nebivolol hydrochloride for Hypertension | Juvenile hypertension

Inclusion criteria

• {"criterion_text":"- Age 12-17 years\n- body weight greater than or equal to 40 kg\n- Hypertension diagnosed according to the recommendations of the Paediatric Section of the Polish Society of Hypertension (PTNT) from 2018\n- 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\n- Possibility to postpone or discontinue antihypertensive treatment for 6 weeks in the opinion of the investigator\n- Informed consent to participate in the study by the participant's legal guardian and the participant himself"}

Exclusion criteria

• {"criterion_text":"- Hypersensitivity to the active substance or to any of the excipients\n- Taking sympathomimetic drugs (administered systemically)\n- Participation in another clinical trial within the last 30 days (not applicable to patients participating in observational and non-interventional studies)\n- pregnancy or breastfeeding\n- Lack of consent to the use of highly effective methods of contraception in interacting teenagers\n- Lack of consent to the use of condoms in intercourse adolescents\n- active infection with fever at the time of randomization (transient exclusion criterion)\n- 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\n- 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\")\n- diabetes\n- symptomatic hypertension requiring immediate antihypertensive treatment, including hypertensive crisis, hypertension treated with more than or 2 antihypertensive drugs\n- 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}\n- 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\n- other serious illness that may affect the results or interpretation of the test results\n- 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"}

Primary endpoints

• {"endpoint_text":"- 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)","definition_or_measurement_approach":"Office (oscillometric) blood pressure measurement at end of Study Period II (week 6) in each group (A-B)"}
• {"endpoint_text":"- Number of patients whose blood pressure normalised arterial disease assessed by office measurement in the Ill study period (week 38)","definition_or_measurement_approach":"Office (oscillometric) blood pressure measurement at end of Study Period III (week 38)"}
• {"endpoint_text":"- the number of patients with adverse events and serious adverse events at the end of Study Period II in each group (A-B).","definition_or_measurement_approach":"Count of adverse events and serious adverse events recorded through end of Study Period II (week 6) in each group (A-B)"}
• {"endpoint_text":"- the number of patients who had adverse events and serious adverse events during the Ill study period.","definition_or_measurement_approach":"Count of adverse events and serious adverse events occurring during Study Period III (week 38)"}

Secondary endpoints

• {"endpoint_text":"- 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)","definition_or_measurement_approach":"Ambulatory blood pressure monitoring (ABPM) normalization at end of Study Period II (week 6) per group and at week 38 for all patients"}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Change in mean and Z-score of systolic, diastolic and mean BP measured by office measurements and ABPM at week 6 and week 38"}
• {"endpoint_text":"- 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)","definition_or_measurement_approach":"Home blood pressure measurements (HBPM) normalization during last week of Study Period II and last week of Study Period III (week 38)"}

Poland

Earliest CTIS Part Ii Submission Date

21-10-2024

Latest Decision Or Authorization Date

02-12-2024

Processing Time Days

42

Number Of Sites

1

Number Of Participants

150

Primary sponsor

Full Name

Medical University Of Warsaw

Organisation Type

Educational Institution

Country Of Registered Address

Poland