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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
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
Secondary ID [1] 0 0
2023-507640-36-00
Secondary ID [2] 0 0
D6970C00009
Universal Trial Number (UTN)
Trial acronym
Bax24
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Resistant Hypertension 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Hypertension

Intervention/exposure
Study type
Interventional
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).
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from baseline in ambulatory 24-hour average SBP
Timepoint [1] 0 0
At Week 12
Secondary outcome [1] 0 0
Change from baseline in ambulatory night-time average SBP
Timepoint [1] 0 0
At Week 12
Secondary outcome [2] 0 0
Change from baseline in ambulatory daytime average SBP
Timepoint [2] 0 0
At Week 12
Secondary outcome [3] 0 0
Change from baseline in seated SBP
Timepoint [3] 0 0
At Week 12
Secondary outcome [4] 0 0
Participants achieving ambulatory 24-hour average SBP of < 130 mmHg
Timepoint [4] 0 0
At Week 12
Secondary outcome [5] 0 0
Change from baseline in ambulatory 24-hour average DBP
Timepoint [5] 0 0
At Week 12
Secondary outcome [6] 0 0
Change from baseline in ambulatory night-time average DBP
Timepoint [6] 0 0
At Week 12
Secondary outcome [7] 0 0
Change from baseline in the average ambulatory daytime average DBP
Timepoint [7] 0 0
At Week 12
Secondary outcome [8] 0 0
Change from baseline on seated DBP
Timepoint [8] 0 0
At Week 12
Secondary outcome [9] 0 0
Achieving a nocturnal SBP dipping of = 10%
Timepoint [9] 0 0
At Week 12.

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.
Minimum age
18 Years
Maximum age
130 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
5/09/2025
Actual
Sample size
Target
212
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Clayton
Recruitment hospital [2] 0 0
Research Site - Perth
Recruitment postcode(s) [1] 0 0
3168 - Clayton
Recruitment postcode(s) [2] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
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United States of America
State/province [2] 0 0
California
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United States of America
State/province [3] 0 0
Florida
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United States of America
State/province [4] 0 0
Indiana
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United States of America
State/province [5] 0 0
Kentucky
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United States of America
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New York
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United States of America
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North Carolina
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United States of America
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Pennsylvania
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United States of America
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Texas
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Argentina
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Caba
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Argentina
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Capital Federal
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Argentina
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Cordoba
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Argentina
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Lanus Este
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Argentina
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Rosario
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Argentina
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San Miguel de Tucuman
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Argentina
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San Vicente
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Belgium
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Gent
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Belgium
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Mons
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Bulgaria
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Sofia
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Alberta
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Ontario
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Quebec
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Czechia
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Brandys nad Labem
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Czechia
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Broumov
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Czechia
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Louny
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Germany
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Berlin
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Germany
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Elsterwerda
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Erfurt
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Frankfurt
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Germany
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Kaiserslautern
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Athens
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Attica
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Greece
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Thessaloniki
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Budapest
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Hungary
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Kalocsa
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Hungary
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Nyíregyháza
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Pécs
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Szeged
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Malaysia
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Kota Bharu
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Muar
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Sarawak Miri
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Angeles City
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Iloilo City
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Riyadh
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Kosice
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Svidník
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Santa Coloma de Gramenet
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Terrassa (Barcelona)
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Valencia
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New Taipei
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Taoyuan
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Bangkok
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Chiang Mai
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Thailand
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Muang
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Turkey
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Adana
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Ankara
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Turkey
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Istanbul
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Kahramanmaras
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Kayseri
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Turkey
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Odunpazari
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United Kingdom
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Canterbury
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Corby
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London
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Prescot
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Stockport
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Swindon
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Thetford
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United Kingdom
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Weston-Super-Mare
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United Kingdom
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Yate
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Vietnam
State/province [88] 0 0
Hanoi
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Vietnam
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Ho Chi Minh
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Vietnam
State/province [90] 0 0
Hochiminh city

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
AstraZeneca Clinical Study Information Center
Address 0 0
Country 0 0
Phone 0 0
1-877-240-9479
Fax 0 0
Email 0 0
information.center@astrazeneca.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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)
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.
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.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/


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