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Study on Predicting Blood Pressure Response in Hypertension Patients Using Amlodipine, Olmesartan Medoxomil, Hydrochlorothiazide, and Drug Combination

Verified siteRegistered drugNo placebo
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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 medications on people with primary hypertension, which is a condition characterized by high blood pressure. The trial will use several medications: Amlodipine, Olmesartan medoxomil, Hydrochlorothiazide, and a combination of Olmesartan medoxomil/Amlodipine. These medications are commonly used to help lower blood pressure. The purpose of the study is to identify specific biological markers, known as MOMICs, that can predict how well a person's blood pressure will respond to these treatments.

Participants in the study will be given one of the medications or a placebo. The study will last for a period of four weeks. During this time, participants will take the medication orally in the form of tablets. The study aims to observe changes in blood pressure over a 24-hour period and during nighttime, to see how effectively the medications work in lowering blood pressure. The study will also look at any side effects that may occur and how they relate to changes in specific biological markers.

The trial will help researchers understand which biological markers can predict a person's response to blood pressure medications. This information could lead to more personalized treatment plans for people with high blood pressure, ensuring they receive the most effective medication for their condition. The study is expected to be completed by October 2025.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on criteria such as age (18 to 75 years) and blood pressure levels (systolic blood pressure between 130-164).

    Female participants must ensure they are not at risk of pregnancy during the trial.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to establish baseline blood pressure and other health parameters.

    Participants not currently on blood pressure medication or those who have completed a 4-week wash-out period from a single antihypertensive drug are eligible.

  3. Step 3

    Medication administration

    Participants are assigned to one of the following medications: amlodipine, olmesartan medoxomil, hydrochlorothiazide, or a combination of olmesartan medoxomil and amlodipine.

    All medications are administered orally in tablet form.

  4. Step 4

    Medication dosage and frequency

    The dosage for amlodipine is 10 mg per day.

    The dosage for olmesartan medoxomil is 40 mg per day.

    The dosage for hydrochlorothiazide is 25 mg per day.

    The combination of olmesartan medoxomil and amlodipine is administered as 20 mg/5 mg per day.

  5. Step 5

    Monitoring and data collection

    Blood pressure is monitored over a 24-hour period to assess the response to the medication.

    Biomarker profiles are created using blood and urine samples to predict blood pressure response.

  6. Step 6

    Evaluation of results

    The primary goal is to identify biomarkers that predict changes in 24-hour blood pressure.

    Secondary evaluations include the predictive value of biomarkers for night-time blood pressure changes and the correlation between biomarkers and any adverse effects.

  7. Step 7

    Completion of the trial

    The trial is expected to conclude by October 2025.

    Participants' data will contribute to understanding the effectiveness of blood pressure medications based on individual biomarker profiles.

Who can join the trial?

5 criteria

  • Age between 18 and 75 years old at the time of joining the study.
  • Have a 24-hour **systolic blood pressure** (the top number in a blood pressure reading) between 130 and 164, which is considered grade 1-2 **hypertension** (high blood pressure), without using any blood pressure-lowering medications. If currently using one blood pressure medication, a 4-week break from it is required before joining.
  • Need for **antihypertensive therapy** (treatment to lower blood pressure) as per the 2023 guidelines from the European Society of Hypertension.
  • Female participants must not be breastfeeding and must not be at risk of becoming pregnant. This can be due to being at least one year postmenopausal, having had surgery to prevent pregnancy, or agreeing to use a reliable form of birth control during the study. Acceptable methods include birth control pills, approved implants, long-term injections, intrauterine devices, or having had a tubal ligation (surgical procedure to prevent pregnancy).
  • Participants should either not be taking any blood pressure medication or be taking only one type of blood pressure medication.

Who cannot join the trial?

5 criteria

  • Patients who do not have primary (essential) hypertension, which is a condition where the blood pressure is high without a known cause, cannot participate.
  • Patients who are not within the specified age range for the study cannot participate. The exact age range is not provided here.
  • Patients who are part of a vulnerable population, which means they might need special protection or care, cannot participate.
  • Patients who do not fit into the specified clinical trial groups cannot participate. The specific groups are not detailed here.
  • Patients who do not meet other specific criteria set by the study, which are not listed here, cannot participate.
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Investigated drugs

  • Olmesartan

    is a medication used to treat high blood pressure. It works by relaxing blood vessels so that blood can flow more easily, helping to lower blood pressure and reduce the risk of heart-related issues.

  • Amlodipine

    is another medication for high blood pressure. It helps to relax and widen blood vessels, making it easier for the heart to pump blood and lowering blood pressure.

  • Hydrochlorothiazide

    is a diuretic, often called a "water pill." It helps the body get rid of excess salt and water through urine, which can help lower blood pressure.

  • Olmesartan/Amlodipine

    is a combination medication that includes both olmesartan and amlodipine. This combination works together to more effectively lower blood pressure by relaxing blood vessels and improving blood flow.

What is already known about the treatment

  • Olmesartan

    This medication is taken orally and is used to treat high blood pressure, also known as hypertension. It is currently well-established in medical practice and literature as an effective treatment for this condition. Olmesartan works by blocking the action of certain natural substances that tighten the blood vessels, allowing blood to flow more smoothly and the heart to pump more efficiently. It belongs to a class of drugs known as angiotensin receptor blockers (ARBs).

  • Amlodipine

    Administered orally, amlodipine is used to manage high blood pressure and angina. It is widely recognized in medical literature as a reliable treatment option. Amlodipine functions by relaxing the blood vessels, which helps to lower blood pressure and improve blood flow. It is classified as a calcium channel blocker.

  • Hydrochlorothiazide

    This medication is taken orally and is used to treat high blood pressure and fluid retention. It is well-documented in medical literature as an effective diuretic. Hydrochlorothiazide works by helping the kidneys eliminate excess salt and water from the body, which helps to lower blood pressure. It is part of the thiazide diuretics class.

  • Olmesartan/Amlodipine

    This combination medication is taken orally and is used to treat high blood pressure. It is recognized in medical literature as an effective combination therapy. The combination works by both blocking substances that tighten blood vessels and relaxing the blood vessels, which helps to lower blood pressure. It combines an angiotensin receptor blocker (olmesartan) and a calcium channel blocker (amlodipine).

Investigated diseases

Primary (essential) hypertension – This is a common 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. The exact cause is not known, but it is believed to be a combination of genetic and environmental factors. As the condition progresses, it may cause damage to blood vessels and organs, including the heart, kidneys, and brain. People with this condition may not experience any symptoms for many years, even as damage occurs. Regular monitoring of blood pressure is important to manage and understand the progression of this disease.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-505239-10-00Protocol code114516Estimated enrolment96 patientsSponsorStichting Radboud universitair medisch centrum

sourced from the EU Clinical Trials Register and site verification

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