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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06034743




Registration number
NCT06034743
Ethics application status
Date submitted
6/09/2023
Date registered
13/09/2023

Titles & IDs
Public title
A Study to Investigate the Efficacy and Safety of Baxdrostat in Participants With Uncontrolled Hypertension on Two or More Medications Including Participants With Resistant Hypertension
Scientific 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
Secondary ID [1] 0 0
D6970C00002
Universal Trial Number (UTN)
Trial acronym
BaxHTN
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Uncontrolled Hypertension 0 0
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).

Experimental: 1 mg baxdrostat - 1 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 strengths:

* 1 mg per tablet for 1 mg baxdrostat Arm;
* 2 mg per tablet for 2 mg baxdrostat Arm.

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 seated systolic blood pressure for 2 mg baxdrostat
Timepoint [1] 0 0
At Week 12
Primary outcome [2] 0 0
Change from baseline in seated systolic blood pressure for 1 mg baxdrostat
Timepoint [2] 0 0
At Week 12
Secondary outcome [1] 0 0
Change from randomised withdrawal baseline (Week 24) in seated systolic blood pressure (SBP) for 2 mg baxdrostat
Timepoint [1] 0 0
At Week 32
Secondary outcome [2] 0 0
Change from baseline in seated SBP for 2 mg baxdrostat
Timepoint [2] 0 0
At Week 12
Secondary outcome [3] 0 0
Change from baseline in seated diastolic blood pressure (DBP) for 2 mg baxdrostat
Timepoint [3] 0 0
At Week 12
Secondary outcome [4] 0 0
Achieving seated SBP < 130 mmHg for 2 mg baxdrostat
Timepoint [4] 0 0
At Week 12
Secondary outcome [5] 0 0
Change from baseline in seated SBP for 1 mg baxdrostat
Timepoint [5] 0 0
At Week 12
Secondary outcome [6] 0 0
Change from baseline in seated DBP for 1 mg baxdrostat
Timepoint [6] 0 0
At Week 12
Secondary outcome [7] 0 0
Achieving seated SBP < 130 mmHg for 1 mg baxdrostat
Timepoint [7] 0 0
At Week 12

Eligibility
Key inclusion criteria
* Male or female participants must be = 18 years old
* Mean sitting systolic blood pressure on automated office blood pressure measurement = 140 mmHg and < 170 mmHg at Screening
* Fulfil at least 1 of the following 2 criteria:

1. uHTN subpopulation: have a stable regimen of 2 antihypertensive medications, from different therapeutic classes (at least one must be a diuretic), at maximum tolerated dose in the judgement of the Investigator
2. rHTN subpopulation: have a stable regimen of = 3 antihypertensive medications, from different therapeutic classes (at least one must be a diuretic), at maximum tolerated dose in the judgement of the Investigator
* Estimated glomerular filtration rate = 45 mL/min/1.73m2 at Screening
* Serum potassium (K+) level = 3.5 and < 5.0 mmol/L at Screening
* Randomisation Criterion:
* Sitting systolic blood pressure on attended automated office blood pressure measurement of = 135 mmHg at the Baseline Visit
Minimum age
18 Years
Maximum age
130 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Mean sitting systolic blood pressure on attended automated office blood pressure measurement = 170 mmHg
* Mean seated diastolic blood pressure on attended automated office blood pressure measurement = 110 mmHg
* Serum sodium level < 135 mmol/L at Screening
* 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 heart failure 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
22/11/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
13/10/2025
Actual
Sample size
Target
720
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 - Darlinghurst
Recruitment hospital [3] 0 0
Research Site - Epping
Recruitment hospital [4] 0 0
Research Site - Geelong
Recruitment hospital [5] 0 0
Research Site - Liverpool
Recruitment hospital [6] 0 0
Research Site - New Lambton Heights
Recruitment hospital [7] 0 0
Research Site - Perth
Recruitment hospital [8] 0 0
Research Site - Wollongong
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Research Site - Woolloongabba
Recruitment postcode(s) [1] 0 0
3168 - Clayton
Recruitment postcode(s) [2] 0 0
2010 - Darlinghurst
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3076 - Epping
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3220 - Geelong
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2170 - Liverpool
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2305 - New Lambton Heights
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6000 - Perth
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2500 - Wollongong
Recruitment postcode(s) [9] 0 0
4102 - Woolloongabba
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Vietnam
State/province [218] 0 0
Hanoi
Country [219] 0 0
Vietnam
State/province [219] 0 0
Ho Chi Minh
Country [220] 0 0
Vietnam
State/province [220] 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
[email protected]
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/NCT06034743