Oedema Trials in Disease

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

This clinical trial is designed for patients who develop swelling in their legs, known as peripheral oedema, as a side effect of long-term treatment with amlodipine, a commonly prescribed blood pressure medication. The study investigates whether switching to a similar medication called levamlodipine can help reduce this swelling while still effectively controlling blood pressure.

Who can participate:

• Adults between 18 and 79 years old
• Patients with high blood pressure that is currently controlled with 1 to 3 medications, including amlodipine (5 mg or 10 mg) taken for at least 1 month
• Blood pressure should be less than 140/90 mm Hg
• Patients experiencing moderate or severe leg swelling suspected to be caused by the calcium channel blocker medication, or those who find long-term amlodipine treatment unacceptable due to this side effect
• Willingness to complete health questionnaires and sign an informed consent form
• Women of childbearing potential must use highly effective birth control during the trial, or be post-menopausal for at least 12 months, or be surgically sterile

Who cannot participate:

• Patients who have moderate or severe oedema and are on long-term treatment with amlodipine

What the trial involves:

The main goal of this study is to evaluate how well leg swelling improves when patients switch from amlodipine to levamlodipine. Both medications belong to a group of drugs called calcium channel blockers, which help relax blood vessels and improve blood flow.

The trial lasts up to 70 days and includes several steps:

1. Initial assessment: When joining the study, participants undergo a thorough evaluation of the swelling in both legs using visual examination, severity grading, and a patient questionnaire about how the swelling affects daily life.
2. Medication switch: Participants taking amlodipine (2.5 mg) are switched to levamlodipine (1.25 mg), both taken orally in tablet form.
3. Periodic evaluations: Throughout the trial, regular assessments monitor changes in ankle circumference and swelling severity using specific measurement methods. Participants complete questionnaires at each visit to provide feedback on their symptoms.
4. Safety monitoring: Regular checks of blood pressure, heart rate, body temperature, and laboratory tests ensure participant safety throughout the study.
5. Final assessment: At the end of the trial, a comprehensive evaluation measures ankle volume using the water displacement method, and participants complete a final questionnaire about their experience.

Investigational drugs:

Amlodipine is a well-established medication used to treat high blood pressure and chest pain. It works by relaxing blood vessels so blood can flow more easily. However, it can cause peripheral oedema as a side effect in some patients.

Levamlodipine is a similar medication to amlodipine, also used to manage high blood pressure. This trial is testing whether levamlodipine causes less leg swelling compared to amlodipine while still effectively controlling blood pressure. Like amlodipine, it belongs to the calcium channel blocker class and works by preventing calcium from entering vascular smooth muscle cells, leading to blood vessel relaxation and reduced blood pressure.