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.

NCT07618806 | Not Yet Recruiting Phase 3 FDA Drug

• 1 other identifier: LEVAML155226
• Study Type: interventional
• Target: 344
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Hypertension; Oedema

Outcome Measures

Primary Outcomes (1)

• Ankle Foot Volume (AFV) change as measured by water displacement volumetry.

  Change from baseline to Week 16 (or at the time of discontinuation due to unbearable edema, if measurement is available) of Ankle Foot Volume (AFV) as measured by water displacement volumetry.

  baseline to week 16

Secondary Outcomes (1)

• Mean change from baseline in sitting SBP/DBP at week 16

  baseline to 16 weeks

Study Arms (2)

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.

Drug: Amlodipine

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.

Drug: Amlodipine

Interventions

Amlodipine DRUG

amlodipine is an active comparator, levamlodipine is experimental

Also known as: levamlodipine

Amlodipine; Levamlodipine

Eligibility Criteria

• Age: 50 Years - 79 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• \. 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 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

Sponsors & Collaborators

• Zentiva, k.s.: lead

MeSH Terms

Conditions

Hypertension; Edema

Interventions

Amlodipine; levamlodipine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Helena Krist

CONTACT

+420 607 006 440; helena.krist@zentiva.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: In this double-blind clinical trial, patients, investigators, and all site staff involved are unaware of the treatment assignment a patient receives. Each patient will receive an identical medication kit containing either one of the two investigational medicinal products (Levamlodipine or Amlodipine). Unblinding will only occur after the completion of the trial and final data collection, unless emergency unblinding is required for patient safety.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2026
• First Posted: June 1, 2026
• Study Start (Estimated): November 30, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): May 31, 2028
• Last Updated: June 1, 2026

Record last verified: 2026-05