Study Comparing Eplerenone and Irbesartan for Lowering Blood Pressure in Obese Patients with Hypertension

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What is this study about?

This clinical trial is focused on studying the effects of different treatments for hypertension, which is a condition characterized by high blood pressure. The study compares two treatment strategies: one based on the medication eplerenone and the other on irbesartan. Both medications are commonly used to help lower blood pressure in patients with hypertension.

The purpose of the study is to determine which treatment strategy is more effective in managing blood pressure in patients who are both obese and have hypertension. Participants in the study will receive either eplerenone or irbesartan, and their blood pressure will be monitored over a period of time to assess the effectiveness of each treatment. The study will also involve the use of a placebo to help compare the results.

Throughout the study, participants will take their assigned medication orally, and their progress will be tracked over several weeks. The study aims to provide valuable information on how these medications can help manage blood pressure in patients with specific health conditions, ultimately contributing to better treatment options for those with hypertension.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes measuring blood pressure and body mass index (BMI).

Eligibility criteria include being between 30 and 75 years old, having a BMI between 30 and 39.99 kg/m², and specific blood pressure ranges.

2 medication administration

Participants are assigned to one of two treatment strategies: eplerenone-based or irbesartan-based treatment.

The medications are administered orally in the form of tablets or capsules.

3 medication details

For the eplerenone-based strategy, the medication Inosamin (eplerenone) is used at a dosage of 25 mg.

For the irbesartan-based strategy, the medication LUCIDEL (irbesartan) is used at a dosage of 150 mg.

4 additional medications

Additional medications may include Fludex (indapamide) at 1.5 mg and Amlopen (amlodipine) at 5 mg, both administered orally.

5 monitoring and follow-up

Participants undergo regular monitoring to assess blood pressure changes over 24-hour periods.

The primary goal is to evaluate the effectiveness of the treatment in lowering blood pressure.

6 study duration

The study is expected to conclude by June 30, 2025.

Participants will be involved in the study until its completion or until they choose to withdraw.

Who Can Join the Study?

Age between 30 and 75 years.
Have a systolic blood pressure (the top number in a blood pressure reading) between 140 and 179 mmHg, or a diastolic blood pressure (the bottom number) between 90 and 119 mmHg.
Average 24-hour systolic blood pressure greater than 130 mmHg, or average 24-hour diastolic blood pressure greater than 80 mmHg. This means your blood pressure is measured over a full day to get an average reading.
Have a Body Mass Index (BMI) between 30 and 39.99 kg/m². BMI is a number calculated from your weight and height to see if you are in a healthy weight range.
Be able to understand and agree to participate in the study.

Who Cannot Join the Study?

People who have high blood pressure (also known as hypertension) cannot participate.
Individuals who are not within the age range specified for the study are excluded. The study is open to adults, which typically means people aged 18 and older.
Both men and women can participate, so gender is not a reason for exclusion.
People who are considered part of a vulnerable population are not excluded, meaning the study does not specifically exclude groups like pregnant women or those with certain disabilities.

Where you can join this trial?

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Site Name	City	Country	Status
Lnrgn Gfzfonp Hmrtmrhc Ox Aulbfc	Athens	Greece

Trial status

Country	Status	Recruitment Start
Greece	Not yet recruiting	30.04.2021

Trial locations

Investigated drugs:

Eplerenone is a medication used in this study to help lower blood pressure. It works by blocking certain hormones in the body that can raise blood pressure. This medication is often used to treat high blood pressure and heart failure.

Irbesartan is another medication involved in the study, which is also used to lower blood pressure. It belongs to a class of drugs called angiotensin receptor blockers (ARBs). Irbesartan helps relax blood vessels, making it easier for the heart to pump blood, which can help reduce blood pressure.

Investigated diseases:

Hypertension

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. Over time, this increased pressure can cause damage to the blood vessels and organs, particularly the heart, brain, kidneys, and eyes. It often develops over many years and can go unnoticed due to a lack of symptoms. As it progresses, it may lead to complications such as heart disease or stroke. Regular monitoring of blood pressure is essential to manage and understand the progression of this condition.

Trial ID:

2024-519749-31-00

Protocol code:

HEBRO-001

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study Comparing Eplerenone and Irbesartan for Lowering Blood Pressure in Obese Patients with Hypertension

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?