drugset / Trial / NCT07618806

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

Phase 3 Not yet recruiting 344 enrolled Zentiva, k.s.
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2026-11-30
Primary completion
2027-12-31
Completion
2028-05-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Amlodipine Other / unclassified 10 mg Oral
Subject S-amlodipine Unknown 5 mg Oral

Indications