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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06344104




Registration number
NCT06344104
Ethics application status
Date submitted
27/03/2024
Date registered
3/04/2024

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 Double-Blind, Randomised, Placebo-Controlled, Multicentre Study Evaluating 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
D6970C00008
Universal Trial Number (UTN)
Trial acronym
BaxAsia
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 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).
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from baseline in seated SBP at Week 12
Timepoint [1] 0 0
At Week 12
Secondary outcome [1] 0 0
Change from baseline in seated SBP at Week 12
Timepoint [1] 0 0
At Week 12
Secondary outcome [2] 0 0
Change from RWD baseline (Week 24) in seated SBP at Week 32
Timepoint [2] 0 0
At Week 32
Secondary outcome [3] 0 0
Change from baseline in the mean ambulatory 24-hour SBP at Week 12 as measured by ABPM
Timepoint [3] 0 0
At Week 12
Secondary outcome [4] 0 0
Change from baseline in the mean ambulatory 24-hour SBP at Week 12 as measured by ABPM
Timepoint [4] 0 0
At Week 12
Secondary outcome [5] 0 0
Change from baseline in seated DBP at Week 12
Timepoint [5] 0 0
At Week 12
Secondary outcome [6] 0 0
Achieving seated SBP < 140 mmHg at Week 12
Timepoint [6] 0 0
At Week 12
Secondary outcome [7] 0 0
Change from baseline in seated DBP at Week 12
Timepoint [7] 0 0
At Week 12
Secondary outcome [8] 0 0
Achieving seated SBP < 140 mmHg at Week 12
Timepoint [8] 0 0
At Week 12
Secondary outcome [9] 0 0
Change from baseline in seated SBP at Week 12
Timepoint [9] 0 0
At Week 12
Secondary outcome [10] 0 0
Change from baseline in seated SBP at Week 12
Timepoint [10] 0 0
At Week 12

Eligibility
Key inclusion criteria
* Male or female participants must be = 18 years old.
* Mean seated SBP on automated office blood pressure measurement (AOBPM) = 140 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 must 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 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.• Mean seated SBP on AOBPM = 135 mmHg at Baseline.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Mean seated SBP on AOBPM = 170 mmHg.
* Mean seated DBP on AOBPM = 105 mmHg.
* 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.

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
8/04/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
20/05/2026
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Coffs Harbour
Recruitment hospital [2] 0 0
Research Site - Gosford
Recruitment hospital [3] 0 0
Research Site - Hoppers Crossing
Recruitment hospital [4] 0 0
Research Site - Ipswich
Recruitment postcode(s) [1] 0 0
02450 - Coffs Harbour
Recruitment postcode(s) [2] 0 0
2250 - Gosford
Recruitment postcode(s) [3] 0 0
3029 - Hoppers Crossing
Recruitment postcode(s) [4] 0 0
4305 - Ipswich
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Bahia Blanca
Country [2] 0 0
Argentina
State/province [2] 0 0
Caba
Country [3] 0 0
Argentina
State/province [3] 0 0
Ciudad de Buenos Aires
Country [4] 0 0
Argentina
State/province [4] 0 0
San Miguel de Tucuman
Country [5] 0 0
Argentina
State/province [5] 0 0
San Nicolas de los Arroyos
Country [6] 0 0
China
State/province [6] 0 0
Baotou
Country [7] 0 0
China
State/province [7] 0 0
Beijing
Country [8] 0 0
China
State/province [8] 0 0
Bengbu
Country [9] 0 0
China
State/province [9] 0 0
Changde
Country [10] 0 0
China
State/province [10] 0 0
Changsha
Country [11] 0 0
China
State/province [11] 0 0
Changzhou
Country [12] 0 0
China
State/province [12] 0 0
Chengdu
Country [13] 0 0
China
State/province [13] 0 0
Chongqing
Country [14] 0 0
China
State/province [14] 0 0
Deyang
Country [15] 0 0
China
State/province [15] 0 0
Guangzhou
Country [16] 0 0
China
State/province [16] 0 0
Ha'er Bin
Country [17] 0 0
China
State/province [17] 0 0
Hangzhou
Country [18] 0 0
China
State/province [18] 0 0
Hefei
Country [19] 0 0
China
State/province [19] 0 0
Heze
Country [20] 0 0
China
State/province [20] 0 0
Jiujiang
Country [21] 0 0
China
State/province [21] 0 0
Luoyang
Country [22] 0 0
China
State/province [22] 0 0
Meihekou
Country [23] 0 0
China
State/province [23] 0 0
Nanchang
Country [24] 0 0
China
State/province [24] 0 0
Nanchong
Country [25] 0 0
China
State/province [25] 0 0
Nanjing
Country [26] 0 0
China
State/province [26] 0 0
Ningbo
Country [27] 0 0
China
State/province [27] 0 0
Panjin
Country [28] 0 0
China
State/province [28] 0 0
Puyang
Country [29] 0 0
China
State/province [29] 0 0
Qiqihar
Country [30] 0 0
China
State/province [30] 0 0
Sanya
Country [31] 0 0
China
State/province [31] 0 0
Shanghai
Country [32] 0 0
China
State/province [32] 0 0
Shenyang
Country [33] 0 0
China
State/province [33] 0 0
Taiyuan
Country [34] 0 0
China
State/province [34] 0 0
Tianjin
Country [35] 0 0
China
State/province [35] 0 0
Wuhan
Country [36] 0 0
China
State/province [36] 0 0
Xianyang
Country [37] 0 0
China
State/province [37] 0 0
Xuzhou
Country [38] 0 0
China
State/province [38] 0 0
Yangzhou
Country [39] 0 0
China
State/province [39] 0 0
Yinchuan
Country [40] 0 0
China
State/province [40] 0 0
Zhengzhou
Country [41] 0 0
China
State/province [41] 0 0
Zigong
Country [42] 0 0
Hong Kong
State/province [42] 0 0
Hong Kong
Country [43] 0 0
India
State/province [43] 0 0
Bangalore
Country [44] 0 0
India
State/province [44] 0 0
Belgaum
Country [45] 0 0
India
State/province [45] 0 0
Kanpur
Country [46] 0 0
India
State/province [46] 0 0
New Delhi
Country [47] 0 0
India
State/province [47] 0 0
Surat
Country [48] 0 0
Japan
State/province [48] 0 0
Chuo-ku
Country [49] 0 0
Japan
State/province [49] 0 0
Hamamatsu-shi
Country [50] 0 0
Japan
State/province [50] 0 0
Kagoshima-shi
Country [51] 0 0
Japan
State/province [51] 0 0
Koga-shi
Country [52] 0 0
Japan
State/province [52] 0 0
Meguro-ku
Country [53] 0 0
Japan
State/province [53] 0 0
Minato-ku
Country [54] 0 0
Japan
State/province [54] 0 0
Minokamo shi
Country [55] 0 0
Japan
State/province [55] 0 0
Osaka-shi
Country [56] 0 0
Japan
State/province [56] 0 0
Toshima-ku
Country [57] 0 0
Japan
State/province [57] 0 0
Tsukuba-shi
Country [58] 0 0
Japan
State/province [58] 0 0
Utsunomiya-shi
Country [59] 0 0
Japan
State/province [59] 0 0
Yokohama-shi
Country [60] 0 0
Korea, Republic of
State/province [60] 0 0
Daejeon
Country [61] 0 0
Korea, Republic of
State/province [61] 0 0
Seoul
Country [62] 0 0
Philippines
State/province [62] 0 0
Iloilo City
Country [63] 0 0
Philippines
State/province [63] 0 0
Quezon City
Country [64] 0 0
Russian Federation
State/province [64] 0 0
Ivanovo
Country [65] 0 0
Russian Federation
State/province [65] 0 0
Moscow
Country [66] 0 0
Russian Federation
State/province [66] 0 0
Saint-Petersburg
Country [67] 0 0
Russian Federation
State/province [67] 0 0
St Petersburg
Country [68] 0 0
Russian Federation
State/province [68] 0 0
Tver
Country [69] 0 0
Turkey
State/province [69] 0 0
Ankara
Country [70] 0 0
Turkey
State/province [70] 0 0
Edirne
Country [71] 0 0
Turkey
State/province [71] 0 0
Kahramanmaras
Country [72] 0 0
Turkey
State/province [72] 0 0
Karsiyaka
Country [73] 0 0
Turkey
State/province [73] 0 0
Kayseri
Country [74] 0 0
Turkey
State/province [74] 0 0
Kocaeli
Country [75] 0 0
Turkey
State/province [75] 0 0
Mersin
Country [76] 0 0
Vietnam
State/province [76] 0 0
Can Tho
Country [77] 0 0
Vietnam
State/province [77] 0 0
Hanoi
Country [78] 0 0
Vietnam
State/province [78] 0 0
Ho Chi Minh
Country [79] 0 0
Vietnam
State/province [79] 0 0
Hochiminh city
Country [80] 0 0
Vietnam
State/province [80] 0 0
Hochiminh

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/NCT06344104