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

Condition(s) targeted: Hypertension

Intervention: Eplerenone (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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.

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 design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Primary outcome: Efficacy of eplerenone in children

Secondary outcome: Safety and tolerability of eplerenone in hypertensive children

Minimum age: 6 Years. Maximum age: 16 Years. Gender(s): Both.

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

Pfizer Investigational Site, Moscow, Russian Federation

Pfizer Investigational Site, St. Petersburg, Russian Federation

Pfizer Investigational Site, Smolensk, Russian Federation

Pfizer Investigational Site, Cape Town, South Africa

Pfizer Investigational Site, Little Rock, Arkansas, United States

Pfizer Investigational Site, Beverly Hills, California, United States

Pfizer Investigational Site, Los Angeles, California, United States

Pfizer Investigational Site, Inglewood, California, United States

Pfizer Investigational Site, Santo Domingo, DN, Dominican Republic

Pfizer Investigational Site, Miami, Florida, United States

Pfizer Investigational Site, Jacksonville, Florida, United States

Pfizer Investigational Site, Soweto, Gauteng, South Africa

Pfizer Investigational Site, Capital Park, Gauteng, South Africa

Pfizer Investigational Site, Johannesburg, Gauteng, South Africa

Pfizer Investigational Site, Pretoria, Gauteng, South Africa

Pfizer Investigational Site, Augusta, Georgia, United States

Pfizer Investigational Site, PARK RIDGE, Illinois, United States

Pfizer Investigational Site, Bangalore, Karnataka, India

Pfizer Investigational Site, Louisville, Kentucky, United States

Pfizer Investigational Site, Polokwane, Lipompo Province, South Africa

Pfizer Investigational Site, Shreveport, Louisiana, United States

Pfizer Investigational Site, Boston, Massachusetts, United States

Pfizer Investigational Site, Ann Arbor, Michigan, United States

Pfizer Investigational Site, Jackson, Mississippi, United States

Pfizer Investigational Site, Tupelo, Mississippi, United States

Pfizer Investigational Site, Livingston, New Jersey, United States

Pfizer Investigational Site, 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, Columbus, Ohio, United States

Pfizer Investigational Site, Cleveland, Ohio, United States

Pfizer Investigational Site, Youngstown, Ohio, United States

Pfizer Investigational Site, Tulsa, Oklahoma, United States

Pfizer Investigational Site, Portland, Oregon, United States

Pfizer Investigational Site, Philadelphia, Pennsylvania, United States

Pfizer Investigational Site, Chennai, Tamil Nadu, India

Pfizer Investigational Site, Memphis, Tennessee, United States

Pfizer Investigational Site, Houston, Texas, United States

Pfizer Investigational Site, Katy, Texas, United States

Pfizer Investigational Site, Beaumont, Texas, United States

Pfizer Investigational Site, Parow, Western Cape, South Africa

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

Link to ClinicalStudyResults.org posting:

Starting date: September 2004
Ending date: January 2007
Last updated: January 23, 2008