Essential HypertensionPhase 3NCT06863987
A Phase III Clinical Study of Valsartan Oral Solution for the Treatment of Hypertension in Children and Adolescents
A Phase 3 study testing Valsartan Oral Solution in people with Essential Hypertension, run by Shandong New Time Pharmaceutical Co., LTD at 1 site in China.
Trial summary
This study was an randomized, double-Blind, placebo-controlled, multicenter Phase II/III study. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Essential Hypertension
- What is being tested?
- Valsartan Oral Solution
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 342 participants
- Where
- 1 siteChina
- Study dates
- 5 Feb 2025to Dec 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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
This study was an randomized, double-Blind, placebo-controlled, multicenter Phase II/III study.
Read the 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).
- Conditions
- Essential Hypertension
- Being tested
- Valsartan Oral Solution, Placebo
- Medical subject headings
- Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Valsartan Oral SolutionDrug
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).
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Valsartan Oral Solution |
| 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 weeks of randomized placebo withdrawal period
Secondary outcomes (6)
Change in mean seated diastolic blood pressure (MSDBP) from the end of week 6 to the end of week 8
Measured: 2 weeks of randomized placebo withdrawal
Change in MSSBP and MSDBP from baseline to the end of week 6
Measured: 6 weeks of Trial drug administration period
Change in MSSBP and MSDBP from baseline to the end of week 8
Measured: 8 weeks of Trial drug administration period and randomized placebo withdrawal period
Blood pressure control rate
Measured: 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
Measured: up to 3 months
Palatability evaluation by VAS (visual analog scale)
Measured: the first 8 days of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2025
- Study start5 Feb 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Essential HypertensionStudies of the same condition, open and under way.
- More trials run by Shandong New Time Pharmaceutical Co., LTDThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 342 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong New Time Pharmaceutical Co., LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06863987
- Sponsor's protocol ID
- NTP-XST-OS-Ⅲ
- Status last verified
- Mar 2025
- First submitted
- 4 Mar 2025
- Last updated
- 7 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06863987
- Acronym / sponsor ID
- NTP-XST-OS-Ⅲ
- Conditions
- Essential Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 342 participants (estimated)
- Lead sponsor
- Shandong New Time Pharmaceutical Co., LTDIndustry (pharma, biotech, devices)
- Study start
- 5 Feb 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 7 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Valsartan Oral Solution | Experimental | Drug: Valsartan Oral SolutionScreening 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 | Drug: PlaceboScreening 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. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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);
Key exclusion criteria (13 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Valsartan Oral SolutionValsartan 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). | Drug | Valsartan Oral Solution |
| Placeboplacebo, 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. | Drug | Placebo |
Primary outcome
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.
Time frame: 2 weeks of randomized placebo withdrawal period
6 secondary outcomes
Change in mean seated diastolic blood pressure (MSDBP) from the end of week 6 to the end of week 8
Time frame: 2 weeks of randomized placebo withdrawal
Change in MSSBP and MSDBP from baseline to the end of week 6
Time frame: 6 weeks of Trial drug administration period
Change in MSSBP and MSDBP from baseline to the end of week 8
Time frame: 8 weeks of Trial drug administration period and randomized placebo withdrawal period
Blood pressure control rate
Time frame: 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
Time frame: up to 3 months
Palatability evaluation by VAS (visual analog scale)
Time frame: the first 8 days of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Valsartan Oral Solution in people with Essential Hypertension, run by Shandong New Time Pharmaceutical Co., LTD at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 7 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 2 weeks of randomized placebo withdrawal period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2025.