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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT06344104
Registration number
NCT06344104
Ethics application status
Date submitted
27/03/2024
Date registered
3/04/2024
Date last updated
3/06/2024
Titles & IDs
Public title
A Phase III Study to Investigate the Efficacy and Safety of Baxdrostat in Asian Participants With Uncontrolled Hypertension on Two or More Medications Including Participants With Resistant Hypertension
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Scientific title
A Double-Blind, Randomized, Placebo-Controlled, Multicentre Study Evaluating the Efficacy and Safety of Baxdrostat in Asian Participants With Uncontrolled Hypertension on Two or More Medications Including Participants With Resistant Hypertension
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Secondary ID [1]
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D6970C00008
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Universal Trial Number (UTN)
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Trial acronym
BaxAsia
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Uncontrolled Hypertension
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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)
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 strength:
1 mg per tablet for 1mg baxdrostat Arm
2 mg per tablet for 2mg baxdrostat Arm
Treatment: Drugs: Placebo
Placebo tablet 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 siSBP at Week 12
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Assessment method [1]
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To assess the effect of 2 mg baxdrostat versus placebo on siSBP at 12 weeks
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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 siSBP at Week 12
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Assessment method [1]
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To assess the effect of 1 mg baxdrostat versus placebo on siSBP at 12 weeks
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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 RWD baseline (Week 24) in siSBP at Week 32
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Assessment method [2]
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To assess the effect of 2 mg baxdrostat versus placebo on siSBP at 8 weeks after randomised withdrawal
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Timepoint [2]
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At Week 32
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Secondary outcome [3]
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Change from baseline in the mean ambulatory 24-hour SBP at Week 12 as measured by ABPM
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Assessment method [3]
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To assess the effect of treatment with baxdrostat 2 mg vs placebo on ambulatory 24-hour average 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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Change from baseline in the mean ambulatory 24-hour SBP at Week 12 as measured by ABPM
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Assessment method [4]
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To assess the effect of treatment with baxdrostat 1 mg vs placebo on ambulatory 24-hour average SBP 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 siDBP at Week 12
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Assessment method [5]
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To assess the effect of 2 mg baxdrostat versus placebo on siDBP 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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Achieving siSBP < 140 mmHg at Week 12
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Assessment method [6]
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To assess the effect of 2 mg baxdrostat versus placebo on achieving siSBP < 140 mmHg 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 siDBP at Week 12
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Assessment method [7]
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To assess the effect of 1 mg baxdrostat versus placebo on siDBP 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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Achieving siSBP < 140 mmHg at Week 12
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Assessment method [8]
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To assess the effect of 1 mg baxdrostat versus placebo on achieving siSBP < 140 mmHg 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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Change from baseline in siSBP at Week 12
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Assessment method [9]
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To assess the effect of 2 mg baxdrostat versus placebo on siSBP at Week 12 in the rHTN subgroup
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Timepoint [9]
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At Week 12
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Secondary outcome [10]
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Change from baseline in siSBP at Week 12
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Assessment method [10]
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To assess the effect of 1 mg baxdrostat versus placebo on siSBP at Week 12 in the rHTN subgroup
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Timepoint [10]
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At Week 12
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Eligibility
Key inclusion criteria
- Male or female participants must be = 18 years old
- Mean siSBP on automated office blood pressure measurement (AOBPM) = 140 mmHg and < 170
mmHg at Screening.
- Fulfil at least 1 of the following 2 criteria:
1. uHTN subpopulation: have a stable regimen (= 4 weeks) of 2 antihypertensive
medications, from different therapeutic classes (at least one should be a
diuretic), at maximum tolerated dose in the judgement of the Investigator
2. rHTN subpopulation: have a stable regimen (= 4 weeks) 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
- Estimated glomerular filtration rate = 45 mL/min/1.73m2 at Screening
- Serum potassium (K+) level = 3.5 and < 5.0 mmol/L at Screening
- Mean siSBP on AOBPM = 140 mmHg at Baseline.
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Minimum age
18
Years
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Maximum age
No limit
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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 siSBP on AOBPM = 170 mmHg at randomisation
- Mean siDBP on AOBPM = 105 mmHg at randomization• Serum sodium level (Na+) < 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
- NYHA functional heart failure class IV at Screening
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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
8/04/2024
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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
20/05/2026
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Actual
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Sample size
Target
300
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Research Site - Coffs Harbour
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Recruitment hospital [2]
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Research Site - Gosford
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Recruitment hospital [3]
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Research Site - Margate
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Recruitment postcode(s) [1]
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02450 - Coffs Harbour
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Recruitment postcode(s) [2]
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2250 - Gosford
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Recruitment postcode(s) [3]
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33063 - Margate
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Recruitment outside Australia
Country [1]
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Argentina
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State/province [1]
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Caba
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Argentina
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Ciudad de Buenos Aires
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Argentina
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San Miguel de Tucuman
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Argentina
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San Nicolas de los Arroyos
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China
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Baotou
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China
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Beijing
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China
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Bengbu
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China
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Changde
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China
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Changsha
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China
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Changzhou
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China
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Chengdu
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China
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Chongqing
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China
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Deyang
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China
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Guangzhou
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China
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Ha'er Bin
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China
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Hangzhou
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China
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Hefei
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China
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Heze
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China
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Jiujiang
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China
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Luoyang
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China
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Meihekou
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China
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Nanchang
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China
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Nanchong
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China
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Nanjing
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China
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Ningbo
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China
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Panjin
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China
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Puyang
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China
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Qiqihar
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China
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Sanya
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China
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Shanghai
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China
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Shenyang
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China
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Taiyuan
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China
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Tianjin
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China
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Wuhan
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China
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Xianyang
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China
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Xuzhou
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China
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Yangzhou
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China
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Yinchuan
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China
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Zhengzhou
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China
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Zigong
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Hong Kong
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India
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Bangalore
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India
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Belgaum
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India
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Kanpur
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India
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New Delhi
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India
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Surat
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Chuo-ku
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Japan
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Minato-ku
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Japan
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Japan
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Japan
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Korea, Republic of
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Daejeon
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Philippines
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Russian Federation
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Ivanovo
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Russian Federation
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Moscow
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Russian Federation
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Saint-Petersburg
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Russian Federation
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St Petersburg
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Russian Federation
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Tver
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Turkey
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Ankara
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Turkey
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Edirne
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Turkey
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Kahramanmaras
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Turkey
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Kayseri
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Turkey
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Kocaeli
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Vietnam
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Hanoi
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Vietnam
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Ho Chi Minh
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Vietnam
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Hochiminh city
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Vietnam
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Hochiminh
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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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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to measure the efficacy and safety of baxdrostat in Asian
participants with uHTN or rHTN. The main objective is to compare the difference in SBP change
from baseline at Week 12 of treatment between participants receiving 2 mg baxdrostat or 1 mg
baxdrostat tablets and participants receiving placebo tablets.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT06344104
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Phone
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Fax
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Email
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Contact person for public queries
Name
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AstraZeneca Clinical Study Information Center
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Address
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Country
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Phone
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1-877-240-9479
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT06344104
Download to PDF