In short
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.
At a glance
- 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
What is Levamlodipine Succinate?
Levamlodipine succinate is a medication that belongs to a class of drugs called calcium channel blockers (CCBs). It is also known by its product name "S-Amlodipine TAB (VAM)" and is manufactured by ZENTIVA, K.S. 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.
- 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.
How Levamlodipine Works
As a calcium channel blocker, levamlodipine works by:
- Relaxing and widening blood vessels, which helps to lower blood pressure.
- Potentially reducing the side effect of peripheral edema, which is sometimes associated with other calcium channel blockers like amlodipine.
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.
- Effective blood pressure control: The medication aims to maintain blood pressure control in patients who were previously stable on amlodipine.
- Potentially better tolerability: Some patients may find levamlodipine more acceptable for long-term treatment compared to amlodipine.
Dosage Information
Based on the clinical trial information:
- Levamlodipine succinate is available in tablet form.
- The dosage strength mentioned in the trial is 1.25 mg.
- The maximum daily dose is 5 mg.
- The maximum total dose amount over the course of treatment is 245 mg.
- The medication is taken orally.
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.
- Heart rate changes: Your heart rate may be monitored during treatment.
- Peripheral edema: While levamlodipine aims to reduce this side effect, it's still important to monitor for any swelling in your legs or feet.
- 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.
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). Key points about this study include:
- Main objective: To evaluate the effect of switching from amlodipine to levamlodipine on peripheral edema in both legs.
- Study participants: Adults aged 18-79 with controlled hypertension who are experiencing moderate to severe peripheral edema while on amlodipine treatment.
- Measurements: The study will use various techniques to measure peripheral edema, including water displacement method and ankle circumference measurements.
- Additional assessments: The trial will also monitor blood pressure, heart rate, medication compliance, and overall safety.
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.