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.

• Azilsartan medoximil (Drug), also known as Edarbi: All subjects were randomized to 80mg azilsartan medoxomil (azilsartan) daily or placebo and followed for six months.
• Placebo (Drug): All subjects were randomized to 80mg azilsartan medoxomil (azilsartan) daily or placebo and followed for six months.

Primary outcomes

• 24-hour BP (Systolic) [26 weeks]: To evaluate the effect of an angiotensin receptor blocker (azilsartan medoximil) on blood pressure in postmenopausal females.
• 24-hour BP (Diastolic) [26 weeks]: To evaluate the effect of an angiotensin receptor blocker (azilsartan medoximil) on blood pressure in postmenopausal females.

Secondary outcomes

• Difference in 24-hour Urine Aldosterone Change From Baseline [26 weeks]: To evaluate the effect of an angiotensin receptor blocker (azilsartan medoximil) on urinary aldosterone levels in postmenopausal females

Sex: Female, ages: 45 Years to 70 Years

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

Participant flow

Outcome results

• 24-hour BP (Systolic) (Primary), Mean, mmHg: Azilsartan Medoximil. 113 +/- 14; Placebo 129 +/- 904
• Difference in 24-hour Urine Aldosterone Change From Baseline (Secondary), Mean, percentage of changes: Azilsartan Medoximil. -47.3 +/- 32.9; Placebo -5.3 +/- 52.3
• 24-hour BP (Diastolic) (Primary), Mean, mmHg: Azilsartan Medoximil. 75 +/- 8.8; Placebo 89 +/- 11

Adverse events

Time frame: 6 months

Other adverse events by term

• George Bakris, MD, Principal investigator, University of Chicago