baxdrostat
DrugBaxdrostat tablet administered orally, once daily (QD).
Other names: CIN-107
NCT Number: NCT07007793
This is a Phase III, multicentre, randomised, double-blind, placebo-controlled, parallel-group study to evaluate the safety, tolerability, and efficacy of baxdrostat versus placebo, on the reduction of Seated Blood Pressure (SBP) and achieving normalization of the Renin Angiotensin Aldosterone System (RAAS) in approximately 250 participants ≥ 18 years of age with Primary Aldosteronism (PA), with or without prior treatment with Mineralocorticoid Receptor Antagonists (MRAs) or potassium-sparing diuretics.
Baxdrostat (or placebo) will be administered once daily, up-titrated after 2 weeks based on clinical response and tolerability.
The study is planned to be conducted globally in approximately 90 study centres and 12 countries.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 3
Research Site, Brisbane, Australia
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
≤ 105 mmHg.
Exclusion criteria
If taking an MRA or potassium sparing diuretic at Screening: Mean seated SBP > 160 mmHg or mean seated DBP ≥ 100 mmHg.
Baxdrostat tablet administered orally, once daily (QD).
Other names: CIN-107
Placebo tablet matching baxdrostat, administered orally, once daily (QD).
Time frame: At week 8
To assess the effect of baxdrostat versus placebo on seated Systolic Blood Pressure (SBP) at Week 8
Time frame: At week 8
To assess the effect of baxdrostat vs placebo on achieving normalization of renin at week 8
Time frame: At week 52
To assess the effect of baxdrostat versus placebo on the percent change in DRC 8 weeks after the start of RWD
Time frame: At week 52
To assess the effect of baxdrostat versus placebo on seated Systolic Blood Pressure (SBP) 8 weeks after the start of Randomised withdrawal (RWD)
Time frame: At week 8
To assess the effect of baxdrostat vs placebo on achieving normalization of renin at week 8, in participants with dysregulated RAAS at baseline.
Time frame: At week 8
To assess the effect of baxdrostat versus placebo on achieving serum potassium ≥ 3.7 mmol/L without potassium supplementation at Week 8 in participants with serum potassium < 3.7 mmol/L or potassium supplementation at baseline
Time frame: At week 8
To assess the effect of baxdrostat versus placebo on achieving 24-hour urine aldosterone < 10 μg at Week 8 in participants with 24-hour urine aldosterone
≥ 10 μg at baseline
Time frame: At week 8
To assess the effect of baxdrostat versus placebo on 24-hour urine albumin at Week 8
Time frame: up to 54 weeks
To assess the safety and tolerability of baxdrostat. Occurrence of Adverse Events (AEs), Serious Adverse Events (SAEs), deaths, AEs leading to discontinuation of IMP and adverse events of special interest (AESIs) (hyperkalemia and hyponatremia)
Contact information is provided by the study sponsor or research team.
AstraZeneca
Industry
A Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy and Safety of Baxdrostat in Adult Participants With Primary Aldosteronism
Acronym: BaxPA
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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