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ESONIA - The evaluation of efficacy and safety of Nebivolol in the treatment of arterial hypertension in adolescents.
EU CTIS ID: 2024-518622-32-00
What this study is testing
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.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age 12-17 years
- body weight greater than or equal to 40 kg
- Hypertension diagnosed according to the recommendations of the Paediatric Section of the Polish Society of Hypertension (PTNT) from 2018
- 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
- Possibility to postpone or discontinue antihypertensive treatment for 6 weeks in the opinion of the investigator
- Informed consent to participate in the study by the participant's legal guardian and the participant himself
You likely can't join if
- Hypersensitivity to the active substance or to any of the excipients
- Taking sympathomimetic drugs (administered systemically)
- Participation in another clinical trial within the last 30 days (not applicable to patients participating in observational and non-interventional studies)
- pregnancy or breastfeeding
- Lack of consent to the use of highly effective methods of contraception in interacting teenagers
- Lack of consent to the use of condoms in intercourse adolescents
See the full eligibility criteria
- Age 12-17 years
- body weight greater than or equal to 40 kg
- Hypertension diagnosed according to the recommendations of the Paediatric Section of the Polish Society of Hypertension (PTNT) from 2018
- 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
- Possibility to postpone or discontinue antihypertensive treatment for 6 weeks in the opinion of the investigator
- Informed consent to participate in the study by the participant's legal guardian and the participant himself
- Hypersensitivity to the active substance or to any of the excipients
- Taking sympathomimetic drugs (administered systemically)
- Participation in another clinical trial within the last 30 days (not applicable to patients participating in observational and non-interventional studies)
- pregnancy or breastfeeding
- Lack of consent to the use of highly effective methods of contraception in interacting teenagers
- Lack of consent to the use of condoms in intercourse adolescents
- active infection with fever at the time of randomization (transient exclusion criterion)
- 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
- 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")
- diabetes
- symptomatic hypertension requiring immediate antihypertensive treatment, including hypertensive crisis, hypertension treated with more than or 2 antihypertensive drugs
- 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}
- 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
- other serious illness that may affect the results or interpretation of the test results
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.