Study identifier:D6970C00009
ClinicalTrials.gov identifier:NCT06168409
EudraCT identifier:N/A
CTIS identifier:2023-507640-36-00
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Effect of Baxdrostat on Ambulatory Blood Pressure in Participants with Resistant Hypertension
Resistant hypertension
Phase 3
No
Baxdrostat, Placebo
All
212
Interventional
18 Years - 130 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Feb 2025 by AstraZeneca
AstraZeneca
-
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).
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.
Location
Status
Location
Gent, Belgium, 9000
Status
Recruiting
Location
Mons, Belgium, 7000
Status
Recruiting
Location
CABA, Argentina, C1425AGC
Status
Recruiting
Location
CABA, Argentina, C1119ACN
Status
Recruiting
Location
Perth, Australia, 6000
Status
Recruiting
Location
Elsterwerda, Germany, 04910
Status
Withdrawn
Location
Madrid, Spain, 28040
Status
Recruiting
Location
Sofia, Bulgaria, 1750
Status
Withdrawn
Arms | Assigned Interventions |
---|---|
Experimental: 2 mg baxdrostat 2 mg baxdrostat administered orally, once daily (QD). | Drug: Baxdrostat Baxdrostat tablet administered orally, once daily (QD). Unit dose strength: • 2 mg per tablet. Other Name: CIN-107 |
Placebo Comparator: Placebo Placebo administered orally, once daily (QD) | Drug: Placebo Placebo tablet matching baxdrostat, administered orally, once daily (QD). |
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