Effect of Azilsartan on Aldosterone in Postmenopausal Females

October 10, 2017 updated by: University of Chicago
The purpose of the research is to evaluate the effect of azilsartan medoximil on blood pressure and urinary aldosterone levels in postmenopausal females.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chicago

Collaborators

Takeda

Investigators

  • Principal Investigator: George Bakris, MD, University of Chicago

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

January 22, 2013

First Submitted That Met QC Criteria

January 22, 2013

First Posted (Estimate)

January 24, 2013

Study Record Updates

Last Update Posted (Actual)

November 9, 2017

Last Update Submitted That Met QC Criteria

October 10, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-1179

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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