Effect of Azilsartan on Aldosterone in Postmenopausal Females

The study is a randomized, placebo-controlled trial of post-menopausal females with stage 1 hypertension. The goal is to randomize 40 post-menopausal females with stage 1 hypertension and assess whether azilsartan reduces urinary aldosterone levels. We will compare subjects having azilsartan medoximil (treatment group) with placebo group. Additionally, a small sub-study comparing pre-menopausal and post-menopausal female aldosterone levels was performed as well as the presence of aldosterone production in fat cell cultures of a subset of 3 patients in the randomized trial.

Inclusion criteria

• Female
• Ages 45-70
• Post-menopause: have not had a menstrual period for one year or more
• Diagnosed with Stage 1 hypertension
• Body Mass Index (BMI) greater than or equal to 28

Exclusion criteria

• Male
• Diagnosed with Stage 2 hypertension
• Stage 1 hypertension requiring more than one agent
• Pregnancy or attempting pregnancy
• Use of oral contraceptive pills
• Use of hormone replacement therapy
• Use of steroids
• Stage 3 or greater kidney disease
• Diabetes mellitus
• untreated hypothyroidism or hyperthyroidism
• primary hyperaldosteronism
• Cushing's disease
• obstructive sleep apnea
• chronic illness, e.g. chronic liver disease
• NYHA class III or greater heart failure
• moderate to severe lung disease