BaxPa: Baxdrostrat in Participants with PA
Research type
Research Study
Full title
A Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy and Safety of Baxdrostat in Adult Participants with Primary Aldosteronism
IRAS ID
1012246
Contact name
James Beddoes
Contact email
Sponsor organisation
AstraZeneca AB
Research summary
This is a Phase 3, randomized, placebo-controlled trial. Phase 3 means the researchers want to find out if the results they saw in Phase 2 studies for baxdrostat are the same in a larger group of participants. Randomized means that a computer program will randomly assign the treatment each participant takes. Placebo-controlled means that some participants will take a placebo. The placebo in this trial looks like baxdrostat but does not have any baxdrostat in it. Certain parts of this trial will be double-blind. Double-blind means none of the participants, researchers, or trial doctors will know what treatment each participant takes in these parts. In this trial, some of the staff will know what the participants are taking. The participants will be randomized to a treatment in the double-blind parts. Another part of this trial will be open-label. In this trial, open-label means the participants, researchers, and trial doctors will know that participants are taking baxdrostat during this part, but they will not know the dose.This trial will include a double-blind randomized withdrawal (RWD) period. RWD means that after all participants have taken baxdrostat in the open-label period, each participant will be randomized to either continue taking baxdrostat or switch to taking the placebo. Researchers do this so they can learn more about what happens in the body when people stop taking baxdrostat.
Baxdrostat and the placebo are taken once a day as 2 tablets by mouth. Baxdrostat is measured in milligrams (mg). The participants taking baxdrostat will either take 2 mg of baxdrostat (1 mg in each tablet) or 4 mg of baxdrostat (2 mg in each tablet). The trial will last up to 14 months, and the participants will take treatment for about 12 months (1 year). This trial will include 3 treatment periods and up to about 180 participants.REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
25/NW/0172
Date of REC Opinion
14 Jul 2025
REC opinion
Further Information Favourable Opinion