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

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial focuses on treating difficult-to-treat hypertension, a condition where blood pressure remains high despite current treatments. The study evaluates several medications including Elestar HCT (containing olmesartan medoxomil, amlodipine, and hydrochlorothiazide) and Triplixam (containing indapamide, amlodipine besilate, and perindopril arginine). Additional medications being studied include Spironol, Toramide, and Espiro.

The purpose of the study is to find the most effective treatment approach for patients whose high blood pressure is not well controlled with their current medications. The study is divided into three phases to evaluate different treatment strategies and compare the effectiveness of various medication combinations.

During the trial, participants will receive different combinations of blood pressure medications as tablets taken by mouth. The treatment period lasts up to 30 weeks, during which doctors will monitor blood pressure using various measurement methods to determine how well the medications are working. The medications being tested include different types of drugs that work in various ways to lower blood pressure, such as water pills (diuretics), calcium channel blockers, and drugs that affect blood vessel function.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial blood pressure measurement

    Your blood pressure will be measured using ambulatory blood pressure monitoring (ABPM) to confirm if current treatment is effective

    You will also need to measure your blood pressure at home using a home blood pressure monitor (HBPM) for 6 days

  2. Step 2

    Treatment modification - Phase B

    Your current medication will be changed to one of two triple-drug combinations in a single tablet:

    Option 1: Triplixam (perindopril + indapamide + amlodipine)

    Option 2: Elestar HCT (olmesartan + hydrochlorothiazide + amlodipine)

    This treatment will continue for 12 weeks

  3. Step 3

    Blood pressure evaluation

    After 12 weeks, your blood pressure will be measured again using ABPM

    The goal is to achieve blood pressure values below 125/80 mmHg over 24 hours

  4. Step 4

    Additional treatment - Phase C

    If needed, you may receive one of three additional medications:

    Spironol (spironolactone) 25 mg tablet

    Espiro (eplerenone) 25 mg film-coated tablet

    Toramide (torasemide) 10 mg tablet

    This additional treatment will continue for 12 weeks

  5. Step 5

    Final evaluation

    Your blood pressure will be measured one final time using ABPM

    The effectiveness of the additional medication will be evaluated

Who can join the trial?

9 criteria

  • Both women and men can participate in the study
  • Age must be between 18 and 70 years old
  • Must have a documented history of hypertension (high blood pressure)
  • Must have been receiving treatment for high blood pressure for at least 6 months
  • Must have a blood pressure reading of 130/80 mm Hg or higher when measured at the doctor's office while seated
  • Must be currently taking 3 or more medications for high blood pressure, including:
    • A medication that blocks certain hormones affecting blood pressure (ACE inhibitor or ARB)
    • A water pill (thiazide, thiazide-like, or loop diuretic)
    • Must have been on a stable blood pressure medication plan with no changes for at least 4 weeks
    • Must be willing and able to follow all study procedures and attend clinic visits

Who cannot join the trial?

15 criteria

  • Age below 18 or above 65 years
  • Diagnosed secondary hypertension (high blood pressure caused by another medical condition)
  • History of severe allergic reactions to any of the study medications
  • Pregnant or breastfeeding women
  • Current participation in other clinical trials
  • Uncontrolled diabetes (blood sugar levels that remain high despite treatment)
  • History of heart attack or stroke in the past 6 months
  • Severe kidney or liver disease
  • Inability to follow study procedures or attend scheduled visits
  • Malignant hypertension (extremely high blood pressure that requires immediate medical attention)
  • Taking medications that could interact with study drugs
  • History of drug or alcohol abuse within the past year
  • Orthostatic hypotension (significant drop in blood pressure when standing up)
  • Significant mental health conditions that could affect participation
  • Any condition that the study doctor believes would make participation unsafe
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Investigated drugs

  • Perindopril

    is an ACE inhibitor medication that helps lower blood pressure by relaxing blood vessels.

  • Indapamide

    is a diuretic (water pill) that helps reduce blood pressure by removing excess fluid from the body.

  • Amlodipine

    is a calcium channel blocker that helps lower blood pressure by relaxing blood vessels and improving blood flow.

  • Eplerenone

    is a medication that blocks aldosterone, a hormone that can increase blood pressure. It helps lower blood pressure by reducing sodium and water retention in the body.

  • Spironolactone

    is another aldosterone blocker that works similarly to eplerenone to help control blood pressure by affecting how the body handles salt and water.

  • Torasemide

    is a loop diuretic that helps lower blood pressure by increasing the amount of water and salt your body removes through urine.

What is already known about the treatment

  • Eplerenone

    An oral medication belonging to the class of mineralocorticoid receptor antagonists that works by blocking aldosterone receptors in the body, helping to lower blood pressure by reducing sodium and water retention. This selective aldosterone blocker is primarily used to treat high blood pressure and heart failure, with fewer hormonal side effects compared to older medications in its class. The medication is typically taken as a tablet once or twice daily with or without food.

  • Spironolactone

    An oral potassium-sparing diuretic that acts as an aldosterone antagonist, helping to treat high blood pressure by blocking hormone receptors that affect sodium and water balance in the body. This medication has been widely used in clinical practice for decades and is available as tablets taken once or twice daily. It's particularly effective in treating resistant hypertension and certain hormonal conditions.

  • Torasemide

    A long-acting loop diuretic taken orally that helps treat high blood pressure by increasing water and salt elimination through the kidneys. This medication is typically administered once daily in tablet form and provides more consistent blood pressure control throughout the day compared to some other diuretics. It's commonly used in combination therapy for patients with uncontrolled hypertension.

Investigated diseases

Hypertension - A chronic medical condition where blood pressure in the arteries is persistently elevated above normal levels. It occurs when the force of blood pushing against the walls of blood vessels remains consistently too high. The condition typically develops over many years and often has no noticeable symptoms in its early stages. High blood pressure can affect various organs over time, including the heart, blood vessels, and kidneys. The condition may be influenced by both genetic and lifestyle factors. Blood pressure measurements consist of two numbers: systolic pressure (when the heart beats) and diastolic pressure (when the heart rests between beats). Note: While "Overpressure" appears in the source data, it is not a standard medical term in English for a disease condition. The correct medical term is "Hypertension," which I have described above.
Trial detailsLast updated 5 Nov 2026
Age18+ yearsPhasePhase ITrial ID2024-517628-20-00Protocol code2020/ABM/01/00037Estimated enrolment1 154 patientsSponsorAgencja Badań Medycznych

sourced from the EU Clinical Trials Register and site verification

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