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

Официальное название

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

Обзор

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

Подробное описание

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).

Вмешательства

• Препарат 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).
• Препарат 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.

Первичные конечные точки

• 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. [Срок оценки: 2 weeks of randomized placebo withdrawal period]

Вторичные конечные точки (6)

• Change in mean seated diastolic blood pressure (MSDBP) from the end of week 6 to the end of week 8 [Срок оценки: 2 weeks of randomized placebo withdrawal]
• Change in MSSBP and MSDBP from baseline to the end of week 6 [Срок оценки: 6 weeks of Trial drug administration period]
• Change in MSSBP and MSDBP from baseline to the end of week 8 [Срок оценки: 8 weeks of Trial drug administration period and randomized placebo withdrawal period]
• Blood pressure control rate [Срок оценки: 8 weeks of Trial drug administration period and randomized placebo withdrawal period]
• Adverse events (AEs)/serious adverse events (SAEs) were collected by vital signs, physical examination, laboratory tests, and 12-lead electrocardiogram to assess safety [Срок оценки: up to 3 months]
• Palatability evaluation by VAS (visual analog scale) [Срок оценки: the first 8 days of treatment]

Критерии участия

Критерии включения

• 6 years old ≤ age ≤ 17 years old, male or female;
• 18kg ≤ weight ≤ 160kg;
• 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;
• 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);

• The legal guardian and/or the person himself/herself voluntarily signed the informed consent form.

Критерии исключения

• those with confirmed or previous hypertensive emergencies, hypertensive sub-emergencies;
• Patients with secondary hypertension;
• Medication adherence <80% and/or >120% during the placebo washout period at the V2 visit;
• Patients with diabetes mellitus judged uncontrollable by the investigator;
• Persons with associated electrolyte disturbances (e.g., severe hyponatremia);
• those with a prior history of biliary cirrhosis and cholestasis;
• persons with a prior history of organ transplantation;
• patients with known active gastritis, duodenal ulcer or gastric ulcer or gastrointestinal/rectal bleeding within 3 months prior to the first dose;
• 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);
• 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;
• 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;
• Females with a history of menstruation who have had a positive pregnancy test;
• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Shandong New Time Pharmaceutical Co.LTD, — Linyi

Идентификаторы

NCT: NCT06863987 · NTP-XST-OS-Ⅲ

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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