NCT06344104CompletedPhase 3
A Study to Investigate the Efficacy and Safety of Baxdrostat in Participants With Uncontrolled Hypertension on Two or More Medications Including Participants With Resistant Hypertension
A Double-Blind, Randomised, Placebo-Controlled, Multicentre Study Evaluating the Efficacy and Safety of Baxdrostat in Participants With Uncontrolled Hypertension on Two or More Medications Including Participants With Resistant Hypertension
Source: ClinicalTrials.gov · Last updated 21 Apr 2026
Brief summary (registry, in English)
The purpose of this study is to measure the efficacy and safety of baxdrostat in participants with uHTN or rHTN. The main objective is to compare the difference in SBP change from baseline at Week 12 of treatment between participants receiving 2 mg baxdrostat or 1 mg baxdrostat tablets and participants receiving placebo tablets.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 326 (actual)
- First submitted
- 27 Mar 2024
- Start date
- 8 Apr 2024
- Primary completion date
- 24 Nov 2025
- Lead sponsor
- AstraZeneca
- Diseases
- High blood pressure
- NCT number
- NCT06344104
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 326
- From 8 Apr 2024 to the primary completion date, 24 Nov 2025
- 73 sites in 11 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
- NYHA functional heart failure class IV at Screening.
Lab values
- Serum sodium level (Na+) \< 135 mmol/L at Screening.
Other
- Mean seated SBP on AOBPM ≥ 170 mmHg.
- Mean seated DBP on AOBPM ≥ 105 mmHg.
Who the study is looking for
- Male or female participants must be ≥ 18 years old.
- Mean seated SBP on automated office blood pressure measurement (AOBPM) ≥ 140 mmHg at Screening.
- Fulfil at least 1 of the following 2 criteria:
- uHTN subpopulation: have a stable regimen (≥ 4 weeks) of 2 antihypertensive medications, from different therapeutic classes (at least one must be a diuretic), at maximum tolerated dose in the judgement of the Investigator.
- rHTN subpopulation: have a stable regimen (≥ 4 weeks) 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.
- Estimated glomerular filtration rate ≥ 45 mL/min/1.73m2 at Screening.
- Serum potassium (K+) level ≥ 3.5 and \< 5.0 mmol/L at Screening.• Mean seated SBP on AOBPM ≥ 135 mmHg at Baseline.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (73)
Sites in registry order. Save your city in your profile to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.