Effect of Azilsartan on Aldosterone in Postmenopausal Females

This study is currently recruiting participants.
Verified January 2013 by University of Chicago
Sponsor:
Collaborator:
Takeda
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT01774591
First received: January 22, 2013
Last updated: September 6, 2013
Last verified: January 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:
  • To evaluate the effect of an angiotensin receptor blocker (azilsartan medoximil) on blood pressure in postmenopausal females. [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the effect of an angiotensin receptor blocker (azilsartan medoximil) on urinary aldosterone levels in postmenopausal females. [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: January 2013
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2018 (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
Placebo Comparator: Placebo
Subjects randomized to the placebo arm will take 80 mg of placebo tablets by mouth each day
Drug: Placebo

Detailed Description:

The study is a randomized, placebo-controlled trial of 40 post-menopausal females with stage 1 hypertension

  Eligibility

Ages Eligible for Study:   45 Years to 70 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01774591

Contacts
Contact: Carrie Schlaffer 773-702-2591 cschalff@medicine.bsd.uchicago.edu

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

No publications provided

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT01774591     History of Changes
Other Study ID Numbers: 12-1179
Study First Received: January 22, 2013
Last Updated: September 6, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Chicago:
Post Menopause
Female
Obese

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 21, 2014