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The Long-term Study to Evaluate the Safety of Eplerenone in the Treatment of Hypertension in Children Aged 6 to 16 Years

NCT ID: NCT00147615

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

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Study Completion Date

2006-06-30

Brief Summary

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To assess the long-term safety and toleration of eplerenone in the children aged 6 to 16 years with high blood pressure. The study will last at least 1 year and about 140 patients will participate.

Detailed Description

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Conditions

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Hypertension

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Eplerenone

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Males and females aged 6 to 16 years
* The seated 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 4 or 5
* 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

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Los Angeles, California, United States

Site Status

Pfizer Investigational Site

Park Ridge, Illinois, United States

Site Status

Pfizer Investigational Site

Durham, North Carolina, United States

Site Status

Pfizer Investigational Site

Columbus, Ohio, United States

Site Status

Pfizer Investigational Site

Columbus, Ohio, United States

Site Status

Pfizer Investigational Site

Houston, Texas, United States

Site Status

Pfizer Investigational Site

Katy, Texas, United States

Site Status

Pfizer Investigational Site

Hyderabad, Andhra Pradesh, India

Site Status

Pfizer Investigational Site

Bangalore, Karnataka, India

Site Status

Pfizer Investigational Site

Chennai, Tamil Nadu, India

Site Status

Pfizer Investigational Site

Chennai, , India

Site Status

Pfizer Investigational Site

Mumbai, , India

Site Status

Pfizer Investigational Site

New Delhi, , India

Site Status

Pfizer Investigational Site

Moscow, , Russia

Site Status

Pfizer Investigational Site

Moscow, , Russia

Site Status

Pfizer Investigational Site

Moscow, , Russia

Site Status

Pfizer Investigational Site

Saint Petersburg, , Russia

Site Status

Pfizer Investigational Site

Saint Petersburg, , Russia

Site Status

Pfizer Investigational Site

Saint Petersburg, , Russia

Site Status

Pfizer Investigational Site

Saint Petersburg, , Russia

Site Status

Pfizer Investigational Site

Smolensk, , Russia

Site Status

Countries

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United States India Russia

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6141077&StudyName=The+long%2Dterm+study+to+evaluate+the+safety+of+Eplerenone+in+the+treatment+of+hypertension+in+children+aged+6+to+16+years

To obtain contact information for a study center near you, click here.

Other Identifiers

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A6141077

Identifier Type: -

Identifier Source: org_study_id