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

Resistant Hypertension Clinical Trial

— BaxAsia  

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06344104
• Other study ID #: D6970C00008
• Status: Recruiting
• Phase: Phase 3
• Start date: April 8, 2024
• Est. completion date: May 8, 2026

Study information

• Verified date: April 2024
• Source: AstraZeneca
• Contact: AstraZeneca Clinical Study Information Center
• Phone: 1-877-240-9479
• Email: information.center[@]astrazeneca.com
• Is FDA regulated: No
• 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 8, 2026
• Est. primary completion date: May 8, 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

Related Conditions & MeSH terms

• Hypertension
• Resistant Hypertension
• Uncontrolled Hypertension

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
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
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