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

NCT06168409

CompletedPhase 3

Sponsor: AstraZeneca

Conditions: Resistant Hypertension

Interventions: Baxdrostat, Placebo

Countries: United States, Argentina, Australia, Belgium, Bulgaria, Canada, Czechia, Germany

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).

Eligibility overview

Sex: ALL

Age: 18 Years to 130 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
Locations (102)
  • Surprise, Arizona, United States
  • Hollywood, Florida, United States
  • Lake Worth, Florida, United States
  • Port Charlotte, Florida, United States
  • Fort Wayne, Indiana, United States
  • Lexington, Kentucky, United States
  • The Bronx, New York, United States
  • Greenville, North Carolina, United States
  • Jacksonville, North Carolina, United States
  • Kinston, North Carolina, United States
  • New Bern, North Carolina, United States
  • Wilmington, North Carolina, United States
  • Langhorne, Pennsylvania, United States
  • Brownsville, Texas, United States
  • Corpus Christi, Texas, United States
  • Lampasas, Texas, United States
  • CABA, Argentina
  • CABA, Argentina
  • Capital Federal, Argentina
  • Córdoba, Argentina
  • Lanús Este, Argentina
  • Rosario, Argentina
  • San Miguel de Tucumán, Argentina
  • San Vicente, Argentina
  • Clayton, Australia
  • Perth, Australia
  • Ghent, Belgium
  • Sofia, Bulgaria
  • Sofia, Bulgaria
  • Sofia, Bulgaria
  • + 72 more on CT.gov