Clinical trial NCT06344104: 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
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Uncontrolled Hypertension
Resistant Hypertension
Keywords: Hypertension
Uncontrolled hypertension
Resistant hypertension
Blood pressure
Baxdrostat
CIN-107
Aldosterone
Aldosterone synthase
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2024-04-03
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: placebo control
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to measure the efficacy and safety of baxdrostat in 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.

Detailed 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 participants aged ≥ 18 years with HTN (≥ 140 mmHg at Screening; ≥ 135 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).

Eligibility criteria: 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.

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.

Primary outcomes:
measure: Change from baseline in seated SBP at Week 12
timeFrame: At Week 12
Secondary outcomes:
measure: Change from baseline in seated SBP at Week 12
timeFrame: At Week 12
measure: Change from RWD baseline (Week 24) in seated SBP at Week 32
timeFrame: At Week 32
measure: Change from baseline in the mean ambulatory 24-hour SBP at Week 12 as measured by ABPM
timeFrame: At Week 12
measure: Change from baseline in the mean ambulatory 24-hour SBP at Week 12 as measured by ABPM
timeFrame: At Week 12
measure: Change from baseline in seated DBP at Week 12
timeFrame: At Week 12
measure: Achieving seated SBP < 140 mmHg at Week 12
timeFrame: At Week 12
measure: Change from baseline in seated DBP at Week 12
timeFrame: At Week 12
measure: Achieving seated SBP < 140 mmHg at Week 12
timeFrame: At Week 12
measure: Change from baseline in seated SBP at Week 12
timeFrame: At Week 12
measure: Change from baseline in seated SBP at Week 12
timeFrame: At Week 12
Other outcomes:
measure: Number of participants with adverse events (AEs)
timeFrame: Up to week 54
Locations:
city: Bahia Blanca
country: Argentina
facility: Research Site
city: Caba
country: Argentina
facility: Research Site
city: Ciudad de Buenos Aires
country: Argentina
facility: Research Site
city: San Miguel de Tucuman
country: Argentina
facility: Research Site
city: San Nicolas de los Arroyos
country: Argentina
facility: Research Site
city: Coffs Harbour
country: Australia
facility: Research Site
city: Gosford
country: Australia
facility: Research Site
city: Hoppers Crossing
country: Australia
facility: Research Site
city: Ipswich
country: Australia
facility: Research Site
city: Baotou
country: China
facility: Research Site
city: Beijing
country: China
facility: Research Site
city: Beijing
country: China
facility: Research Site
city: Bengbu
country: China
facility: Research Site
city: Changde
country: China
facility: Research Site
city: Changsha
country: China
facility: Research Site
city: Changsha
country: China
facility: Research Site
city: Changzhou
country: China
facility: Research Site
city: Chengdu
country: China
facility: Research Site
city: Chongqing
country: China
facility: Research Site
city: Chongqing
country: China
facility: Research Site
city: Chongqing
country: China
facility: Research Site
city: Deyang
country: China
facility: Research Site
city: Guangzhou
country: China
facility: Research Site
city: Ha'er Bin
country: China
facility: Research Site
city: Hangzhou
country: China
facility: Research Site
city: Hefei
country: China
facility: Research Site
city: Heze
country: China
facility: Research Site
city: Jiujiang
country: China
facility: Research Site
city: Luoyang
country: China
facility: Research Site
city: Meihekou
country: China
facility: Research Site
city: Nanchang
country: China
facility: Research Site
city: Nanchong
country: China
facility: Research Site
city: Nanjing
country: China
facility: Research Site
city: Ningbo
country: China
facility: Research Site
city: Panjin
country: China
facility: Research Site
city: Puyang
country: China
facility: Research Site
city: Qiqihar
country: China
facility: Research Site
city: Sanya
country: China
facility: Research Site
city: Shanghai
country: China
facility: Research Site
city: Shanghai
country: China
facility: Research Site
city: Shenyang
country: China
facility: Research Site
city: Shenyang
country: China
facility: Research Site
city: Shenyang
country: China
facility: Research Site
city: Taiyuan
country: China
facility: Research Site
city: Tianjin
country: China
facility: Research Site
city: Tianjin
country: China
facility: Research Site
city: Wuhan
country: China
facility: Research Site
city: Wuhan
country: China
facility: Research Site
city: Wuhan
country: China
facility: Research Site
city: Xianyang
country: China
facility: Research Site
city: Xianyang
country: China
facility: Research Site
city: Xuzhou
country: China
facility: Research Site
city: Yangzhou
country: China
facility: Research Site
city: Yinchuan
country: China
facility: Research Site
city: Zhengzhou
country: China
facility: Research Site
city: Zigong
country: China
facility: Research Site
city: Hong Kong
country: Hong Kong
facility: Research Site
city: Hong Kong
country: Hong Kong
facility: Research Site
city: Hong Kong
country: Hong Kong
facility: Research Site
city: Bangalore
country: India
facility: Research Site
city: Belgaum
country: India
facility: Research Site
city: Kanpur
country: India
facility: Research Site
city: New Delhi
country: India
facility: Research Site
city: New Delhi
country: India
facility: Research Site
city: Surat
country: India
facility: Research Site
city: Chuo-ku
country: Japan
facility: Research Site
city: Chuo-ku
country: Japan
facility: Research Site
city: Hamamatsu-shi
country: Japan
facility: Research Site
city: Kagoshima-shi
country: Japan
facility: Research Site
city: Koga-shi
country: Japan
facility: Research Site
city: Meguro-ku
country: Japan
facility: Research Site
city: Minato-ku
country: Japan
facility: Research Site
city: Minokamo shi
country: Japan
facility: Research Site
city: Osaka-shi
country: Japan
facility: Research Site
city: Toshima-ku
country: Japan
facility: Research Site
city: Tsukuba-shi
country: Japan
facility: Research Site
city: Utsunomiya-shi
country: Japan
facility: Research Site
city: Yokohama-shi
country: Japan
facility: Research Site
city: Yokohama-shi
country: Japan
facility: Research Site
city: Daejeon
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Iloilo City
country: Philippines
facility: Research Site
city: Quezon City
country: Philippines
facility: Research Site
city: Ivanovo
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Saint-Petersburg
country: Russian Federation
facility: Research Site
city: Saint-Petersburg
country: Russian Federation
facility: Research Site
city: St Petersburg
country: Russian Federation
facility: Research Site
city: Tver
country: Russian Federation
facility: Research Site
city: Ankara
country: Turkey
facility: Research Site
city: Ankara
country: Turkey
facility: Research Site
city: Edirne
country: Turkey
facility: Research Site
city: Kahramanmaras
country: Turkey
facility: Research Site
city: Karsiyaka
country: Turkey
facility: Research Site
city: Kayseri
country: Turkey
facility: Research Site
city: Kocaeli
country: Turkey
facility: Research Site
city: Mersin
country: Turkey
facility: Research Site
city: Can Tho
country: Vietnam
facility: Research Site
city: Da Nang
country: Vietnam
facility: Research Site
city: Hanoi
country: Vietnam
facility: Research Site
city: Ho Chi Minh
country: Vietnam
facility: Research Site
city: Ho Chi Minh
country: Vietnam
facility: Research Site
city: Hochiminh city
country: Vietnam
facility: Research Site
city: Hochiminh
country: Vietnam
facility: Research Site
Study officials:
References: