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BaxHTN: 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

Sponsor
AstraZeneca (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT06034743
Collaborator
(none)
720
Enrollment
123
Locations
3
Arms
22.4
Anticipated Duration (Months)
5.9
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
720 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Baxdrostat in Participants With Uncontrolled Hypertension on Two or More Medications Including Participants With Resistant Hypertension
Anticipated Study Start Date :
Dec 1, 2023
Anticipated Primary Completion Date :
Oct 13, 2025
Anticipated Study Completion Date :
Oct 13, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: 2 mg baxdrostat

2 mg baxdrostat administered orally, once daily (QD).

Drug: Baxdrostat
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.
Other Names:
  • CIN-107

    		•
    Experimental: 1 mg baxdrostat

    1 mg baxdrostat administered orally, once daily (QD).

    Drug: Baxdrostat
    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.
    Other Names:
  • CIN-107

    		•
    Placebo Comparator: Placebo

    Placebo administered orally, once daily (QD).

    Drug: Placebo
    Placebo tablet matching baxdrostat, administered orally, once daily (QD).

    Outcome Measures

    Primary Outcome Measures

    1. Change from baseline in seated systolic blood pressure for 2 mg baxdrostat [At Week 12]

      To assess the effect of 2 mg baxdrostat versus placebo on seated systolic blood pressure at Week 12

    2. Change from baseline in seated systolic blood pressure for 1 mg baxdrostat [At Week 12]

      To assess the effect of 1 mg baxdrostat versus placebo on seated systolic blood pressure at Week 12

    Secondary Outcome Measures

    1. Change from randomised withdrawal baseline (Week 24) in seated systolic blood pressure (SBP) for 2 mg baxdrostat [At Week 32]

      To assess the effect of 2 mg baxdrostat vs placebo on seated systolic blood pressure (SBP) at 8 weeks after randomised withdrawal

    2. Change from baseline in seated SBP for 2 mg baxdrostat [At Week 12]

      To assess the effect of 2 mg baxdrostat vs placebo on seated SBP at Week 12 in the resistant hypertension (rHTN) subpopulation

    3. Change from baseline in seated diastolic blood pressure (DBP) for 2 mg baxdrostat [At Week 12]

      To assess the effect of 2 mg baxdrostat vs placebo on seated diastolic blood pressure (DBP) at Week 12

    4. Achieving seated SBP < 130 mmHg for 2 mg baxdrostat [At Week 12]

      To assess the effect of 2 mg baxdrostat vs placebo on achieving seated SBP < 130 mmHg at Week 12

    5. Change from baseline in seated SBP for 1 mg baxdrostat [At Week 12]

      To assess the effect of 1 mg baxdrostat vs placebo on seated SBP at Week 12 in the rHTN subpopulation

    6. Change from baseline in seated DBP for 1 mg baxdrostat [At Week 12]

      To assess the effect of 1 mg baxdrostat vs placebo on seated DBP at Week 12

    7. Achieving seated SBP < 130 mmHg for 1 mg baxdrostat [At Week 12]

      To assess the effect of 1 mg baxdrostat vs placebo on achieving seated SBP < 130 mmHg at Week 12

    8. The change from baseline in the mean ambulatory 24-hour SBP as measured by ambulatory blood pressure monitoring (ABPM) for 2 mg baxdrostat [At Week 12]

      To assess the effect of treatment with baxdrostat 2 mg vs placebo on ambulatory 24-hour average SBP at Week 12

    9. The change from baseline in the mean ambulatory 24-hour SBP as measured by ABPM for 1 mg baxdrostat [At Week 12]

      To assess the effect of treatment with baxdrostat 1 mg vs placebo on ambulatory 24-hour average SBP at Week 12

    Other Outcome Measures

    1. Number of participants with adverse events (AEs) [Up to Week 54]

      To assess the safety and tolerability of baxdrostat versus placebo. Occurrence of adverse events (AE), including serious adverse events (SAEs), adverse events leading to treatment discontinuation (DAE) and adverse events of special interest (AESI).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 130 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Male or female participants must be ≥ 18 years old

    • Mean sitting systolic blood pressure on automated office blood pressure measurement ≥ 140 mmHg and < 170 mmHg at Screening

    • Fulfil at least 1 of the following 2 criteria:

    1. uHTN subpopulation: have a stable regimen of 2 antihypertensive medications, from different therapeutic classes (at least one should be a diuretic), at maximum tolerated dose in the judgement of the Investigator

    2. rHTN subpopulation: 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

    • Estimated glomerular filtration rate ≥ 45 mL/min/1.73m2 at Screening

    • Serum potassium (K+) level ≥ 3.5 and < 5.0 mmol/L at Screening

    • Randomisation Criterion:

    • Sitting systolic blood pressure on attended automated office blood pressure measurement of ≥ 135 mmHg at baseline

    Exclusion Criteria:

    • Mean sitting systolic blood pressure on attended automated office blood pressure measurement ≥ 170 mmHg at Randomisation

    • Mean seated diastolic blood pressure on attended automated office blood pressure measurement ≥ 110 mmHg at Randomisation

    • Serum sodium level < 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

    • New York Heart Association functional heart failure class IV at Screening

    • Persistent atrial fibrillation

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Research Site Saraland Alabama United States 36571
    2 Research Site Sun City West Arizona United States 85375
    3 Research Site Surprise Arizona United States 85374
    4 Research Site Anaheim California United States 92805
    5 Research Site Lincoln California United States 95648
    6 Research Site Stanford California United States 94304
    7 Research Site Clearwater Florida United States 33765
    8 Research Site Atlanta Georgia United States 30344
    9 Research Site Chicago Illinois United States 60612
    10 Research Site Oak Brook Illinois United States 60523
    11 Research Site Springfield Illinois United States 62702
    12 Research Site Munster Indiana United States 46321
    13 Research Site Lexington Kentucky United States 40503
    14 Research Site Boston Massachusetts United States 02215
    15 Research Site Troy Michigan United States 48085
    16 Research Site Rochester Minnesota United States 55905
    17 Research Site Columbia Missouri United States 65212
    18 Research Site Kansas City Missouri United States 64111
    19 Research Site Kansas City Missouri United States 64128
    20 Research Site Kansas City Missouri United States 64151
    21 Research Site Bronx New York United States 10455
    22 Research Site Rosedale New York United States 11422
    23 Research Site Chapel Hill North Carolina United States 27599
    24 Research Site New Bern North Carolina United States 28562
    25 Research Site Toledo Ohio United States 43614
    26 Research Site Grants Pass Oregon United States 97527
    27 Research Site Corpus Christi Texas United States 78404
    28 Research Site Dallas Texas United States 75390
    29 Research Site Houston Texas United States 77054
    30 Research Site Sugar Land Texas United States 77479
    31 Research Site Manassas Virginia United States 20110
    32 Research Site Madison Wisconsin United States 53792
    33 Research Site Milwaukee Wisconsin United States 53295
    34 Research Site Caba Argentina C1119ACN
    35 Research Site Perth Australia 6000
    36 Research Site Wollongong Australia 2500
    37 Research Site Braunau am Inn Austria 5280
    38 Research Site Wien Austria 1090
    39 Research Site Aalst Belgium 9300
    40 Research Site Genk Belgium 3600
    41 Research Site Gent Belgium 9000
    42 Research Site Leuven Belgium 3000
    43 Research Site Liège Belgium 4000
    44 Research Site Mons Belgium 7000
    45 Research Site Pleven Bulgaria 5800
    46 Research Site Sofia Bulgaria 1527
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    48 Research Site Sofia Bulgaria 1680
    49 Research Site North Vancouver British Columbia Canada V7M 2H4
    50 Research Site Cambridge Ontario Canada N1R 6V6
    51 Research Site Toronto Ontario Canada M6G 1M2
    52 Research Site Waterloo Ontario Canada N2J 3Z4
    53 Research Site Chicoutimi Quebec Canada G7H 7K9
    54 Research Site St Jean sur Richelieu Quebec Canada J3A 1J2
    55 Research Site Benesov Czechia 256 01
    56 Research Site Brandys nad Labem Czechia 250 01
    57 Research Site Broumov Czechia 55001
    58 Research Site Louny Czechia 440 01
    59 Research Site Ostrava Czechia 708 52
    60 Research Site Pribram Czechia 261 01
    61 Research Site Uherske Hradiste Czechia 686 01
    62 Research Site Bad Homburg Germany 61348
    63 Research Site Bad Oeynhausen Germany 32545
    64 Research Site Berlin Germany 13347
    65 Research Site Erlangen Germany 91054
    66 Research Site Frankfurt am Main Germany 60590
    67 Research Site Hannover Germany 30625
    68 Research Site Homburg Germany 66424
    69 Research Site Kaiserslautern Germany 67655
    70 Research Site Leipzig Germany 04103
    71 Research Site Mannheim Germany 68167
    72 Research Site Regensburg Germany 93053
    73 Research Site Budapest Hungary 1115
    74 Research Site Kaposvár Hungary 7400
    75 Research Site Nyíregyháza Hungary 4400
    76 Research Site Szeged Hungary 6725
    77 Research Site Delhi India 110029
    78 Research Site Delhi India 110060
    79 Research Site Hyderabad India 500032
    80 Research Site Jaipur India 302004
    81 Research Site Kanpur India 208002
    82 Research Site Kolkata India 700014
    83 Research Site Kolkata India 700020
    84 Research Site Manipal India 576104
    85 Research Site Mysuru India 570004
    86 Research Site Mysuru India 570015
    87 Research Site New Delhi India 110002
    88 Research Site New Delhi India 110017
    89 Research Site Puducherry India 605006
    90 Research Site Pune India 411013
    91 Research Site Surat India 395001
    92 Research Site Ashdod Israel 7747629
    93 Research Site Haifa Israel 3109601
    94 Research Site petach Tikva Israel 49100
    95 Research Site Ramat Gan Israel 52621
    96 Research Site Rehovot Israel 76100
    97 Research Site Hoogeveen Netherlands 7909 AA
    98 Research Site Nijmegen Netherlands 6525 GA
    99 Research Site Utrecht Netherlands 3508 AB
    100 Research Site Białystok Poland 15-540
    101 Research Site Bydgoszcz Poland 85-095
    102 Research Site Chrzanów Poland 32-500
    103 Research Site Gdańsk Poland 80-214
    104 Research Site Gdynia Poland 81-338
    105 Research Site Kraków Poland 30-688
    106 Research Site Lodz Poland 91-002
    107 Research Site Poznań Poland 61-848
    108 Research Site Warszawa Poland 02-172
    109 Research Site Warszawa Poland 02-758
    110 Research Site Warszawa Poland 04-628
    111 Research Site Kosice Slovakia 04022
    112 Research Site Moldava nad Bodvou Slovakia 04501
    113 Research Site Presov Slovakia 080 01
    114 Research Site Rimavska Sobota Slovakia 979 01
    115 Research Site Trnava Slovakia 91701
    116 Research Site Kaohsiung Taiwan 81362
    117 Research Site Taipei Taiwan 10002
    118 Research Site Bangkok Thailand 10330
    119 Research Site Bangkok Thailand 10400
    120 Research Site Bangkok Thailand 10700
    121 Research Site Chiang Mai Thailand 50200
    122 Research Site Hat Yai Thailand 90110
    123 Research Site Muang Thailand 22000

    Sponsors and Collaborators

    • AstraZeneca

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    AstraZeneca
    ClinicalTrials.gov Identifier:
    NCT06034743
    Other Study ID Numbers:
    • D6970C00002
    First Posted:
    Sep 13, 2023
    Last Update Posted:
    Sep 13, 2023
    Last Verified:
    Sep 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by AstraZeneca
    Hypertension
    Uncontrolled hypertension
    Resistant hypertension
    Blood pressure
    Baxdrostat
    CIN-107
    Aldosterone
    Aldosterone synthase
    Additional relevant MeSH terms:
    Hypertension

    Study Results

    No Results Posted as of Sep 13, 2023