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

Part of paid clinical trials in Saraland, Alabama.

Sponsor
AstraZeneca
Study ID
NCT06034743
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 130 Years
Healthy Volunteers
Not accepted

Interventions

  • Baxdrostat — DRUG
    Baxdrostat tablet administered orally, once daily (QD). Unit dose strengths: * 1 mg per tablet for 1 mg baxdrostat Arm; * 2 mg per tablet for 2 mg baxdrostat Arm.
  • Placebo — DRUG
    Placebo tablet matching baxdrostat, administered orally, once daily (QD).

Study Details

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 once daily (QD) orally, on the reduction of systolic blood pressure in approximately 720 participants aged ≥ 18 years with hypertension, despite a stable regimen of 2 antihypertensive agents at baseline, one of which is a diuretic (uncontrolled hypertension); or ≥ 3 antihypertensive agents at baseline, one of which is a diuretic (treatment-resistant hypertension).

Key Dates

Start date
Nov 22, 2023
Status verified
Nov 2025
Primary completion
May 21, 2025
Completion
Oct 10, 2025

Study Design

Enrollment
796 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 2 mg baxdrostat
    2 mg baxdrostat administered orally, once daily (QD).
  • Experimental: 1 mg baxdrostat
    1 mg baxdrostat administered orally, once daily (QD).
  • Placebo Comparator: Placebo
    Placebo administered orally, once daily (QD).

Primary Outcome Measure

Change from baseline in seated systolic blood pressure for 2 mg baxdrostat [ Time Frame: At Week 12 ]

Locations (43)

FacilityCityStateZIPSite coordinators
Research SiteSaralandAlabama36571-
Research SiteScottsdaleArizona85054-
Research SiteSun City WestArizona85375-
Research SiteSurpriseArizona85374-
Research SiteLittle RockArkansas72211-
Research SiteFresnoCalifornia93720-
Research SiteLincolnCalifornia95648-
Research SiteOrangeCalifornia92868-
Research SiteRancho CucamongaCalifornia91730-
Research SiteStanfordCalifornia94304-
Research SiteNew HavenConnecticut06510-
Research SiteClearwaterFlorida33765-
Research SiteJacksonvilleFlorida32204-
Research SitePort OrangeFlorida32127-
Research SiteAtlantaGeorgia30344-
Research SiteDecaturGeorgia30033-
Research SiteSpringfieldIllinois62702-
Research SiteMunsterIndiana46321-
Research SiteLexingtonKentucky40503-
Research SiteDetroitMichigan48202-
Research SiteRochesterMinnesota55905-
Research SiteOlive BranchMississippi38654-
Research SiteKansas CityMissouri64111-
Research SiteKansas CityMissouri64128-
Research SiteKansas CityMissouri64151-
Research SiteRosedaleNew York11422-
Research SiteThe BronxNew York10455-
Research SiteChapel HillNorth Carolina27599-
Research SiteNew BernNorth Carolina28562-
Research SiteToledoOhio43614-
Research SiteGrants PassOregon97527-
Research SiteBethlehemPennsylvania18017-
Research SiteLanghornePennsylvania19047-
Research SiteEast ProvidenceRhode Island02914-
Research SiteMemphisTennessee38105-
Research SiteBrownsvilleTexas78526-
Research SiteCorpus ChristiTexas78404-
Research SiteHoustonTexas77054-
Research SiteSugar LandTexas77479-
Research SiteManassasVirginia20110-
Research SiteSuffolkVirginia23435-
Research SiteMadisonWisconsin53792-
Research SiteMilwaukeeWisconsin53295-

Related coverage on Hipa.ai

Find similar trials in Saraland, AL

By condition
Hypertension (high blood pressure)
By specialty
CardiologyHeart disease
By research site
Research Site· Saraland, ALResearch Site· Scottsdale, AZResearch Site· Sun City West, AZResearch Site· Surprise, AZResearch Site· Little Rock, ARResearch Site· Fresno, CA

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