N/A
Completed N=5
A Study of Azilsartan in Children From 6 to Less Than 16 Years Old With High Blood Pressure
Source: ClinicalTrials.gov NCT05107960 ↗Enrolled (actual)
5
Serious AEs
0.0%
Results posted
Sep 2025
Primary outcomePrimary: Number of Participants Who Experienced at Least One Treatment-Emergent Adverse Event (TEAE) — 0 Participants
Summary
The main aim of this study is to check for side effects from treatment with azilsartan and how well azilsartan controls blood pressure in children from 6 to less than 16 years old with high blood pressure.
The study sponsor will not be involved in how the participants are treated but will provide instructions on how the clinics will record what happens during the study.
During the study, participants with high blood pressure will take azilsartan tablets or azilsartan granules once a day according to their clinic's standard practice. The study doctors will check for side effects from azilsartan for up to 12 months after treatment starts.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Experienced at Least One Treatment-Emergent Adverse Event (TEAE) |
— | — |
| PRIMARY Number of Participants Who Experienced at Least One Serious Adverse Event (SAE) |
— | — |
| PRIMARY Mean Value of Systolic Blood Pressure |
121.8; 109.8; 112.3; 117.5; 113.3; 115.5 | — |
| PRIMARY Mean Value of Diastolic Blood Pressure |
72.8; 65.8; 68.0; 77.5; 64.0; 58.5 | — |
| PRIMARY Change From Baseline in Mean Value of Systolic Blood Pressure |
-8.5; -14.7; 2.5; -5.0; -10.0; -33.0 | — |
| PRIMARY Change From Baseline in Mean Value of Diastolic Blood Pressure |
-9.0; -3.3; 12.0; -10.8; -6.0; -24.0 | — |
Eligibility Criteria
Inclusion Criteria
- Participants aged 6 years or older and less than 16 years
- Participants with hypertension
Exclusion Criteria Participants with contraindications to azilsartan.
Data sourced from ClinicalTrials.gov (NCT05107960). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.