BAXPA: A study to assess efficacy and safety of Baxdrostat in Adults with Primary Aldosteronism
Summary
This study will research a new medication to treat Primary Aldosteronism. This medication works to decrease the production of aldosterone.
This study will last for approximately 1 year. Participants will receive a placebo or the study medication for the first 8 weeks of the study. Then, everyone will receive the study medication up to week 44. Finally, participants will receive placebo or study medication for the final 8 weeks of the study.
The study will look at whether blood pressure control gets better. It will also assess changes in electrolytes, such as potassium and sodium and will measure if other lab tests change. Adults living with primary aldosteronism will be included. They should expect to be on stable blood pressure medication. Some of these medications may need adjusting by the study doctor at the beginning of this study. There are a total of 14 study visits, occuring every 2 weeks until week 16, and every 4-10 weeks afterwards until week 54.
Participants will be followed very closely by the study team to manage the symptoms of primary aldosteronism and any changes to health as a result of participating in this study.
Eligibility
Eligible ages: 18 to 100
Inclusion criteria:
1) Male of female ≥ 18 years old
2) Diagnosed with Primary Aldosteronism
3) Are willing to stop some medications that treat blood pressure, as directed by the study doctor (Mineralcorticoid Receptor Antagonists and potassium-sparing diuretics)
4) Must have healthy kidney functions as indicated by eGFR > 45 at screening visit
5) Specific serum potassium levels at screening
6) Females of child-bearing-potential must be willing to use contraception up to one month after the study medication has been stopped
Exclusion criteria:
1) Excessively high or low blood pressure
2) Surgical treatment for kidney issues must be evaluated
3) Other heart, liver, endocrine or secondary causes of hypertension considered relevant in the protocol or by the study doctor
4) Current medications will be reviewed and assessed by the study team and may be exclusionary or require adjustment
Participate
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Additional information
Contact information
Jane Booth
Principal investigator:
Alexander Leung
Clinical trial:
Yes
REB-ID:
REB25-0951