Status:

COMPLETED

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

Lead Sponsor:

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

Conditions:

Hypertension

Eligibility:

All Genders

6-16 years

Phase:

PHASE3

Brief Summary

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 patien...

Eligibility Criteria

Inclusion

  • 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

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

Key Trial Info

Start Date :

September 1 2004

Trial Type :

INTERVENTIONAL

End Date :

January 1 2007

Estimated Enrollment :

320 Patients enrolled

Trial Details

Trial ID

NCT00147589

Start Date

September 1 2004

End Date

January 1 2007

Last Update

December 22 2020

Active Locations (41)

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Page 1 of 11 (41 locations)

1

Pfizer Investigational Site

Little Rock, Arkansas, United States

2

Pfizer Investigational Site

Beverly Hills, California, United States

3

Pfizer Investigational Site

Inglewood, California, United States

4

Pfizer Investigational Site

Los Angeles, California, United States