A Study to Investigate the Effect of Baxdrostat on Ambulatory Blood Pressure in Participants With Resistant Hypertension

Resistant Hypertension Clinical Trial

— Bax24  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06168409
• Other study ID #: D6970C00009
• Status: Recruiting
• Phase: Phase 3
• Start date: March 1, 2024
• Est. completion date: April 25, 2025

Study information

• Verified date: June 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

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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 212
• Est. completion date: April 25, 2025
• Est. primary completion date: April 25, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 130 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension
• Resistant Hypertension

Intervention

Drug:
• Baxdrostat
Baxdrostat tablet administered orally, once daily (QD). Unit dose strength: • 2 mg per tablet.
• Placebo
Placebo tablet matching baxdrostat, administered orally, once daily (QD).

Locations

Country	Name	City	State
Argentina	Research Site	Caba
Argentina	Research Site	Caba
Argentina	Research Site	Capital Federal
Argentina	Research Site	Lanus Este
Argentina	Research Site	San Miguel de Tucuman
Australia	Research Site	Clayton
Australia	Research Site	Perth
Belgium	Research Site	Gent
Belgium	Research Site	Mons
Bulgaria	Research Site	Sofia
Bulgaria	Research Site	Sofia
Bulgaria	Research Site	Sofia
Bulgaria	Research Site	Sofia
Canada	Research Site	Cambridge	Ontario
Canada	Research Site	Chicoutimi	Quebec
Canada	Research Site	Edmonton	Alberta
Canada	Research Site	North Vancouver	British Columbia
Canada	Research Site	Toronto	Ontario
Canada	Research Site	Waterloo	Ontario
Czechia	Research Site	Brandys nad Labem
Czechia	Research Site	Broumov
Czechia	Research Site	Louny
Germany	Research Site	Bad Homburg
Germany	Research Site	Bad Oeynhausen
Germany	Research Site	Berlin
Germany	Research Site	Elsterwerda
Germany	Research Site	Erfurt
Germany	Research Site	Frankfurt
Greece	Research Site	Athens
Greece	Research Site	Attica
Greece	Research Site	Thessaloniki
Hungary	Research Site	Budapest
Hungary	Research Site	Nyíregyháza
Hungary	Research Site	Pécs
Malaysia	Research Site	Kota Bharu
Malaysia	Research Site	Muar
Malaysia	Research Site	Sarawak Miri
Philippines	Research Site	Angeles City
Philippines	Research Site	Iloilo City
Poland	Research Site	Gdansk
Poland	Research Site	Kraków
Poland	Research Site	Lodz
Poland	Research Site	Poznan
Poland	Research Site	Warszawa
Poland	Research Site	Warszawa
Saudi Arabia	Research Site	Riyadh
Saudi Arabia	Research Site	Riyadh
Slovakia	Research Site	Brezno
Slovakia	Research Site	Kosice
Slovakia	Research Site	Svidník
South Africa	Research Site	Cape Town
South Africa	Research Site	Durban
Spain	Research Site	Barcelona
Spain	Research Site	Madrid
Spain	Research Site	Madrid
Spain	Research Site	Oviedo
Taiwan	Research Site	New Taipei
Taiwan	Research Site	Taipei
Taiwan	Research Site	Taoyuan
Thailand	Research Site	Bangkok
Thailand	Research Site	Bangkok
Thailand	Research Site	Bangkok
Thailand	Research Site	Chiang Mai
Thailand	Research Site	Muang
Turkey	Research Site	Adana
Turkey	Research Site	Ankara
Turkey	Research Site	Istanbul
Turkey	Research Site	Odunpazari
United Kingdom	Research Site	Canterbury
United Kingdom	Research Site	London
United Kingdom	Research Site	Prescot
United Kingdom	Research Site	Stockport
United Kingdom	Research Site	Swindon
United Kingdom	Research Site	Thetford
United States	Research Site	Bronx	New York
United States	Research Site	Brownsville	Texas
United States	Research Site	Corpus Christi	Texas
United States	Research Site	Fort Wayne	Indiana
United States	Research Site	Greenville	North Carolina
United States	Research Site	Hollywood	Florida
United States	Research Site	Huntington Park	California
United States	Research Site	Jacksonville	Florida
United States	Research Site	Jacksonville	North Carolina
United States	Research Site	Kinston	North Carolina
United States	Research Site	Lake Worth	Florida
United States	Research Site	Lampasas	Texas
United States	Research Site	Langhorne	Pennsylvania
United States	Research Site	Lexington	Kentucky
United States	Research Site	Los Angeles	California
United States	Research Site	New Bern	North Carolina
United States	Research Site	Port Charlotte	Florida
United States	Research Site	Surprise	Arizona
United States	Research Site	Tampa	Florida
United States	Research Site	Wilmington	North Carolina
Vietnam	Research Site	Hanoi
Vietnam	Research Site	Ho Chi Minh
Vietnam	Research Site	Hochiminh city

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Vietnam,  Argentina,  Australia,  Belgium,  Bulgaria,  Canada,  Czechia,  Germany,  Greece,  Hungary,  Malaysia,  Philippines,  Poland,  Saudi Arabia,  Slovakia,  South Africa,  Spain,  Taiwan,  Thailand,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in ambulatory 24-hour average SBP	To assess the effect of treatment with baxdrostat 2 mg versus placebo on ambulatory 24-hour average SBP at Week 12.	At Week 12
Secondary	Change from baseline in ambulatory night-time average SBP	To assess the effect of treatment with baxdrostat 2 mg versus placebo on ambulatory night-time average SBP at Week 12.	At Week 12
Secondary	Change from baseline in ambulatory daytime average SBP	To assess the effect of treatment with baxdrostat 2 mg versus placebo on ambulatory daytime average SBP at Week 12.	At Week 12
Secondary	Change from baseline in seated SBP	To assess the effect of treatment with baxdrostat 2 mg versus placebo on seated SBP at Week 12.	At Week 12
Secondary	Participants achieving ambulatory 24-hour average SBP of < 130 mmHg	To assess the effect of treatment with baxdrostat 2 mg versus placebo on achieving ambulatory 24-hour average SBP < 130 mmHg at Week 12.	At Week 12
Secondary	Change from baseline in ambulatory 24-hour average DBP	To assess the effect of treatment with baxdrostat 2 mg versus placebo on ambulatory 24-hour average DBP at Week 12.	At Week 12
Secondary	Change from baseline in ambulatory night-time average DBP	To assess the effect of treatment with baxdrostat 2 mg versus placebo on ambulatory night-time average DBP at Week 12.	At Week 12
Secondary	Change from baseline in the average ambulatory daytime average DBP	To assess the effect of treatment with baxdrostat 2 mg versus placebo on ambulatory daytime average DBP at Week 12.	At Week 12
Secondary	Change from baseline on seated DBP	To assess the effect of treatment with baxdrostat 2 mg versus placebo on seated DBP at Week 12.	At Week 12
Secondary	Achieving a nocturnal SBP dipping of = 10%	To assess the effect of treatment with baxdrostat 2 mg versus placebo in the nocturnal dipping pattern at Week 12.	At Week 12.