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.
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.
Body Mass Index between 18.5 and 34.9 kg/m², inclusive, at Screening
1. 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).
Clinically significant heart failure, defined as New York Heart Association (NYHA) Class II-IV heart failure, based on medical history, clinical evaluation, and investigator judgement. NT-proBNP values may be used as a supportive laboratory parameter in the clinical assessment of suspected heart failure but shall not be used as a stand-alone exclusion criterion in the absence of corresponding clinical signs or symptoms.
Clinically relevant ischemic heart disease
Clinically significant arrhythmias