Effect of Azilsartan on Aldosterone in Postmenopausal Females

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 26, 2014