A study testing two medications, zibotentan and dapagliflozin, in people with high blood pressure
This research is looking into whether a combination of two medicines, Zibotentan and Dapagliflozin, can effectively reduce high blood pressure in people who aren't getting enough relief from their current treatments. High blood pressure is a common problem that can lead to serious health issues like heart attacks and strokes if not well-managed. Even with existing medicines, many individuals find it hard to get their blood pressure into a healthy range. This study hopes to find a new way to help these patients by combining the two drugs, which work in different ways to affect blood pressure and fluid levels in the body. If successful, this could offer a new treatment option in the future.
At a glance
What is this study about?
This study is looking at high blood pressure, also known as hypertension. It's a very common condition that can unfortunately increase your risk of serious health problems like heart attacks and strokes. Even with many medicines available today, some people still find it difficult to get their blood pressure under control. In fact, about one in three people on medication still don't reach their target blood pressure levels.
This research project, called a 'Phase II study', wants to see if combining two medicines, Zibotentan and Dapagliflozin, could be a good solution. Zibotentan works by relaxing blood vessels, which can lower blood pressure. However, it can sometimes cause the body to hold onto too much fluid. Dapagliflozin, on the other hand, helps your kidneys remove extra sugar and water from your body. The idea is that Dapagliflozin might help prevent the fluid build-up that Zibotentan could cause, making the combination more effective and safer for lowering blood pressure.
The main goal is to find out if this combination therapy is a useful way to treat high blood pressure, especially for those who are struggling to manage it with their current medications. If this study shows promising results, it could pave the way for new treatment options for people with high blood pressure in the future.
Key takeaways
- This study explores a new combination of medicines for uncontrolled high blood pressure.
- It targets individuals already taking at least two blood pressure medications.
- Participation involves 9 visits over about 18 weeks at Cambridge University Hospital.
- You will receive both active medicine and a dummy pill at different times, without knowing which you have.
- Potential benefits include better blood pressure control; risks include possible side effects.
- Strict rules apply for women of childbearing age and male participants regarding pregnancy.
Who may be eligible?
This study is looking for adults aged 18 or older who have high blood pressure that isn't fully controlled, even though they are already taking at least two different blood pressure medications. Your blood pressure readings will need to be above certain levels, both in the clinic and at home, for you to be considered for the study.
There are also some important rules about who cannot join. For example, if you have very high or very low blood pressure, or if your high blood pressure is caused by another specific medical condition, you won't be able to take part. Women who could become pregnant, are pregnant, or are breastfeeding cannot join. Men can participate if they are surgically sterile, choose not to have sex during the study, or agree to use very effective contraception with their partner. Those with certain heart conditions, uncontrolled diabetes, or severe kidney or liver problems are also not suitable for this study.
To make sure the study is safe for everyone, you cannot take part if you are already on certain medications that are similar to the ones being tested, or if you have a history of drug or alcohol abuse. The research team will carefully check all these details to see if the study is right 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 18 years old or older?
- Do you have high blood pressure that is not well-controlled, even with at least two medications?
- Are you male and surgically sterile, abstinent, or willing to use effective contraception with your partner?
- Are you female and unable to have children (e.g., post-menopause or after certain surgeries)?
- Do you have good kidney function (eGFR >45ml/min/1.73m2)?
- Do you *not* have type 1 diabetes or type 2 diabetes on insulin?
What does participation involve?
If you join this study, you will visit the research site at Cambridge University Hospital NHS Foundation Trust 9 times over about 18 weeks. You will take part in what's called a 'randomised, placebo-controlled, double-blind, crossover study'. This means you'll be given either the actual study medication (Zibotentan and Dapagliflozin) or a 'placebo' (a dummy pill with no active medicine) for part of the study, and then you'll switch to the other. You won't know whether you're taking the active medication or the placebo, and neither will the study team, so everyone stays 'blinded'.
During your visits, you'll have regular blood pressure checks, blood tests, and the medical team will monitor you closely for any side effects from the medication. The study team will make sure to use correctly sized cuffs for blood pressure readings to avoid discomfort and will stop if you feel uncomfortable. For blood tests, experienced staff will do their best to get samples with minimal discomfort, with a maximum of three attempts per visit. You'll also be given contact information for the research team so you can report any side effects immediately.
Potential risks and benefits
Locations (1)
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Common questions
What is high blood pressure?
High blood pressure (hypertension) is when the force of your blood pushing against your artery walls is consistently too high, which can damage your heart and blood vessels over time.
What kind of medicines are being tested?
The study is testing two different medicines together: Zibotentan, which helps relax blood vessels, and Dapagliflozin, which helps remove excess water and sugar from your body.
How long will I be in the study?
If you take part, your involvement will last for about 18 weeks, and you will have 9 visits to the research clinic during that time.
Why can't women who might get pregnant join?
One of the medicines, Zibotentan, carries a risk if a woman becomes pregnant, so for safety reasons, women who could have children are not eligible for this study.
Who is paying for this research?
The study is being funded by the NIHR Cambridge Biomedical Research Centre and the pharmaceutical company AstraZeneca, both in the UK.
How to find out more
Sonakshi Kadyan
Always speak to your GP or specialist before deciding to take part in a study.
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