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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06344104
Other study ID # D6970C00008
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date April 8, 2024
Est. completion date May 20, 2026

Study information

Verified date May 2024
Source AstraZeneca
Contact AstraZeneca Clinical Study Information Center
Phone 1-877-240-9479
Email information.center@astrazeneca.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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 QD orally, on the reduction of SBP in approximately 300 Asian participants aged ≥ 18 years with HTN (≥ 140 mmHg at Screening; ≥ 140 mmHg at randomisation) despite a stable regimen of 2 antihypertensive agents at baseline, one of which is a diuretic (uHTN); or ≥ 3 antihypertensive agents at baseline, one of which is a diuretic (rHTN).


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date May 20, 2026
Est. primary completion date May 20, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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. 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

Study Design


Intervention

Drug:
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
Placebo
Placebo tablet administered orally, once daily (QD).

Locations

Country Name City State
Argentina Research Site Caba
Argentina Research Site Ciudad de Buenos Aires
Argentina Research Site San Miguel de Tucuman
Argentina Research Site San Nicolas de los Arroyos
Australia Research Site Coffs Harbour
Australia Research Site Gosford
Australia Research Site Margate
China Research Site Baotou
China Research Site Beijing
China Research Site Beijing
China Research Site Bengbu
China Research Site Changde
China Research Site Changsha
China Research Site Changsha
China Research Site Changzhou
China Research Site Chengdu
China Research Site Chongqing
China Research Site Chongqing
China Research Site Deyang
China Research Site Guangzhou
China Research Site Ha'er Bin
China Research Site Hangzhou
China Research Site Hefei
China Research Site Heze
China Research Site Jiujiang
China Research Site Luoyang
China Research Site Meihekou
China Research Site Nanchang
China Research Site Nanchong
China Research Site Nanjing
China Research Site Ningbo
China Research Site Panjin
China Research Site Puyang
China Research Site Qiqihar
China Research Site Sanya
China Research Site Shanghai
China Research Site Shanghai
China Research Site Shenyang
China Research Site Shenyang
China Research Site Taiyuan
China Research Site Tianjin
China Research Site Tianjin
China Research Site Wuhan
China Research Site Wuhan
China Research Site Wuhan
China Research Site Xianyang
China Research Site Xianyang
China Research Site Xuzhou
China Research Site Yangzhou
China Research Site Yinchuan
China Research Site Zhengzhou
China Research Site Zigong
Hong Kong Research Site Hong Kong
Hong Kong Research Site Hong Kong
Hong Kong Research Site Hong Kong
Hong Kong Research Site Hong Kong
India Research Site Bangalore
India Research Site Belgaum
India Research Site Kanpur
India Research Site New Delhi
India Research Site New Delhi
India Research Site Surat
Japan Research Site Chuo-ku
Japan Research Site Chuo-ku
Japan Research Site Kagoshima-shi
Japan Research Site Meguro-ku
Japan Research Site Minato-ku
Japan Research Site Tsukuba-shi
Japan Research Site Utsunomiya-shi
Japan Research Site Yokohama-shi
Japan Research Site Yokohama-shi
Korea, Republic of Research Site Daejeon
Korea, Republic of Research Site Seoul
Korea, Republic of Research Site Seoul
Korea, Republic of Research Site Seoul
Korea, Republic of Research Site Seoul
Korea, Republic of Research Site Seoul
Philippines Research Site Iloilo City
Philippines Research Site Quezon City
Russian Federation Research Site Ivanovo
Russian Federation Research Site Moscow
Russian Federation Research Site Moscow
Russian Federation Research Site Moscow
Russian Federation Research Site Saint-Petersburg
Russian Federation Research Site Saint-Petersburg
Russian Federation Research Site St Petersburg
Russian Federation Research Site Tver
Turkey Research Site Ankara
Turkey Research Site Edirne
Turkey Research Site Kahramanmaras
Turkey Research Site Kayseri
Turkey Research Site Kocaeli
Vietnam Research Site Hanoi
Vietnam Research Site Ho Chi Minh
Vietnam Research Site Hochiminh
Vietnam Research Site Hochiminh city

Sponsors (1)

Lead Sponsor Collaborator
AstraZeneca

Countries where clinical trial is conducted

Argentina,  Australia,  China,  Hong Kong,  India,  Japan,  Korea, Republic of,  Philippines,  Russian Federation,  Turkey,  Vietnam, 

Outcome

Type Measure Description Time frame Safety issue
Other Number of participants with adverse events (AEs) To assess the safety and tolerability of baxdrostat versus placebo. Occurrence of adverse events (AE), including serious adverse events (SAEs), adverse events leading to treatment discontinuation (DAE) and adverse events of special interest (AESI) Up to week 54
Primary Change from baseline in siSBP at Week 12 To assess the effect of 2 mg baxdrostat versus placebo on siSBP at 12 weeks At Week 12
Secondary Change from baseline in siSBP at Week 12 To assess the effect of 1 mg baxdrostat versus placebo on siSBP at 12 weeks At Week 12
Secondary Change from RWD baseline (Week 24) in siSBP at Week 32 To assess the effect of 2 mg baxdrostat versus placebo on siSBP at 8 weeks after randomised withdrawal At Week 32
Secondary Change from baseline in the mean ambulatory 24-hour SBP at Week 12 as measured by ABPM To assess the effect of treatment with baxdrostat 2 mg vs placebo on ambulatory 24-hour average SBP at Week 12 At Week 12
Secondary Change from baseline in the mean ambulatory 24-hour SBP at Week 12 as measured by ABPM To assess the effect of treatment with baxdrostat 1 mg vs placebo on ambulatory 24-hour average SBP at Week 12 At Week 12
Secondary Change from baseline in siDBP at Week 12 To assess the effect of 2 mg baxdrostat versus placebo on siDBP at Week 12 At Week 12
Secondary Achieving siSBP < 140 mmHg at Week 12 To assess the effect of 2 mg baxdrostat versus placebo on achieving siSBP < 140 mmHg at Week 12 At Week 12
Secondary Change from baseline in siDBP at Week 12 To assess the effect of 1 mg baxdrostat versus placebo on siDBP at Week 12. At Week 12
Secondary Achieving siSBP < 140 mmHg at Week 12 To assess the effect of 1 mg baxdrostat versus placebo on achieving siSBP < 140 mmHg at Week 12 At Week 12
Secondary Change from baseline in siSBP at Week 12 To assess the effect of 2 mg baxdrostat versus placebo on siSBP at Week 12 in the rHTN subgroup At Week 12
Secondary Change from baseline in siSBP at Week 12 To assess the effect of 1 mg baxdrostat versus placebo on siSBP at Week 12 in the rHTN subgroup At Week 12
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