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
Parallel
Amlodipine
Drugamlodipine is an active comparator, levamlodipine is experimental
Ankle Foot Volume (AFV) change as measured by water displacement volumetry.
Change from baseline to Week 16 (or at the time of discontinuation due to unbearable edema, if measurement is available) of Ankle Foot Volume (AFV) as measured by water displacement volumetry.
Mean change from baseline in sitting SBP/DBP at week 16
Mean change from baseline in sitting SBP/DBP at week 16
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