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Amlodipine Besilate

Clinical trials involving Amlodipine Besilate are studying different questions, including edema in people who use amlodipine, blood pressure control in hard-to-treat hypertension, and bioequivalence in healthy volunteers. These trials look at safety, effectiveness, and how the drug is used in specific study settings. The target groups include adults with edema, adults with hypertension, and healthy men and women.

Table of contents

Trial overview

The trial data include four studies that mention Amlodipine Besilate in different research settings.[1][2][3][4] These studies are not all about the same disease or the same goal.[1][2][3][4] They include a Phase 2 edema study, a Phase 2 hypertension study, a Phase 1 bioequivalence study, and one oncology study where Amlodipine Besilate is listed among several other drugs.[1][2][3][4]

Edema study in long-term amlodipine users

The PERLA trial, NCT 2024-511312-24-00, is a Phase 2 study in patients with moderate or severe oedema after long-term treatment with amlodipine.[2] It was completed and enrolled 60 people.[2] The study compares S-Amlodipine TAB (VAM) with Amlodipine and focuses on whether swelling in both legs improves after switching treatment.[2]

The main question is how much the leg swelling changes from the start of the study to the end of Period 2, using the water displacement method to measure leg volume.[2] This method measures swelling by seeing how much water is displaced when the leg is placed in a special container.[2] The study also compares objective measurements with the patient’s own report of swelling severity and tolerability.[2]

Difficult-to-treat hypertension study

The study with NCT 2024-517628-20-00 is an interventional trial in people with hypertension and overpressure.[3] It is authorised and has a large enrollment of 1154 participants.[3] The trial uses a low-intervention design and has three parts called Phase A, Phase B, and Phase C in the outcome description.[3]

Phase A checks how many patients still have uncontrolled blood pressure while on their current treatment, using 24-hour blood pressure monitoring.[3] Phase B studies whether switching to a triple single-pill combination helps patients reach blood pressure control after 12 weeks.[3] Phase C compares the change in 24-hour systolic blood pressure between treatment groups after 12 weeks, including eplerenone, torasemide, and spironolactone groups.[3]

This trial is important because it studies people whose blood pressure is hard to control and measures control in a structured way over time.[3]

Bioequivalence study in healthy volunteers

The study with NCT 2023-503822-38-00 is a Phase 1 randomized, open-label, single-dose, two-period, cross-over bioequivalence study.[4] It enrolled 60 healthy male and female subjects and was completed.[4] The trial compares a test capsule containing Rosuvastatin/Amlodipine/Ramipril with reference products taken together under fasting conditions.[4]

The main goal is to see whether the test product and the reference products have similar pharmacokinetic properties, which means how the body absorbs and handles the medicine.[4] The study measures AUC and Cmax for rosuvastatin, amlodipine, and ramipril and uses 90% confidence intervals to compare the test-to-reference ratios.[4] The accepted comparison range in the trial is 80.00% to 125.00% for both AUC and Cmax.[4]

Other trial listing Amlodipine Besilate

The trial with NCT NCT04837885 is a Phase 2 study in adults with gastroenteropancreatic neuroendocrine tumours, also called GEP-NETs, with dominant liver metastases.[1] It was authorised and enrolled 23 participants.[1] The title focuses on intra-arterial hepatic infusion of radiolabelled somatostatin analogs, and Amlodipine Besilate appears in the intervention list as AMLOR 10 mg.[1]

The primary outcome in this study is uptake of 68Ga-DOTA-peptides in up to 5 liver metastases on PET scan after intra-hepatic injection.[1] The brief summary compares PET scan uptake after intra-hepatic infusion with uptake after intravenous administration.[1] This means the study is mainly about imaging and uptake measurement in liver metastases, not about a direct amlodipine-focused treatment question.[1]

Main endpoints and outcome measures

The trials use different endpoints depending on the question being studied.[1][2][3][4] In the edema study, the endpoint is change in edema volume measured by water displacement.[2] In the hypertension study, the endpoints include the percentage of patients with uncontrolled blood pressure, the percentage who reach blood pressure control, and the change in 24-hour systolic blood pressure.[3] In the bioequivalence study, the endpoints are AUC and Cmax for the test and reference medicines.[4] In the GEP-NET study, the endpoint is PET-scan uptake of 68Ga-DOTA-peptides in liver metastases.[1]

Who is being studied

The patient groups are very different across the studies.[1][2][3][4] One trial includes adults with moderate or severe oedema after long-term amlodipine use.[2] Another includes people with hypertension or overpressure, with a large sample size of 1154.[3] One study includes healthy male and female volunteers, which is common in early bioequivalence research.[4] The oncology study includes adults with GEP-NETs and dominant liver metastases.[1]

Trial ID Phase Condition studied Status Enrollment
NCT04837885 Phase 2 Gastroenteropancreatic neuroendocrine tumours with dominant liver metastases Authorised 23
2024-511312-24-00 Phase 2 Moderate or severe oedema on long-term amlodipine treatment Completed 60
2024-517628-20-00 Low Intervention Hypertension, Overpressure Authorised 1154
2023-503822-38-00 Phase 1 Not applicable; healthy subjects in a bioequivalence study Completed 60

FAQ

  • What kinds of clinical trials are studying Amlodipine Besilate? The trials include a Phase 2 study in people with edema, a Phase 2 study in difficult-to-treat hypertension, and a Phase 1 bioequivalence study in healthy adults. Each trial asks a different research question about use, effect, or drug comparison.
  • Who can take part in these trials? The study groups are different. Some trials include adults with moderate or severe edema after long-term amlodipine use, some include people with hypertension, and one includes healthy male and female volunteers.
  • What is being measured in the trial about edema? That trial measures change in edema using the water displacement method, which is a way to measure leg volume. It also compares objective measurements with how patients feel about their swelling and tolerability.
  • What is being studied in the hypertension trial? The hypertension trial studies how well current treatment works, how many patients reach blood pressure control after switching treatment, and how blood pressure changes over 12 weeks. It uses 24-hour ambulatory blood pressure monitoring, which measures blood pressure throughout the day and night.
  • What does the bioequivalence study mean? Bioequivalence means comparing a test medicine with reference medicines to see if the body handles them in a similar way. In this study, the test capsule is compared with separate reference products in healthy volunteers under fasting conditions.

Ongoing Clinical Trials on Amlodipine Besilate

  • 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 Intra-Arterial Infusion of Lutetium (177Lu) Oxodotreotide for Adults with Gastroenteropancreatic Neuroendocrine Tumors with Liver Metastases

    Recruiting

    1 1 1
    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 on Reducing Peripheral Edema in Patients Switching from Amlodipine Besilate to Levamlodipine Succinate

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Czechia

Glossary

  • Phase 1: An early trial stage, often done in healthy volunteers, to study how the body handles a medicine and compare products.
  • Phase 2: A trial stage that looks at whether a treatment may work and gathers more information about safety and use in patients.
  • Bioequivalence: A comparison showing whether two medicine products behave in a similar way in the body.
  • AUC: Area Under the Curve. This is a measure of how much of a medicine gets into the body over time.
  • Cmax: The highest level of a medicine measured in the blood after it is taken.
  • ABPM: Ambulatory Blood Pressure Monitoring. A method that checks blood pressure over 24 hours during normal daily life.
  • SBP: Systolic blood pressure, the top number in a blood pressure reading.
  • DBP: Diastolic blood pressure, the bottom number in a blood pressure reading.
  • Uncontrolled blood pressure: Blood pressure that stays above the target range set by the study.
  • Edema: Swelling caused by extra fluid in the tissues, often seen in the legs.
  • Cross-over study: A study design where participants receive more than one treatment in a planned order.
  • Healthy volunteers: People without the illness being studied who join a trial to help test a medicine product.

References

  1. https://clinicaltrials.eu/trial/study-of-intra-arterial-infusion-of-lutetium-177lu-oxodotreotide-for-adults-with-gastroenteropancreatic-neuroendocrine-tumors-with-liver-metastases/
  2. https://clinicaltrials.gov/study/2024-511312-24-00
  3. https://clinicaltrials.gov/study/2024-517628-20-00
  4. https://clinicaltrials.gov/study/2023-503822-38-00