Resistant Hypertension Clinical Trial
— BaxHTNOfficial 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
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).
| Status | Recruiting |
| Enrollment | 720 |
| Est. completion date | October 13, 2025 |
| Est. primary completion date | October 13, 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 130 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Research Site | Buenos Aires | |
| Argentina | Research Site | Caba | |
| Argentina | Research Site | Caba | |
| Argentina | Research Site | Cordoba | |
| Argentina | Research Site | Córdoba | |
| Argentina | Research Site | Mar del Plata | |
| Argentina | Research Site | Mendoza | |
| Argentina | Research Site | Rosario | |
| Argentina | Research Site | San Miguel de Tucuman | |
| Argentina | Research Site | San Nicolás | |
| Argentina | Research Site | San Vicente | |
| Australia | Research Site | Clayton | |
| Australia | Research Site | Epping | |
| Australia | Research Site | Geelong | |
| Australia | Research Site | Liverpool | |
| Australia | Research Site | New Lambton Heights | |
| Australia | Research Site | Perth | |
| Australia | Research Site | Wollongong | |
| Australia | Research Site | Woolloongabba | |
| Austria | Research Site | Braunau am Inn | |
| Austria | Research Site | St. Pölten | |
| Austria | Research Site | Wien | |
| Belgium | Research Site | Aalst | |
| Belgium | Research Site | Genk | |
| Belgium | Research Site | Gent | |
| Belgium | Research Site | Leuven | |
| Belgium | Research Site | Liège | |
| Belgium | Research Site | Mons | |
| Bulgaria | Research Site | Pleven | |
| 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 | Ottawa | Ontario |
| Canada | Research Site | St Jean sur Richelieu | Quebec |
| Canada | Research Site | Toronto | Ontario |
| Canada | Research Site | Waterloo | Ontario |
| Czechia | Research Site | Benesov | |
| Czechia | Research Site | Brandys nad Labem | |
| Czechia | Research Site | Broumov | |
| Czechia | Research Site | Louny | |
| Czechia | Research Site | Ostrava | |
| Czechia | Research Site | Pribram | |
| Czechia | Research Site | Uherske Hradiste | |
| Denmark | Research Site | Aarhus | |
| Denmark | Research Site | Herning | |
| Denmark | Research Site | Holbæk | |
| France | Research Site | Bobigny | |
| France | Research Site | Bordeaux | |
| France | Research Site | Lille | |
| France | Research Site | Paris | |
| France | Research Site | Paris Cedex 14 | |
| France | Research Site | Poitiers | |
| France | Research Site | Sr Priest En Jarez | |
| France | Research Site | Toulon | |
| France | Research Site | Toulouse | |
| France | Research Site | Tours CEDEX | |
| Germany | Research Site | Bad Homburg | |
| Germany | Research Site | Bad Oeynhausen | |
| Germany | Research Site | Berlin | |
| Germany | Research Site | Berlin | |
| Germany | Research Site | Dortmund | |
| Germany | Research Site | Düsseldorf | |
| Germany | Research Site | Elsterwerda | |
| Germany | Research Site | Erfurt | |
| Germany | Research Site | Erlangen | |
| Germany | Research Site | Essen | |
| Germany | Research Site | Frankfurt | |
| Germany | Research Site | Frankfurt | |
| Germany | Research Site | Frankfurt am Main | |
| Germany | Research Site | Hannover | |
| Germany | Research Site | Hannover | |
| Germany | Research Site | Homburg | |
| Germany | Research Site | Kaiserslautern | |
| Germany | Research Site | Leipzig | |
| Germany | Research Site | Lübeck | |
| Germany | Research Site | Mainz | |
| Germany | Research Site | Mannheim | |
| Germany | Research Site | Marburg | |
| Germany | Research Site | Regensburg | |
| Germany | Research Site | Wermsdorf | |
| Hungary | Research Site | Budapest | |
| Hungary | Research Site | Kaposvár | |
| Hungary | Research Site | Nyíregyháza | |
| Hungary | Research Site | Szeged | |
| India | Research Site | Delhi | |
| India | Research Site | Delhi | |
| India | Research Site | Guntur | |
| India | Research Site | Hyderabad | |
| India | Research Site | Jaipur | |
| India | Research Site | Kanpur | |
| India | Research Site | Kolkata | |
| India | Research Site | Kolkata | |
| India | Research Site | Kolkata | |
| India | Research Site | Manipal | |
| India | Research Site | Mysuru | |
| India | Research Site | Mysuru | |
| India | Research Site | New Delhi | |
| India | Research Site | New Delhi | |
| India | Research Site | Puducherry | |
| India | Research Site | Pune | |
| India | Research Site | Surat | |
| Israel | Research Site | Ashdod | |
| Israel | Research Site | Haifa | |
| Israel | Research Site | petach Tikva | |
| Israel | Research Site | Ramat Gan | |
| Israel | Research Site | Rehovot | |
| Italy | Research Site | Acquaviva delle Fonti | |
| Italy | Research Site | Bologna | |
| Italy | Research Site | Brescia | |
| Italy | Research Site | Milano | |
| Italy | Research Site | Milano | |
| Italy | Research Site | Milano | |
| Italy | Research Site | Pisa | |
| Italy | Research Site | Roma | |
| Italy | Research Site | Torino | |
| Italy | Research Site | Udine | |
| Japan | Research Site | Adachi-ku | |
| Japan | Research Site | Chuo-ku | |
| Japan | Research Site | Chuo-ku | |
| Japan | Research Site | Chuo-ku | |
| Japan | Research Site | Kanazawa-shi | |
| Japan | Research Site | Koga-shi | |
| Japan | Research Site | Kyoto-shi | |
| Japan | Research Site | Nagasaki-shi | |
| Japan | Research Site | Okayama-shi | |
| Japan | Research Site | Osaka-shi | |
| Japan | Research Site | Sapporo-shi | |
| Japan | Research Site | Tsuchiura-shi | |
| Korea, Republic of | Research Site | Bucheon-si | |
| Korea, Republic of | Research Site | Busan | |
| Korea, Republic of | Research Site | Daejeon | |
| Korea, Republic of | Research Site | Incheon | |
| Korea, Republic of | Research Site | Seoul | |
| Korea, Republic of | Research Site | Seoul | |
| Korea, Republic of | Research Site | Seoul | |
| Korea, Republic of | Research Site | Seoul | |
| Korea, Republic of | Research Site | Seoul | |
| Korea, Republic of | Research Site | Seoul | |
| Korea, Republic of | Research Site | Seoul | |
| Korea, Republic of | Research Site | Seoul | |
| Malaysia | Research Site | Kajang | |
| Malaysia | Research Site | Kota Bharu | |
| Malaysia | Research Site | Kuching | |
| Malaysia | Research Site | Melaka | |
| Malaysia | Research Site | Muar | |
| Malaysia | Research Site | Sarawak Miri | |
| Malaysia | Research Site | Seri Manjung | |
| Netherlands | Research Site | Amsterdam | |
| Netherlands | Research Site | Hoogeveen | |
| Netherlands | Research Site | Nijmegen | |
| Netherlands | Research Site | Utrecht | |
| Poland | Research Site | Bialystok | |
| Poland | Research Site | Bydgoszcz | |
| Poland | Research Site | Chrzanów | |
| Poland | Research Site | Gdansk | |
| Poland | Research Site | Gdynia | |
| Poland | Research Site | Kraków | |
| Poland | Research Site | Lodz | |
| Poland | Research Site | Poznan | |
| Poland | Research Site | Warszawa | |
| Poland | Research Site | Warszawa | |
| Poland | Research Site | Warszawa | |
| Slovakia | Research Site | Bratislava | |
| Slovakia | Research Site | Brezno | |
| Slovakia | Research Site | Kosice | |
| Slovakia | Research Site | Moldava nad Bodvou | |
| Slovakia | Research Site | Presov | |
| Slovakia | Research Site | Rimavska Sobota | |
| Slovakia | Research Site | Svidník | |
| Slovakia | Research Site | Trnava | |
| South Africa | Research Site | Cape Town | |
| South Africa | Research Site | Centurion | |
| South Africa | Research Site | Claremont | |
| South Africa | Research Site | Durban | |
| South Africa | Research Site | Kwadwesi | |
| South Africa | Research Site | Somerset West | |
| South Africa | Research Site | Worcester | |
| Spain | Research Site | Barcelona | |
| Spain | Research Site | Barcelona | |
| Spain | Research Site | Ferrol | |
| Spain | Research Site | Granada | |
| Spain | Research Site | Madrid | |
| Spain | Research Site | Madrid | |
| Spain | Research Site | Majadahonda | |
| Spain | Research Site | Oviedo | |
| Spain | Research Site | Sevilla | |
| Spain | Research Site | Terrassa | |
| Sweden | Research Site | Göteborg | |
| Sweden | Research Site | Stockholm | |
| Sweden | Research Site | Uppsala | |
| Taiwan | Research Site | Kaohsiung | |
| Taiwan | Research Site | Kaohsiung | |
| Taiwan | Research Site | Taichung | |
| Taiwan | Research Site | Taichung | |
| Taiwan | Research Site | Taipei | |
| Taiwan | Research Site | Taipei | |
| Taiwan | Research Site | Taipei City | |
| Taiwan | Research Site | Yung Kang City | |
| Thailand | Research Site | Bangkok | |
| Thailand | Research Site | Bangkok | |
| Thailand | Research Site | Bangkok | |
| Thailand | Research Site | Chiang Mai | |
| Thailand | Research Site | Hat Yai | |
| Thailand | Research Site | Muang | |
| Thailand | Research Site | Muang | |
| Thailand | Research Site | Pathumthani | |
| Turkey | Research Site | Adana | |
| Turkey | Research Site | Ankara | |
| Turkey | Research Site | Bursa | |
| Turkey | Research Site | Dinar | |
| Turkey | Research Site | Istanbul | |
| Turkey | Research Site | Izmir | |
| Turkey | Research Site | Kütahya | |
| Turkey | Research Site | Odunpazari | |
| United Kingdom | Research Site | Bristol | |
| United Kingdom | Research Site | Chesterfield | |
| United Kingdom | Research Site | Dundee | |
| United Kingdom | Research Site | Glasgow | |
| United Kingdom | Research Site | London | |
| United Kingdom | Research Site | Prescot | |
| United Kingdom | Research Site | Stockport | |
| United Kingdom | Research Site | Yate | |
| United States | Research Site | Anaheim | California |
| United States | Research Site | Atlanta | Georgia |
| United States | Research Site | Augusta | Georgia |
| United States | Research Site | Bethlehem | Pennsylvania |
| United States | Research Site | Birmingham | Alabama |
| United States | Research Site | Birmingham | Alabama |
| United States | Research Site | Boston | Massachusetts |
| United States | Research Site | Bronx | New York |
| United States | Research Site | Brownsville | Texas |
| United States | Research Site | Chapel Hill | North Carolina |
| United States | Research Site | Chicago | Illinois |
| United States | Research Site | Clearwater | Florida |
| United States | Research Site | Clearwater | Florida |
| United States | Research Site | Columbia | Missouri |
| United States | Research Site | Corpus Christi | Texas |
| United States | Research Site | Dallas | Texas |
| United States | Research Site | Decatur | Georgia |
| United States | Research Site | Detroit | Michigan |
| United States | Research Site | East Providence | Rhode Island |
| United States | Research Site | Fresno | California |
| United States | Research Site | Grants Pass | Oregon |
| United States | Research Site | Hinsdale | Illinois |
| United States | Research Site | Houston | Texas |
| United States | Research Site | Jacksonville | Florida |
| United States | Research Site | Kansas City | Missouri |
| United States | Research Site | Kansas City | Missouri |
| United States | Research Site | Kansas City | Missouri |
| United States | Research Site | Langhorne | Pennsylvania |
| United States | Research Site | Lexington | Kentucky |
| United States | Research Site | Lincoln | California |
| United States | Research Site | Little Rock | Arkansas |
| United States | Research Site | Madison | Wisconsin |
| United States | Research Site | Manassas | Virginia |
| United States | Research Site | Memphis | Tennessee |
| United States | Research Site | Milwaukee | Wisconsin |
| United States | Research Site | Munster | Indiana |
| United States | Research Site | New Bern | North Carolina |
| United States | Research Site | New Haven | Connecticut |
| United States | Research Site | Olive Branch | Mississippi |
| United States | Research Site | Orange | California |
| United States | Research Site | Port Orange | Florida |
| United States | Research Site | Rancho Cucamonga | California |
| United States | Research Site | Rochester | Minnesota |
| United States | Research Site | Rochester | New York |
| United States | Research Site | Rosedale | New York |
| United States | Research Site | Saraland | Alabama |
| United States | Research Site | Scottsdale | Arizona |
| United States | Research Site | Springfield | Illinois |
| United States | Research Site | Stanford | California |
| United States | Research Site | Suffolk | Virginia |
| United States | Research Site | Sugar Land | Texas |
| United States | Research Site | Sun City West | Arizona |
| United States | Research Site | Surprise | Arizona |
| United States | Research Site | Toledo | Ohio |
| United States | Research Site | Troy | Michigan |
| Vietnam | Research Site | Da Nang | |
| Vietnam | Research Site | Ha Noi | |
| Vietnam | Research Site | Hanoi | |
| Vietnam | Research Site | Ho Chi Minh | |
| Vietnam | Research Site | Ho Chi Minh | |
| Vietnam | Research Site | Hochiminh city |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
United States, Vietnam, Argentina, Australia, Austria, Belgium, Bulgaria, Canada, Czechia, Denmark, France, Germany, Hungary, India, Israel, Italy, Japan, Korea, Republic of, Malaysia, Netherlands, Poland, Slovakia, South Africa, Spain, Sweden, Taiwan, Thailand, Turkey, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Number of participants with adverse events (AEs) | 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 | |
| Primary | Change from baseline in seated systolic blood pressure for 2 mg baxdrostat | To assess the effect of 2 mg baxdrostat versus placebo on seated systolic blood pressure at Week 12 | At Week 12 | |
| Primary | Change from baseline in seated systolic blood pressure for 1 mg baxdrostat | To assess the effect of 1 mg baxdrostat versus placebo on seated systolic blood pressure at Week 12 | At Week 12 | |
| Secondary | Change from randomised withdrawal baseline (Week 24) in seated systolic blood pressure (SBP) for 2 mg baxdrostat | 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 | |
| Secondary | Change from baseline in seated SBP for 2 mg baxdrostat | 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 | |
| Secondary | Change from baseline in seated diastolic blood pressure (DBP) for 2 mg baxdrostat | To assess the effect of 2 mg baxdrostat vs placebo on seated diastolic blood pressure (DBP) at Week 12 | At Week 12 | |
| Secondary | Achieving seated SBP < 130 mmHg for 2 mg baxdrostat | To assess the effect of 2 mg baxdrostat vs placebo on achieving seated SBP < 130 mmHg at Week 12 | At Week 12 | |
| Secondary | Change from baseline in seated SBP for 1 mg baxdrostat | To assess the effect of 1 mg baxdrostat vs placebo on seated SBP at Week 12 in the rHTN subpopulation | At Week 12 | |
| Secondary | Change from baseline in seated DBP for 1 mg baxdrostat | To assess the effect of 1 mg baxdrostat vs placebo on seated DBP at Week 12 | At Week 12 | |
| Secondary | Achieving seated SBP < 130 mmHg for 1 mg baxdrostat | To assess the effect of 1 mg baxdrostat vs placebo on achieving seated SBP < 130 mmHg at Week 12 | At Week 12 | |
| Secondary | The change from baseline in the mean ambulatory 24-hour SBP as measured by ambulatory blood pressure monitoring (ABPM) for 2 mg baxdrostat | To assess the effect of treatment with baxdrostat 2 mg vs placebo on ambulatory 24-hour average SBP at Week 12 | At Week 12 | |
| Secondary | The change from baseline in the mean ambulatory 24-hour SBP as measured by ABPM for 1 mg baxdrostat | To assess the effect of treatment with baxdrostat 1 mg vs placebo on ambulatory 24-hour average SBP at Week 12 | At Week 12 |
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