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New study aims to stop ankle swelling from blood pressure meds

NCT ID NCT07618806

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
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Paused for now. It may or may not start again.
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Running, but no longer taking on new participants.
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The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

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Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
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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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 344 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Nov 2026

An estimate. Start dates often move.

Expected to finish

May 2028

An estimate. End dates often move.

Lead sponsor

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

50 to 79 years

Sex

Female participants only

Healthy volunteers

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

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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