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Study on the Effectiveness and Safety of Nebivolol for Treating High Blood Pressure in Adolescents

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a medication called nebivolol hydrochloride in treating arterial hypertension, commonly known as high blood pressure, in adolescents. Arterial hypertension is a condition where the blood pressure in the arteries is consistently too high, which can lead to serious health issues if not managed properly. The study aims to evaluate how effective and safe nebivolol is for adolescents who have been diagnosed with this condition.

Participants in the study will receive either the medication or a placebo, and their blood pressure will be monitored over a period of time. The study will last for several weeks, during which the participants' blood pressure will be measured regularly to assess any changes. The goal is to see if nebivolol can help normalize blood pressure levels in these young patients and to monitor any side effects that may occur.

The study is designed to provide valuable information about the use of nebivolol in treating high blood pressure in adolescents, which is important because managing blood pressure early can help prevent more serious health problems later in life. Participants will be closely monitored by healthcare professionals throughout the study to ensure their safety and well-being.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the participant will be informed about the trial's purpose, procedures, and potential risks and benefits. Consent from both the participant and their legal guardian is required.
Step 2
Initial assessment
An initial health assessment will be conducted to confirm eligibility. This includes checking age, weight, and blood pressure levels to ensure they meet the study criteria.
Step 3
Medication administration
Participants will begin taking the medication nebivolol hydrochloride, which is provided in the form of a 5 mg tablet. The medication is taken orally once a day.
The duration of this medication phase is divided into two main periods: the first period lasts for 6 weeks, and the second period extends to 38 weeks.
Step 4
Regular check-ups
Participants will attend regular check-ups to monitor blood pressure and assess any side effects. These check-ups will include office measurements and may involve additional home blood pressure monitoring.
Step 5
Evaluation of results
At the end of the 6-week period, the participant's blood pressure will be evaluated to determine if it has normalized.
Further evaluations will occur at the end of the 38-week period to assess long-term effects and safety of the medication.
Step 6
Completion of the study
Upon completion of the study, participants will undergo a final assessment to review overall health and any changes in blood pressure.
Participants will receive information about the study's findings and any necessary follow-up care.

Who can join the trial?

9 criteria

Age between 12 and 17 years old
Body weight of at least 40 kg (about 88 pounds)
Diagnosed with hypertension (high blood pressure) according to the guidelines from the Pediatric Section of the Polish Society of Hypertension from 2018
check
Need for medication to lower blood pressure because:
- High blood pressure continues even after 6-12 months of trying non-medication methods
- There are symptoms or signs of organ damage
- High blood pressure is due to another condition
- There is chronic kidney disease at stage 1G-2G
- Ability to stop or delay blood pressure medication for 6 weeks, as determined by the study doctor
- Agreement to participate in the study from both the participant and their legal guardian

Who cannot join the trial?

9 criteria

Patients with severe liver problems cannot participate. This means if your liver is not working well, you cannot join the study.
Patients with severe kidney problems are excluded. If your kidneys are not functioning properly, you cannot take part.
If you have heart failure, which is when the heart doesn't pump blood as well as it should, you cannot participate.
Patients with severe asthma or other serious lung diseases cannot join. Asthma is a condition where your airways narrow and swell, making it hard to breathe.
If you have diabetes that is not well controlled, you cannot participate. Diabetes is a condition where your blood sugar levels are too high.
Patients who are pregnant or breastfeeding cannot take part in the study.
If you have a history of allergic reactions to the study medication or similar drugs, you cannot join. An allergic reaction is when your body reacts badly to something, causing symptoms like a rash or difficulty breathing.
Patients who are currently participating in another clinical trial cannot join this study.
If you have any other serious medical conditions that the study doctors think might interfere with the study, you cannot participate.

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Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
Warsaw, Poland

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Investigated drugs

Nebivolol is a medication used to treat high blood pressure, also known as hypertension. It works by relaxing blood vessels, which helps to lower blood pressure and makes it easier for the heart to pump blood around the body. In this clinical trial, the focus is on understanding how well nebivolol works in reducing blood pressure in teenagers with high blood pressure and ensuring it is safe for them to use.

Nebivolol Hydrochloride

What is already known about the treatment

Nebivolol – Nebivolol is a medication administered orally, typically in the form of a tablet. It is currently being studied for its effectiveness and safety in treating high blood pressure in adolescents, a condition that can lead to serious health issues like heart and kidney problems if not managed. Nebivolol works by relaxing blood vessels, which helps to lower blood pressure and improve blood flow. It belongs to a class of drugs known as beta-blockers, which are commonly used to manage heart-related conditions.

Investigated diseases

Hypertension – Hypertension, also known as high blood pressure, is a condition where the force of the blood against the artery walls is consistently too high. It often develops over many years and can lead to health problems, such as heart disease. In adolescents, it can manifest as tensile hypertension, which is characterized by elevated blood pressure levels. Over time, hypertension can cause subclinical organ damage, including left ventricular hypertrophy and changes in the eyes. It may also lead to microalbuminuria, indicating kidney stress. If not managed, hypertension can progress and contribute to more severe health issues in adulthood.