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

December 19, 2020 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Peds I (Pediatric Eplerenone Development Study I): A Randomized, Double-Blind, Placebo Withdrawal, Parallel Group, Dose-Response Study To Evaluate The Efficacy And Safety Of Eplerenone In The Treatment Of Hypertension In Children

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

320

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Dominican Republic
    • DN
      • Santo Domingo, DN, Dominican Republic
        • Pfizer Investigational Site
  • India
    • Karnataka
      • Bangalore, Karnataka, India
        • Pfizer Investigational Site
    • Tamil Nadu
      • Chennai, Tamil Nadu, India
        • Pfizer Investigational Site
  • Russian Federation
      • Moscow, Russian Federation
        • Pfizer Investigational Site
      • Smolensk, Russian Federation
        • Pfizer Investigational Site
      • St. Petersburg, Russian Federation
        • Pfizer Investigational Site
  • South Africa
      • Cape Town, South Africa
        • Pfizer Investigational Site
    • Gauteng
      • Capital Park, Gauteng, South Africa
        • Pfizer Investigational Site
      • Johannesburg, Gauteng, South Africa
        • Pfizer Investigational Site
      • Pretoria, Gauteng, South Africa
        • Pfizer Investigational Site
      • Soweto, Gauteng, South Africa
        • Pfizer Investigational Site
    • Lipompo Province
      • Polokwane, Lipompo Province, South Africa
        • Pfizer Investigational Site
    • Western Cape
      • Parow, Western Cape, South Africa
        • Pfizer Investigational Site
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States
        • Pfizer Investigational Site
    • California
      • Beverly Hills, California, United States
        • Pfizer Investigational Site
      • Inglewood, California, United States
        • Pfizer Investigational Site
      • Los Angeles, California, United States
        • Pfizer Investigational Site
    • Florida
      • Jacksonville, Florida, United States
        • Pfizer Investigational Site
      • Miami, Florida, United States
        • Pfizer Investigational Site
    • Georgia
      • Augusta, Georgia, United States
        • Pfizer Investigational Site
    • Illinois
      • Park Ridge, Illinois, United States
        • Pfizer Investigational Site
    • Kentucky
      • Louisville, Kentucky, United States
        • Pfizer Investigational Site
    • Louisiana
      • Shreveport, Louisiana, United States
        • Pfizer Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States
        • Pfizer Investigational Site
    • Michigan
      • Ann Arbor, Michigan, United States
        • Pfizer Investigational Site
    • Mississippi
      • Jackson, Mississippi, United States
        • Pfizer Investigational Site
      • Tupelo, Mississippi, United States
        • Pfizer Investigational Site
    • New Jersey
      • Livingston, New Jersey, United States
        • Pfizer Investigational Site
    • North Carolina
      • Carrboro, North Carolina, United States
        • Pfizer Investigational Site
      • Chapel Hill, North Carolina, United States
        • Pfizer Investigational Site
      • Pittsboro, North Carolina, United States
        • Pfizer Investigational Site
    • Ohio
      • Cleveland, Ohio, United States
        • Pfizer Investigational Site
      • Columbus, Ohio, United States
        • Pfizer Investigational Site
      • Youngstown, Ohio, United States
        • Pfizer Investigational Site
    • Oklahoma
      • Tulsa, Oklahoma, United States
        • Pfizer Investigational Site
    • Oregon
      • Portland, Oregon, United States
        • Pfizer Investigational Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
        • Pfizer Investigational Site
    • Tennessee
      • Memphis, Tennessee, United States
        • Pfizer Investigational Site
    • Texas
      • Beaumont, Texas, United States
        • Pfizer Investigational Site
      • Houston, Texas, United States
        • Pfizer Investigational Site
      • Katy, Texas, United States
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Efficacy of eplerenone in children

Secondary Outcome Measures

Outcome Measure
Safety and tolerability of eplerenone in hypertensive children

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2004

Study Completion (Actual)

January 1, 2007

Study Registration Dates

First Submitted

September 2, 2005

First Submitted That Met QC Criteria

September 2, 2005

First Posted (Estimate)

September 7, 2005

Study Record Updates

Last Update Posted (Actual)

December 22, 2020

Last Update Submitted That Met QC Criteria

December 19, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A6141001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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