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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
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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
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Secondary ID [1]
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D6970C00002
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Universal Trial Number (UTN)
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Trial acronym
BaxHTN
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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 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).
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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 seated systolic blood pressure for 2 mg baxdrostat
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Assessment method [1]
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To assess the effect of 2 mg baxdrostat versus placebo on seated systolic blood pressure at Week 12
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Timepoint [1]
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At Week 12
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Primary outcome [2]
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Change from baseline in seated systolic blood pressure for 1 mg baxdrostat
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Assessment method [2]
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To assess the effect of 1 mg baxdrostat versus placebo on seated systolic blood pressure at Week 12
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Timepoint [2]
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At Week 12
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Secondary outcome [1]
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Change from randomised withdrawal baseline (Week 24) in seated systolic blood pressure (SBP) for 2 mg baxdrostat
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Assessment method [1]
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To assess the effect of 2 mg baxdrostat vs placebo on seated systolic blood pressure (SBP) at 8 weeks after randomised withdrawal
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Timepoint [1]
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At Week 32
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Secondary outcome [2]
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Change from baseline in seated SBP for 2 mg baxdrostat
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Assessment method [2]
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To assess the effect of 2 mg baxdrostat vs placebo on seated SBP at Week 12 in the resistant hypertension (rHTN) subpopulation
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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 diastolic blood pressure (DBP) for 2 mg baxdrostat
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Assessment method [3]
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To assess the effect of 2 mg baxdrostat vs placebo on seated diastolic blood pressure (DBP) 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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Achieving seated SBP < 130 mmHg for 2 mg baxdrostat
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Assessment method [4]
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To assess the effect of 2 mg baxdrostat vs placebo on achieving seated 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 seated SBP for 1 mg baxdrostat
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Assessment method [5]
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To assess the effect of 1 mg baxdrostat vs placebo on seated SBP at Week 12 in the rHTN subpopulation
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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 seated DBP for 1 mg baxdrostat
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Assessment method [6]
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To assess the effect of 1 mg baxdrostat vs placebo on seated 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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Achieving seated SBP < 130 mmHg for 1 mg baxdrostat
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Assessment method [7]
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To assess the effect of 1 mg baxdrostat vs placebo on achieving seated SBP \< 130 mmHg at Week 12
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Timepoint [7]
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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 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
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Minimum age
18
Years
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Maximum age
130
Years
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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 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
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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
22/11/2023
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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
13/10/2025
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Actual
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Sample size
Target
720
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Final
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Recruitment in Australia
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Research Site - Clayton
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3168 - Clayton
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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
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Recruitment postcode(s) [9]
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4102 - Woolloongabba
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Recruitment outside Australia
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Italy
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Italy
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Brescia
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Italy
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Milano
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Italy
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Pisa
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Italy
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Roma
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Italy
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Torino
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Italy
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Udine
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Adachi-ku
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Japan
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Chuo-ku
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Japan
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Japan
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Japan
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Kyoto-shi
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Japan
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Nagasaki-shi
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Japan
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Japan
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Japan
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Busan
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Incheon
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Seoul
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Kajang
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Malaysia
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Kuching
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Melaka
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Malaysia
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Muar
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Malaysia
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Malaysia
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Amsterdam
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Nijmegen
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Utrecht
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Chrzanów
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Poland
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Lodz
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Brezno
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Kosice
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Moldava nad Bodvou
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Presov
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Slovakia
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Rimavska Sobota
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Svidník
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Trnava
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Worcester
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Barcelona
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Ferrol
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Granada
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Sevilla
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Terrassa (Barcelona)
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Taiwan
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Taipei
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Taiwan
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Yung Kang City
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Bangkok
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Chiang Mai
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Thailand
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Hat Yai
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Thailand
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Muang
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Thailand
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Pathumthani
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Adana
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Turkey
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Bursa
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Dinar
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Istanbul
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Turkey
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Odunpazari
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United Kingdom
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Harrow
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Hownslow
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London
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Prescot
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Stockport
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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
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Da Nang
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Ha Noi
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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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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
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).
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Trial website
https://clinicaltrials.gov/study/NCT06034743
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
0
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0
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Fax
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Contact person for public queries
Name
0
0
AstraZeneca Clinical Study Information Center
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Address
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0
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Country
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0
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Phone
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0
1-877-240-9479
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Fax
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Email
0
0
[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)
Query!
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.
Query!
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/NCT06034743