Effect of Azilsartan on Aldosterone in Postmenopausal Females

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

Detailed Description
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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.

Official Title
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Effect of Azilsartan on Aldosterone in Postmenopausal Females

Conditions
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Hypertension

Intervention / Treatment
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* Drug: Azilsartan medoximil
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: azilsartan medoximil.<br>Subjects randomized to azilsartan medoximil arm will take 80 mg of azilsartan medoximil tablets by mouth each day. | Drug: Azilsartan medoximil<br>* All subjects were randomized to 80mg azilsartan medoxomil (azilsartan) daily or placebo and followed for six months.<br>* Other names: Edarbi;|
| Placebo Comparator: Placebo<br>Subjects randomized to the placebo arm will take 80 mg of placebo tablets by mouth each day | Drug: Placebo<br>* All subjects were randomized to 80mg azilsartan medoxomil (azilsartan) daily or placebo and followed for six months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24-hour BP (Systolic) | To evaluate the effect of an angiotensin receptor blocker (azilsartan medoximil) on blood pressure in postmenopausal females. | 26 weeks | 
| 24-hour BP (Diastolic) | To evaluate the effect of an angiotensin receptor blocker (azilsartan medoximil) on blood pressure in postmenopausal females. | 26 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in 24-hour Urine Aldosterone Change From Baseline | To evaluate the effect of an angiotensin receptor blocker (azilsartan medoximil) on urinary aldosterone levels in postmenopausal females | 26 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Post Menopause, Female, Obese