Study on Baxdrostat for Lowering Blood Pressure in Patients with Resistant Hypertension

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What is this study about?

This clinical trial is focused on studying resistant hypertension, a condition where blood pressure remains high despite using at least three different types of blood pressure medications, including a diuretic. The study will test a new treatment called Baxdrostat, which is a synthetic small molecule taken as a tablet. Participants in the study will either receive Baxdrostat or a placebo, which looks like the medication but does not contain the active substance.

The purpose of the study is to determine if Baxdrostat can effectively reduce blood pressure in people with resistant hypertension. Participants will be randomly assigned to receive either Baxdrostat or the placebo. The study will last for several weeks, during which participants will take the assigned tablets and have their blood pressure monitored regularly. The main focus will be on changes in blood pressure over a 24-hour period at the end of the study.

Throughout the study, participants will continue their usual blood pressure medications alongside the trial treatment. The goal is to see if Baxdrostat can help lower blood pressure more effectively than the placebo. This research aims to provide new insights into managing resistant hypertension and improving treatment options for those affected by this condition.

1 joining the study

Upon joining the study, the participant is required to meet specific criteria, including being 18 years or older and having a stable regimen of at least three different blood pressure medications, one of which must be a diuretic.

The participant’s blood pressure must be within a certain range, and other health parameters such as kidney function and potassium levels are assessed.

2 randomization

Participants are randomly assigned to receive either baxdrostat or a placebo. This process is double-blind, meaning neither the participant nor the researchers know which treatment is being administered.

The dosage for baxdrostat is 2 mg, taken orally in tablet form.

3 treatment period

The treatment period lasts for 12 weeks. During this time, participants continue their assigned treatment and maintain their existing blood pressure medication regimen.

Participants are monitored for changes in their 24-hour average systolic blood pressure (SBP) and other related measurements.

4 monitoring and assessments

Throughout the study, participants undergo regular assessments to monitor blood pressure changes, both during the day and at night.

The primary goal is to observe any changes in the 24-hour average SBP by the end of the 12-week period.

5 completion of the study

At the end of the 12 weeks, participants complete the study. Final assessments are conducted to evaluate the effects of the treatment on blood pressure.

The study aims to determine if baxdrostat effectively reduces blood pressure and is safe for individuals with resistant hypertension.

Who Can Join the Study?

  • The participant must be at least 18 years old when they sign the consent form.
  • The average systolic blood pressure (SBP), which is the top number in a blood pressure reading, should be 140 mmHg or higher but less than 170 mmHg when measured while seated during the screening.
  • The participant should be taking at least three different blood pressure medications from different classes, including at least one diuretic (a medication that helps the body get rid of extra salt and water), at the highest dose they can handle, for at least four weeks before the screening. If they don’t meet this requirement, they might be allowed to try again at the doctor’s discretion. Beta blockers used for other conditions like migraines or heart issues should not be counted as blood pressure medications for this study.
  • The participant should have an estimated glomerular filtration rate (eGFR) of 45 mL/min/1.73 m² or higher during the screening. This is a test that checks how well the kidneys are working.
  • The level of potassium in the blood should be 3.5 mmol/L or higher but less than 5.0 mmol/L during the screening. Potassium is a mineral that helps with nerve and muscle function.
  • For randomization, which is the process of assigning participants to different groups in the study, the average ambulatory systolic blood pressure should be 130 mmHg or higher. This is the blood pressure measured over 24 hours while the participant goes about their daily activities.

Who Cannot Join the Study?

  • Patients who have a type of high blood pressure called resistant hypertension, which means their blood pressure stays high even when taking at least three different blood pressure medications, including one that helps the body get rid of extra salt and water (a diuretic).

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Hospital Clinico San Carlos Madrid Spain

Other Sites

Site Name City Country Status
Diagnostics And Consultation Center Convex Ltd. Sofia Bulgaria
Herz Und Diabeteszentrum NRW Bad Oeynhausen Universitaetsklinik Der Ruhr-Universitaet Bochum Bad Oeynhausen Germany
Universitair Ziekenhuis Gent Gent Belgium
HELIOS Klinikum Erfurt GmbH Erfurt Germany
Hospital Universitario 12 De Octubre Madrid Spain
Hospital Del Mar Barcelona Spain
Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy Warsaw Poland
Az Maria Middelares Gent Gent Belgium
Mtz Clinical Research Powered By Pratia Warsaw Poland
Interna SK s.r.o. Svidnik Slovakia
Ippokratio General Hospital Of Thessaloniki Thessaloniki Greece
Del-Budai Centrumkorhaz Szent Imre Egyetemi Oktatokorhaz Budapest Hungary
Kalimat Medical Center Ltd. Sofia Bulgaria
Cardio D&R s.r.o. Kosice Kosice Slovakia
Kardiopraxis Schirmer Kaiserslautern Germany
KardioBusak s.r.o. Louny Czechia
Hippokration Hospital Athens Greece
Medicus Services s.r.o. Brandys Nad Labem Czechia
Uniwersytecki Szpital Kliniczny W Bialymstoku Bialystok Poland
Zugloi Egeszseguegyi Szolgalat Budapest Hungary
Hospital Clinic De Barcelona Barcelona Spain
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz Nyiregyhaza Hungary
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie Cracow Poland
Uniteversity Muliprofile Hospital For Active Treatment Tsaritsa Yoanna-Isul EAD Sofia Bulgaria
Diagnostic Consultation Center XX-Sofia EOOD Sofia Bulgaria
Fundacio Assistencial De Mutua De Terrassa Fpc Terrassa Spain
Zentrum fuer klinische Studien Suedbrandenburg GmbH Elsterwerda Germany
Uniwersytecki Szpital Kliniczny W Poznaniu Poznan Poland
Innera s.r.o. Benesov Czechia
CHU Helora La Louviere Belgium
Edumed s.r.o. Nachod Czechia
Infer-Med Kft. Pecs Hungary
Klweftrxuflj Kjww Szeged Hungary
Nwvenqxia S Pxmmtlaivwfm Bkppos Nrnr Brezno Slovakia
Sxuducg Eajnzacghsf Kurq Kalocsa Hungary
Fhuoaley Hivuflkt Dn Lmpurwiqspfcjsf Sntj Santa Coloma De Gramenet Spain
Ldyjw Ghghytm Herozmgx Ol Atakks Athens Greece
Daacvgnths Ciozxdnbksnw Cenojf (bqut &xqwzmwowmvo Axuerkmvzmj Eqcv Sofia Bulgaria
Gquyzu Uvdmflaaap Fvtxeubbh Frankfurt Germany
Upikvpwxukcuff Cnzyxay Kifhlwtzx Gdansk Poland
Zuxkmzi fwg klzcvniyb Saflgre Brj Hadwbrc Bad Homburg Germany
Nyfz Skxjjuup Jrg Zootdqgs Pdreih Pvbw Siaqy Lodz Poland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
15.04.2024
Bulgaria Bulgaria
Not recruiting
15.04.2024
Czechia Czechia
Not recruiting
15.04.2024
Germany Germany
Not recruiting
15.04.2024
Greece Greece
Not recruiting
15.04.2024
Hungary Hungary
Not recruiting
15.04.2024
Poland Poland
Not recruiting
15.04.2024
Slovakia Slovakia
Not recruiting
15.04.2024
Spain Spain
Not recruiting
15.04.2024

Trial locations

Investigated drugs:

Baxdrostat is a medication being studied for its potential to lower blood pressure in people with resistant hypertension. Resistant hypertension is a condition where blood pressure remains high despite treatment with multiple blood pressure medications. The trial aims to see how well Baxdrostat can reduce the average systolic blood pressure over a 24-hour period after 12 weeks of treatment.

Resistant Hypertension – Resistant hypertension is a condition where blood pressure remains above the desired level despite the use of at least three different types of blood pressure-lowering medications, including a diuretic, at their maximum tolerated doses. This condition is characterized by the body’s inability to respond adequately to standard treatments, leading to persistently high blood pressure. Over time, the continued elevation of blood pressure can lead to increased stress on the heart and blood vessels. The condition may require additional medical interventions to manage effectively. It is important to monitor blood pressure regularly to assess the effectiveness of any treatment adjustments.

Trial ID:
2023-507640-36-00
Protocol code:
Bax24 / D6970C00009
NCT ID:
NCT06168409
Trial Phase:
Therapeutic confirmatory (Phase III)

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