Effect of Azilsartan on Aldosterone in Postmenopausal Females

The University of Chicago

Status: Completed

Conditions: Hypertension

Treatments: Drug: Placebo; Drug: Azilsartan medoximil

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01774591

12-1179

Details and patient eligibility

About

The purpose of the research is to evaluate the effect of azilsartan medoximil on blood pressure and urinary aldosterone levels in postmenopausal females.

Full description

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.

Enrollment: 21 patients

Sex: Female

Ages: 45 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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21 participants in 2 patient groups, including a placebo group

azilsartan medoximil.

Active Comparator group

Description:

Subjects randomized to azilsartan medoximil arm will take 80 mg of azilsartan medoximil tablets by mouth each day.

Treatment:

Drug: Azilsartan medoximil

Placebo

Placebo Comparator group

Description:

Subjects randomized to the placebo arm will take 80 mg of placebo tablets by mouth each day

Treatment:

Drug: Placebo