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 (BaxHTN)

April 10, 2024 updated by: AstraZeneca

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

720

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: AstraZeneca Clinical Study Information Center
Phone Number: 1-877-240-9479
Email: information.center@astrazeneca.com

Study Locations

Argentina
- - Buenos Aires, Argentina, AR-CP 1221
    - Not yet recruiting
    - Research Site
  - Caba, Argentina, C1119ACN
    - Recruiting
    - Research Site
  - Caba, Argentina, C1425AGC
    - Recruiting
    - Research Site
  - Cordoba, Argentina, X5003DCP
    - Recruiting
    - Research Site
  - Córdoba, Argentina, 5000
    - Recruiting
    - Research Site
  - Mar del Plata, Argentina, B7600
    - Recruiting
    - Research Site
  - Mendoza, Argentina, M5500
    - Not yet recruiting
    - Research Site
  - Rosario, Argentina, S2000PBJ
    - Not yet recruiting
    - Research Site
  - San Miguel de Tucuman, Argentina, 4000
    - Recruiting
    - Research Site
  - San Nicolás, Argentina, B2900DMH
    - Recruiting
    - Research Site
  - San Vicente, Argentina, 5006
    - Recruiting
    - Research Site
Australia
- - Clayton, Australia, 3168
    - Recruiting
    - Research Site
  - Epping, Australia, 3076
    - Recruiting
    - Research Site
  - Geelong, Australia, 3220
    - Recruiting
    - Research Site
  - Liverpool, Australia, 2170
    - Not yet recruiting
    - Research Site
  - New Lambton Heights, Australia, 2305
    - Not yet recruiting
    - Research Site
  - Perth, Australia, 6000
    - Recruiting
    - Research Site
  - Wollongong, Australia, 2500
    - Recruiting
    - Research Site
  - Woolloongabba, Australia, 4102
    - Recruiting
    - Research Site
Austria
- - Braunau am Inn, Austria, 5280
    - Recruiting
    - Research Site
  - St. Pölten, Austria, 3100
    - Recruiting
    - Research Site
  - Wien, Austria, 1090
    - Not yet recruiting
    - Research Site
Belgium
- - Aalst, Belgium, 9300
    - Not yet recruiting
    - Research Site
  - Genk, Belgium, 3600
    - Withdrawn
    - Research Site
  - Gent, Belgium, 9000
    - Not yet recruiting
    - Research Site
  - Leuven, Belgium, 3000
    - Not yet recruiting
    - Research Site
  - Liège, Belgium, 4000
    - Not yet recruiting
    - Research Site
  - Mons, Belgium, 7000
    - Not yet recruiting
    - Research Site
Bulgaria
- - Pleven, Bulgaria, 5800
    - Recruiting
    - Research Site
  - Sofia, Bulgaria, 1527
    - Recruiting
    - Research Site
  - Sofia, Bulgaria, 1618
    - Recruiting
    - Research Site
  - Sofia, Bulgaria, 1680
    - Recruiting
    - Research Site
  - Sofia, Bulgaria, 1709
    - Recruiting
    - Research Site
Canada
- Alberta
  - Edmonton, Alberta, Canada, T6G 2C8
    - Not yet recruiting
    - Research Site
- British Columbia
  - North Vancouver, British Columbia, Canada, V7M 2H4
    - Recruiting
    - Research Site
- Ontario
  - Cambridge, Ontario, Canada, N1R 6V6
    - Recruiting
    - Research Site
  - Ottawa, Ontario, Canada, K1H 8L6
    - Not yet recruiting
    - Research Site
  - Toronto, Ontario, Canada, M6G 1M2
    - Recruiting
    - Research Site
  - Waterloo, Ontario, Canada, N2T 0C1
    - Recruiting
    - Research Site
- Quebec
  - Chicoutimi, Quebec, Canada, G7H 7K9
    - Recruiting
    - Research Site
  - St Jean sur Richelieu, Quebec, Canada, J3A 1J2
    - Recruiting
    - Research Site
Czechia
- - Benesov, Czechia, 256 01
    - Recruiting
    - Research Site
  - Brandys nad Labem, Czechia, 250 01
    - Recruiting
    - Research Site
  - Broumov, Czechia, 55001
    - Recruiting
    - Research Site
  - Louny, Czechia, 440 01
    - Recruiting
    - Research Site
  - Ostrava, Czechia, 708 52
    - Not yet recruiting
    - Research Site
  - Pribram, Czechia, 261 01
    - Recruiting
    - Research Site
  - Uherske Hradiste, Czechia, 686 01
    - Recruiting
    - Research Site
Denmark
- - Aarhus, Denmark, 8200
    - Recruiting
    - Research Site
  - Herning, Denmark, 7400
    - Not yet recruiting
    - Research Site
  - Holbæk, Denmark, 4300
    - Recruiting
    - Research Site
France
- - Bobigny, France, 93000
    - Not yet recruiting
    - Research Site
  - Bordeaux, France, 33076
    - Recruiting
    - Research Site
  - Lille, France, 59037
    - Not yet recruiting
    - Research Site
  - Paris, France, 75015
    - Not yet recruiting
    - Research Site
  - Paris Cedex 14, France, 75013
    - Not yet recruiting
    - Research Site
  - Poitiers, France, 86021
    - Not yet recruiting
    - Research Site
  - Sr Priest En Jarez, France, 42270
    - Not yet recruiting
    - Research Site
  - Toulon, France, 83100
    - Recruiting
    - Research Site
  - Toulouse, France, 31059
    - Not yet recruiting
    - Research Site
  - Tours CEDEX, France, 37044
    - Recruiting
    - Research Site
Germany
- - Bad Homburg, Germany, 61348
    - Recruiting
    - Research Site
  - Bad Oeynhausen, Germany, 32545
    - Not yet recruiting
    - Research Site
  - Berlin, Germany, 12203
    - Recruiting
    - Research Site
  - Berlin, Germany, 13347
    - Recruiting
    - Research Site
  - Dortmund, Germany, 44137
    - Recruiting
    - Research Site
  - Düsseldorf, Germany, 40225
    - Not yet recruiting
    - Research Site
  - Elsterwerda, Germany, 04910
    - Recruiting
    - Research Site
  - Erfurt, Germany, 99089
    - Not yet recruiting
    - Research Site
  - Erlangen, Germany, 91054
    - Not yet recruiting
    - Research Site
  - Essen, Germany, 45355
    - Recruiting
    - Research Site
  - Frankfurt, Germany, 60596
    - Recruiting
    - Research Site
  - Frankfurt, Germany, 60590
    - Not yet recruiting
    - Research Site
  - Frankfurt am Main, Germany, 60590
    - Withdrawn
    - Research Site
  - Hannover, Germany, 30625
    - Not yet recruiting
    - Research Site
  - Hannover, Germany, 30449
    - Recruiting
    - Research Site
  - Homburg, Germany, 66424
    - Not yet recruiting
    - Research Site
  - Kaiserslautern, Germany, 67655
    - Not yet recruiting
    - Research Site
  - Leipzig, Germany, 04103
    - Recruiting
    - Research Site
  - Lübeck, Germany, 23562
    - Withdrawn
    - Research Site
  - Mainz, Germany, 55131
    - Withdrawn
    - Research Site
  - Mannheim, Germany, 68167
    - Not yet recruiting
    - Research Site
  - Marburg, Germany, 35043
    - Withdrawn
    - Research Site
  - Regensburg, Germany, 93053
    - Not yet recruiting
    - Research Site
  - Wermsdorf, Germany, 04779
    - Not yet recruiting
    - Research Site
Hungary
- - Budapest, Hungary, 1115
    - Not yet recruiting
    - Research Site
  - Kaposvár, Hungary, 7400
    - Not yet recruiting
    - Research Site
  - Nyíregyháza, Hungary, 4400
    - Not yet recruiting
    - Research Site
  - Szeged, Hungary, 6725
    - Not yet recruiting
    - Research Site
India
- - Delhi, India, 110029
    - Not yet recruiting
    - Research Site
  - Delhi, India, 110060
    - Not yet recruiting
    - Research Site
  - Guntur, India, 522001
    - Not yet recruiting
    - Research Site
  - Hyderabad, India, 500032
    - Recruiting
    - Research Site
  - Jaipur, India, 302004
    - Withdrawn
    - Research Site
  - Kanpur, India, 208002
    - Recruiting
    - Research Site
  - Kolkata, India, 700020
    - Not yet recruiting
    - Research Site
  - Kolkata, India, 700014
    - Not yet recruiting
    - Research Site
  - Kolkata, India, 700053
    - Withdrawn
    - Research Site
  - Manipal, India, 576104
    - Suspended
    - Research Site
  - Mysuru, India, 570004
    - Recruiting
    - Research Site
  - Mysuru, India, 570015
    - Recruiting
    - Research Site
  - New Delhi, India, 110017
    - Recruiting
    - Research Site
  - New Delhi, India, 110002
    - Not yet recruiting
    - Research Site
  - Puducherry, India, 605006
    - Not yet recruiting
    - Research Site
  - Pune, India, 411013
    - Withdrawn
    - Research Site
  - Surat, India, 395001
    - Not yet recruiting
    - Research Site
Israel
- - Ashdod, Israel, 7747629
    - Recruiting
    - Research Site
  - Haifa, Israel, 3109601
    - Recruiting
    - Research Site
  - Ramat Gan, Israel, 52621
    - Recruiting
    - Research Site
  - Rehovot, Israel, 76100
    - Recruiting
    - Research Site
  - petach Tikva, Israel, 49100
    - Recruiting
    - Research Site
Italy
- - Acquaviva delle Fonti, Italy, 70021
    - Not yet recruiting
    - Research Site
  - Bologna, Italy, 40138
    - Not yet recruiting
    - Research Site
  - Brescia, Italy, 25123
    - Not yet recruiting
    - Research Site
  - Milano, Italy, 20122
    - Not yet recruiting
    - Research Site
  - Milano, Italy, 20138
    - Recruiting
    - Research Site
  - Milano, Italy, 20149
    - Recruiting
    - Research Site
  - Pisa, Italy, 56126
    - Recruiting
    - Research Site
  - Roma, Italy, 00189
    - Not yet recruiting
    - Research Site
  - Torino, Italy, 10126
    - Not yet recruiting
    - Research Site
  - Udine, Italy, 33100
    - Not yet recruiting
    - Research Site
Japan
- - Adachi-ku, Japan, 121-0815
    - Recruiting
    - Research Site
  - Chuo-ku, Japan, 103-0028
    - Recruiting
    - Research Site
  - Chuo-ku, Japan, 103-0027
    - Recruiting
    - Research Site
  - Chuo-ku, Japan, 260-0804
    - Recruiting
    - Research Site
  - Kanazawa-shi, Japan, 920-8530
    - Recruiting
    - Research Site
  - Koga-shi, Japan, 306-0232
    - Recruiting
    - Research Site
  - Kyoto-shi, Japan, 607-8062
    - Recruiting
    - Research Site
  - Nagasaki-shi, Japan, 850-8555
    - Recruiting
    - Research Site
  - Okayama-shi, Japan, 700-0804
    - Recruiting
    - Research Site
  - Osaka-shi, Japan, 559-0012
    - Recruiting
    - Research Site
  - Sapporo-shi, Japan, 003-0026
    - Recruiting
    - Research Site
  - Tsuchiura-shi, Japan, 300-0062
    - Recruiting
    - Research Site
Korea, Republic of
- - Bucheon-si, Korea, Republic of, 420-717
    - Recruiting
    - Research Site
  - Busan, Korea, Republic of, 49241
    - Recruiting
    - Research Site
  - Daejeon, Korea, Republic of, 35015
    - Recruiting
    - Research Site
  - Incheon, Korea, Republic of, 21565
    - Recruiting
    - Research Site
  - Seoul, Korea, Republic of, 03722
    - Recruiting
    - Research Site
  - Seoul, Korea, Republic of, 05505
    - Recruiting
    - Research Site
  - Seoul, Korea, Republic of, 03080
    - Recruiting
    - Research Site
  - Seoul, Korea, Republic of, 02841
    - Recruiting
    - Research Site
  - Seoul, Korea, Republic of, 08308
    - Recruiting
    - Research Site
  - Seoul, Korea, Republic of, 04763
    - Recruiting
    - Research Site
  - Seoul, Korea, Republic of, 07441
    - Recruiting
    - Research Site
  - Seoul, Korea, Republic of, 07804
    - Recruiting
    - Research Site
Malaysia
- - Kajang, Malaysia, 43000
    - Recruiting
    - Research Site
  - Kota Bharu, Malaysia, 15586
    - Recruiting
    - Research Site
  - Kuching, Malaysia, 93586
    - Recruiting
    - Research Site
  - Melaka, Malaysia, 75400
    - Recruiting
    - Research Site
  - Muar, Malaysia, 84000
    - Recruiting
    - Research Site
  - Sarawak Miri, Malaysia, 98000
    - Recruiting
    - Research Site
  - Seri Manjung, Malaysia, 32040
    - Recruiting
    - Research Site
Netherlands
- - Amsterdam, Netherlands, 1100 DD
    - Withdrawn
    - Research Site
  - Hoogeveen, Netherlands, 7909 AA
    - Recruiting
    - Research Site
  - Nijmegen, Netherlands, 6525 GA
    - Recruiting
    - Research Site
  - Utrecht, Netherlands, 3508 AB
    - Recruiting
    - Research Site
Poland
- - Białystok, Poland, 15-540
    - Recruiting
    - Research Site
  - Bydgoszcz, Poland, 85-095
    - Recruiting
    - Research Site
  - Chrzanów, Poland, 32-500
    - Recruiting
    - Research Site
  - Gdańsk, Poland, 80-214
    - Recruiting
    - Research Site
  - Gdynia, Poland, 81-338
    - Recruiting
    - Research Site
  - Kraków, Poland, 30-688
    - Recruiting
    - Research Site
  - Lodz, Poland, 91-002
    - Recruiting
    - Research Site
  - Poznań, Poland, 61-848
    - Recruiting
    - Research Site
  - Warszawa, Poland, 02-758
    - Recruiting
    - Research Site
  - Warszawa, Poland, 04-628
    - Recruiting
    - Research Site
  - Warszawa, Poland, 02-172
    - Recruiting
    - Research Site
Slovakia
- - Bratislava, Slovakia, 85101
    - Withdrawn
    - Research Site
  - Brezno, Slovakia, 977 01
    - Recruiting
    - Research Site
  - Kosice, Slovakia, 04022
    - Recruiting
    - Research Site
  - Moldava nad Bodvou, Slovakia, 04501
    - Not yet recruiting
    - Research Site
  - Presov, Slovakia, 080 01
    - Recruiting
    - Research Site
  - Rimavska Sobota, Slovakia, 979 01
    - Not yet recruiting
    - Research Site
  - Svidník, Slovakia, 08901
    - Recruiting
    - Research Site
  - Trnava, Slovakia, 91701
    - Withdrawn
    - Research Site
South Africa
- - Cape Town, South Africa, 7500
    - Recruiting
    - Research Site
  - Centurion, South Africa, 0157
    - Recruiting
    - Research Site
  - Claremont, South Africa, 7708
    - Recruiting
    - Research Site
  - Durban, South Africa, 4001
    - Recruiting
    - Research Site
  - Kwadwesi, South Africa, 6201
    - Recruiting
    - Research Site
  - Somerset West, South Africa, 7130
    - Recruiting
    - Research Site
  - Worcester, South Africa, 6850
    - Recruiting
    - Research Site
Spain
- - Barcelona, Spain, 08036
    - Recruiting
    - Research Site
  - Barcelona, Spain, 8003
    - Recruiting
    - Research Site
  - Ferrol, Spain, 15401
    - Recruiting
    - Research Site
  - Granada, Spain, 18014
    - Recruiting
    - Research Site
  - Madrid, Spain, 28040
    - Recruiting
    - Research Site
  - Madrid, Spain, 28041
    - Recruiting
    - Research Site
  - Majadahonda, Spain, 28250
    - Recruiting
    - Research Site
  - Oviedo, Spain, 33011
    - Not yet recruiting
    - Research Site
  - Sevilla, Spain, 41014
    - Recruiting
    - Research Site
  - Terrassa, Spain, 08021
    - Recruiting
    - Research Site
Sweden
- - Göteborg, Sweden, 413 45
    - Recruiting
    - Research Site
  - Stockholm, Sweden, SE-18288
    - Not yet recruiting
    - Research Site
  - Uppsala, Sweden, 75185
    - Recruiting
    - Research Site
Taiwan
- - Kaohsiung, Taiwan, 81362
    - Recruiting
    - Research Site
  - Kaohsiung, Taiwan, 80756
    - Recruiting
    - Research Site
  - Taichung, Taiwan, 40447
    - Recruiting
    - Research Site
  - Taichung, Taiwan, 40201
    - Recruiting
    - Research Site
  - Taipei, Taiwan, 10002
    - Recruiting
    - Research Site
  - Taipei, Taiwan, 11217
    - Recruiting
    - Research Site
  - Taipei City, Taiwan, 110
    - Recruiting
    - Research Site
  - Yung Kang City, Taiwan, 71044
    - Recruiting
    - Research Site
Thailand
- - Bangkok, Thailand, 10330
    - Recruiting
    - Research Site
  - Bangkok, Thailand, 10400
    - Not yet recruiting
    - Research Site
  - Bangkok, Thailand, 10700
    - Recruiting
    - Research Site
  - Chiang Mai, Thailand, 50200
    - Recruiting
    - Research Site
  - Hat Yai, Thailand, 90110
    - Recruiting
    - Research Site
  - Muang, Thailand, 22000
    - Not yet recruiting
    - Research Site
  - Muang, Thailand, 40002
    - Recruiting
    - Research Site
  - Pathumthani, Thailand, 12120
    - Recruiting
    - Research Site
Turkey
- - Adana, Turkey, 01060
    - Recruiting
    - Research Site
  - Ankara, Turkey, 06230
    - Recruiting
    - Research Site
  - Bursa, Turkey, 16059
    - Recruiting
    - Research Site
  - Dinar, Turkey, 03400
    - Recruiting
    - Research Site
  - Istanbul, Turkey, 34862
    - Not yet recruiting
    - Research Site
  - Izmir, Turkey
    - Recruiting
    - Research Site
  - Kütahya, Turkey, 43100
    - Not yet recruiting
    - Research Site
  - Odunpazarı, Turkey, 26080
    - Not yet recruiting
    - Research Site
United Kingdom
- - Bristol, United Kingdom, BS34 6BQ
    - Recruiting
    - Research Site
  - Chesterfield, United Kingdom, S40 4AA
    - Recruiting
    - Research Site
  - Dundee, United Kingdom, DD1 9SY
    - Recruiting
    - Research Site
  - Glasgow, United Kingdom, G51 4TF
    - Recruiting
    - Research Site
  - London, United Kingdom, EC1M 6BQ
    - Recruiting
    - Research Site
  - Prescot, United Kingdom, L35 5DR
    - Recruiting
    - Research Site
  - Stockport, United Kingdom
    - Recruiting
    - Research Site
  - Yate, United Kingdom, BS37 4AX
    - Recruiting
    - Research Site
United States
- Alabama
  - Birmingham, Alabama, United States, 35233
    - Recruiting
    - Research Site
  - Birmingham, Alabama, United States, 35205
    - Not yet recruiting
    - Research Site
  - Saraland, Alabama, United States, 36571
    - Recruiting
    - Research Site
- Arizona
  - Scottsdale, Arizona, United States, 85054
    - Not yet recruiting
    - Research Site
  - Sun City West, Arizona, United States, 85375
    - Recruiting
    - Research Site
  - Surprise, Arizona, United States, 85374
    - Recruiting
    - Research Site
- Arkansas
  - Little Rock, Arkansas, United States, 72211
    - Recruiting
    - Research Site
- California
  - Anaheim, California, United States, 92805
    - Withdrawn
    - Research Site
  - Fresno, California, United States, 93720
    - Recruiting
    - Research Site
  - Lincoln, California, United States, 95648
    - Recruiting
    - Research Site
  - Orange, California, United States, 92868
    - Not yet recruiting
    - Research Site
  - Rancho Cucamonga, California, United States, 91730
    - Recruiting
    - Research Site
  - Stanford, California, United States, 94304
    - Recruiting
    - Research Site
- Connecticut
  - New Haven, Connecticut, United States, 06510
    - Not yet recruiting
    - Research Site
- Florida
  - Clearwater, Florida, United States, 33765
    - Recruiting
    - Research Site
  - Clearwater, Florida, United States, 33756
    - Withdrawn
    - Research Site
  - Jacksonville, Florida, United States, 32204
    - Recruiting
    - Research Site
  - Port Orange, Florida, United States, 32127
    - Recruiting
    - Research Site
- Georgia
  - Atlanta, Georgia, United States, 30344
    - Recruiting
    - Research Site
  - Augusta, Georgia, United States, 30904
    - Not yet recruiting
    - Research Site
  - Decatur, Georgia, United States, 30033
    - Not yet recruiting
    - Research Site
- Illinois
  - Chicago, Illinois, United States, 60612
    - Not yet recruiting
    - Research Site
  - Hinsdale, Illinois, United States, 60521
    - Recruiting
    - Research Site
  - Springfield, Illinois, United States, 62702
    - Recruiting
    - Research Site
- Indiana
  - Munster, Indiana, United States, 46321
    - Recruiting
    - Research Site
- Kentucky
  - Lexington, Kentucky, United States, 40503
    - Recruiting
    - Research Site
- Massachusetts
  - Boston, Massachusetts, United States, 02215
    - Not yet recruiting
    - Research Site
- Michigan
  - Detroit, Michigan, United States, 48202
    - Not yet recruiting
    - Research Site
  - Troy, Michigan, United States, 48085
    - Withdrawn
    - Research Site
- Minnesota
  - Rochester, Minnesota, United States, 55905
    - Recruiting
    - Research Site
- Mississippi
  - Olive Branch, Mississippi, United States, 38654
    - Recruiting
    - Research Site
- Missouri
  - Columbia, Missouri, United States, 65212
    - Not yet recruiting
    - Research Site
  - Kansas City, Missouri, United States, 64111
    - Recruiting
    - Research Site
  - Kansas City, Missouri, United States, 64128
    - Recruiting
    - Research Site
  - Kansas City, Missouri, United States, 64151
    - Recruiting
    - Research Site
- New York
  - Bronx, New York, United States, 10455
    - Recruiting
    - Research Site
  - Rochester, New York, United States, 14618
    - Not yet recruiting
    - Research Site
  - Rosedale, New York, United States, 11422
    - Recruiting
    - Research Site
- North Carolina
  - Chapel Hill, North Carolina, United States, 27599
    - Recruiting
    - Research Site
  - New Bern, North Carolina, United States, 28562
    - Recruiting
    - Research Site
- Ohio
  - Toledo, Ohio, United States, 43614
    - Not yet recruiting
    - Research Site
- Oregon
  - Grants Pass, Oregon, United States, 97527
    - Recruiting
    - Research Site
- Pennsylvania
  - Bethlehem, Pennsylvania, United States, 18017
    - Recruiting
    - Research Site
  - Langhorne, Pennsylvania, United States, 19047
    - Not yet recruiting
    - Research Site
- Rhode Island
  - East Providence, Rhode Island, United States, 02914
    - Not yet recruiting
    - Research Site
- Tennessee
  - Memphis, Tennessee, United States, 38105
    - Not yet recruiting
    - Research Site
- Texas
  - Brownsville, Texas, United States, 78526
    - Recruiting
    - Research Site
  - Corpus Christi, Texas, United States, 78404
    - Recruiting
    - Research Site
  - Dallas, Texas, United States, 75390
    - Withdrawn
    - Research Site
  - Houston, Texas, United States, 77054
    - Recruiting
    - Research Site
  - Sugar Land, Texas, United States, 77479
    - Recruiting
    - Research Site
- Virginia
  - Manassas, Virginia, United States, 20110
    - Recruiting
    - Research Site
  - Suffolk, Virginia, United States, 23435
    - Recruiting
    - Research Site
- Wisconsin
  - Madison, Wisconsin, United States, 53792
    - Not yet recruiting
    - Research Site
  - Milwaukee, Wisconsin, United States, 53295
    - Recruiting
    - Research Site
Vietnam
- - Da Nang, Vietnam, 550000
    - Not yet recruiting
    - Research Site
  - Ha Noi, Vietnam, 100000
    - Not yet recruiting
    - Research Site
  - Hanoi, Vietnam, 100000
    - Not yet recruiting
    - Research Site
  - Ho Chi Minh, Vietnam, 700000
    - Not yet recruiting
    - Research Site
  - Ho Chi Minh, Vietnam, 70000
    - Not yet recruiting
    - Research Site
  - Hochiminh city, Vietnam, 700000
    - Not yet recruiting
    - Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Quadruple

Number of Arms

Arms and Interventions

Participant Group / 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in seated systolic blood pressure for 2 mg baxdrostat Time Frame: At Week 12	To assess the effect of 2 mg baxdrostat versus placebo on seated systolic blood pressure at Week 12	At Week 12
Change from baseline in seated systolic blood pressure for 1 mg baxdrostat Time Frame: At Week 12	To assess the effect of 1 mg baxdrostat versus placebo on seated systolic blood pressure at Week 12	At Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from randomised withdrawal baseline (Week 24) in seated systolic blood pressure (SBP) for 2 mg baxdrostat Time Frame: 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	At Week 32
Change from baseline in seated SBP for 2 mg baxdrostat Time Frame: 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	At Week 12
Change from baseline in seated diastolic blood pressure (DBP) for 2 mg baxdrostat Time Frame: At Week 12	To assess the effect of 2 mg baxdrostat vs placebo on seated diastolic blood pressure (DBP) at Week 12	At Week 12
Achieving seated SBP < 130 mmHg for 2 mg baxdrostat Time Frame: At Week 12	To assess the effect of 2 mg baxdrostat vs placebo on achieving seated SBP < 130 mmHg at Week 12	At Week 12
Change from baseline in seated SBP for 1 mg baxdrostat Time Frame: At Week 12	To assess the effect of 1 mg baxdrostat vs placebo on seated SBP at Week 12 in the rHTN subpopulation	At Week 12
Change from baseline in seated DBP for 1 mg baxdrostat Time Frame: At Week 12	To assess the effect of 1 mg baxdrostat vs placebo on seated DBP at Week 12	At Week 12
Achieving seated SBP < 130 mmHg for 1 mg baxdrostat Time Frame: At Week 12	To assess the effect of 1 mg baxdrostat vs placebo on achieving seated SBP < 130 mmHg at Week 12	At Week 12
The change from baseline in the mean ambulatory 24-hour SBP as measured by ambulatory blood pressure monitoring (ABPM) for 2 mg baxdrostat Time Frame: At Week 12	To assess the effect of treatment with baxdrostat 2 mg vs placebo on ambulatory 24-hour average SBP at Week 12	At Week 12
The change from baseline in the mean ambulatory 24-hour SBP as measured by ABPM for 1 mg baxdrostat Time Frame: At Week 12	To assess the effect of treatment with baxdrostat 1 mg vs placebo on ambulatory 24-hour average SBP at Week 12	At Week 12

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with adverse events (AEs) Time Frame: 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).	Up to Week 54

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 22, 2023

Primary Completion (Estimated)

October 13, 2025

Study Completion (Estimated)

October 13, 2025

Study Registration Dates

First Submitted

September 6, 2023

First Submitted That Met QC Criteria

September 6, 2023

First Posted (Actual)

September 13, 2023

Study Record Updates

Last Update Posted (Actual)

April 11, 2024

Last Update Submitted That Met QC Criteria

April 10, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

D6970C00002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

"Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.

IPD Sharing Time Frame

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD Sharing Access Criteria

When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

IPD Sharing Supporting Information Type

STUDY_PROTOCOL
SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Estimated)

Phase

Contacts and Locations

Study Contact

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Other Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

IPD Sharing Time Frame

IPD Sharing Access Criteria

IPD Sharing Supporting Information Type

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

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Clinical Trials on Baxdrostat

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