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

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What is this study about?

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.

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 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 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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

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Other Sites

Site Name City Country Status
Sapsvpucu Rrqllml Ufsrwrmdeo Mnltrzr Cbtjta Nijmegen The Netherlands

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
The Netherlands The Netherlands
Recruiting
01.10.2023

Trial locations

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.

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 ID:
2023-505239-10-00
Protocol code:
114516
NCT ID:
NCT05917275
Trial Phase:
Therapeutic confirmatory (Phase III)

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