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.

Sponsor
Zentiva, k.s.
Study ID
NCT07618806
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
FEMALE
Age
50 Years - 79 Years
Healthy Volunteers
Not accepted

Interventions

  • Amlodipine — DRUG
    amlodipine is an active comparator, levamlodipine is experimental

Study Details

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.

Key Dates

First listed
Jun 1, 2026
Start date
Nov 30, 2026
Status verified
May 2026
Primary completion
Dec 31, 2027
Completion
May 31, 2028

Study Design

Enrollment
344 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Amlodipine
    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.
  • Experimental: Levamlodipine
    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.

Primary Outcome Measure

Ankle Foot Volume (AFV) change as measured by water displacement volumetry. [ Time Frame: baseline to week 16 ]

Central Contacts

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