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Study on the Effects of Amlodipine and Irbesartan in Patients with High Blood Pressure

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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 combination for patients with Arterial Hypertension, commonly known as high blood pressure. The treatment being tested is a fixed-dose combination of two drugs, irbesartan and amlodipine, which are combined into a single pill called Combipress. These medications work together to help lower blood pressure by relaxing blood vessels and improving blood flow.

The purpose of the study is to evaluate how effective and safe this combination is for people who have been newly diagnosed with high blood pressure or those whose blood pressure is not well controlled with their current treatment. Participants in the study will take the medication by mouth in the form of a film-coated tablet. The study will last for a period of up to 16 weeks, during which participants will have regular check-ups to monitor their blood pressure and any potential side effects. Some participants may receive a placebo, which is a pill that looks like the medication but does not contain the active ingredients.

Throughout the study, the researchers will assess how many participants reach their target blood pressure levels and will also monitor any adverse events, which are any unwanted effects that might occur. The study aims to provide valuable information on whether this combination of irbesartan and amlodipine can be a beneficial treatment option for managing high blood pressure. Participants' experiences and feedback will be crucial in understanding the medication's impact on daily life and overall health.

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 patient will provide written and dated informed consent, confirming understanding and agreement to participate.
The patient must be at least 18 years old and able to comply with the study requirements.
Step 2
Initial assessment
The patient will undergo an initial assessment to confirm eligibility, including a review of medical history and current health status.
The patient must have arterial hypertension, either newly diagnosed or uncontrolled, and meet specific criteria regarding previous treatments and health conditions.
Step 3
Medication administration
The patient will begin taking a fixed-dose combination of two drugs, irbesartan and amlodipine, in the form of a film-coated tablet.
The medication is taken orally, with available dosages being 300 mg/10 mg, 150 mg/5 mg, 300 mg/5 mg, or 150 mg/10 mg, as determined by the study protocol.
Step 4
Treatment period
The treatment period lasts up to 16 weeks, during which the patient will continue taking the medication as prescribed.
The patient will be monitored for efficacy, which includes achieving target blood pressure levels, and safety, which involves tracking any adverse events.
Step 5
Follow-up assessments
Follow-up assessments will occur at 8-10 weeks and 16 weeks to evaluate the patient's blood pressure and overall response to the medication.
The need for additional medication to control blood pressure will be assessed, and the correlation with home blood pressure monitoring will be evaluated.
Step 6
Completion of the study
Upon completion of the 16-week period, the patient's participation in the study will conclude.
Final assessments will be conducted to ensure the patient's health and to gather data on the study's outcomes.

Who can join the trial?

12 criteria

Provide a written and dated agreement to participate in the study.
Be a male or female who is at least 18 years old.
Be willing and able to follow the study's rules and requirements.
check
Have been newly diagnosed with **hypertension** (high blood pressure) in one of the following categories:
- Grade 1 with high risk for heart and blood vessel problems.
- Grade 2, regardless of heart and blood vessel risk.
- Grade 3, regardless of heart and blood vessel risk.
- check
  Have **uncontrolled hypertension** while on:
  - One medication (monotherapy).
  - Two medications, including a **RAS blocker** and a **thiazide diuretic**.
  - Complete a break from previous blood pressure medications for a certain period, if you have Grade 1 or 2 hypertension. This may also apply to Grade 3, as decided by the study doctor.
  - Have normal levels of **serum potassium**, which is a mineral in your blood.
  - Have an **Estimated Glomerular Filtration Rate (eGFR)** greater than 30 mL/min/1.73m², which measures how well your kidneys are working.
  - Be able to swallow tablets.

Who cannot join the trial?

10 criteria

Patients with other serious health conditions that might interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who have had an allergic reaction to similar medications in the past.
Patients who are currently participating in another clinical trial.
Patients with a history of drug or alcohol abuse.
Patients who have a condition that affects their ability to understand or follow the study instructions.
Patients with severe liver or kidney problems.
Patients with uncontrolled diabetes or other uncontrolled medical conditions.
Patients who have had a heart attack or stroke in the past six months.
Patients with a history of certain heart conditions, such as heart failure.

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Verified sites

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EVAGGELISMOS"General Hospital of Athens
Athens, Greece
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Hippokration Hospital
Athens, Greece
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Laiko General Hospital Of Athens
Athens, Greece

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Investigated drugs

Irbesartan 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 strokes, heart attacks, and kidney problems. Amlodipine is another medication that helps to lower blood pressure. It is a type of drug known as a calcium channel blocker, which helps to relax and widen blood vessels, making it easier for the heart to pump blood. The clinical trial is evaluating a fixed combination of these two medications, Irbesartan/Amlodipine, to see how effective and safe it is for patients who have just been diagnosed with high blood pressure or those whose blood pressure is not well controlled with other treatments.

What is already known about the treatment

Irbesartan/Amlodipine – This medication is administered orally in the form of a fixed-dose combination tablet. It is currently being evaluated in clinical trials for its effectiveness and safety in treating arterial hypertension, particularly in newly diagnosed patients or those with uncontrolled high blood pressure. The main therapeutic use of this combination is to lower blood pressure and reduce the risk of cardiovascular events. Irbesartan works by blocking the action of a substance in the body that causes blood vessels to tighten, while amlodipine relaxes and widens blood vessels, improving blood flow. This medication is classified as an antihypertensive agent, specifically an angiotensin II receptor blocker combined with a calcium channel blocker.

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. Over time, this increased pressure can lead to damage of the blood vessels and organs, such as the heart, kidneys, and brain. The condition often develops gradually and may not present noticeable symptoms initially. It is typically identified through routine blood pressure measurements. If left unmanaged, it can contribute to more serious health issues, including heart disease and stroke. Regular monitoring and lifestyle adjustments are crucial in managing this condition effectively.