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Ongoing Clinical Trials for Hypertension

This article provides detailed information about 20 ongoing clinical trials investigating new treatments and approaches for hypertension (high blood pressure). These studies are being conducted across Europe and test various medications including allopurinol, olmesartan, orforglipron, and several other investigational drugs. The trials focus on different aspects of blood pressure management, from resistant hypertension to hypertension in patients with chronic kidney disease, obesity, and other conditions.

Clinical trial locations

Study of Allopurinol to Reduce Cardiovascular Events in High-Risk Patients with Heart Disease and Long-COVID Syndrome

This trial is being conducted in Poland and focuses on people who have a high risk of cardiovascular problems, including those who have experienced long-COVID symptoms. The study tests allopurinol, a medication commonly used to lower uric acid levels in the blood, to determine whether it can help reduce the risk of serious cardiovascular events such as heart attacks, strokes, or heart-related procedures.

Main inclusion criteria: Participants must be between 40 and 70 years old with blood uric acid levels above 5 mg/dl. They must also meet at least one high cardiovascular risk condition, such as a calculated 10-year risk of death from heart disease or documented history of stroke, heart failure, poor blood flow to legs, or irregular heartbeat.

Main exclusion criteria: People currently taking allopurinol or similar medications, those with known allergies to allopurinol, severe kidney or liver disease, active cancer, pregnancy or breastfeeding, participation in other trials within 30 days, severe mental illness, or life expectancy less than 12 months are excluded from participation.

Study focus: The trial investigates whether allopurinol can prevent serious cardiovascular events by lowering uric acid levels. Throughout the approximately 5-year treatment period, participants will undergo regular check-ups including heart examinations, blood vessel examinations, blood tests, blood pressure measurements, and heart rhythm checks.

Investigational drug: Allopurinol works by blocking an enzyme that produces uric acid in the body. Researchers believe it may help protect the heart and blood vessels beyond its traditional use in gout management.

Study of Optimal Treatment for Uncontrolled Hypertension Using Triple Drug Combinations (Olmesartan/Amlodipine/Hydrochlorothiazide or Perindopril/Indapamide/Amlodipine) with Additional Diuretics

This Polish trial evaluates several medication combinations for difficult-to-treat hypertension, where blood pressure remains high despite current treatments. The study includes Elestar HCT (olmesartan medoxomil, amlodipine, and hydrochlorothiazide), Triplixam (indapamide, amlodipine besilate, and perindopril arginine), and additional medications including Spironol, Toramide, and Espiro.

Main inclusion criteria: Both women and men aged 18-70 years with documented hypertension who have been receiving treatment for at least 6 months can participate. Participants must have blood pressure readings of 130/80 mmHg or higher at the doctor’s office and be currently taking 3 or more medications for high blood pressure, including an ACE inhibitor or ARB and a diuretic. Their medication plan must have been stable for at least 4 weeks.

Main exclusion criteria: People younger than 18 or older than 65 years, those with diagnosed secondary hypertension, severe allergic reactions to study medications, pregnant or breastfeeding women, current participation in other trials, uncontrolled diabetes, recent heart attack or stroke (past 6 months), severe kidney or liver disease, inability to follow procedures, malignant hypertension, significant mental health conditions, or orthostatic hypotension are excluded.

Study focus: The trial is divided into three phases to evaluate different treatment strategies and compare effectiveness of various medication combinations. The treatment period lasts up to 30 weeks, during which doctors will monitor blood pressure using various measurement methods.

Investigational drugs: The study involves perindopril (ACE inhibitor), indapamide (diuretic), amlodipine (calcium channel blocker), eplerenone and spironolactone (aldosterone blockers), and torasemide (loop diuretic), all working through different mechanisms to control blood pressure.

Study of orforglipron in people with high blood pressure who are overweight or have obesity

This trial, conducted in Poland, Germany, Czechia, Spain, and Greece, evaluates orforglipron (LY3502970) for people who have both high blood pressure and are either overweight or have obesity. The study involves testing orforglipron against a placebo in a carefully controlled setting over 36 weeks.

Main inclusion criteria: Adult participants aged 18-64 years with high blood pressure (systolic pressure of 140 or higher, or diastolic pressure of 90 or higher) and a Body Mass Index of 25 or higher. Participants must either not be currently taking any blood pressure medications or be on stable medications for at least 30 days before starting the study.

Main exclusion criteria: People with severe high blood pressure (consistently above 180/110 mmHg), pregnant or breastfeeding women, recent heart attack or stroke (within 6 months), current participation in other trials, severe kidney or liver disease, uncontrolled diabetes, substance abuse history (past year), mental health conditions interfering with participation, medications that could interact with the study drug, history of allergic reactions to similar medications, inability to follow procedures, major surgery planned during the study, or malignant tumors (cancer) within the past 5 years are excluded.

Study focus: The research aims to determine how safe and effective orforglipron is in treating high blood pressure in people who are overweight or have obesity, measuring changes in systolic and diastolic blood pressure over 36 weeks.

Investigational drug: Orforglipron is a once-daily oral medication belonging to a new class of drugs that may help control blood pressure while also potentially supporting weight management.

Study on Blood Pressure Management with Amiloride Hydrochloride, Indapamide, and Furosemide for Patients with Uncontrolled Hypertension and Chronic Kidney Disease

This French trial focuses on people with uncontrolled high blood pressure who also have moderate to severe chronic kidney disease. The study explores the effectiveness of different diuretics, including Amiloride Hydrochloride, Indapamide, Furosemide, and Hydrochlorothiazide, to help lower blood pressure and manage fluid levels.

Main inclusion criteria: Participants must be aged 18-79 years, covered by social security, and have advanced or moderate chronic kidney disease (eGFR between 15.0 to 44.9 ml/min/1.73m²). They must also have high blood pressure being treated with at least one medication affecting the renin-angiotensin system (like ACE inhibitors or ARBs) at the highest tolerated dose, stable for at least one month. Blood pressure must be uncontrolled when measured in a doctor’s office (higher than 140/90 mmHg) and confirmed by home monitoring (higher than 135/85 mmHg).

Main exclusion criteria: Patients with uncontrolled hypertension not meeting the specific criteria for the study, those at high risk of end-stage kidney disease, cardiovascular events, or mortality are excluded from participation.

Study focus: The trial aims to see if using diuretics can help reduce the risk of worsening kidney disease, heart problems, and other serious health issues in people with both conditions. The study lasts up to 36 months with regular check-ups to monitor health and treatment effects.

Investigational drugs: Diuretics are medications taken orally that help the body eliminate excess salt and water through urine, reducing strain on the heart and kidneys.

Study on Semaglutide for Patients with Obesity and Resistant Hypertension to Improve Blood Pressure Control

This Irish trial studies semaglutide on individuals with obesity and resistant hypertension, a type of high blood pressure that remains high despite taking multiple medications. The study aims to see if targeting obesity with semaglutide can help improve blood pressure control compared to a placebo.

Main inclusion criteria: Participants must have obesity (BMI of 30 or higher) and resistant hypertension, meaning average systolic blood pressure is 130 mmHg or higher measured at least six times at home, while taking three or more medications to lower blood pressure, including a diuretic. They must provide written informed consent and be available for study activities.

Main exclusion criteria: People with certain cardiovascular disorders, those outside specific age ranges, vulnerable populations needing special protection, and individuals who cannot participate safely according to the study doctors are excluded.

Study focus: The 36-week trial monitors changes in blood pressure, body weight, and other health-related factors to assess the effectiveness and safety of semaglutide in managing resistant hypertension and obesity. The study also evaluates treatment acceptability, side effects, quality of life, and medication adherence.

Investigational drug: Semaglutide is administered as a solution for injection using a pre-filled pen at varying dosages (0.25 mg, 0.5 mg, 1 mg, 1.7 mg, or 2.4 mg). It works by helping to control appetite and reduce body weight, which may also help in managing blood pressure levels.

Study on the Effectiveness and Safety of Nebivolol for Treating High Blood Pressure in Adolescents

This Polish trial studies nebivolol hydrochloride in treating high blood pressure in adolescents. The study aims to evaluate how effective and safe nebivolol is for adolescents diagnosed with this condition, with regular blood pressure monitoring over several weeks.

Main inclusion criteria: Adolescents aged 12-17 years with body weight of at least 40 kg who have diagnosed hypertension according to Polish guidelines can participate. They must need medication to lower blood pressure because high blood pressure continues after 6-12 months of non-medication methods, there are symptoms or signs of organ damage, high blood pressure is due to another condition, or there is chronic kidney disease at stage 1G-2G. The ability to stop or delay blood pressure medication for 6 weeks (as determined by the study doctor) and agreement from both the participant and legal guardian are required.

Main exclusion criteria: Adolescents with severe liver or kidney problems, heart failure, severe asthma or serious lung diseases, uncontrolled diabetes, pregnancy or breastfeeding, history of allergic reactions to study medication or similar drugs, current participation in another trial, or other serious medical conditions that might interfere are excluded.

Study focus: The study is divided into two main periods (6 weeks and 38 weeks) to assess whether nebivolol can help normalize blood pressure levels and monitor any side effects. Participants will have regular check-ups including office measurements and may involve home blood pressure monitoring.

Investigational drug: Nebivolol is a beta-blocker medication that works by relaxing blood vessels, helping to lower blood pressure and making it easier for the heart to pump blood. It is provided as a 5 mg tablet taken orally once daily.

Study on the Effects of Amlodipine and Irbesartan in Patients with High Blood Pressure

This Greek trial studies a fixed-dose combination of irbesartan and amlodipine called Combipress for patients with newly diagnosed high blood pressure or those whose blood pressure is not well controlled with current treatment. The medications work together to help lower blood pressure by relaxing blood vessels and improving blood flow.

Main inclusion criteria: Participants must be at least 18 years old, willing and able to follow study requirements, and have high blood pressure either newly diagnosed (Grade 1 with high cardiovascular risk, or Grade 2-3 regardless of risk) or uncontrolled on current treatment. They must have normal potassium levels, adequate kidney function (eGFR greater than 30 mL/min/1.73m²), and be able to swallow tablets. Written informed consent is required.

Main exclusion criteria: People with other serious health conditions interfering with the study, pregnant or breastfeeding women, history of allergic reactions to similar medications, current participation in another trial, history of drug or alcohol abuse, conditions affecting ability to understand or follow instructions, severe liver or kidney problems, uncontrolled diabetes or other medical conditions, recent heart attack or stroke (within 6 months), or certain heart conditions like heart failure are excluded.

Study focus: The 16-week study evaluates how effective and safe this combination is for managing high blood pressure, monitoring how many participants reach target blood pressure levels and tracking any adverse events.

Investigational drugs: Irbesartan relaxes blood vessels by blocking certain hormones, helping reduce the risk of strokes, heart attacks, and kidney problems. Amlodipine is a calcium channel blocker that helps relax and widen blood vessels. Available dosages are 300 mg/10 mg, 150 mg/5 mg, 300 mg/5 mg, or 150 mg/10 mg.

Study on the Effects of Baxdrostat and Dapagliflozin in Adults with Chronic Kidney Disease and High Blood Pressure

This large multi-country trial (conducted in Germany, Czechia, Poland, Italy, Slovakia, Hungary, Romania, Bulgaria, Belgium, Spain, Denmark, Greece, France, Netherlands, and Sweden) tests whether combining baxdrostat and dapagliflozin is more effective than using dapagliflozin alone in improving kidney health and reducing cardiovascular death risk.

Main inclusion criteria: Participants must be at least 18 years old with chronic kidney disease showing specific kidney function levels (eGFR between 30-60 mL/min/1.73 m² with UACR between 30-500 mg/g, or eGFR between 30-75 mL/min/1.73 m² with UACR between 500-5000 mg/g or UPCR between 700-7000 mg/g). They must have hypertension with systolic blood pressure at least 130 mmHg within 4 weeks before screening and at least 120 mmHg at randomization. Participants must be on stable, maximum tolerated dose of ACE inhibitor or ARB for at least 4 weeks and have specific potassium levels based on eGFR.

Main exclusion criteria: People with severe liver disease, history of allergic reactions to study drugs, pregnant or breastfeeding women, uncontrolled diabetes, recent heart attack or stroke (past 6 months), drug or alcohol abuse (past year), medications interfering with study drugs, serious infection requiring hospitalization, cancer history (except certain skin cancers), or history of organ transplant are excluded.

Study focus: The treatment period lasts up to 60 days, monitoring kidney function decline, need for dialysis or transplant, and cardiovascular deaths. Blood pressure and other health markers are also tracked.

Investigational drugs: Baxdrostat is a new medication being tested that inhibits an enzyme involved in blood pressure regulation. Dapagliflozin is an established SGLT2 inhibitor that helps kidneys excrete more glucose while protecting kidney function.

Evaluating Citrulline, Folic Acid, Vericiguat, and Tadalafil Combination for Patients with Treatment-Resistant High Blood Pressure

This Swedish trial tests a combination of four substances: L-citrulline (amino acid), folic acid (B vitamin), vericiguat (soluble guanylate cyclase stimulator), and tadalafil (phosphodiesterase type 5 inhibitor) as add-on therapy for patients whose blood pressure is difficult to control with standard treatments.

Main inclusion criteria: Participants aged 18-80 years must have office blood pressure with systolic ≥ 140 mmHg and 130 mmHg and 80 mmHg. They must have treatment-resistant hypertension, taking at least 3 different blood pressure medications at optimal doses (including ACE inhibitors or ARBs, calcium channel blockers, and diuretics), and have elevated NOX5/ADMA levels (greater than 170 pg/ml).

Main exclusion criteria: Pregnant or breastfeeding women, people with liver problems or severe liver disease, severe kidney disease (eGFR < 30 mL/min/1.73 m²), recent heart attack, stroke, or severe heart failure (past 6 months), taking nitrates, very low blood pressure (systolic 180 mmHg), allergies to study medications, non-arteritic anterior ischemic optic neuropathy, or current participation in another trial are excluded.

Study focus: This three-way crossover Phase IIa trial measures changes in systolic and diastolic blood pressure using both office measurements and 24-hour ambulatory monitoring, with particular focus on patients with high levels of certain substances that may contribute to resistant hypertension.

Investigational drugs: L-citrulline helps blood vessels produce nitric oxide to widen vessels. Folic acid plays a role in nitric oxide production. Vericiguat enhances soluble guanylate cyclase activity to relax blood vessels. Tadalafil (PDE5 inhibitor) helps relax blood vessels and improve blood flow.

Study Comparing Eplerenone and Irbesartan for Lowering Blood Pressure in Obese Patients with Hypertension

This Greek trial compares two treatment strategies for people who are both obese and have high blood pressure: one based on eplerenone and the other on irbesartan. The study aims to determine which treatment strategy is more effective in managing blood pressure in this specific patient population.

Main inclusion criteria: Participants aged 30-75 years with BMI between 30 and 39.99 kg/m² can participate. They must have systolic blood pressure between 140 and 179 mmHg or diastolic blood pressure between 90 and 119 mmHg. Average 24-hour systolic blood pressure must be greater than 130 mmHg or average 24-hour diastolic blood pressure greater than 80 mmHg. Participants must be able to understand and agree to participate in the study.

Main exclusion criteria: The study does not specifically exclude based on gender or vulnerable population status, but participants must be within the specified age range.

Study focus: Participants receive either eplerenone-based or irbesartan-based treatment, with regular monitoring to assess blood pressure changes over 24-hour periods. Additional medications may include indapamide and amlodipine. The study is expected to conclude by June 30, 2025.

Investigational drugs: Eplerenone (selective aldosterone receptor antagonist) blocks hormones that can raise blood pressure and is used to treat high blood pressure and heart failure. Irbesartan (angiotensin receptor blocker) helps relax blood vessels, making it easier for the heart to pump blood.

Study on the Effect of Aprepitant on Aldosterone Levels in Patients with Obstructive Sleep Apnea and High Blood Pressure

This French trial studies aprepitant’s effects on patients who have both obstructive sleep apnea (breathing repeatedly stops and starts during sleep) and high blood pressure. The study aims to see how aprepitant affects aldosterone production, a hormone that can influence blood pressure levels.

Main inclusion criteria: Participants must have severe obstructive sleep apnea syndrome (apnea and hypopnea index of 30 or more per hour) and essential hypertension (systolic blood pressure of 140 or more and/or diastolic blood pressure of 90 or more). Adults aged 18-75 years affiliated with social security can participate. They must agree to replace diuretics with another blood pressure medication not affecting the renin-angiotensin system. Women of childbearing age must use effective mechanical contraception and have negative pregnancy tests. Postmenopausal women must have had no periods for at least 12 months before the first visit.

Main exclusion criteria: People without obstructive sleep apnea syndrome or high blood pressure, those outside the age range, unwilling to follow procedures, pregnant or breastfeeding, with other interfering medical conditions, taking medications affecting results, history of allergic reactions to study medication, recent participation in another trial, history of substance abuse, mental health conditions affecting ability to follow instructions, recent major surgery, uncontrolled diabetes, or history of kidney disease affecting function are excluded.

Study focus: The trial evaluates the effect of aprepitant on aldosterone secretion through various measurements including 24-hour aldosteronuria, blood pressure, aldosteronemia, reninemia, plasma and urinary electrolytes, cortisol, and plasma ACTH.

Investigational drug: Aprepitant is a substance P antagonist that works by blocking a specific receptor involved in hormone production, potentially helping reduce aldosterone production and lower blood pressure. It is administered orally in capsule form.

Summary

These 20 ongoing clinical trials represent diverse approaches to managing hypertension across different patient populations. A notable concentration of trials is observed in countries such as Poland, Germany, and France, reflecting active research centers in these regions. Several trials focus on patients with resistant or uncontrolled hypertension, a particularly challenging condition affecting approximately 10% of all hypertension patients.

The investigational drugs span multiple pharmacological classes, including aldosterone synthase inhibitors (baxdrostat, lorundrostat), SGLT2 inhibitors (dapagliflozin), GLP-1 receptor agonists (semaglutide, orforglipron), and novel combinations of established medications. Several studies specifically target patients with comorbidities such as chronic kidney disease, obesity, or obstructive sleep apnea, recognizing the complex interplay between these conditions and blood pressure control.

Many trials evaluate combination therapies, reflecting the clinical reality that most patients require multiple medications to achieve target blood pressure levels. The studies generally range from 12 weeks to 5 years in duration, with most monitoring both office and ambulatory blood pressure measurements to provide comprehensive assessment of treatment effectiveness. These trials collectively aim to expand treatment options for patients whose hypertension remains inadequately controlled despite current therapeutic approaches.

Ongoing Clinical Trials on Hypertension

  • A study to evaluate the effect of baxdrostat and dapagliflozin in reducing protein in the urine for patients with chronic kidney disease and high blood pressure

    Recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Bulgaria Spain

  • Evaluating Citrulline, Folic Acid, Vericiguat, and Tadalafil Combination for Patients with Treatment-Resistant High Blood Pressure

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Sweden

  • Study of Optimal Treatment for Uncontrolled Hypertension Using Triple Drug Combinations (Olmesartan/Amlodipine/Hydrochlorothiazide or Perindopril/Indapamide/Amlodipine) with Additional Diuretics

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Poland

  • Study of Allopurinol to Reduce Cardiovascular Events in High-Risk Patients with Heart Disease and Long-COVID Syndrome

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Poland

  • Study on the Effect of Aprepitant on Aldosterone Levels in Patients with Obstructive Sleep Apnea and High Blood Pressure

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    France

  • Study Comparing Eplerenone and Irbesartan for Lowering Blood Pressure in Obese Patients with Hypertension

    Not yet recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Greece

  • Study on the Effects of Bosentan on Blood Pressure in Patients with Uncontrolled Hypertension

    Not yet recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    France

  • A study comparing the absorption of rosuvastatin, amlodipine, and ramipril in healthy men and women.

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Czechia

  • Study of orforglipron in people with high blood pressure who are overweight or have obesity

    Not recruiting

    1 1
    Investigated diseases:
    Czechia Germany Greece Poland Spain

  • Study on the Long-Term Safety and Effectiveness of Lorundrostat for Patients with Uncontrolled and Resistant Hypertension

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Bulgaria France Germany Italy The Netherlands Poland +2

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