A Study to Evaluate the Efficacy and Safety of Eplerenone in the Treatment of Hypertension in Children. - Full Text View

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00147589

Purpose

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.

Condition	Intervention	Phase
Hypertension	Drug: Eplerenone	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Efficacy of eplerenone in children

Secondary Outcome Measures:

Safety and tolerability of eplerenone in hypertensive children

Estimated Enrollment:	320
Study Start Date:	September 2004
Study Completion Date:	January 2007

Eligibility

Ages Eligible for Study:	6 Years to 16 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00147589

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Locations

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

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Link to ClinicalStudyResults.org posting: This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	A6141001
Study First Received:	September 2, 2005
Last Updated:	January 23, 2008
ClinicalTrials.gov Identifier:	NCT00147589 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Eplerenone
Aldosterone Antagonists
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists

Vascular Diseases
Cardiovascular Diseases
Pharmacologic Actions
Hypertension

ClinicalTrials.gov processed this record on November 25, 2009