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NCT00147589 Clinical Trial

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

Hypertension Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00147589
Other study ID # A6141001
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date September 2004
Est. completion date January 2007

Study information
Verified date December 2020
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 patients will participate.

Recruitment information / eligibility
Status Completed
Enrollment 320
Est. completion date January 2007
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 6 Years to 16 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Eplerenone

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

Sponsors (1)
Lead Sponsor Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Countries where clinical trial is conducted

United States,  Dominican Republic,  India,  Russian Federation,  South Africa, 

Outcome
Type Measure Description Time frame Safety issue
Primary Efficacy of eplerenone in children
Secondary Safety and tolerability of eplerenone in hypertensive children
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