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Amlodipine

Clinical trials investigating Amlodipine are studying how it is used in different patient groups, including people with hypertension, obesity-related hypertension, and reversible cerebral vasoconstriction syndrome. These studies look at outcomes such as blood pressure control, symptom reduction, safety, and drug bioequivalence.

Table of contents

Overview of the Amlodipine trials

The trials in this set study Amlodipine in different research settings, mainly for blood pressure control and related cardiovascular questions.[1][2] Most studies are in people with hypertension, but the data also include a study in reversible cerebral vasoconstriction syndrome, a cardiovascular prevention study in inflammatory rheumatic disease, and one healthy volunteer bioequivalence study.[3][4]

Trials in hypertension

Several trials focus on hypertension, which means high blood pressure.[1][2] One Phase 3 study in primary (essential) hypertension is looking for blood and urine biomarker patterns that may predict who responds better to blood pressure-lowering treatment, including an Amlodipine group.[1]

Another large low-intervention study is testing treatment strategies for difficult-to-treat hypertension and measures whether patients have uncontrolled blood pressure or reach blood pressure control after changing treatment.[2] A separate Phase 3 study in obese hypertensive patients compares an eplerenone-based strategy with an irbesartan-based strategy and includes Amlodipine in the treatment arms listed in the trial record.[3]

There is also a Phase 3 study of a fixed-dose combination of irbesartan and Amlodipine in people with arterial hypertension, where the study looks at how many patients reach the target systolic blood pressure and also tracks safety and treatment adherence.[6] Another completed low-intervention study examined single-pill combinations with telmisartan and Amlodipine, with or without hydrochlorothiazide, and measured 24-hour blood pressure reduction and blood pressure variability.[5]

These hypertension studies show that Amlodipine is being researched mostly as part of combination treatment rather than alone.[2][5][6] The main question is whether these treatment plans help more patients reach blood pressure targets or improve 24-hour blood pressure readings.[1][2][5]

Trials in other conditions

One Phase 3 trial studies Amlodipine in reversible cerebral vasoconstriction syndrome, a condition in which blood vessels in the brain narrow and widen in a reversible way.[7] The study is double-blind and placebo-controlled, which means neither the patient nor the research team knows who receives the study drug or placebo during the trial.[7]

The main outcome in this trial is the frequency of recurring headache attacks, and the trial includes patients without parenchymal lesions or subarachnoid hemorrhage on CT or MRI.[7] This means the study is focused on a specific group of patients with the syndrome and without certain brain scan findings.[7]

Another Phase 3 trial includes Amlodipine in a cardiovascular prevention strategy for patients with chronic inflammatory rheumatic diseases such as rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, and systemic lupus erythematosus.[4] This study looks at whether a carotid ultrasound-based strategy can help identify and treat patients at higher cardiovascular risk and reduce major cardiovascular events.[4]

Main outcomes and endpoints

The trials measure different endpoints, which are the main results the researchers want to study.[1][6] In the hypertension studies, common endpoints include the change in 24-hour systolic blood pressure, the percentage of patients with uncontrolled or controlled blood pressure, and blood pressure variability.[2][5][6]

In the biomarker study, the main endpoint is the predictive value of a multi-omics profile, meaning a pattern built from blood and urine tests, to separate people who have a larger or smaller drop in 24-hour blood pressure within each treatment group.[1] In the reversible cerebral vasoconstriction syndrome study, the main endpoint is the frequency of recurring headache.[7]

The cardiovascular prevention trial measures major cardiovascular events, including acute myocardial infarction, stroke, unstable angina requiring hospital admission, peripheral artery revascularization, and death due to cardiovascular disease.[4] The Phase 1 bioequivalence study measures pharmacokinetic outcomes such as AUC and Cmax, which show total drug exposure and peak blood level.[8]

Who can participate

Eligibility depends on the trial.[1][4][7] Some studies include adults with primary or arterial hypertension, while others focus on obese patients with hypertension or patients with difficult-to-treat hypertension.[1][2][3][6]

One study is limited to patients with inflammatory rheumatic diseases and low to moderate cardiovascular risk, and one study includes patients with reversible cerebral vasoconstriction syndrome without certain brain scan findings.[4][7] The bioequivalence study includes healthy male and female volunteers under fasting conditions.[8]

Trial phases and study types

Most of the Amlodipine trials listed here are Phase 3 studies, which usually test whether a treatment works in larger groups and continue safety checks.[1][3][4][6][7]

There is one Phase 1 study in healthy volunteers that compares a test capsule containing rosuvastatin, Amlodipine, and ramipril with separate reference products.[8] The set also includes low-intervention studies, which means the research uses treatment approaches that are closer to routine care than highly complex experimental testing.[2][5]

Key points for patients

  • Most Amlodipine trials in this set are about blood pressure lowering and whether patients reach target levels.[1][6]

  • Some studies test Amlodipine as part of a single-pill combination, which means more than one medicine is placed in one tablet.[5][6]

  • One study looks at whether blood and urine markers can help predict who responds best to treatment.[1]

  • One study checks whether Amlodipine can reduce recurring headache in reversible cerebral vasoconstriction syndrome.[7]

  • One study in healthy volunteers checks whether a new capsule gives similar drug exposure to reference products.[8]

Trial ID Phase Condition studied Status Enrollment
NCT05917275 Phase 3 Primary (essential) hypertension Authorised 96
2024-517628-20-00 Low Intervention Hypertension, Overpressure Authorised 1154
2024-519749-31-00 Phase 3 Hypertension Authorised 198
2025-521086-28-00 Phase 3 Chronic inflammatory rheumatic diseases with cardiovascular risk prevention Authorised 1250
2023-504812-13-00 Low Intervention Arterial hypertension Completed 191
2024-511705-31-00 Phase 3 Arterial Hypertension Authorised 346
2023-503822-38-00 Phase 1 Healthy volunteers; bioequivalence study Completed 60
2023-504547-14-01 Phase 3 Reversible cerebral vasoconstriction syndrome Authorised 100

FAQ

  • Who can take part in Amlodipine clinical trials? It depends on the study. Some trials include adults with primary or arterial hypertension, while one study includes patients with reversible cerebral vasoconstriction syndrome, and one bioequivalence study includes healthy volunteers.
  • What are the trials trying to find out? The trials are checking whether Amlodipine-containing treatments improve blood pressure control, reduce headache attacks in a specific brain blood vessel condition, or show similar drug exposure in the body compared with reference products.
  • What phases are these Amlodipine trials in? Most of the trials are Phase 3 studies. There is also one Phase 1 bioequivalence study and some low-intervention studies, which means the treatment is being used in a less intensive research setting.
  • Which conditions are being studied with Amlodipine? The main condition is hypertension, including difficult-to-treat and obesity-related hypertension. Amlodipine is also studied in reversible cerebral vasoconstriction syndrome and in a healthy volunteer bioequivalence study.
  • What do the studies measure as results? Common results include 24-hour blood pressure changes, the number of patients who reach blood pressure targets, headache recurrence, safety events, and bioequivalence measures such as AUC and Cmax, which show how much and how fast the drug enters the body.

Ongoing Clinical Trials on Amlodipine

  • 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 Predicting Blood Pressure Response in Hypertension Patients Using Amlodipine, Olmesartan Medoxomil, Hydrochlorothiazide, and Drug Combination

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands

  • Study on Amlodipine for Treating Reversible Cerebral Vasoconstriction Syndrome in Patients Without Brain Lesions or Hemorrhage

    Not yet recruiting

    1 1 1 1
    Investigated drugs:
    Finland

  • 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

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

    Not recruiting

    1 1 1 1
    Investigated drugs:
    Greece

  • Study on the Effects of Telmisartan, Amlodipine, and Hydrochlorothiazide on Blood Pressure in Patients with Hypertension

    Not recruiting

    1 1 1 1
    Investigated drugs:
    Hungary Poland Slovenia

Glossary

  • Hypertension: High blood pressure. In these trials, this is the main condition being treated or studied.
  • Primary (essential) hypertension: High blood pressure without a single clear cause. One study focuses on this common type.
  • Arterial hypertension: Another term for high blood pressure in the arteries.
  • 24-hour ambulatory blood pressure monitoring (ABPM): A method that checks blood pressure over a full day and night while a person goes about normal activities.
  • 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.
  • Blood pressure control: When blood pressure reaches the target level set by the study or guideline.
  • Phase 3: A later stage of clinical research that tests how well a treatment works and how safe it is in larger groups of people.
  • Phase 1: An early research stage, often used to study how the body handles a treatment.
  • Bioequivalence: A comparison to see whether two products give similar drug exposure in the body.
  • AUC: Area under the curve. This measures the total amount of drug exposure over time.
  • Cmax: The highest level of a drug reached in the blood after taking it.

References

  1. https://clinicaltrials.eu/trial/study-on-predicting-blood-pressure-response-in-hypertension-patients-using-amlodipine-olmesartan-medoxomil-hydrochlorothiazide-and-drug-combination/
  2. https://clinicaltrials.gov/study/2024-517628-20-00
  3. https://clinicaltrials.gov/study/2024-519749-31-00
  4. https://clinicaltrials.gov/study/2025-521086-28-00
  5. https://clinicaltrials.gov/study/2023-504812-13-00
  6. https://clinicaltrials.gov/study/2024-511705-31-00
  7. https://clinicaltrials.gov/study/2023-504547-14-01
  8. https://clinicaltrials.gov/study/2023-503822-38-00