A Study to Investigate the Effect of Baxdrostat on Ambulatory Blood Pressure in Participants With Resistant Hypertension

Completed · Phase 3 · Has a placebo group

Conditions studied: Resistant Hypertension

In brief

This is a Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety, tolerability and the effect of 2 mg Baxdrostat vs. placebo, administered QD orally, on the reduction of SBP, measured by average 24-hour ABPM in 212 participants with rHTN (defined as seated SBP ≥ 140 mmHg at Screening and mean ambulatory SBP ≥ 130 mmHg at baseline, despite a stable regimen of ≥ 3 antihypertensive agents, one of which is a diuretic).

Key facts

Study ID: NCT06168409
Run by: AstraZeneca
People needed: 218
Starts: 2024-03-01
Expected to finish: 2025-08-17
Last updated by the study team: 2026-08-06

Who can join

Age: 18 and older, up to 130. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Participant must be ≥ 18 years old, at the time of signing the informed consent.
Mean seated SBP on AOBPM of ≥ 140 mmHg and < 170 mmHg at Screening.
Have a stable regimen of ≥ 3 antihypertensive medications, from different therapeutic classes (at least one must be a diuretic), at maximum tolerated dose in the judgement of the Investigator, for at least 4 weeks prior to screening. Beta blockers used to treat other conditions (ie, migraine, HF, coronary artery disease) should not be counted as an antihypertensive medication for the purpose of qualifying for this study.
Have eGFR ≥ 45 mL/min/1.73 m2 at Screening.
Serum potassium (K+) level ≥ 3.5 and < 5.0 mmol/L at Screening, determined as per central laboratory
Randomization Criteria: mean ambulatory SBP of ≥ 130 mmHg at randomisation.

You may not qualify if…

Mean seated SBP on AOBPM ≥ 170 mmHg.
Mean seated DBP on AOBPM ≥ 110 mmHg.
Serum sodium level < 135 mmol/L at Screening, as per central laboratory.
Participant has the following known secondary causes of hypertension: renal artery stenosis, uncontrolled or untreated hyperthyroidism, uncontrolled or untreated hypothyroidism, pheochromocytoma, Cushing's syndrome, aortic coarctation.
New York Heart Association functional HF class IV.
Persistent atrial fibrillation.

Where it is running

Research Site — Hollywood, Florida, United States
Research Site — Lake Worth, Florida, United States
Research Site — Port Charlotte, Florida, United States
Research Site — Fort Wayne, Indiana, United States
Research Site — Lexington, Kentucky, United States
Research Site — The Bronx, New York, United States
Research Site — Greenville, North Carolina, United States
Research Site — Jacksonville, North Carolina, United States
Research Site — Kinston, North Carolina, United States
Research Site — New Bern, North Carolina, United States
Research Site — Wilmington, North Carolina, United States
Research Site — Langhorne, Pennsylvania, United States
Research Site — Brownsville, Texas, United States
Research Site — Corpus Christi, Texas, United States
Research Site — Lampasas, Texas, United States
Research Site — CABA, Argentina
Research Site — CABA, Argentina
Research Site — Capital Federal, Argentina
Research Site — Córdoba, Argentina
Research Site — Lanús Este, Argentina
Research Site — Rosario, Argentina
Research Site — San Miguel de Tucumán, Argentina
Research Site — San Vicente, Argentina
Research Site — Clayton, Australia
Research Site — Surprise, Arizona, United States

Full record on ClinicalTrials.gov

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