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Effect of Azilsartan on Aldosterone in Postmenopausal Females

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01774591
First Posted: January 24, 2013
Last Update Posted: November 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Takeda
Information provided by (Responsible Party):
University of Chicago
  Purpose
The purpose of the research is to evaluate the effect of azilsartan medoximil on blood pressure and urinary aldosterone levels in postmenopausal females.

Condition Intervention
Hypertension Drug: Azilsartan medoximil Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Azilsartan on Aldosterone in Postmenopausal Females

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • 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.

  • 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.


Secondary Outcome Measures:
  • 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


Enrollment: 21
Study Start Date: January 2013
Study Completion Date: January 2016
Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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.

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01774591


Locations
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Takeda
Investigators
Principal Investigator: George Bakris, MD University of Chicago
  More Information

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT01774591     History of Changes
Other Study ID Numbers: 12-1179
First Submitted: January 22, 2013
First Posted: January 24, 2013
Results First Submitted: August 4, 2017
Results First Posted: November 9, 2017
Last Update Posted: November 9, 2017
Last Verified: October 2017

Keywords provided by University of Chicago:
Post Menopause
Female
Obese