Baxdrostat for Hyperaldosteronism
(BaxPA Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new medication, baxdrostat, for individuals with primary aldosteronism, a condition causing high blood pressure due to excess hormone production. The goal is to determine if baxdrostat can safely and effectively lower blood pressure and improve hormone levels compared to a placebo. Participants will take either baxdrostat or a placebo pill once daily. Suitable candidates have primary aldosteronism, currently manage high blood pressure with medication, and are willing to adjust their treatments as needed for the study. As a Phase 3 trial, this study is the final step before potential FDA approval, offering participants a chance to contribute to a treatment that could soon become widely available.
Will I have to stop taking my current medications?
If you are taking a mineralocorticoid receptor antagonist (MRA) or potassium-sparing diuretic, you will need to stop these medications before joining the trial. The protocol does not specify about other medications, so it's best to discuss with the trial team.
Is there any evidence suggesting that baxdrostat is likely to be safe for humans?
Research has shown that baxdrostat has been tested for safety in people with hard-to-control high blood pressure. In these studies, most participants tolerated baxdrostat well. Some experienced side effects, but these were not serious for most.
In another study, baxdrostat significantly lowered blood pressure, indicating it works as expected. This study also found that the treatment was generally safe, with manageable side effects.
Overall, evidence suggests that baxdrostat is safe for people, with side effects that are usually mild and manageable.12345Why do researchers think this study treatment might be promising?
Baxdrostat is unique because it targets hyperaldosteronism by specifically inhibiting aldosterone synthase, an enzyme crucial for producing aldosterone. This is different from current treatment options, which often involve mineralocorticoid receptor antagonists like spironolactone that block the effects of aldosterone, rather than its production. Researchers are excited about Baxdrostat because it offers a more direct approach to reducing aldosterone levels, potentially leading to fewer side effects and improved outcomes for patients with hyperaldosteronism.
What evidence suggests that baxdrostat might be an effective treatment for hyperaldosteronism?
Research has shown that baxdrostat, which participants in this trial may receive, produces promising results in lowering blood pressure for people with primary aldosteronism. In earlier studies, about 71% of patients taking baxdrostat achieved a 24-hour average systolic blood pressure (the top number in a blood pressure reading) of less than 130 mmHg. Another study found that baxdrostat significantly lowered seated systolic blood pressure compared to a placebo. These findings suggest that baxdrostat effectively targets aldosterone, a hormone that can raise blood pressure, helping to manage high blood pressure in those with hyperaldosteronism.12346
Are You a Good Fit for This Trial?
This clinical trial is for adults with Primary Aldosteronism, which includes conditions like Hyperaldosteronism and Conn's syndrome. Participants can join whether or not they've been treated before with certain blood pressure medications.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Baxdrostat or placebo is administered once daily, with up-titration after 2 weeks based on clinical response and tolerability
Randomised Withdrawal
Participants undergo randomised withdrawal to assess long-term effects
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Baxdrostat
Find a Clinic Near You
Who Is Running the Clinical Trial?
AstraZeneca
Lead Sponsor
Sir Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Dr. Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology
Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology