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Effect of Azilsartan on Aldosterone in Postmenopausal Females

NCT ID: NCT01774591

Last Updated: 2017-11-09

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2016-01-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Hypertension

Keywords

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Post Menopause Female Obese

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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azilsartan medoximil.

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

Group Type ACTIVE_COMPARATOR

Azilsartan medoximil

Intervention Type DRUG

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

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Azilsartan medoximil

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

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Edarbi

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Takeda

INDUSTRY

Sponsor Role collaborator

University of Chicago

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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George Bakris, MD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

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University of Chicago

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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12-1179

Identifier Type: -

Identifier Source: org_study_id