A Study to Evaluate the Efficacy and Safety of Eplerenone in the Treatment of Hypertension in Children.

NCT ID: NCT00147589

Last Updated: 2020-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

320 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Study Completion Date

2007-01-31

Brief Summary

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To evaluate the efficacy, safety, and toleration of eplerenone in the treatment of children aged 6 to 16 years with high blood pressure. The study will last approximately 10 weeks and about 320 patients will participate.

Detailed Description

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Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Eplerenone

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 6-16 years old male and female
* Systolic blood pressure greater than or equal to the 95th percentile for age, gender, and height, measured on at least 3 separate occasions

Exclusion Criteria

* K/DOQI classification of stages of chronic kidney disease equal to or greater than 3
* Serum or whole blood potassium \> 5.5 mEq/L
Minimum Eligible Age

6 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Little Rock, Arkansas, United States

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Beverly Hills, California, United States

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Inglewood, California, United States

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Los Angeles, California, United States

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Jacksonville, Florida, United States

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Miami, Florida, United States

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Augusta, Georgia, United States

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Park Ridge, Illinois, United States

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Louisville, Kentucky, United States

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Shreveport, Louisiana, United States

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Boston, Massachusetts, United States

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Ann Arbor, Michigan, United States

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Jackson, Mississippi, United States

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Tupelo, Mississippi, United States

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Livingston, New Jersey, United States

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Carrboro, North Carolina, United States

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Chapel Hill, North Carolina, United States

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Pittsboro, North Carolina, United States

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Cleveland, Ohio, United States

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Columbus, Ohio, United States

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Youngstown, Ohio, United States

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Tulsa, Oklahoma, United States

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Portland, Oregon, United States

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Philadelphia, Pennsylvania, United States

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Memphis, Tennessee, United States

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Beaumont, Texas, United States

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Houston, Texas, United States

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Katy, Texas, United States

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Santo Domingo, DN, Dominican Republic

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Bangalore, Karnataka, India

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Chennai, Tamil Nadu, India

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Moscow, , Russia

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Saint Petersburg, , Russia

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Smolensk, , Russia

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Capital Park, Gauteng, South Africa

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Johannesburg, Gauteng, South Africa

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Pretoria, Gauteng, South Africa

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Soweto, Gauteng, South Africa

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Polokwane, Lipompo Province, South Africa

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Parow, Western Cape, South Africa

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Cape Town, , South Africa

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Countries

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United States Dominican Republic India Russia South Africa

Related Links

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Other Identifiers

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A6141001

Identifier Type: -

Identifier Source: org_study_id