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Indapamide

Clinical trials are investigating Indapamide in people with uncontrolled high blood pressure and in patients with chronic kidney disease. These studies look at how well treatment strategies lower blood pressure and whether they can improve kidney and heart-related outcomes. The trials include adults with obesity, difficult-to-treat hypertension, and moderate to severe chronic kidney disease.

Table of Contents

Clinical trial overview

The trial data show that Indapamide is being studied in people with high blood pressure, including patients whose blood pressure is not well controlled and patients with chronic kidney disease.[1][2][3]

These are interventional studies, which means researchers are testing treatment plans and measuring how well they work in real patients.[1][2][3]

Most of the trials are Phase 3 studies, which are later-stage trials that usually involve larger groups and focus on how effective a treatment strategy is.[1][3]

Phase 3 trial in chronic kidney disease and uncontrolled hypertension

The first study, NCT05732727, is an open-label, cluster randomized controlled Phase 3 trial in patients with uncontrolled hypertension and moderate to severe chronic kidney disease.[1]

Open-label means that both the researchers and the patients know which treatment is being used.[1] Cluster randomized means that groups of patients, rather than single patients one by one, are assigned to different treatment approaches.[1]

This trial includes oral Indapamide at 1.5 mg and 2.5 mg, along with other diuretics such as hydrochlorothiazide, furosemide, and amiloride hydrochloride as part of the study treatment algorithm.[1]

The main goal is to see whether a diuretic-based strategy can reduce end-stage kidney disease, kidney function loss, cardiovascular events, and all-cause death.[1]

The primary outcome is a composite endpoint, which means several important events are counted together: kidney failure needing replacement therapy or transplant, a 40% drop in estimated kidney function, heart attack, heart failure hospitalization, stroke, and death from any cause.[1]

Study of difficult-to-treat hypertension and treatment switching

The second study, 2024-517628-20-00, looks at difficult-to-treat hypertension and is described as a low-intervention trial with 1,154 planned participants.[2]

This study compares current antihypertensive treatment with a strategy that switches patients to a triple SPC, which means a single pill containing three blood pressure medicines.[2]

In this trial, Indapamide appears as part of a fixed-dose combination treatment called Triplixam, and the study also includes other medicines such as torasemide, eplerenone, and spironolactone.[2]

The trial has three phases in its analysis plan. Phase A measures how many patients still have uncontrolled blood pressure on 24-hour monitoring, Phase B measures how many reach blood pressure control after 12 weeks, and Phase C compares the change in 24-hour systolic blood pressure between treatment groups.[2]

The blood pressure target used in the study is based on ABPM, or ambulatory blood pressure monitoring, which records blood pressure over 24 hours in daily life.[2]

Phase 3 study in obese hypertensive patients

The third study, 2024-519749-31-00, is a Phase 3 trial in patients with hypertension and obesity.[3]

It compares an eplerenone-based blood pressure lowering strategy with an irbesartan-based strategy over 24 weeks.[3]

Indapamide is listed in the study interventions as Fludex 1.5 mg, which is one of the treatment products used in the trial.[3]

The main outcome is the difference in 24-hour ambulatory blood pressure between the eplerenone arm and the irbesartan arm after 24 weeks compared with the start of the study.[3]

The goal is to show clinical non-inferiority, meaning the eplerenone-based strategy is not worse than the irbesartan-based strategy by an important amount for lowering blood pressure.[3]

Main outcomes and what they mean

Across the studies, the key outcomes focus on blood pressure control, kidney health, heart events, and survival.[1][2][3]

Some outcomes are short-term, such as reaching blood pressure targets after 12 weeks, while others are longer-term, such as kidney failure and death.[1][2]

Trials also use measures like eGFR, which is an estimated kidney function score, and 24-hour systolic and diastolic blood pressure readings.[1][2]

Who the studies are for

The main target groups are adults with uncontrolled hypertension, difficult-to-treat hypertension, obesity with hypertension, and moderate to severe chronic kidney disease.[1][2][3]

These studies are not general population studies; they are aimed at people who already have specific blood pressure or kidney problems.[1][2][3]

Study status and size

All three trials are listed as Authorised, which means they have been approved to move forward in the study process.[1][2][3]

The planned enrollment is 720 patients in NCT05732727, 1,154 patients in 2024-517628-20-00, and 198 patients in 2024-519749-31-00.[1][2][3]

Trial IDPhaseCondition studiedStatusEnrollment
NCT05732727Phase 3Uncontrolled hypertension in patients with moderate to severe chronic kidney diseaseAuthorised720
2024-517628-20-00Low InterventionHypertension, overpressureAuthorised1154
2024-519749-31-00Phase 3HypertensionAuthorised198

FAQ

  • What are clinical trials of Indapamide trying to find out? They are studying whether treatment plans that include Indapamide can improve blood pressure control and protect the kidneys and heart. Some trials also compare Indapamide-based strategies with other treatment approaches.
  • Who may take part in these trials? The target groups include adults with uncontrolled hypertension, obese hypertensive patients, and patients with moderate to severe chronic kidney disease. Each trial has its own eligibility rules.
  • What phases are these Indapamide trials in? The trials listed are mainly Phase 3 studies, which means they test how well a treatment works in larger groups. One study is described as a low-intervention trial.
  • What conditions are being studied? The main conditions are uncontrolled hypertension, difficult-to-treat hypertension, obesity with hypertension, and chronic kidney disease with high blood pressure. The studies focus on treatment strategies for these problems.
  • What outcomes are measured in these trials? The trials measure blood pressure control, changes in 24-hour blood pressure, kidney disease progression, cardiovascular events, and death. Some studies also look at how many patients reach target blood pressure after treatment.

Ongoing Clinical Trials on Indapamide

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

    Recruiting

    1 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

Glossary

  • Hypertension: High blood pressure. It means the force of blood against the artery walls is too high.
  • Uncontrolled blood pressure: Blood pressure that stays above the study target even while treatment is being used.
  • Chronic kidney disease: Long-lasting kidney damage that can slowly get worse over time.
  • Moderate to severe chronic kidney disease: A more advanced stage of kidney disease, where kidney function is reduced more than in early disease.
  • Phase 3: A later stage of clinical research that studies how well a treatment works in larger groups of people.
  • Interventional study: A study where researchers assign a treatment plan and then measure the results.
  • Primary outcome: The main result a trial is designed to measure.
  • Ambulatory blood pressure monitoring (ABPM): A way to measure blood pressure over 24 hours while a person goes about daily life.
  • Systolic blood pressure (SBP): The top number in a blood pressure reading. It shows the pressure when the heart beats.
  • Diastolic blood pressure (DBP): The bottom number in a blood pressure reading. It shows the pressure when the heart rests between beats.
  • End-stage kidney disease: Very advanced kidney failure, when kidney replacement therapy or transplant may be needed.
  • Composite endpoint: A main result made up of several different events, counted together in one outcome.

References