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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Medical University Of Warsaw

Participant type

Pediatric, Patients

Age range

0-17 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Trial duration

21 Jul 2022 → ongoing

Decision date (initial)

2024-12-02

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

External identifiers

EU CT number

2024-518622-32-00

EudraCT number

2020-003881-38

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Others, Efficacy

Evaluation of the effect of nebivolol on peripheral blood pressure assessed by oscillometric office measurement in adolescents with hypertension.Evaluation of the safety of nebivolol in adolescents with hypertension.

Secondary objectives 1

1. Evaluation of the effect of nebivolol on blood pressure in the ABPM (abpm) study and blood pressure in home measurements (home blood pressure measurements - HBPM)

Conditions and MedDRA coding

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 .

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Age 12-17 years
2. body weight greater than or equal to 40 kg
3. Hypertension diagnosed according to the recommendations of the Paediatric Section of the Polish Society of Hypertension (PTNT) from 2018
4. Indication for pharmacological antihypertensive treatment in a child with hypertension according to PTNT criteria: primary hypertension persisting despite 6-12 months of non-pharmacological management, symptomatic, with organ lesions, secondary, with chronic kidney disease at stage 1G-2G
5. Possibility to postpone or discontinue antihypertensive treatment for 6 weeks in the opinion of the investigator
6. Informed consent to participate in the study by the participant's legal guardian and the participant himself

Exclusion criteria 15

1. Hypersensitivity to the active substance or to any of the excipients
2. Hemodynamically acquired or congenital heart defects including aortic coarctation (also after successful surgical treatment), congestive heart failure, cardiomyopathy, grade II-III atrioventricular block or other clinically significant arrhythmias (sick sinus syndrome including sinoatrial block, bradycardia < 60 beats/minute) prior to initiation of treatment, active bronchial asthma
3. chronic kidney disease greater than or equal to 3G defined by KDIGO criteria, condition after kidney transplantation, kidney disease in exacerbation (e.g. nephrotic syndrome in relapse) or acute kidney disease (e.g. acute post-infectious glomerulonephritis) or with hypoalbuminemia (< 3.0 g/dl) – the exclusion criterion is not orthostatic proteinuria with/without left renal vein compression syndrome (,, Nutcracker syndrome")
4. diabetes
5. symptomatic hypertension requiring immediate antihypertensive treatment, including hypertensive crisis, hypertension treated with more than or 2 antihypertensive drugs
6. the presence of severe left ventricular hypertrophy (defined as the left ventricular mass index > 51 g/m27) or severe fundus lesions (Keith-Wegener-Baker Ill-IV grade}
7. hepatic dysfunction/liver disease defined as aspartic tube alanine transaminase or total bilirubin > 2 x upper range of normal, except for genetically confirmed Gilbert's syndrome
8. other serious illness that may affect the results or interpretation of the test results
9. Taking antipsychotic or antidepressant medications that may, in the opinion of the Investigator or Study Coordinator, have a significant effect on blood pressure or the patient's participation in the study
10. Taking sympathomimetic drugs (administered systemically)
11. Participation in another clinical trial within the last 30 days (not applicable to patients participating in observational and non-interventional studies)
12. pregnancy or breastfeeding
13. Lack of consent to the use of highly effective methods of contraception in interacting teenagers
14. Lack of consent to the use of condoms in intercourse adolescents
15. active infection with fever at the time of randomization (transient exclusion criterion)

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 4

1. 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)
2. Number of patients whose blood pressure normalised arterial disease assessed by office measurement in the Ill study period (week 38)
3. the number of patients with adverse events and serious adverse events at the end of Study Period II in each group (A-B).
4. the number of patients who had adverse events and serious adverse events during the Ill study period.

Secondary endpoints 3

1. 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)
2. 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
3. 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)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Medical University Of Warsaw

Sponsor organisation

Medical University Of Warsaw

Address

Ul. Zwirki I Wigury 61

City

Warsaw

Postcode

02-091

Country

Poland

Scientific contact point

Organisation

Medical University Of Warsaw

Contact name

Małgorzata

Public contact point

Organisation

Medical University Of Warsaw

Contact name

Małgorzata

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 7 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications