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 study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy Warsaw Poland
1 Wojskowy Szpital Kliniczny Z Poliklinika samodzielny publiczny zakład opieki zdrowotnej W Lublinie Lublin Poland
SPECJALISTYCZNA PORADNIA KARDIOLOGICZNA I NADCISNIENIA TETNICZEGO prof. Beata Wozakowska-Kaplon Kielce Poland
Samodzielny Publiczny Zakład Opieki Zdrowotnej w Siedlcach Siedlce Poland
Niepublicznym Zakładem Opieki Zdrowotnej SOMED s.c. Sompolno Poland
Uniwersytecki Szpital Kliniczny W Bialymstoku Bialystok Poland
Uniwersytecki Szpital Kliniczny W Opolu Opole Poland
Uniwersytecki Szpital Kliniczny W Poznaniu Poznan Poland
Oyp Mjmslib Shr z oxub Wroclaw Poland
Pcr Slwvi Ctbmcnu Mnlewjtq Lodz Poland
Nvixrsbvxwyc Ztjznh Ozchxb Zggcuzxtos Emkzqox Trymlbb Dnybtwrxzl Gniewkowo Poland
Lxaura Kakydaew Sexsyzznuumfgjk Goncgmd Lwoythfa Przeworsk Poland
Uliusmtovotbj Sjuigzp Khaszvkdc W Ocgtatizo Olsztyn Poland
Sjpmzsbpdrb Peineihuw Ztyftg Zhsgztjf Ohidll Zsxxhwxvde W Ohyrepp Mnwndtmhoque Ostrow Mazowiecka Poland
Mvxzuoujh Iuripgmkp Jaksice Poland
Squqtoi Upwamfrpzbfhx W Kkrlflzq Cracow Poland
Uzqumjvhsphvzq Cizpztb Kkpzsgnfg Gdansk Poland
Sihaehflrux Pdgliwtwl Svsqoky Kjsnfrpia Ixhzqttpely Mvkngnunxdn Srf W Klgtreeccz Katowice Poland

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

Trial status

Country Status Recruitment Start
Poland Poland
Recruiting
24.10.2023

Trial locations

Based on the provided trial information about treating uncontrolled hypertension, the medications involved are:

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.

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 ID:
2024-517628-20-00
Protocol code:
2020/ABM/01/00037
Trial Phase:
Human Pharmacology (Phase I) – Other

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