Effect of Azilsartan on Aldosterone in Postmenopausal Females

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: November 2015

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.

Interventions

  • Drug: Azilsartan medoximil
    • All subjects were randomized to 80mg azilsartan medoxomil (azilsartan) daily or placebo and followed for six months.
  • Drug: Placebo
    • All subjects were randomized to 80mg azilsartan medoxomil (azilsartan) daily or placebo and followed for six months.

Arms, Groups and Cohorts

  • Active Comparator: azilsartan medoximil.
    • Subjects randomized to azilsartan medoximil arm will take 80 mg of azilsartan medoximil tablets by mouth each day.
  • Placebo Comparator: Placebo
    • Subjects randomized to the placebo arm will take 80 mg of placebo tablets by mouth each day

Clinical Trial Outcome Measures

Primary 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 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

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 45 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Chicago
  • Collaborator
    • Takeda
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • George Bakris, MD, Principal Investigator, University of Chicago

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