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NOT YET RECRUITING
NCT07618806
PHASE3

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.

View on ClinicalTrials.gov

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.

Official title: A Prospective, Multicenter, Randomized, Double-Blind, Active-Controlled Phase IIIb Clinical Trial Evaluating the Incidence of Ankle Edema (Ankle Edema Volume) Induced by Levamlodipine Monotherapy vs Amlodipine in Treatment-Naïve or Mildly Uncontrolled Hypertensive Post-Menopausal Women.

Key Details

Gender

FEMALE

Age Range

50 Years - 79 Years

Study Type

INTERVENTIONAL

Enrollment

344

Start Date

2026-11-30

Completion Date

2028-05-31

Last Updated

2026-06-01

Healthy Volunteers

No

Interventions

DRUG

Amlodipine

amlodipine is an active comparator, levamlodipine is experimental