Bax24
Research type
Research Study
Full title
A Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Effect of Baxdrostat on Ambulatory Blood Pressure in Participants with Resistant Hypertension.
IRAS ID
1009017
Contact name
Laura Munoz
Contact email
Sponsor organisation
AstraZeneca AB
Research summary
Trial Design: This is a Phase 3, randomized, double-blinded, placebo-controlled trial. Randomized means that the treatment each participant receives will be randomly assigned by a computer program. Placebo-controlled means that some participants will receive a placebo. In the double-blind part, none of the participants, researchers, trial doctors, or other trial staff will know what treatment each participant receives. Participants will be in this trial for about 20 weeks.
Primary Objective (Question the researchers want to answer during the trial): Does baxdrostat help to lower the participants’ average daily blood pressure compared to a placebo?
Trial Population: This trial will include about 212 participants. All participants will be 18 years of age or older and have resistant hypertension. This means that their systolic blood pressure (BP) while sitting down is between 140 and 169 mmHg and are taking at least 3 different medications to treat their hypertension. People cannot join the trial if they have any serious or long-term health problems that would make it too risky or difficult for them to participate.Treatments and Procedures: Participants will keep taking their usual medicine for their hypertension throughout the trial. Participants will first receive baxdrostat or the placebo during a 2-week period called a run-in period. Then, they will be randomly assigned to receive baxdrostat or the placebo during a 12-week double-blind treatment period. Baxdrostat and the placebo are taken as tablets orally (by mouth).
REC name
London - Chelsea Research Ethics Committee
REC reference
23/LO/0908
Date of REC Opinion
20 Dec 2023
REC opinion
Further Information Favourable Opinion