In short
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.
Key points
- Clinical trials involving Amlodipine Besilate are studying several different patient groups and research questions. One Phase 2 trial looks at edema in adults who had long-term amlodipine treatment, while another Phase 2 trial studies blood pressure control in difficult-to-treat hypertension. A Phase 1 study in healthy volunteers compares a test capsule with reference products to check bioequivalence. Another Phase 2 trial includes adults with gastroenteropancreatic neuroendocrine tumours and dominant liver metastases, but Amlodipine Besilate appears only as one of several listed medicines in that study. Overall, the trial data focus on treatment effects, measurement methods, and product comparison in specific populations.
Trial overview
The trial data include four studies that mention Amlodipine Besilate in different research settings. These studies are not all about the same disease or the same goal. 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.
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. It was completed and enrolled 60 people. The study compares S-Amlodipine TAB (VAM) with Amlodipine and focuses on whether swelling in both legs improves after switching treatment.
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. This method measures swelling by seeing how much water is displaced when the leg is placed in a special container. The study also compares objective measurements with the patient’s own report of swelling severity and tolerability.
Difficult-to-treat hypertension study
The study with NCT 2024-517628-20-00 is an interventional trial in people with hypertension and overpressure. It is authorised and has a large enrollment of 1154 participants. The trial uses a low-intervention design and has three parts called Phase A, Phase B, and Phase C in the outcome description.
Phase A checks how many patients still have uncontrolled blood pressure while on their current treatment, using 24-hour blood pressure monitoring. Phase B studies whether switching to a triple single-pill combination helps patients reach blood pressure control after 12 weeks. Phase C compares the change in 24-hour systolic blood pressure between treatment groups after 12 weeks, including eplerenone, torasemide, and spironolactone groups.
This trial is important because it studies people whose blood pressure is hard to control and measures control in a structured way over time.
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. It enrolled 60 healthy male and female subjects and was completed. The trial compares a test capsule containing Rosuvastatin/Amlodipine/Ramipril with reference products taken together under fasting conditions.
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. The study measures AUC and Cmax for rosuvastatin, amlodipine, and ramipril and uses 90% confidence intervals to compare the test-to-reference ratios. The accepted comparison range in the trial is 80.00% to 125.00% for both AUC and Cmax.
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. It was authorised and enrolled 23 participants. The title focuses on intra-arterial hepatic infusion of radiolabelled somatostatin analogs, and Amlodipine Besilate appears in the intervention list as AMLOR 10 mg.
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. The brief summary compares PET scan uptake after intra-hepatic infusion with uptake after intravenous administration. This means the study is mainly about imaging and uptake measurement in liver metastases, not about a direct amlodipine-focused treatment question.
Main endpoints and outcome measures
The trials use different endpoints depending on the question being studied. In the edema study, the endpoint is change in edema volume measured by water displacement. 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. In the bioequivalence study, the endpoints are AUC and Cmax for the test and reference medicines. In the GEP-NET study, the endpoint is PET-scan uptake of 68Ga-DOTA-peptides in liver metastases.
Who is being studied
The patient groups are very different across the studies. One trial includes adults with moderate or severe oedema after long-term amlodipine use. Another includes people with hypertension or overpressure, with a large sample size of 1154. One study includes healthy male and female volunteers, which is common in early bioequivalence research. The oncology study includes adults with GEP-NETs and dominant liver metastases.