#1 Clinical Trials Search in Europe

Levamlodipine Succinate

The PERLA (Peripheral Edema Resolution evaluated in patients switched from amlodipine to Levamlodipine) clinical trial is investigating the use of Levamlodipine Succinate as a potential alternative to amlodipine for patients with hypertension who experience moderate to severe peripheral edema. This study aims to assess the effectiveness of Levamlodipine Succinate in reducing leg swelling while maintaining blood pressure control, potentially offering a more tolerable treatment option for patients.

Table of Contents

What is Levamlodipine Succinate?

Levamlodipine succinate is a medication that belongs to a class of drugs called calcium channel blockers (CCBs)[1]. It is also known by its product name “S-Amlodipine TAB (VAM)” and is manufactured by ZENTIVA, K.S[1]. Levamlodipine is a refined version of a commonly used blood pressure medication called amlodipine.

Medical Conditions Treated

Levamlodipine succinate is primarily used to treat:

  • Hypertension (high blood pressure): The medication helps control blood pressure in patients who are already on 1-3 antihypertensive drugs, including amlodipine[1].
  • Peripheral edema: This is a condition where excess fluid accumulates in the legs and feet, causing swelling. Levamlodipine is being studied as a potential alternative for patients who experience moderate to severe edema while on long-term amlodipine treatment[1].

How Levamlodipine Works

As a calcium channel blocker, levamlodipine works by:

  • Relaxing and widening blood vessels, which helps to lower blood pressure[1].
  • Potentially reducing the side effect of peripheral edema, which is sometimes associated with other calcium channel blockers like amlodipine[1].

Potential Benefits

Levamlodipine succinate may offer several advantages over traditional amlodipine:

  • Improved management of peripheral edema: The ongoing clinical trial (PERLA) is investigating whether switching from amlodipine to levamlodipine can help resolve peripheral edema in patients[1].
  • Effective blood pressure control: The medication aims to maintain blood pressure control in patients who were previously stable on amlodipine[1].
  • Potentially better tolerability: Some patients may find levamlodipine more acceptable for long-term treatment compared to amlodipine[1].

Dosage Information

Based on the clinical trial information:

  • Levamlodipine succinate is available in tablet form[1].
  • The dosage strength mentioned in the trial is 1.25 mg[1].
  • The maximum daily dose is 5 mg[1].
  • The maximum total dose amount over the course of treatment is 245 mg[1].
  • The medication is taken orally[1].

It’s important to note that dosage should always be determined by your healthcare provider based on your individual needs and medical condition.

Side Effects and Safety

While the full safety profile of levamlodipine succinate is still being studied, potential side effects and safety considerations may include:

  • Blood pressure changes: Your doctor will monitor your blood pressure regularly to ensure it remains well-controlled[1].
  • Heart rate changes: Your heart rate may be monitored during treatment[1].
  • Peripheral edema: While levamlodipine aims to reduce this side effect, it’s still important to monitor for any swelling in your legs or feet[1].
  • Other potential side effects: As with any medication, there may be other side effects. The ongoing clinical trial is monitoring for adverse events to better understand the safety profile of levamlodipine[1].

Always inform your healthcare provider about any side effects you experience while taking this medication.

Current Clinical Trial: PERLA Study

Levamlodipine succinate is currently being studied in a clinical trial called PERLA (Peripheral Edema Resolution evaluated in patients switched from amlodipine to Levamlodipine)[1]. Key points about this study include:

  • Main objective: To evaluate the effect of switching from amlodipine to levamlodipine on peripheral edema in both legs[1].
  • Study participants: Adults aged 18-79 with controlled hypertension who are experiencing moderate to severe peripheral edema while on amlodipine treatment[1].
  • Measurements: The study will use various techniques to measure peripheral edema, including water displacement method and ankle circumference measurements[1].
  • Additional assessments: The trial will also monitor blood pressure, heart rate, medication compliance, and overall safety[1].

This clinical trial aims to provide more information about the effectiveness and safety of levamlodipine succinate, particularly in addressing the issue of peripheral edema associated with calcium channel blockers.

Aspect Details
Study Name PERLA (Peripheral Edema Resolution evaluated in patients switched from amlodipine to Levamlodipine)
Primary Objective Evaluate peripheral edema reduction in legs when switching from amlodipine to Levamlodipine Succinate
Key Inclusion Criteria Ages 18-79, controlled hypertension on amlodipine, moderate to severe peripheral edema
Key Exclusion Criteria Poorly controlled diabetes, severe hypotension, recent cardiovascular events, severe organ diseases
Primary Endpoint Change in leg volume measured by water displacement method
Secondary Endpoints Ankle circumference changes, edema scoring, patient-reported outcomes, blood pressure measurements
Safety Assessments Vital signs, physical examinations, adverse event monitoring, laboratory tests
Maximum Treatment Duration 70 days

FAQ

  • What is the main purpose of the PERLA clinical trial? The main purpose of the PERLA trial is to evaluate the reduction of peripheral edema (swelling) in the legs of patients who switch from amlodipine to Levamlodipine Succinate. The study will use various measurement techniques to assess changes in leg swelling and compare them with patients' reported experiences.
  • Who can participate in this clinical trial? Participants must be between 18 and 79 years old, have controlled hypertension while taking amlodipine, and experience moderate to severe peripheral edema. They must also be willing to complete questionnaires and, if applicable, use effective birth control methods throughout the trial.
  • How will the effectiveness of Levamlodipine Succinate be measured? The effectiveness will be measured through various methods, including water displacement to measure leg volume, ankle circumference measurements, visual assessment of edema by investigators, and patient-reported questionnaires. Blood pressure and heart rate will also be monitored throughout the trial.
  • What are some reasons why a person might not be able to participate in this trial? Exclusion criteria include poorly controlled diabetes, certain medical conditions like severe hypotension or heart failure, use of specific medications that may cause edema, pregnancy or breastfeeding, and recent participation in other clinical trials. People with severe liver, kidney, or pancreatic disease are also excluded.
  • How long does the PERLA clinical trial last? While the exact duration isn't specified, the trial is divided into three periods. The maximum treatment period with Levamlodipine Succinate is mentioned as 70 days, suggesting the trial may last approximately 2-3 months, including baseline assessments and follow-up visits.

Ongoing Clinical Trials on Levamlodipine Succinate

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

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Czechia

Glossary

  • Peripheral Edema: Swelling in the legs, ankles, or feet caused by fluid buildup in the body's tissues. In this trial, it's a side effect associated with certain blood pressure medications.
  • Levamlodipine Succinate: The active ingredient being studied in this trial, which is a form of calcium channel blocker used to treat high blood pressure.
  • Amlodipine: A commonly prescribed calcium channel blocker used to treat high blood pressure, which some patients are switching from in this study.
  • Hypertension: High blood pressure, a condition where the force of blood against artery walls is consistently too high.
  • Systolic Blood Pressure (SBP): The pressure in your arteries when your heart beats, represented by the top number in a blood pressure reading.
  • Diastolic Blood Pressure (DBP): The pressure in your arteries between heartbeats, represented by the bottom number in a blood pressure reading.
  • Ambulatory Blood Pressure Monitoring (ABPM): A method of measuring blood pressure over 24 hours while patients go about their normal daily activities.
  • Home Blood Pressure Monitoring (HBPM): A way for patients to measure their own blood pressure at home using a personal blood pressure device.
  • Adverse Event (AE): Any unfavorable and unintended sign, symptom, or disease that occurs during the study, whether or not it's related to the treatment.

References

  1. http://clinicaltrials.eu/trial/study-on-reducing-peripheral-edema-in-patients-switching-from-amlodipine-besilate-to-levamlodipine-succinate/