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Study on the Effects of Telmisartan, Amlodipine, and Hydrochlorothiazide on Blood Pressure in Patients with Hypertension

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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 treatment for arterial hypertension, commonly known as high blood pressure. The study will use a combination of medications in a single pill, specifically telmisartan and amlodipine, as well as a combination of telmisartan, amlodipine, and hydrochlorothiazide. These medications are designed to help lower blood pressure and improve blood pressure control over a 24-hour period.

The purpose of the study is to assess how effective these single-pill combinations are in reducing blood pressure after 16 weeks of treatment in patients with different grades of high blood pressure. Participants will take the medication orally, and the study will monitor changes in their blood pressure throughout the day and during office visits. The study will also look at how blood pressure varies over 24 hours and how well it is controlled during office visits.

Participants in the study will be monitored over a period of 16 weeks. During this time, they will have regular check-ups to measure their blood pressure and assess the effectiveness of the treatment. The study aims to provide valuable information on how these medications can help manage high blood pressure and improve overall health outcomes for patients with this condition.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial visit and assessment

    Upon joining the clinical trial, you will attend an initial visit. During this visit, your eligibility will be confirmed based on your medical history and current health status.

    Your blood pressure will be measured using a device that monitors it over 24 hours. This is to ensure that your average blood pressure meets the study requirements.

  2. Step 2

    Medication allocation

    If eligible, you will be assigned a medication. The study involves a single-pill combination of telmisartan and amlodipine, or a combination of telmisartan, amlodipine, and hydrochlorothiazide.

    These medications are taken orally in the form of tablets. The specific dosage and combination will be determined by the study protocol.

  3. Step 3

    Treatment phase

    You will take the assigned medication daily for a period of 16 weeks. It is important to adhere to the prescribed dosage and schedule.

    Regular monitoring of your blood pressure will occur throughout this period to assess the effectiveness of the treatment.

  4. Step 4

    Follow-up visits

    You will attend follow-up visits at weeks 4, 8, 12, and 16. During these visits, your blood pressure will be measured, and any changes will be recorded.

    These visits are crucial for monitoring your response to the medication and ensuring your safety throughout the trial.

  5. Step 5

    Final assessment

    At the end of the 16-week treatment period, a final assessment will be conducted. This will include a comprehensive evaluation of your blood pressure and overall health.

    The results will help determine the effectiveness of the medication in managing arterial hypertension.

Who can join the trial?

7 criteria

  • Patients with diagnosed **Grade 1, Grade 2, or Grade 3 Arterial Hypertension** at both the first and second visits.
  • Average 24-hour **Systolic Blood Pressure (SBP)** of **130 mmHg or higher** and/or average 24-hour **Diastolic Blood Pressure (DBP)** of **80 mmHg or higher**, measured using a device that monitors blood pressure over 24 hours.
  • Patients who have not been treated for high blood pressure before, or those whose blood pressure is not controlled with their current single or dual medication (except those already taking telmisartan and amlodipine).
  • **Female or male** patients who are **18 years or older**.
  • Patients who can follow the study rules and procedures, as judged by the study doctor.
  • Patients who have been informed about the study and have voluntarily signed a form agreeing to participate.
  • Patients who have signed a consent form allowing the collection and use of their personal data for analysis and reporting of the study results.

Who cannot join the trial?

10 criteria

  • Patients with any other serious health conditions that might interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who have had an allergic reaction to any of the study medications.
  • Patients who are currently participating in another clinical trial.
  • Patients with a history of drug or alcohol abuse.
  • Patients with uncontrolled diabetes or other uncontrolled medical conditions.
  • Patients with severe liver or kidney disease.
  • Patients with a history of heart attack or stroke in the last six months.
  • Patients who have had a major surgery in the last three months.
  • Patients with a history of cancer in the last five years, except for certain skin cancers.
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Investigated drugs

  • Telmisartan

    is a medication used to help lower high blood pressure. It works by relaxing blood vessels so that blood can flow more easily. This helps to reduce the risk of serious health problems like heart attacks and strokes.

  • Amlodipine

    is another medication that helps to lower blood pressure. It is a type of drug known as a calcium channel blocker. It helps to relax and widen blood vessels, making it easier for the heart to pump blood around the body.

  • Hydrochlorothiazide

    is a medication that helps to lower blood pressure by removing excess salt and water from the body. It is a type of diuretic, sometimes called a "water pill," and it helps to reduce the amount of fluid in the blood vessels, which lowers blood pressure.

What is already known about the treatment

  • Telmisartan/Amlodipine

    This medication is taken as a single-pill combination and is used to treat high blood pressure, also known as arterial hypertension. It works by relaxing blood vessels, which helps to lower blood pressure and improve blood flow. Telmisartan is an angiotensin receptor blocker (ARB), and amlodipine is a calcium channel blocker, both of which help to reduce the workload on the heart. This combination is currently being studied for its effectiveness in reducing blood pressure over a 24-hour period and is well-documented in medical literature for its use in managing hypertension.

  • Telmisartan/Amlodipine/Hydrochlorothiazide

    This medication is also a single-pill combination used to manage high blood pressure. It combines telmisartan and amlodipine, which help relax blood vessels, with hydrochlorothiazide, a diuretic that helps the body get rid of excess salt and water. This combination aims to provide a more comprehensive approach to lowering blood pressure and is being evaluated for its ability to control blood pressure throughout the day. It is recognized in medical literature for its role in treating various stages of hypertension.

Investigated diseases

Arterial hypertension – Arterial hypertension, commonly 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 affect nearly everyone eventually. The condition is characterized by elevated systolic and/or diastolic blood pressure levels. As it progresses, it can lead to damage of blood vessels and organs, particularly the heart, brain, kidneys, and eyes. Over time, the heart may have to work harder to pump blood, which can lead to heart-related complications. The progression of arterial hypertension can be influenced by factors such as age, lifestyle, and genetics.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2023-504812-13-00Protocol codeKCT02/2023-SATELLITEEstimated enrolment191 patientsSponsorKRKA tovarna zdravil d.d. Novo mesto

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© 2026 Clinical Trials EU – European Clinical Trials Information Network

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).