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This study was an randomized, double-Blind, placebo-controlled, multicenter Phase II/III study.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Valsartan Oral Solution | Experimental | 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. |
|
| Placebo | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Valsartan Oral Solution | Drug | 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);
Full dose: <35 kg: 13 mL (equivalent to valsartan 40 mg);
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 weeks of randomized placebo withdrawal period |
| Measure | Description | Time Frame |
|---|---|---|
| Change in mean seated diastolic blood pressure (MSDBP) from the end of week 6 to the end of week 8 | 2 weeks of randomized placebo withdrawal | |
| Change in MSSBP and MSDBP from baseline to the end of week 6 | 6 weeks of Trial drug administration period |
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Inclusion Criteria:
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.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shandong New Time Pharmaceutical Co.LTD, | Linyi | Shandong | China |
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| ID | Term |
|---|---|
| D000075222 | Essential Hypertension |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000068756 | Valsartan |
| ID | Term |
|---|---|
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Placebo | Drug | 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 ;
Placebo dosing during elution phase: <35 kg: 7 mL;
|
|
| Change in MSSBP and MSDBP from baseline to the end of week 8 | 8 weeks of Trial drug administration period and randomized placebo withdrawal period |
| Blood pressure control rate | 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 | up to 3 months |
| Palatability evaluation by VAS (visual analog scale) | the first 8 days of treatment |
| D014633 |
| Valine |
| D000597 | Amino Acids, Branched-Chain |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000601 | Amino Acids, Essential |