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.

Laborértékek

• 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.

• 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).
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