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Clinical Trials in India / NCT07007793
Recruiting Phase 3

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

NCT07007793 · tracked via the Priya Life Science India tracker
Sponsor
AstraZeneca
Phase
Phase 3
Started
2025-08-07
Last updated
2026-07-06

Condition(s) studied

Primary Hyperaldosteronism

Investigational drug(s) / intervention(s)

BaxdrostatPlacebo

Baxdrostat: Baxdrostat tablet administered orally, once daily (QD).

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

Study summary

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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * 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 * Serum potassium level ≥ 3.0 and \< 5.0 mmol/L at Screening determined as per the central laboratory. * Have a stable regimen of antihypertensive medications for at least 4 weeks prior to randomisation * Mean seated SBP on AOBPM of ≥ 135 mmHg and ≤ 170 mmHg and mean DBP of ≤ 105 mmHg. * Serum potassium (local lab) \> 3.0 mmol/L at randomization. Exclusion Criteria: \- If not taking an MRA or potassium sparing diuretic at Screening: Mean seated SBP \> 170 mmHg or mean seated DBP \>105 mmHg (on AOBPM). If taking an MRA or potassium sparing diuretic at Screening: Mean seated SBP \> 160 mmHg or mean seated DBP ≥ 100 mmHg. * 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. * Persistent atrial fibrillation. * Treatment with any MRA or potassium-sparing diuretic within 2 weeks prior to Randomisation.

Primary outcome measure(s)

Trial sites (89)

FacilityCityRegionStatus
Research Site Los Angeles California Withdrawn
Research Site San Francisco California Active Not Recruiting
Research Site Farmington Connecticut Active Not Recruiting
Research Site Chicago Illinois Recruiting
Research Site Springfield Illinois Active Not Recruiting
Research Site Baltimore Maryland Active Not Recruiting
Research Site Boston Massachusetts Active Not Recruiting
Research Site Boston Massachusetts Active Not Recruiting
Research Site Ann Arbor Michigan Active Not Recruiting
Research Site Rochester Minnesota Active Not Recruiting
Research Site Olive Branch Mississippi Recruiting
Research Site Kansas City Missouri Withdrawn
Research Site New York New York Withdrawn
Research Site Cleveland Ohio Active Not Recruiting
Research Site Columbus Ohio Active Not Recruiting
Research Site Portland Oregon Withdrawn
Research Site Bethlehem Pennsylvania Active Not Recruiting
Research Site Philadelphia Pennsylvania Active Not Recruiting
Research Site Columbia South Carolina Recruiting
Research Site Brownsville Texas Withdrawn
Research Site Dallas Texas Active Not Recruiting
Research Site Brisbane Australia Recruiting
Research Site Clayton Australia Recruiting
Research Site Perth Australia Recruiting
Research Site Calgary Alberta Recruiting
Research Site Ottawa Ontario Recruiting
Research Site Toronto Ontario Recruiting
Research Site Montreal Quebec Recruiting
Research Site Beijing China Active Not Recruiting
Research Site Beijing China Active Not Recruiting
Research Site Beijing China Active Not Recruiting
Research Site Changsha China Active Not Recruiting
Research Site Chengdu China Active Not Recruiting
Research Site Chengdu China Withdrawn
Research Site Chongqing China Active Not Recruiting
Research Site Nanjing China Active Not Recruiting
Research Site Shanghai China Active Not Recruiting
Research Site Tianjin China Active Not Recruiting
Research Site Wuhan China Active Not Recruiting
Research Site Wuhan China Completed

+ 49 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07007793 on ClinicalTrials.gov ↗ ← All trials in India