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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
Date last updated
28/10/2024

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
Recruitment hospital [9] 0 0
Research Site - Woolloongabba
Recruitment postcode(s) [1] 0 0
3168 - Clayton
Recruitment postcode(s) [2] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [3] 0 0
3076 - Epping
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3220 - Geelong
Recruitment postcode(s) [5] 0 0
2170 - Liverpool
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2305 - New Lambton Heights
Recruitment postcode(s) [7] 0 0
6000 - Perth
Recruitment postcode(s) [8] 0 0
2500 - Wollongong
Recruitment postcode(s) [9] 0 0
4102 - Woolloongabba
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Da Nang
Country [217] 0 0
Vietnam
State/province [217] 0 0
Ha Noi
Country [218] 0 0
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
This is a Phase III, multicentre, randomised, double-blinded, placebo-controlled, parallel group study to evaluate the safety, tolerability and effect of 1 or 2 mg baxdrostat versus placebo, administered once daily (QD) orally, on the reduction of systolic blood pressure in approximately 720 participants aged = 18 years with hypertension, despite a stable regimen of 2 antihypertensive agents at baseline, one of which is a diuretic (uncontrolled hypertension); or = 3 antihypertensive agents at baseline, one of which is a diuretic (treatment-resistant hypertension).
Trial website
https://clinicaltrials.gov/study/NCT06034743
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06034743