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

Shandong New Time Pharmaceutical

Status and phase: Invitation-only; Phase 3

Conditions: Essential Hypertension

Treatments: Drug: Valsartan Oral Solution; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06863987

NTP-XST-OS-Ⅲ

Details and patient eligibility

About

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

Full 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).

Enrollment: 342 estimated patients

Sex: All

Ages: 6 to 17 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Parallel Assignment

Masking: Double Blind

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342 participants in 2 patient groups, including a placebo group

Valsartan Oral Solution

Experimental group

Description:

Screening Period: all subjects eligible for enrollment at Visit V1 received a 7-day placebo introductory period; Trial drug administration period: subjects eligible for enrollment received a half-dose of valsartan oral solution for one week after visit V2, after which subjects received a full-dose of valsartan oral solution for five weeks, with subjects required to come in for checkups at visits V3 and V4, and subjects were followed up by telephone for medication at visit V5; Randomized Placebo Withdrawal Period: two weeks of receiving valsartan oral solution after randomization at Visit V6, with telephone follow-up of subjects on medication at Visit V7 and subjects required to come to the hospital for check-ups at Visit V8; Safety observation period: after V8 visit, subjects assessed by the investigator to be able to continue the medication and who volunteered to participate in a follow-up study continued to take valsartan oral solution up to 3 months or withdrew early.

Treatment:

Drug: Valsartan Oral Solution

Placebo

Placebo Comparator group

Description:

Screening Period: all subjects eligible for enrollment at Visit V1 received a 7-day placebo introductory period; Trial drug administration period: subjects eligible for enrollment received a half-dose of valsartan oral solution for one week after visit V2, after which subjects received a full-dose of valsartan oral solution for five weeks, with subjects required to come in for checkups at visits V3 and V4, and subjects were followed up by telephone for medication at visit V5; Randomized Placebo Withdrawal Period: two weeks of receiving placebo after randomization at Visit V6, with telephone follow-up of subjects on medication at Visit V7 and subjects required to come to the hospital for check-ups at Visit V8; Safety observation period: after V8 visit, subjects assessed by the investigator to be able to continue the medication and who volunteered to participate in a follow-up study continued to take valsartan oral solution up to 3 months or withdrew early.

Treatment:

Drug: Placebo