Phase 3
Completed N=66
A Study to Evaluate the Long-term Use of Valsartan in Children 6 Months to 5 Years Old With Hypertension
Source: ClinicalTrials.gov NCT00457626 ↗Enrolled (actual)
66
Serious AEs
6.1%
Results posted
May 2021
Primary outcomePrimary: Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) — 114.7; -11.2 millimeters of mercury (mmHg)
◆ Published Evidence
Established
22citations · ~2 / year
Efficacy and safety of valsartan in hypertensive children 6 months to 5 years of age.
Summary
The purpose of this study is to evaluate the efficacy, safety and tolerability of long-term use (up to 18 weeks) of valsartan in children 6 months to 5 years old with hypertension.
Linked Publications
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Efficacy and safety of valsartan in hypertensive children 6 months to 5 years of age.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) |
114.7; -11.2 | — |
| PRIMARY Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP) |
70.7; -6.6 | — |
| PRIMARY Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) |
38; 4 | — |
Eligibility Criteria
Inclusion criteria
- Participants who qualified and entered the core study.
- Participants who participated in the core study, completed Period 1 and were re-randomized in Period 2 and continued for at least 3 days in Period 2.
Exclusion criteria
- Participants who did not complete Period 1 of the core study.
- Participants who were re-randomized in Period 2 of core study but did not continue for => 3 days in Period 2 of the core study.
- Participants who experienced any adverse events considered serious or drug related in the core study.
- Participants excluded from the core study.
Data sourced from ClinicalTrials.gov (NCT00457626) and the linked publication. 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.