[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100637869":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":26,"centralContacts":27,"locations":26,"responsibleParty":33,"collaborators":26,"id":35,"slug":36,"hasResults":37,"nctId":38,"briefTitle":39,"officialTitle":40,"acronym":41,"eligibilityCriteria":42,"healthyVolunteers":37,"sex":43,"minAge":44,"maxAge":45,"enrollmentInfo":46,"targetDuration":26,"studyType":49,"phases":50,"briefSummary":52,"conditions":53,"keywords":26,"overallStatus":56,"whyStopped":26,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":26},{"fullName":5,"class":6},"Zentiva, k.s.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Amlodipine","ACTIVE_COMPARATOR","In the Amlodipine arm, 172 patients will receive the active comparator medication as an oral once-daily monotherapy for a total of 16 weeks. The treatment regimen includes a forced dose up-titration. During the 4-week Initial Phase, patients will take a lower dose of Amlodipine at 5 mg once daily. For the subsequent 12-week Maintenance Phase, the dose is increased to 10 mg once daily.",[13],"Drug: Amlodipine",{"label":15,"type":16,"description":17,"interventionNames":18},"Levamlodipine","EXPERIMENTAL","In the Levamlodipine arm, 172 patients will receive the investigational medication as an oral once-daily monotherapy for a total of 16 weeks. The treatment regimen includes a forced dose up-titration. During the 4-week Initial Phase, patients will take a lower dose of Levamlodipine at 2.5 mg once daily. For the subsequent 12-week Maintenance Phase, the dose is increased to 5 mg once daily.",[13],[20],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","amlodipine is an active comparator, levamlodipine is experimental",[9,15],[25],"levamlodipine",null,[28],{"name":29,"role":30,"phone":31,"phoneExt":26,"email":32},"Helena Krist","CONTACT","+420 607 006 440","helena.krist@zentiva.com",{"type":34,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100637869","phase-3-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-100637869",false,"NCT07618806","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.","A Prospective, Multicenter, Randomized, Double-Blind, Active-Controlled Phase IIIb Clinical Trial Evaluating the Incidence of Ankle Edema (Ankle Edema Volume) Induced by Levamlodipine Monotherapy vs Amlodipine in Treatment-Naïve or Mildly Uncontrolled Hypertensive Post-Menopausal Women.","TERESA","Inclusion Criteria:\n\n1. Post-menopausal women, defined as ≥12 months of spontaneous amenorrhea, not attributable to medications or other medical conditions known to cause amenorrhea.\n2. Aged 50-79 years.\n3. 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.\n\n   \\* A washout period of 14 days is required to minimize residual pharmacodynamic effects on vascular tone and edema development.\n4. Body Mass Index between 18.5 and 34.9 kg\u002Fm², inclusive, at Screening\n5. Able and willing to comprehend and sign a written informed consent form (ICF).\n\n   \\-\n\nExclusion Criteria:\n\n* 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).\n\n  2\\. Use of any CCBs, including dihydropyridine or non dihydropyridine agents (e.g., Amlodipine\u002F 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.\n\n  3\\. Hypoalbuminemia, defined as serum albumin \\\u003C 3.0 g\u002FdL 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) \\\u003C 45 mL\u002Fmin at Screening.\n\n  6\\. Presence of significant cardiovascular conditions, including but not limited to:\n  * 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.\n  * Clinically relevant ischemic heart disease\n  * Clinically significant arrhythmias\n  * Conduction abnormalities of clinical relevance and uncontrolled hypertension. 7. Clinically relevant peripheral vascular disease, including:\n  * Chronic venous insufficiency with clinically significant symptoms ((CEAP ≥ C2))\n  * Other peripheral vascular conditions deemed clinically relevant by the Investigator 8. Known or suspected secondary hypertension, including but not limited to:\n  * Renal artery stenosis\n  * Endocrine causes (e.g., primary aldosteronism, pheochromocytoma, Cushing's syndrome)\n  * 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:\n  * Diuretics (thiazide, loop, potassium-sparing)\n  * SGLT2 inhibitors\n  * Systemic corticosteroids\n  * Non-study antihypertensive agents\n  * Chronic NSAIDs (except low-dose aspirin for heart protection) 11. Participation in another clinical trial within 30 days prior to Screening.","FEMALE","50 Years","79 Years",{"count":47,"type":48},344,"ESTIMATED","INTERVENTIONAL",[51],"PHASE3","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.",[54,55],"Hypertension","Oedema","NOT_YET_RECRUITING","2026-05-25",{"date":59,"type":60},"2026-06-01","ACTUAL",{"date":62,"type":48},"2026-11-30",{"date":64,"type":48},"2028-05-31",{"name":5,"class":6}]