A Greek multicenter, single-arm, low-intervention clinical trial to evaluate the efficacy and safety of irbesartan/amlodipine fixed combination in newly diagnosed patients or patients with uncontrolled arterial hypertension.
High blood pressure is very common. If left untreated, it can increase your risk of heart attacks and strokes. Many people need more than one medicine to bring their blood pressure down to a healthy level. This study tests a single pill that combines two medicines: irbesartan and amlodipine. Taking both treatments together in one tablet may make taking medication simpler and help control blood pressure more effectively. The study is open to adults who have recently been diagnosed with high blood pressure or whose current medication is not working well. Over 16 weeks, doctors will monitor participants' blood pressure in clinic visits and check readings taken at home. They will track how many people reach their target blood pressure and check for any side effects. Taking part helps researchers learn if this combination pill is a safe and convenient treatment option.
At a glance
What is this study about?
High blood pressure, also called hypertension, puts extra strain on your heart and blood vessels. Over time, this extra strain can lead to serious health issues such as heart disease, kidney problems, and strokes. Because high blood pressure rarely causes symptoms on its own, finding reliable and simple ways to keep it under control is essential for long-term health.
Doctors often find that one medicine alone is not enough to lower blood pressure to a safe level. When this happens, combining two different medicines that work in different ways is usually the next step. This study focuses on a tablet called Combipress, which brings together two established medicines—irbesartan and amlodipine—into a single pill. One relaxes the blood vessels by blocking chemicals that tighten them, while the other helps widen the vessels so blood flows more freely.
The main purpose of this study is to see how well this combined tablet helps people reach their target blood pressure over 16 weeks (around four months). Researchers want to find out how many patients hit their healthy target at around two months and four months into the study. They also want to see whether combining two medicines into one pill makes it easier for people to remember their medication every day.
Key takeaways
- Tests a single daily tablet containing two blood pressure medicines (irbesartan and amlodipine).
- Open to adults aged 18 and older with newly diagnosed or poorly controlled high blood pressure.
- The trial lasts for 16 weeks (about four months) and includes regular check-ups.
- Everyone who takes part receives the active study medication; there is no placebo.
- Aims to check how well the pill lowers blood pressure, its safety, and how easy it is to take.
Who may be eligible?
This study is open to adults aged 18 and over who have high blood pressure. You may be able to join if you have recently been diagnosed and need to start treatment.
You may also be eligible if you are already taking blood pressure medication, but your numbers remain too high (uncontrolled blood pressure). Both men and women can take part.
To keep you safe, the study team will carry out health checks before you join. People with certain health conditions, such as severe kidney or liver disease, or those who have had bad reactions to these medicines in the past, may not be able to participate. Your study doctor will review your medical history to make sure the trial is safe for you.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you aged 18 or older?
- Have you been diagnosed with high blood pressure?
- Is your blood pressure still higher than normal, or are you newly diagnosed and untreated?
- Are you able to take a daily tablet for 16 weeks?
- Are you willing to attend clinic check-ups and monitor your blood pressure at home?
What does participation involve?
If you take part, you will be prescribed the combination tablet to take once a day for 16 weeks. The study doctor will choose the dose that is right for you. You will attend regular clinic visits—typically at the start of the study, between weeks 8 and 10, and at week 16. During these appointments, doctors will measure your blood pressure, check your general health, and ask about any side effects. You will also be asked to measure and record your blood pressure at home between visits. If your blood pressure stays too high, your doctor may adjust your dose or add an extra medication. The entire study lasts about four months.
Potential risks and benefits
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Common questions
What is the benefit of a two-in-one pill?
Combining two medicines into a single daily tablet reduces the number of pills you need to take, making it easier to stick to your daily routine.
Will I receive a dummy pill (placebo)?
No. In this study, everyone receives the active combination medicine. There is no dummy pill.
How often will I need to take the study medicine?
You will take the combination tablet once a day, following the instructions given by your study doctor.
What happens if my blood pressure does not improve?
The study team will monitor you closely. If your blood pressure remains higher than it should be, your doctor can increase your dose or add another medicine to protect your health.
Can I leave the study if I change my mind?
Yes. You can withdraw from the study at any point. Deciding to leave will not affect your relationship with your healthcare team or your standard NHS care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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