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ESONIA - The evaluation of efficacy and safety of Nebivolol in the treatment of arterial hypertension in adolescents.

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-518622-32-00
Acronym
ESONIA
Enrollment
150
Registered
2024-12-02
Start date
2022-07-21
Completion date
Unknown
Last updated
2024-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tensile hypertension (HF) occurs in adolescents with a frequency of 10-13%. Subclinical organ lesions (left ventricular hypertrophy, microalbuminuria, hypertensive changes at the fundus of the eyes, changes in the taffin) are found in half of these patients at the time of diagnosis of hypertension and hypertension in the second decade of life is a significant risk factor for liver problems, strokes and renal failure in adulthood .

Brief summary

Number of patients whose blood pressure normalised arterial disease assessed in an office measurement at the end of the second study period (week 6) in each group (A-B), Number of patients whose blood pressure normalised arterial disease assessed by office measurement in the Ill study period (week 38), the number of patients with adverse events and serious adverse events at the end of Study Period II in each group (A-B)., the number of patients who had adverse events and serious adverse events during the Ill study period.

Detailed description

Number of patients whose blood pressure normalised in ABPM at the end of Study Period II (week 6) in each group (A-B) and in Ill Period in all patients (week 38), change in mean and percentile (Z-score) of systolic, diastolic and mean blood pressure assessed in the office measurement and in the ABPM study in the II study period (6 weeks) in each group (A-B) and in the Ill study period (38 weeks) in the study group, Number of patients who achieved normalization of blood pressure as measured at home (HBPM) during the last week of the II study period in each group (A-B) and at the last week of the Ill study period in all patients (week 38)

Interventions

DRUGNebilenin
DRUG5 mg
DRUGtabletki

Sponsors

Medical University Of Warsaw
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
0 Years to 17 Years

Design outcomes

Primary

MeasureTime frame
Number of patients whose blood pressure normalised arterial disease assessed in an office measurement at the end of the second study period (week 6) in each group (A-B), Number of patients whose blood pressure normalised arterial disease assessed by office measurement in the Ill study period (week 38), the number of patients with adverse events and serious adverse events at the end of Study Period II in each group (A-B)., the number of patients who had adverse events and serious adverse events during the Ill study period.

Secondary

MeasureTime frame
Number of patients whose blood pressure normalised in ABPM at the end of Study Period II (week 6) in each group (A-B) and in Ill Period in all patients (week 38), change in mean and percentile (Z-score) of systolic, diastolic and mean blood pressure assessed in the office measurement and in the ABPM study in the II study period (6 weeks) in each group (A-B) and in the Ill study period (38 weeks) in the study group, Number of patients who achieved normalization of blood pressure as measured at home (HBPM) during the last week of the II study period in each group (A-B) and at the last week of the Ill study period in all patients (week 38)

Countries

Poland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026