BaxHTN - Baxdrostat in Participants with uHTN and rHTN
Research type
Research Study
Full 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
IRAS ID
1008507
Contact name
Laura Munoz
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2023-505499-32
Clinicaltrials.gov Identifier
Research summary
Some people still have high blood pressure even after treatment with 2 different types of medications. This is called uncontrolled hypertension. People with high blood pressure who are using at least 3 different types of medications have resistant hypertension. This study aims to evaluate if 1 mg or 2 mg doses of baxdrostat work better than a placebo to lower blood pressure in people with uncontrolled or resistant hypertension. Placebo will look like baxdrostat but will not have any baxdrostat in it.
This is a randomized trial where some parts are double-blind and some parts are open-label. Randomized means that the treatment each participant receives will be randomly assigned by a computer program. In the double-blind parts, none of the participants, researchers, trial doctors, or other trial staff will know what treatment each participant receives. In the open-label parts, the participants, researchers, trial doctors, and other trial staff will know what each participant is receiving.
Approximately 720 participants aged ≥18 years with uncontrolled or resistant hypertension will be enrolled in this study. The study duration will be up to 60 weeks. After an initial treatment with either baxdrostat or placebo, some participants will receive treatment that the medical community thinks is appropriate and widely accepted for hypertension, called standard of care. Some participants will switch from baxdrostat to placebo or the other way around in different parts of the trial. The main objective of the trial is to compare the difference in systolic blood pressure change from baseline at Week 12 of treatment between participants receiving 2 mg baxdrostat or 1 mg baxdrostat tablets and participants receiving placebo tablets, taken by mouth once a day. Other objectives include different assessments of blood pressure, safety, and tolerability of baxdrostat.REC name
London - Chelsea Research Ethics Committee
REC reference
23/LO/0793
Date of REC Opinion
20 Dec 2023
REC opinion
Further Information Favourable Opinion