A Clinical Study Comparing Ankle Swelling Caused by Two Different Blood Pressure Medications, Levamlodipine and Amlodipine, in Post-menopausal Women With Mild High Blood Pressure.

Starting soon · Phase 3

Conditions studied: Hypertension, Oedema

In brief

High blood pressure is often treated with a medication called Amlodipine, but it can cause uncomfortable ankle swelling, especially in women. This 18-week study compares standard Amlodipine with a more purified version called Levamlodipine to see if it causes less ankle swelling while still effectively lowering blood pressure. The study is designed for post-menopausal women aged 50 to 79 with mild to moderate high blood pressure. Participants will take a daily pill and attend four clinic visits. During these visits, doctors will monitor blood pressure and carefully measure ankle volume using a simple, painless water bath method.

Key facts

Study ID

NCT07618806

Run by

Zentiva, k.s.

People needed

344

Starts

2026-11-30

Expected to finish

2028-05-31

Last updated by the study team

2026-06-01

Who can join

Age: 50 and older, up to 79. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Post-menopausal women, defined as ≥12 months of spontaneous amenorrhea, not attributable to medications or other medical conditions known to cause amenorrhea.
• Aged 50-79 years.
• Women with mild to moderate uncontrolled hypertension, defined as an SBP of 140-179 mmHg at Screening and Baseline. Patients may be treatment-naïve or previously treated with ACE inhibitors or ARBs (sartans) at Screening. Previously treated patients must discontinue prior treatment at Screening and complete a protocol-defined washout period of at least 14 days between Screening and randomization (Baseline)*, during which no antihypertensive treatment will be administered, ensuring that all patients start study treatment as antihypertensive monotherapy.
• A washout period of 14 days is required to minimize residual pharmacodynamic effects on vascular tone and edema development.
• Body Mass Index between 18.5 and 34.9 kg/m², inclusive, at Screening
• Able and willing to comprehend and sign a written informed consent form (ICF).

You may not qualify if…

• 1. Presence of peripheral edema at screening and baseline, from any cause, including but not limited to drug-related or non-drug-related etiologies (e.g., chronic venous insufficiency, lymphedema).
• Use of any CCBs, including dihydropyridine or non dihydropyridine agents (e.g., Amlodipine/ Levamlodipine or other CCB therapy) Known hypersensitivity, intolerance, or contraindication to dihydropyridine CCBs, including Amlodipine or Levamlodipine, or to any excipient of the investigational products.
• Hypoalbuminemia, defined as serum albumin < 3.0 g/dL at Screening. 4. Clinically relevant hepatic impairment, defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) values ≥ 2.5 × the site-specific upper limit of normal (ULN) at Screening or other clinically relevant severe hepatic impairment 5. Significant renal impairment, defined as estimated glomerular filtration rate (eGFR) < 45 mL/min at Screening.
• Presence of significant cardiovascular conditions, including but not limited to:
• Clinically significant heart failure, defined as New York Heart Association (NYHA) Class II-IV heart failure, based on medical history, clinical evaluation, and investigator judgement. NT-proBNP values may be used as a supportive laboratory parameter in the clinical assessment of suspected heart failure but shall not be used as a stand-alone exclusion criterion in the absence of corresponding clinical signs or symptoms.
• Clinically relevant ischemic heart disease
• Clinically significant arrhythmias
• Conduction abnormalities of clinical relevance and uncontrolled hypertension. 7. Clinically relevant peripheral vascular disease, including:
• Chronic venous insufficiency with clinically significant symptoms ((CEAP ≥ C2))
• Other peripheral vascular conditions deemed clinically relevant by the Investigator 8. Known or suspected secondary hypertension, including but not limited to:
• Renal artery stenosis
• Endocrine causes (e.g., primary aldosteronism, pheochromocytoma, Cushing's syndrome)
• Other identifiable secondary causes 9. Severe hypertension at Screening, defined as SBP > 180 mmHg or DBP > 110 mmHg 10. Patients will be excluded if they are taking drugs that affect plasma volume or vasodilatory edema assessment, such as:
• Diuretics (thiazide, loop, potassium-sparing)
• SGLT2 inhibitors
• Systemic corticosteroids
• Non-study antihypertensive agents
• Chronic NSAIDs (except low-dose aspirin for heart protection) 11. Participation in another clinical trial within 30 days prior to Screening.

Full record on ClinicalTrials.gov

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