Phase III Clinical Study of Valsartan Oral Solution for the Treatment of Hypertension in Children and Adolescents
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
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE3
Conditions: Essential Hypertension
Lead sponsor: Shandong New Time Pharmaceutical Co., LTD
Sponsor class: INDUSTRY
First posted: 2025-03-07
Enrollment: 342
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: The trial was divided into three parts: a screening period, a treatment period, and an open-label safety observation period, in which the screening period consisted of screening and placebo elution, and the treatment period consisted of the test drug administration period and a randomized placebo withdrawal period.the entire trial process lasts at least 3 months (excluding the screening period).

Eligibility criteria: 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 essential hypertension at the V1 visit, mean seated systolic blood pressure (MSSBP) and/or mean seated diastolic blood pressure (MSDBP) before the first administration of medication (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 Control of Hypertension, Revised Edition 2018" for Chinese children aged 3-17 years for each year of age, height corresponding blood pressure standard) and meets the criteria for 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 informed consent form.

Exclusion Criteria:

1. those with confirmed or previous hypertensive emergencies, hypertensive sub-emergencies;
2. Patients with secondary hypertension;
3. Medication adherence \<80% and/or \>120% during the placebo washout period at the V2 visit;
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 or gastrointestinal/rectal bleeding within 3 months prior to the first dose;
9. Patients with a history of clinically significant drug/food allergy (within 6 months prior to first dose) or history of atopic allergic disease (e.g., asthma, etc.) or known allergy to valsartan and its excipients or other angiotensin II receptor antagonists (ARBs) and/or angiotensin converting enzyme inhibitors (ACEIs);
10. Persons who are infectious disease screen positive for hepatitis B surface antigen and/or core antibody and test positive for HBV-DNA, hepatitis C virus antibody positive and test positive for RNA, HIV positive, or syphilis spirochete antibody positive;
11. Persons who have been treated with any other clinical trial drug/device within 1 month prior to the first dose or within 5 half-lives of the trial drug, whichever is shorter;
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, in the opinion of the investigator, are not suitable for inclusion.

Primary outcomes:
measure: Change in mean seated systolic blood pressure (MSSBP) from the end of week 6 to the end of week 8 in the valsartan oral solution group compared to the placebo group.
timeFrame: 2 weeks of randomized placebo withdrawal period
Secondary outcomes:
measure: Change in mean seated diastolic blood pressure (MSDBP) from the end of week 6 to the end of week 8
timeFrame: 2 weeks of randomized placebo withdrawal
measure: Change in MSSBP and MSDBP from baseline to the end of week 6
timeFrame: 6 weeks of Trial drug administration period
measure: Change in MSSBP and MSDBP from baseline to the end of week 8
timeFrame: 8 weeks of Trial drug administration period and randomized placebo withdrawal period
measure: Blood pressure control rate
timeFrame: 8 weeks of Trial drug administration period and randomized placebo withdrawal period
measure: Adverse events (AEs)/serious adverse events (SAEs) were collected by vital signs, physical examination, laboratory tests, and 12-lead electrocardiogram to assess safety
timeFrame: up to 3 months
measure: Palatability evaluation by VAS (visual analog scale)
timeFrame: the first 8 days of treatment
Other outcomes:
Locations:
city: Linyi
country: China
facility: Shandong New Time Pharmaceutical Co.LTD,
state: Shandong
Study officials:
References: