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

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What is this study about?

This clinical trial is focused on patients who experience peripheral edema, which is swelling in the legs, as a side effect of long-term treatment with a medication called amlodipine. Amlodipine is commonly used to treat high blood pressure. The study will explore the effects of switching from amlodipine to a different medication called levamlodipine, which is also used to manage blood pressure. Both medications belong to a group of drugs known as calcium channel blockers, which help relax blood vessels and improve blood flow.

The purpose of the study is to evaluate how well the swelling in the legs improves when patients switch from amlodipine to levamlodipine. Participants will take part in a series of visits where their leg swelling will be assessed using different methods. These methods will include both objective measurements and subjective assessments, where patients will report their own experiences with the swelling. The study will also involve a comparison of these assessments to understand the effectiveness and tolerability of the treatment switch.

Throughout the study, participants will be monitored for any changes in their condition, and their overall health will be checked regularly. The study will last for a period of up to 70 days, during which participants will take the study medication and attend scheduled visits for evaluations. The goal is to determine if switching to levamlodipine can help reduce the swelling in patients who have not tolerated amlodipine well due to its side effects.

1 initial assessment

Upon joining the study, an initial assessment is conducted to evaluate the presence of peripheral edema in both legs. This involves both objective and subjective assessment methods.

The assessment includes a visual examination and grading of edema severity, as well as a patient-reported questionnaire to understand the impact of edema on daily life.

2 medication switch

Participants currently taking amlodipine are switched to levamlodipine. The medications are administered orally in tablet form.

The dosage for amlodipine is 2.5 mg, and for levamlodipine, it is 1.25 mg. The frequency and duration of administration are determined by the study protocol.

3 periodic evaluations

Throughout the trial, periodic evaluations are conducted to monitor changes in ankle circumference and edema severity using the figure-of-eight method and semiquantitative scoring.

Participants complete a patient-reported questionnaire at each visit to provide feedback on the tolerability and severity of edema.

4 safety monitoring

Safety is monitored through regular checks of vital signs such as blood pressure, heart rate, and body temperature.

Physical examinations and laboratory tests are conducted to ensure participant safety throughout the trial.

5 completion and follow-up

At the end of the trial, a final assessment is conducted to evaluate the change in ankle volume using the water displacement method.

Participants return any unused medication and complete a final questionnaire to report their experience during the trial.

Who Can Join the Study?

Patients must be willing to participate in the trial and sign an informed consent form. This means they agree to join the study after understanding what it involves.
Patients should be between 18 and 79 years old.
Patients must have arterial hypertension, which is high blood pressure, that is controlled with 1 to 3 medications, including amlodipine at a dose of 10 mg or 5 mg for at least 1 month. The blood pressure should be less than 140/90 mm Hg.
Patients must be willing to complete a questionnaire about their health and symptoms.
Patients should have peripheral edema, which is swelling in the legs, suspected to be caused by calcium channel blockers like amlodipine. The swelling should be moderate or severe, as assessed by the study doctor, or the patient should find the long-term treatment with amlodipine unacceptable based on their questionnaire answers.
Women who can have children must agree to use a highly effective form of birth control during the trial, or they must be post-menopausal for at least 12 months, or they must be surgically sterile, meaning they have had surgery to prevent pregnancy.

Who Cannot Join the Study?

Patients who have moderate or severe oedema (swelling) and are on long-term treatment with a medication called amlodipine cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Zdravi-fit s.r.o.	Protivin	Czechia

Other Sites

Site Name	City	Country	Status
Kardio Michal Cepelak s.r.o.	Klatovy	Czechia

Trial status

Country	Status	Recruitment Start
Czechia	Not recruiting	14.06.2024

Trial locations

Investigated drugs:

Amlodipine is a medication used to treat high blood pressure and chest pain. It works by relaxing blood vessels so that blood can flow more easily. In this trial, patients who are experiencing peripheral edema, a type of swelling in the legs, are being switched from this medication to another to see if the swelling improves.

Levamlodipine is a medication similar to amlodipine, used to manage high blood pressure. It is being tested in this trial to see if it causes less peripheral edema compared to amlodipine. The trial aims to evaluate if switching to levamlodipine can reduce the swelling in patients’ legs while still effectively controlling blood pressure.

Investigated diseases:

Oedema

Peripheral Edema – Peripheral edema is a condition characterized by the swelling of tissues, typically in the lower limbs, due to the accumulation of excess fluid. It often occurs as a result of prolonged standing or sitting, and can be exacerbated by certain medications, such as amlodipine. The swelling is usually noticeable in the feet, ankles, and legs, and may cause discomfort or a feeling of heaviness. The condition can progress gradually, with the severity of swelling varying throughout the day. In some cases, the skin over the swollen area may appear stretched or shiny. Peripheral edema is often assessed through both visual inspection and measurement techniques to determine the extent of fluid retention.

Trial ID:

2024-511312-24-00

Protocol code:

PERLA

Trial Phase:

Therapeutic exploratory (Phase II)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?