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