The Phase 3 trial (NCT06168409) investigating Baxdrostat for resistant hypertension reached primary completion on 2025-08-17. This study aimed to evaluate the effect of Baxdrostat on ambulatory blood pressure in participants with resistant hypertension.
Background
The trial focused on resistant hypertension, a condition defined by elevated blood pressure despite treatment with multiple antihypertensive agents.
Trial design
The study, identified as NCT06168409, was a Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel group study. It enrolled 218 participants diagnosed with resistant hypertension, defined as seated SBP ≥ 140 mmHg at screening and mean ambulatory SBP ≥ 130 mmHg at baseline, despite a stable regimen of ≥ 3 antihypertensive agents, including a diuretic. The trial evaluated the safety, tolerability, and effect of 2 mg Baxdrostat versus placebo, administered once daily orally, on the reduction of systolic blood pressure (SBP), measured by average 24-hour ambulatory blood pressure monitoring (ABPM).
What this means
The primary completion of this Phase 3 trial signifies that all planned participant visits and data collection for the main study objectives have concluded. The study investigated Baxdrostat as a potential treatment for resistant hypertension, a condition where blood pressure remains high despite medication. The completion of this phase is a critical step towards the eventual analysis and reporting of the trial's findings, which will provide insights into Baxdrostat's efficacy and safety profile in this challenging patient population. Future data releases will detail the impact on ambulatory blood pressure.
Source
The information regarding the primary completion of this trial was obtained from ClinicalTrials.gov, a public database of clinical studies. The record for study NCT06168409, titled "A Study to Investigate the Effect of Baxdrostat on Ambulatory Blood Pressure in Participants With Resistant Hypertension," was updated on 2025-08-17 on clinicaltrials.gov.