Clinical trial NCT00147589: A Study to Evaluate the Efficacy and Safety of Eplerenone in the Treatment of Hypertension in Children.
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-07
Enrollment: 320
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 patients will participate.


Eligibility criteria: 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

Primary outcomes:
measure: Efficacy of eplerenone in children
Secondary outcomes:
measure: Safety and tolerability of eplerenone in hypertensive children
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Pfizer Investigational Site
state: Arkansas
city: Beverly Hills
country: United States
facility: Pfizer Investigational Site
state: California
city: Inglewood
country: United States
facility: Pfizer Investigational Site
state: California
city: Los Angeles
country: United States
facility: Pfizer Investigational Site
state: California
city: Jacksonville
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Augusta
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Park Ridge
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Louisville
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Shreveport
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Boston
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Ann Arbor
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Jackson
country: United States
facility: Pfizer Investigational Site
state: Mississippi
city: Tupelo
country: United States
facility: Pfizer Investigational Site
state: Mississippi
city: Livingston
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: Carrboro
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Chapel Hill
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Pittsboro
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Cleveland
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Columbus
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Youngstown
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Tulsa
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Portland
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: Philadelphia
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Memphis
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Beaumont
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Katy
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Santo Domingo
country: Dominican Republic
facility: Pfizer Investigational Site
state: DN
city: Bangalore
country: India
facility: Pfizer Investigational Site
state: Karnataka
city: Chennai
country: India
facility: Pfizer Investigational Site
state: Tamil Nadu
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: Smolensk
country: Russian Federation
facility: Pfizer Investigational Site
city: St. Petersburg
country: Russian Federation
facility: Pfizer Investigational Site
city: Capital Park
country: South Africa
facility: Pfizer Investigational Site
state: Gauteng
city: Johannesburg
country: South Africa
facility: Pfizer Investigational Site
state: Gauteng
city: Pretoria
country: South Africa
facility: Pfizer Investigational Site
state: Gauteng
city: Soweto
country: South Africa
facility: Pfizer Investigational Site
state: Gauteng
city: Polokwane
country: South Africa
facility: Pfizer Investigational Site
state: Lipompo Province
city: Parow
country: South Africa
facility: Pfizer Investigational Site
state: Western Cape
city: Cape Town
country: South Africa
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: