Baxdrostat in resistant hypertension: safety and efficacy study

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    What is this study about?

    This study is testing a medication named baxdrostat in people who have high blood pressure that can’t be controlled with their current medication. The study will compare people who are given baxdrostat daily with people who are given a placebo. The goal of the study is to find out if baxdrostat is safe to take and if it helps lower blood pressure. The study will look at the effects of 1 mg and 2 mg doses of baxdrostat on blood pressure. The study will also look at whether Baxdrostat helps reach a blood pressure reading below 130 mmHg.

    Learn more about this Trial

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      Locations

      Where does the clinical trial take place?

      Braunau am Inn , Austria

      St. Pu00f6lten , Austria

      Wien , Austria

      Aalst , Belgium

      Gent , Belgium

      Leuven , Belgium

      Liu00e8ge , Belgium

      Mons , Belgium

      Pleven , Bulgaria

      Sofia , Bulgaria

      Sofia , Bulgaria

      Sofia , Bulgaria

      Sofia , Bulgaria

      Benesov , Czechia

      Brandys nad Labem , Czechia

      Broumov , Czechia

      Louny , Czechia

      Ostrava , Czechia

      Pribram , Czechia

      Uherske Hradiste , Czechia

      Aarhus , Denmark

      Herning , Denmark

      Holbu00e6k , Denmark

      Bobigny , France

      Bordeaux , France

      Lille , France

      Paris Cedex 14 , France

      Paris , France

      Poitiers , France

      Sr Priest En Jarez , France

      Toulon , France

      Toulouse , France

      Tours CEDEX , France

      Bad Homburg , Germany

      Bad Oeynhausen , Germany

      Berlin , Germany

      Berlin , Germany

      Dortmund , Germany

      Du00fcsseldorf , Germany

      Elsterwerda , Germany

      Erfurt , Germany

      Erlangen , Germany

      Essen , Germany

      Frankfurt am Main , Germany

      Frankfurt , Germany

      Frankfurt , Germany

      Hannover , Germany

      Hannover , Germany

      Homburg , Germany

      Kaiserslautern , Germany

      Leipzig , Germany

      Lu00fcbeck , Germany

      Mannheim , Germany

      Marburg , Germany

      Regensburg , Germany

      Wermsdorf , Germany

      Budapest , Hungary

      Kaposvu00e1r , Hungary

      Nyu00edregyhu00e1za , Hungary

      Szeged , Hungary

      Acquaviva delle Fonti , Italy

      Bologna , Italy

      Brescia , Italy

      Milano , Italy

      Milano , Italy

      Milano , Italy

      Pisa , Italy

      Roma , Italy

      Torino , Italy

      Udine , Italy

      Amsterdam , Netherlands

      Hoogeveen , Netherlands

      Nijmegen , Netherlands

      Utrecht , Netherlands

      Biau0142ystok , Poland

      Bydgoszcz , Poland

      Chrzanu00f3w , Poland

      Gdau0144sk , Poland

      Gdynia , Poland

      Kraku00f3w , Poland

      Lodz , Poland

      Poznau0144 , Poland

      Warszawa , Poland

      Warszawa , Poland

      Warszawa , Poland

      Brezno , Slovakia

      Kosice , Slovakia

      Moldava nad Bodvou , Slovakia

      Presov , Slovakia

      Rimavska Sobota , Slovakia

      Svidnu00edk , Slovakia

      Barcelona , Spain

      Barcelona , Spain

      Ferrol , Spain

      Granada , Spain

      Madrid , Spain

      Madrid , Spain

      Majadahonda , Spain

      Oviedo , Spain

      Sevilla , Spain

      Terrassa , Spain

      Gu00f6teborg , Sweden

      Stockholm , Sweden

      Uppsala , Sweden

      Bristol , United Kingdom

      Chesterfield , United Kingdom

      Dundee , United Kingdom

      Glasgow , United Kingdom

      London , United Kingdom

      Prescot , United Kingdom

      Stockport , United Kingdom

      Yate , United Kingdom


      Study Steps

      How Complex Will My Study Be and What Phases Will I Go Through?

      I apologize, but it seems that I was unable to locate the specific steps a patient needs to take in this clinical trial, such as taking a given drug for a certain period. However, I did find the inclusion criteria which are the conditions the patient must meet to participate in the trial:

      Inclusion Criteria:

      1. Male or female participants must be ≥ 18 years old.
      2. Mean sitting systolic blood pressure on automated office blood pressure measurement ≥ 140 mmHg and < 170 mmHg at Screening.
      3. Fulfill at least one of the following two 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.
      4. Estimated glomerular filtration rate ≥ 45 mL/min/1.73m2 at Screening.
      5. Serum potassium (K+) level ≥ 3.5 and < 5.0 mmol/L at Screening.

      .

      If you would like to know more detailed steps regarding what patients are required to do during the trial, such as drug dosage, frequency, and duration of the study period, please let me know, and I will continue to search for that information.


      Diseases Under Investigation

      What Conditions Qualify Me for This Study?

      To join the study, you should not have the following diseases, as they are part of the exclusion criteria:

      1. Renal artery stenosis
      2. Uncontrolled or untreated hyperthyroidism
      3. Uncontrolled or untreated hypothyroidism
      4. Pheochromocytoma
      5. Cushing’s syndrome
      6. Aortic coarctation
      7. New York Heart Association functional heart failure class IV at screening
      8. Persistent atrial fibrillation

      If you have any of these conditions, you would not be eligible to participate in the study.


      Terms and conditions

      What Requirements I Have to Meet To Join This Study?

      When Am I Eligible to Join the Study?

      To join the study, you must meet the following inclusion criteria:

      Age:

      • Must be 18 years old or older.

      Blood Pressure at Screening:

      • Mean sitting systolic blood pressure (the top number in a blood pressure reading, indicating the pressure in the arteries when the heart beats) must be greater than or equal to 140 mmHg but less than 170 mmHg when measured with an automated office blood pressure device.

      Medication Regimen:
      Fulfill at least one of the following two criteria:

      1. uHTN subpopulation: Must have a stable regimen of 2 antihypertensive medications from different therapeutic classes (at least one should be a diuretic), at a maximum tolerated dose as judged by the Investigator.
      2. rHTN subpopulation: Must have a stable regimen of 3 or more antihypertensive medications from different therapeutic classes (at least one should be a diuretic), at a maximum tolerated dose as judged by the Investigator.

      Estimated Glomerular Filtration Rate (eGFR) at Screening:

      • Must be greater than or equal to 45 mL/min/1.73m². The eGFR is a test used to check how well the kidneys are filtering blood.

      Serum Potassium Level at Screening:

      • Must be greater than or equal to 3.5 and less than 5.0 mmol/L. Serum potassium levels indicate the amount of potassium in the blood, which is important for heart and muscle function.

      Randomisation Criterion:

      • Sitting systolic blood pressure must be greater than or equal to 135 mmHg when measured on attended automated office blood pressure measurement before randomization into the study.

      What Reasons Could Exclude Me from the Study?

      Exclusion Criteria:

      1. Mean sitting systolic blood pressure ≥ 170 mmHg at Randomisation: If your systolic blood pressure (the top number, representing the pressure when your heart beats) measured in a sitting position, is 170 millimeters of mercury (mmHg) or higher during randomization, you cannot participate.
      2. Mean seated diastolic blood pressure ≥ 110 mmHg at Randomisation: If your diastolic blood pressure (the bottom number, representing the pressure when your heart is at rest between beats) measured in a sitting position, is 110 mmHg or higher during randomization, you are excluded from the trial.
      3. Serum sodium level < 135 mmol/L at Screening: If the amount of sodium in your blood is below 135 millimoles per liter (mmol/L) when tested, you are not eligible.
      4. Known secondary causes of hypertension: You cannot take part if you have certain conditions causing high blood pressure, including:
        • Renal artery stenosis: Narrowing of the arteries that supply blood to the kidneys.
        • Uncontrolled or untreated hyperthyroidism: Overactive thyroid gland that isn’t managed properly.
        • Uncontrolled or untreated hypothyroidism: Underactive thyroid gland that isn’t managed properly.
        • Pheochromocytoma: A rare tumor of the adrenal gland tissue.
        • Cushing’s syndrome: A condition caused by excessive cortisol levels in the body.
        • Aortic coarctation: A congenital narrowing of the aorta.
      5. New York Heart Association functional heart failure class IV at Screening: This is the most severe form of heart failure, where symptoms occur at rest and worsen with any physical activity.
      6. Persistent atrial fibrillation: A heart rhythm disorder where the upper chambers of the heart beat irregularly and often rapidly.

      Please note that this list is for your general information; if you have medical questions or don’t understand something, it’s important to discuss them with your healthcare provider.


      Investigational Medicinal Product

      What Products Are Being Used in This Study?

      The drug involved in the study is Baxdrostat (active substance: CIN-107). Below is a brief description of this active substance:

      1. CIN-107 (Baxdrostat): Baxdrostat is an investigational oral medication. Although the specific description of its pharmacological properties isn’t quoted in the documents provided, based on its usage in a clinical trial for hypertension, it is likely designed to manage high blood pressure. It is given in tablet form once daily (QD) with dosage options of 1 mg or 2 mg per tablet.

      Have the Medicinal Substances Used in the Trial Been Previously Studied in Medicine?

      The clinical trial is mainly investigating the efficacy and safety of a drug known as Baxdrostat, with the study participants being assigned to different arms receiving either 1 mg or 2 mg doses of the active substance, or a placebo comparator. Below is the list of substances involved in the trial along with a description of their known status in medicine:

      1. Baxdrostat (CIN-107): It is an experimental drug and is the main focus of this clinical trial. It is a tablet administered orally once daily. Baxdrostat is being studied for its effect on reducing systolic blood pressure in participants with uncontrolled hypertension on two or more medications including those with resistant hypertension. This substance is being investigated in a Phase III clinical trial, indicating that while it may have been studied previously and potentially known to some extent in the medical literature, it is not yet fully approved or widely recognized in clinical practice for the indication being studied.
      2. Placebo: A placebo tablet, matching baxdrostat in appearance, administered orally once daily. A placebo is a substance with no therapeutic effect used as a control in testing new drugs and is well known in medical literature and practice for its use in clinical trials.

      The data extracted does not provide further information on the novelty or established status of Baxdrostat in medical literature beyond its use in this clinical trial.


      Study ID

      CT-EU-00033148

      Recruitment status

      Recruting new patients

      Start of the trial

      7 months ago

      Study phase

      Phase
      III

      Medicinal Product