New study aims to stop ankle swelling from blood pressure meds
NCT ID NCT07618806
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study compares two blood pressure medications, amlodipine and a purer version called levamlodipine, to see which causes less ankle swelling in post-menopausal women. About 344 women aged 50-79 with mild to moderate high blood pressure will take a daily pill for 18 weeks. Doctors will measure ankle swelling using a simple water bath method and check blood pressure at four clinic visits.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 344 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Nov 2026
An estimate. Start dates often move.
- Expected to finish
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May 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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50 to 79 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Post-menopausal women, defined as ≥12 months of spontaneous amenorrhea, not attributable to medications or other medical conditions known to cause amenorrhea. 2. Aged 50-79 years. 3. 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. 4. Body Mass Index between 18.5 and 34.9 kg/m², inclusive, at Screening 5. Able and willing to comprehend and sign a written informed consent form (ICF). \- Exclusion Criteria: * 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). 2\. 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. 3\. 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. 6\. 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
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How to take part
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The official record
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A doctor treating you
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Other studies related to the condition(s) this trial covers.
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