A Clinical Study Comparing Ankle Swelling Caused by Two Different Blood Pressure Medications, Lev… (NCT07618806) | Clinical Trial Compass
Not Yet RecruitingPhase 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.
344 participantsStarted 2026-11-30
Plain-language summary
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.
Who can participate
Age range
50 Years – 79 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
. 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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Ankle Foot Volume (AFV) change as measured by water displacement volumetry.