Arterial hypertension in adolescents MedDRA version: 21.1 Level: LLT Classification code 10081425 Term: Arterial hypertension System Organ Class: 100000004866
Conditions
Interventions
Trade Name: Nebilenin
Product Name: Nebivolol 5 mg
Pharmaceutical Form: Tablet
INN or Proposed INN: NEBIVOLOL HYDROCHLORIDE
CAS Number: 152520-56-4
Concentration unit: mg milligram(s)
Concentration ty
Sponsors
Warszawski Uniwersytet Medyczny
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 12-17 years old, body weight = 40 kg 2. Arterial hypertension diagnosed according to the Pediatric Division of the Polish Society of Hypertension (PTNT) from a year 2018. 3. Indication for the pharmacological treatment in children with hypertension according to the PTNT criteria: primary arterial hypertension that persists despite a 6-12 month of non-pharmacological regime; symptomatic, with organ changes in no more then one organ (evaluated within last three months); secondary, with chronic kidney disease in the stadium 1G-2G 4. No contraindication to postpone or withold a hypertension treatment for 6 weeks based on investigator’s judgement 5. Informed consent signed by the participant of the study and their legal guardian. Are the trial subjects under 18? yes Number of subjects for this age range: 150 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Hypersensitivity to the active ingredient or any excipients. 2. Acquired or congenital heart defects including coarctation of the aorta (also after succesfull medical treatment), congestive heart failure, cardiomyopathy, II-IIIrd degree atrioventricular block or other clinically relevant heart rhythm disorders (sick sinus syndrom including sinoatrial block, bradycardia with less then 60 beats per minute), bronchial asthma or repetetive episodes of obstruction in the medical record. 3. Chronic kidney disease in the stadium =3G defined accroding to KDIGO criteria, kidney transplantation, kidney disease during exacerbation (in ex. nephrotic syndrome) or acute kidney disease ( in ex. post-infectious glomerulonephritis) or with hypoalbuminemia ( 51 g/m2,7) or severe fundus changes (III-IVth degree according to Keitha-Wegenera-Bakera) 7. Hepatic disfunction/hepatic disease defined as alanine or asparagine transferase activity or total bilirubine level > 2 x upper normal range 8. Other sever disease that can have an impact on the results or interpretaion of the study 9. Treatment with antipsychotic or antidepressant drugs 10. Treatment with sympathomimetic drugs (in systemic use) 11. Participation in other clinical trial in the last 30 days (excluding non-interventional and observational studies) 12. Pregnancy and lactation period with breast feeding (blood pregnancy test for beta HCG is performer at the study beginning) 13. Active infection with fever at the randomization visit (criterium for a temporary exclusion)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1.Evaluation of the effect of nebivolol on peripheral arterial blood pressure assessed in oscillometric measurements at the in-patient visits in adolescents with hypertension. 2.Safety evaluation of nebivolol in adolescents with hypertension. ;Secondary Objective: Assessment of the effect of nebivolol on blood pressure in the ABPM measurements (ambulatory blood pressure monitoring).;Primary end point(s): 1. Number of patients with normalization of blood pressure assessed at the in-patient visits at the end of the II period of the study (6 weeks) in each subgroup (A-B) 2. Number of patients with normalization of blood pressure assessed at the in-patient visits during the III period of the study (at week 38) 3. Number of patients with adverse events and serious adverse events in each subgroup (A-B) in the II period of the study 4. Number of patients with adverse events and serious adverse events in the III period of the study. ;Timepoint(s) of evaluation of this end point: week 6th (endpoint 1 and 3) and week 38th (endpoint 2 and 4) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Number of patients with normalization of blood pressure evaluated through ABPM (ambulatory blood pressure monitoring) measurements in each study subgroup (A-B) at the end of II study period (week 6) and at the end of III study period among all participants. 2. Change in mean and percentile values (Z-score) of systolic, diastolic and mean pressure assessed at the in-patient visit measurements and through ABPM tests in the second period of the study (week 6) in each subgroup (A-B) and in the third period of the study (week 38) among all participants. ;Timepoint(s) of evaluation of this end point: week 6th and week 38th | — |
Countries
Poland
Contacts
Public ContactPunkt Informacyjny Badania Kliniczn
Dr hab. n. med. Malgorzata Panczyk-Tomaszewska
Outcome results
None listed