Summary
Bax24 is a study designed to test the safety, tolerability and effectiveness of a new blood pressure medication called baxdrostat. This study is for people with difficult to control blood pressure, who are currently taking at least 3 blood pressure medications, at least one of which being a diuretic. Eligible patients will receive either baxdrostat 2mg or a placebo. Baxdrostat has already been tested in patients with difficult-to-control high blood pressure in earlier research called Phase 2 studies.
Throughout the Bax24 study, you will keep taking your regular blood pressure medication. You may need to stop taking certain medicines. The study doctor will discuss this with you in detail.
During the study, you will need to:
- Take the study medication at home, except of specific study visit days, where the medication will be taken on site.
- Keep taking regular blood pressure medications.
- Attend regular study appointments for clinical examinations and procedures, including blood pressure measurements, blood tests, and ECGs.
- Wear an ambulatory blood pressure monitoring device for 25 hours, at 2 specific time points in the study. The device will be fitted at the study site by a member of the study team.
Key points
Inclusion Criteria
- Male or female participants must be ≥ 18 years old
- Mean systolic blood pressure at screening visit in clinic ≥ 140 mmHg and < 170 mmHg
- Have a stable regimen of at least 3 blood pressure medications, at least one of which being a diuretic*.
* Diuretics include but are not limited to indapamide, bumetanide, furosemide, and bendroflumethiazide.
Exclusion Criteria
- Mean systolic blood pressure at screening visit in clinic ≥ 170 mmHg
- Mean diastolic blood pressure at screening visit in clinic ≥ 110 mmHg
- Secondary causes of hypertension: renal artery stenosis, uncontrolled or untreated hyperthyroidism, uncontrolled or untreated hypothyroidism, pheochromocytoma, Cushing’s syndrome, aortic coarctation
- New York Heart Association functional heart failure class IV at Screening
- Medical history of stroke, acute coronary syndrome, hypertensive encephalopathy, or hospitalisation for heart failure in the 6 months prior to screening
- Persistent atrial fibrillation
- Patients who are pregnant or breastfeeding
Duration
This study will last approximately 20 weeks and have at least 11 study site visits. Each visit will l ast between 15 minutes and 2.5 hours. The study is split into 4 parts:
- Screening- participants will be screened within 4 weeks of consenting to the study to determine whether they are fully eligible.
- Run-in- a 2 week ‘practice’ period, where participants will take either baxdrostat or placebo before the treatment period starts. Participants will have an ABPM during this period.
- Treatment- a 12 week period where participants will take either baxdrostat or placebo, whilst remaining on their original antihypertensive regimen. Blood pressure measurements will continue to be taken to assess if the medication is helping to lower blood pressure. Participants will have an ABPM again, towards the end of this period.
- Follow-up- a final visit for tests and assessments 2 weeks after finishing treatment, to monitoring your health and well-being and check the effects of the drug.
Further Resources
https://www.astrazenecaclinicaltrials.com/study/D6970C00009
https://clinicaltrials.gov/study/NCT06168409?id=D6970C00009&rank=1
What to do next if you are interested in participating
If you are interested to find out more, and possibly participate, please fill in this screening form [custom web form for this study].
Alternatively, please call 07788130868 or email nhsnwl.baxhtn@nhs.net for further information.
Legal matters
By submitting the form above you agree for us to hold your personal data for the purposes of assessing your suitability for this study, or other similar studies, and also to hold the data during the period of a study that you participate in. Assessment of suitability for participation normally involves the collection of personal medical information. We may need to share this information with your registered GP surgery. If you participate in a study we may be required to share personal medical information that is relevant to the study with the sponsor so that the effectiveness and outcome can be evaluated.
We take informed consent very seriously, and will discuss this with you in detail before you participate in any study. Informed consent means that you understand what the study is about, what is involved, potential risks, data collection, communication, and various other matters so that you have a complete view and have time to consider everything before agreeing to participate.