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.
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.
detailed description
Overview and Trial Design The TERESA trial is a prospective, multicenter, randomized, double-blind, active-controlled, parallel-group Phase IIIb clinical study. The trial is designed to evaluate the incidence and volume of ankle edema induced by Levamlodipine monotherapy compared to standard Amlodipine monotherapy. The study consists of an 18-week participation period per patient, which includes a 2-week screening phase and a 16-week continuous treatment phase.
Background and Rationale Hypertension is a leading cause of preventable premature mortality and is responsible for a significant proportion of cardiovascular morbidity globally. Calcium channel blockers (CCBs), such as amlodipine, are widely recommended as first-line therapies due to their potent antihypertensive effects. However, a common and dose-dependent adverse effect of long-acting dihydropyridine CCBs is peripheral ankle edema, which can lead to reduced adherence or discontinuation of the medication. This adverse effect is significantly more prevalent in women. Amlodipine is a racemic mixture consisting of equal proportions of two enantiomers: R(+)-amlodipine and S(-)-amlodipine (Levamlodipine). Clinical evidence indicates that Levamlodipine is the active enantiomer responsible for lowering blood pressure. Conversely, R(+)-amlodipine provides little effect on blood pressure but is associated with adverse effects, including peripheral edema. This study aims to determine whether a purified formulation containing only Levamlodipine offers superior tolerability regarding peripheral edema while maintaining effective blood pressure control.
Study Population The trial focuses on a population highly susceptible to CCB-induced peripheral edema: post-menopausal women aged 50 to 79 years. Key Inclusion Criteria: Participants must have mild to moderate uncontrolled hypertension, defined as a systolic blood pressure (SBP) between 140 and 179 mmHg at screening and baseline. Patients must have a Body Mass Index (BMI) between 18.5 and 34.9 kg/m². Patients can be treatment-naïve or previously treated with angiotensin-converting enzyme (ACE) inhibitors or angiotensin II receptor blockers (ARBs). If previously treated with ACE inhibitors or ARBs, patients must complete a 14-day washout period to ensure all participants begin the trial on antihypertensive monotherapy. Key Exclusion Criteria: Patients must not have baseline peripheral edema from any cause. Any prior exposure to CCBs (dihydropyridine or non-dihydropyridine) is strictly prohibited to prevent confounding carry-over effects. Additional exclusion criteria include severe hypertension (SBP \> 180 mmHg or diastolic blood pressure \> 110 mmHg), significant renal impairment (eGFR \< 45 mL/min), hypoalbuminemia, and clinically significant heart failure or peripheral vascular disease.
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.