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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06168409
Registration number
NCT06168409
Ethics application status
Date submitted
5/12/2023
Date registered
13/12/2023
Titles & IDs
Public title
A Study to Investigate the Effect of Baxdrostat on Ambulatory Blood Pressure in Participants With Resistant Hypertension
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Scientific title
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Effect of Baxdrostat on Ambulatory Blood Pressure in Participants With Resistant Hypertension
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Secondary ID [1]
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D6970C00009
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Universal Trial Number (UTN)
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Trial acronym
Bax24
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Resistant Hypertension
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Condition category
Condition code
Cardiovascular
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Hypertension
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Baxdrostat
Treatment: Drugs - Placebo
Experimental: 2 mg baxdrostat - 2 mg baxdrostat administered orally, once daily (QD).
Placebo comparator: Placebo - Placebo administered orally, once daily (QD)
Treatment: Drugs: Baxdrostat
Baxdrostat tablet administered orally, once daily (QD). Unit dose strength:
• 2 mg per tablet.
Treatment: Drugs: Placebo
Placebo tablet matching baxdrostat, administered orally, once daily (QD).
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change from baseline in ambulatory 24-hour average SBP
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Assessment method [1]
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To assess the effect of treatment with baxdrostat 2 mg versus placebo on ambulatory 24-hour average SBP at Week 12.
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Timepoint [1]
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At Week 12
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Secondary outcome [1]
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Change from baseline in ambulatory night-time average SBP
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Assessment method [1]
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To assess the effect of treatment with baxdrostat 2 mg versus placebo on ambulatory night-time average SBP at Week 12.
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Timepoint [1]
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At Week 12
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Secondary outcome [2]
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Change from baseline in ambulatory daytime average SBP
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Assessment method [2]
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To assess the effect of treatment with baxdrostat 2 mg versus placebo on ambulatory daytime average SBP at Week 12.
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Timepoint [2]
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At Week 12
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Secondary outcome [3]
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Change from baseline in seated SBP
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Assessment method [3]
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To assess the effect of treatment with baxdrostat 2 mg versus placebo on seated SBP at Week 12.
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Timepoint [3]
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At Week 12
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Secondary outcome [4]
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Participants achieving ambulatory 24-hour average SBP of < 130 mmHg
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Assessment method [4]
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To assess the effect of treatment with baxdrostat 2 mg versus placebo on achieving ambulatory 24-hour average SBP \< 130 mmHg at Week 12.
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Timepoint [4]
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At Week 12
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Secondary outcome [5]
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Change from baseline in ambulatory 24-hour average DBP
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Assessment method [5]
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To assess the effect of treatment with baxdrostat 2 mg versus placebo on ambulatory 24-hour average DBP at Week 12.
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Timepoint [5]
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At Week 12
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Secondary outcome [6]
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Change from baseline in ambulatory night-time average DBP
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Assessment method [6]
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To assess the effect of treatment with baxdrostat 2 mg versus placebo on ambulatory night-time average DBP at Week 12.
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Timepoint [6]
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At Week 12
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Secondary outcome [7]
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Change from baseline in the average ambulatory daytime average DBP
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Assessment method [7]
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To assess the effect of treatment with baxdrostat 2 mg versus placebo on ambulatory daytime average DBP at Week 12.
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Timepoint [7]
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At Week 12
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Secondary outcome [8]
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Change from baseline on seated DBP
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Assessment method [8]
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To assess the effect of treatment with baxdrostat 2 mg versus placebo on seated DBP at Week 12.
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Timepoint [8]
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At Week 12
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Secondary outcome [9]
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Achieving a nocturnal SBP dipping of = 10%
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Assessment method [9]
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To assess the effect of treatment with baxdrostat 2 mg versus placebo in the nocturnal dipping pattern at Week 12.
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Timepoint [9]
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At Week 12.
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Eligibility
Key inclusion criteria
* Participant must be = 18 years old, at the time of signing the informed consent.
* Mean seated SBP on AOBPM of = 140 mmHg and < 170 mmHg at Screening.
* Have a stable regimen of = 3 antihypertensive medications, from different therapeutic classes (at least one should be a diuretic), at maximum tolerated dose in the judgement of the Investigator, for at least 4 weeks prior to Screening (participants who do not meet this criterion may be rescreened at the Investigator's discretion). Beta blockers used to treat other conditions (ie, migraine, HF, coronary artery disease) should not be counted as an antihypertensive medication for the purpose of qualifying for this study.
* Have eGFR = 45 mL/min/1.73 m2 at Screening.
* Serum potassium (K+) level = 3.5 and < 5.0 mmol/L at Screening, determined as per central laboratory
* Randomization Criteria: mean ambulatory SBP of = 130 mmHg at randomisation.
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Minimum age
18
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Maximum age
130
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Mean seated SBP on AOBPM = 170 mmHg at Screening.
* Mean seated DBP on AOBPM = 110 mmHg at Screening.
* Serum sodium level < 135 mmol/L at Screening, as per central laboratory.
* Participant 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.
* New York Heart Association functional HF class IV at Screening.
* Persistent atrial fibrillation.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/03/2024
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
25/04/2025
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Actual
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Sample size
Target
212
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Accrual to date
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Final
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Recruitment in Australia
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Recruitment hospital [1]
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Research Site - Clayton
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Research Site - Perth
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3168 - Clayton
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Recruitment postcode(s) [2]
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6000 - Perth
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
AstraZeneca
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
This is a Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety, tolerability and the effect of 2 mg Baxdrostat vs. placebo, administered QD orally, on the reduction of SBP, measured by average 24-hour ABPM in 212 participants with rHTN (defined as seated SBP = 140 mmHg at Screening and mean ambulatory SBP = 130 mmHg at baseline, despite a stable regimen of = 3 antihypertensive agents, one of which is a diuretic).
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Trial website
https://clinicaltrials.gov/study/NCT06168409
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Contact person for public queries
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AstraZeneca Clinical Study Information Center
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1-877-240-9479
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment:
https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
"Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
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When will data be available (start and end dates)?
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at:
https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
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Available to whom?
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://vivli.org/
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06168409