Effect of Azilsartan on Aldosterone in Postmenopausal Females

Not Applicable

Completed

• Conditions: Hypertension
• Interventions: Drug: Azilsartan medoximil; Drug: Placebo

• Registration Number: NCT01774591
• Lead Sponsor: University of Chicago

Brief Summary

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

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-01-22
• Study First Submitted QC: 2013-01-22
• Study First Posted: 2013-01-24
• Primary Completion: 2015-11
• Study Completion: 2016-01
• Results First Submitted: 2017-08-04
• Status Verified: 2017-10
• Results First Submitted QC: 2017-10-10
• Last Update Submitted: 2017-10-10
• Results First Posted: 2017-11-09
• Last Update Posted: 2017-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 21

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
azilsartan medoximil.	Azilsartan medoximil	Subjects randomized to azilsartan medoximil arm will take 80 mg of azilsartan medoximil tablets by mouth each day.
Placebo	Placebo	Subjects randomized to the placebo arm will take 80 mg of placebo tablets by mouth each day

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of Chicago; 🇺🇸 Chicago, Illinois, United States