NCT01774591

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable hypertension

Timeline
Completed

Started Jan 2013

Typical duration for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

January 22, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 24, 2013

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

November 9, 2017

Completed
Last Updated

November 9, 2017

Status Verified

October 1, 2017

Enrollment Period

2.8 years

First QC Date

January 22, 2013

Results QC Date

August 4, 2017

Last Update Submit

October 10, 2017

Conditions

Hypertension

Keywords

Post MenopauseFemaleObese

Outcome Measures

Primary Outcomes (2)

  • 24-hour BP (Systolic)

    To evaluate the effect of an angiotensin receptor blocker (azilsartan medoximil) on blood pressure in postmenopausal females.

    26 weeks

  • 24-hour BP (Diastolic)

    To evaluate the effect of an angiotensin receptor blocker (azilsartan medoximil) on blood pressure in postmenopausal females.

    26 weeks

Secondary Outcomes (1)

  • Difference in 24-hour Urine Aldosterone Change From Baseline

    26 weeks

Study Arms (2)

azilsartan medoximil.

ACTIVE COMPARATOR

Subjects randomized to azilsartan medoximil arm will take 80 mg of azilsartan medoximil tablets by mouth each day.

Drug: Azilsartan medoximil

Placebo

PLACEBO COMPARATOR

Subjects randomized to the placebo arm will take 80 mg of placebo tablets by mouth each day

Drug: Placebo

Interventions

Azilsartan medoximilDRUG

All subjects were randomized to 80mg azilsartan medoxomil (azilsartan) daily or placebo and followed for six months.

Also known as: Edarbi
azilsartan medoximil.
PlaceboDRUG

All subjects were randomized to 80mg azilsartan medoxomil (azilsartan) daily or placebo and followed for six months.

Placebo

Eligibility Criteria

Age45 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

HypertensionObesity

Interventions

azilsartan

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
George L. Bakris, MD
Organization
University of Chicago
bbrisky@medicine.bsd.uchicago.edu
773-702-7936

Study Officials

  • George Bakris, MD

    University of Chicago

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2013

First Posted

January 24, 2013

Study Start

January 1, 2013

Primary Completion

November 1, 2015

Study Completion

January 1, 2016

Last Updated

November 9, 2017

Results First Posted

November 9, 2017

Record last verified: 2017-10

Locations

US(1)