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A Study to Assess Efficacy and Safety of Baxdrostat in Participants With Primary Aldosteronism

ConditionPrimary Hyperaldosteronism
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorAstraZeneca

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female participants must be ≥ 18 years of age

Participants with a documented diagnosis of PA that fulfils the criteria defined in the 2016 or 2025 Endocrine Society Guidelines.

Participants willing and able to cease dosing of MRA or potassium sparing diuretics per study requirement for participants taking an MRA or potassium sparing diuretic at Screening.

eGFR ≥ 45 mL/min/1.73m2 at Screening

Disqualifiers

Previous surgical intervention for an adrenal adenoma or have a planned adrenalectomy, renal nerve denervation, or adrenal ablative procedure during the course of the study.

Has the following known secondary causes of HTN: renal artery stenosis, uncontrolled or untreated hyperthyroidism, uncontrolled or untreated hypothyroidism, pheochromocytoma, Cushing's syndrome, aortic coarctation.

Serum sodium level < 135 mmol/L at Screening, determined as per central laboratory.

New York Heart Association functional HF class IV at Screening.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Baxdrostat

    Drug

    Baxdrostat tablet administered orally, once daily (QD).

  • Placebo

    Drug

    Placebo tablet matching baxdrostat, administered orally, once daily (QD).

Treatment groups

250 Participants
are divided into 2 treatment groups
Group A: BaxdrostatExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change from baseline in seated Systolic Blood Pressure (SBP) 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
2

Achieving normalization of the Renin Angiotensin Aldosterone System (RAAS) at week 8.

To assess the effect of baxdrostat vs placebo on achieving normalization of renin at week 8

Time frame
At week 8

Secondary outcomes

1

Percent change from RWD baseline (Week 44) in Direct Renin Concentration (DRC) 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
2

Change from Randomised withdrawal (RWD) baseline (Week 44) in seated Systolic Blood Pressure (SBP) 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 52
3

Achieving normalization of the Renin Angiotensin Aldosterone System (RAAS) 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
4

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

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

Other outcomes

1

Number of participants with adverse events (AEs)

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)

Time frame
up to 54 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

AstraZeneca

Lead sponsor

Source ClinicalTrials.gov
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