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NCT06034743 (Baxdrostat in Uncontrolled or resistant hypertension): BVCT ex-ante prediction vs. reported outcome

On 11 Apr 2025, BioinvestGPT's BVCT predicted technical partial success and commercial failure for this trial. The 30 Aug 2025 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant (weak additive efficacy) and commercially maybe sufficient (more benefit for resistant hypertension than for uncontrolled hypertension).

Clinical Trial

NCTID
NCT06034743
Acronym
BaxHTN
Drug Name
Baxdrostat
Drug MoA
selective aldosterone synthase inhibitor
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Cardiovascular Diseases
Indication
Uncontrolled or resistant hypertension
Human Patients
796
Sponsor
AstraZeneca
Phase
Phase 3

Prediction of , index 1965

Prospective Prediction
Prediction Index
1965
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient additive clinical benefit in seated SBP for the mixed uncontrolled/resistant hypertension patients without further resistance/biomarker-based stratifications; as baxdrostat; which is non-inferior non-superior to lorundrostat; could deliver commercially sufficient additive clinical benefit only for either resistant hypertension patients or uncontrolled hypertension patients featuring aberrant plasma aldosterone level/aldosterone-to-renin ratio)
Technical Prediction
partial SUCCESS (statistically maybe significant yet very weak additive clinical benefit in seated SBP with a negative dose-response relationship)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
141 days in advance
Readout Data Interpretation
baxdrostat 2mg + SoC achieved 9.8 mmHg placebo-adjusted reduction in seated SBP at week 12 for uncontrolled or resistant hypertension (p<0.001); and 10.3 mmHg seated SBP at week 12 for resistant hypertension (p<0.0001 in Bax24 trial); which are non-superior to 6-12 mmHg placebo-adjusted 24hr ABPM reduction achieved by adding a third therapy to two standard anti-hypertension medications (see add'l link below and DOI- 10.1016/j.ejim.2023.04.021)
Press Release
Additional Readout Data
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant (weak additive efficacy) and commercially maybe sufficient (more benefit for resistant hypertension than for uncontrolled hypertension)
Prediction Classification
True Positive (TP)

ClinicalTrials.gov record

ClinicalTrials.gov record, retrieved 2026-09-24. Third-party data.

Official title
A Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Baxdrostat in Participants With Uncontrolled Hypertension on Two or More Medications Including Participants With Resistant Hypertension
Phase
Phase 3
Status
Completed
Enrollment
796
Lead sponsor
AstraZeneca
Conditions
Uncontrolled Hypertension; Resistant Hypertension
Interventions
DRUG: Baxdrostat; DRUG: Placebo
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2023-11-22
Primary completion
2025-05-21
Completion
2025-10-10
Results first posted
2026-07-30
Primary outcomes
  • Change From Baseline in Seated Systolic Blood Pressure for 2 mg Baxdrostat (At Week 12)
  • Change From Baseline in Seated Systolic Blood Pressure for 1 mg Baxdrostat (At Week 12)

NCT06034743 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

How to read these records: evidence · methodology · all trials