Clinical trial NCT06168409: A Study to Investigate the Effect of Baxdrostat on Ambulatory Blood Pressure in Participants With Resistant Hypertension
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Effect of Baxdrostat on Ambulatory Blood Pressure in Participants With Resistant Hypertension
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Resistant Hypertension
Keywords: Hypertension
Resistant hypertension
Blood pressure
Baxdrostat
CIN-107
Aldosterone
Aldosterone synthase
Aldosterone synthase inhibitor
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2023-12-13
Enrollment: 217
Sex: ALL
Minimum age (years): 18
Maximum age (years): 130
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety, tolerability and the effect of 2 mg Baxdrostat vs. placebo, administered QD orally, on the reduction of SBP, measured by average 24-hour ABPM in 212 participants with rHTN (defined as seated SBP ≥ 140 mmHg at Screening and mean ambulatory SBP ≥ 130 mmHg at baseline, despite a stable regimen of ≥ 3 antihypertensive agents, one of which is a diuretic).

Detailed description: This is a Phase III, multicentre, randomised, double-blind, placebo-controlled, parallel group study to evaluate the safety, tolerability and the effect of 2 mg baxdrostat versus placebo, administered once a day (QD) orally, on the reduction of ambulatory SBP in participants with rHTN, defined as BP targets not being achieved in an individual despite the use of at least 3 antihypertensive agents of different classes (at maximum tolerated dose in the judgement of the Investigator), one of which is a diuretic.

Eligibility criteria: Inclusion Criteria:

* Participant must be ≥ 18 years old, at the time of signing the informed consent.
* Mean seated SBP on AOBPM of ≥ 140 mmHg and \< 170 mmHg at Screening.
* Have a stable regimen 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, for at least 4 weeks prior to Screening (participants who do not meet this criterion may be rescreened at the Investigator's discretion). Beta blockers used to treat other conditions (ie, migraine, HF, coronary artery disease) should not be counted as an antihypertensive medication for the purpose of qualifying for this study.
* Have eGFR ≥ 45 mL/min/1.73 m2 at Screening.
* Serum potassium (K+) level ≥ 3.5 and \< 5.0 mmol/L at Screening, determined as per central laboratory
* Randomization Criteria: mean ambulatory SBP of ≥ 130 mmHg at randomisation.

Exclusion Criteria:

* Mean seated SBP on AOBPM ≥ 170 mmHg at Screening.
* Mean seated DBP on AOBPM ≥ 110 mmHg at Screening.
* Serum sodium level \< 135 mmol/L at Screening, as per central laboratory.
* Participant 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 HF class IV at Screening.
* Persistent atrial fibrillation.

Primary outcomes:
measure: Change from baseline in ambulatory 24-hour average SBP
timeFrame: At Week 12
Secondary outcomes:
measure: Change from baseline in ambulatory night-time average SBP
timeFrame: At Week 12
measure: Change from baseline in ambulatory daytime average SBP
timeFrame: At Week 12
measure: Change from baseline in seated SBP
timeFrame: At Week 12
measure: Participants achieving ambulatory 24-hour average SBP of < 130 mmHg
timeFrame: At Week 12
measure: Change from baseline in ambulatory 24-hour average DBP
timeFrame: At Week 12
measure: Change from baseline in ambulatory night-time average DBP
timeFrame: At Week 12
measure: Change from baseline in the average ambulatory daytime average DBP
timeFrame: At Week 12
measure: Change from baseline on seated DBP
timeFrame: At Week 12
measure: Achieving a nocturnal SBP dipping of ≥ 10%
timeFrame: At Week 12.
Other outcomes:
Locations:
city: Surprise
country: United States
facility: Research Site
state: Arizona
city: Hollywood
country: United States
facility: Research Site
state: Florida
city: Lake Worth
country: United States
facility: Research Site
state: Florida
city: Port Charlotte
country: United States
facility: Research Site
state: Florida
city: Fort Wayne
country: United States
facility: Research Site
state: Indiana
city: Lexington
country: United States
facility: Research Site
state: Kentucky
city: Bronx
country: United States
facility: Research Site
state: New York
city: Greenville
country: United States
facility: Research Site
state: North Carolina
city: Jacksonville
country: United States
facility: Research Site
state: North Carolina
city: Kinston
country: United States
facility: Research Site
state: North Carolina
city: New Bern
country: United States
facility: Research Site
state: North Carolina
city: Wilmington
country: United States
facility: Research Site
state: North Carolina
city: Langhorne
country: United States
facility: Research Site
state: Pennsylvania
city: Brownsville
country: United States
facility: Research Site
state: Texas
city: Corpus Christi
country: United States
facility: Research Site
state: Texas
city: Lampasas
country: United States
facility: Research Site
state: Texas
city: Caba
country: Argentina
facility: Research Site
city: Caba
country: Argentina
facility: Research Site
city: Capital Federal
country: Argentina
facility: Research Site
city: Cordoba
country: Argentina
facility: Research Site
city: Lanus Este
country: Argentina
facility: Research Site
city: Rosario
country: Argentina
facility: Research Site
city: San Miguel de Tucuman
country: Argentina
facility: Research Site
city: San Vicente
country: Argentina
facility: Research Site
city: Clayton
country: Australia
facility: Research Site
city: Perth
country: Australia
facility: Research Site
city: Gent
country: Belgium
facility: Research Site
city: Sofia
country: Bulgaria
facility: Research Site
city: Sofia
country: Bulgaria
facility: Research Site
city: Sofia
country: Bulgaria
facility: Research Site
city: Edmonton
country: Canada
facility: Research Site
state: Alberta
city: North Vancouver
country: Canada
facility: Research Site
state: British Columbia
city: Cambridge
country: Canada
facility: Research Site
state: Ontario
city: Toronto
country: Canada
facility: Research Site
state: Ontario
city: Waterloo
country: Canada
facility: Research Site
state: Ontario
city: Chicoutimi
country: Canada
facility: Research Site
state: Quebec
city: Terrebonne
country: Canada
facility: Research Site
state: Quebec
city: Benesov
country: Czechia
facility: Research Site
city: Brandys nad Labem
country: Czechia
facility: Research Site
city: Broumov
country: Czechia
facility: Research Site
city: Louny
country: Czechia
facility: Research Site
city: Bad Homburg
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Frankfurt
country: Germany
facility: Research Site
city: Kaiserslautern
country: Germany
facility: Research Site
city: Athens
country: Greece
facility: Research Site
city: Attica
country: Greece
facility: Research Site
city: Thessaloniki
country: Greece
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Kalocsa
country: Hungary
facility: Research Site
city: Nyíregyháza
country: Hungary
facility: Research Site
city: Pécs
country: Hungary
facility: Research Site
city: Kota Bharu
country: Malaysia
facility: Research Site
city: Muar
country: Malaysia
facility: Research Site
city: Sarawak Miri
country: Malaysia
facility: Research Site
city: Angeles City
country: Philippines
facility: Research Site
city: Iloilo City
country: Philippines
facility: Research Site
city: Białystok
country: Poland
facility: Research Site
city: Gdańsk
country: Poland
facility: Research Site
city: Kraków
country: Poland
facility: Research Site
city: Lodz
country: Poland
facility: Research Site
city: Poznań
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: Riyadh
country: Saudi Arabia
facility: Research Site
city: Riyadh
country: Saudi Arabia
facility: Research Site
city: Brezno
country: Slovakia
facility: Research Site
city: Kosice
country: Slovakia
facility: Research Site
city: Svidník
country: Slovakia
facility: Research Site
city: Cape Town
country: South Africa
facility: Research Site
city: Durban
country: South Africa
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Santa Coloma de Gramenet
country: Spain
facility: Research Site
city: Terrassa (Barcelona)
country: Spain
facility: Research Site
city: Valencia
country: Spain
facility: Research Site
city: New Taipei
country: Taiwan
facility: Research Site
city: Taipei
country: Taiwan
facility: Research Site
city: Taoyuan
country: Taiwan
facility: Research Site
city: Bangkok
country: Thailand
facility: Research Site
city: Bangkok
country: Thailand
facility: Research Site
city: Bangkok
country: Thailand
facility: Research Site
city: Chiang Mai
country: Thailand
facility: Research Site
city: Muang
country: Thailand
facility: Research Site
city: Adana
country: Turkey
facility: Research Site
city: Ankara
country: Turkey
facility: Research Site
city: Kahramanmaras
country: Turkey
facility: Research Site
city: Kayseri
country: Turkey
facility: Research Site
city: Odunpazarı
country: Turkey
facility: Research Site
city: Corby
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: Prescot
country: United Kingdom
facility: Research Site
city: Swindon
country: United Kingdom
facility: Research Site
city: Thetford
country: United Kingdom
facility: Research Site
city: Weston-Super-Mare
country: United Kingdom
facility: Research Site
city: Yate
country: United Kingdom
facility: Research Site
city: Hanoi
country: Vietnam
facility: Research Site
city: Ho Chi Minh
country: Vietnam
facility: Research Site
city: Hochiminh city
country: Vietnam
facility: Research Site
Study officials:
References: