The Long-Term Study to Evaluate the Safety of Eplerenone in the Treatment of Hypertension in Children Aged 6 to 16 Years

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 assess the long-term safety and toleration of eplerenone in the children aged 6 to 16 years with high blood pressure. The study will last at least 1 year and about 140 patients will participate.

Official title: Peds II (Pediatric Eplerenone Development Study II)--An Open Label, Long-Term Study To Evaluate The Safety Of Eplerenone In The Treatment Of Hypertension In Children

Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study

Primary outcome: Safety of eplerenone in hypertensive children

Secondary outcome: Efficacy and pharmacokinetics of eplerenone in hypertensive children

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

Criteria:

Inclusion Criteria:

- Males and females aged 6 to 16 years

- The seated 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 4 or 5

- Serum or whole blood potassium > 5. 5. mEq/L

Pfizer Investigational Site, Mumbai 400 012, India

Pfizer Investigational Site, New Delhi 110029, India

Pfizer Investigational Site, Chennai 600 031, India

Pfizer Investigational Site, Moscow 119991, Russian Federation

Pfizer Investigational Site, Moscow 117869, Russian Federation

Pfizer Investigational Site, Moscow 127412, Russian Federation

Pfizer Investigational Site, St. Petersburg 194291, Russian Federation

Pfizer Investigational Site, St. Petersburg 194100, Russian Federation

Pfizer Investigational Site, Smolensk 214019, Russian Federation

Pfizer Investigational Site, St. Petersburg, Russian Federation

Pfizer Investigational Site, St. Petersburg 196191, Russian Federation

Pfizer Investigational Site, Hyderabad, Andhra Pradesh 500 033, India

Pfizer Investigational Site, Los Angeles, California 90048, United States

Pfizer Investigational Site, PARK RIDGE, Illinois 60068, United States

Pfizer Investigational Site, Bangalore, Karnataka 560034, India

Pfizer Investigational Site, Durham, North Carolina 27710, United States

Pfizer Investigational Site, Columbus, Ohio 43205, United States

Pfizer Investigational Site, Columbus, Ohio 43205-2696, United States

Pfizer Investigational Site, Chennai, Tamil Nadu 600 008, India

Pfizer Investigational Site, Houston, Texas 77030, United States

Pfizer Investigational Site, Katy, Texas 77094, United States

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

Link to ClinicalStudyResults.org Posting:

Starting date: October 2004
Ending date: June 2006
Last updated: June 4, 2007