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

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00147615

Purpose

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.

Condition	Intervention	Phase
Hypertension	Drug: Eplerenone	Phase III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
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

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:

Safety of eplerenone in hypertensive children

Secondary Outcome Measures:

Efficacy and pharmacokinetics of eplerenone in hypertensive children

Estimated Enrollment:	140
Study Start Date:	October 2004
Estimated Study Completion Date:	June 2006

Eligibility

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00147615

Locations

United States, California
Pfizer Investigational Site
Los Angeles, California, United States, 90048
United States, Illinois
Pfizer Investigational Site
PARK RIDGE, Illinois, United States, 60068
United States, North Carolina
Pfizer Investigational Site
Durham, North Carolina, United States, 27710
United States, Ohio
Pfizer Investigational Site
Columbus, Ohio, United States, 43205
Pfizer Investigational Site
Columbus, Ohio, United States, 43205-2696
United States, Texas
Pfizer Investigational Site
Houston, Texas, United States, 77030
Pfizer Investigational Site
Katy, Texas, United States, 77094
India
Pfizer Investigational Site
Mumbai, India, 400 012
Pfizer Investigational Site
New Delhi, India, 110029
Pfizer Investigational Site
Chennai, India, 600 031
India, Andhra Pradesh
Pfizer Investigational Site
Hyderabad, Andhra Pradesh, India, 500 033
India, Karnataka
Pfizer Investigational Site
Bangalore, Karnataka, India, 560034
India, Tamil Nadu
Pfizer Investigational Site
Chennai, Tamil Nadu, India, 600 008
Russian Federation
Pfizer Investigational Site
Moscow, Russian Federation, 119991
Pfizer Investigational Site
Moscow, Russian Federation, 117869
Pfizer Investigational Site
Moscow, Russian Federation, 127412
Pfizer Investigational Site
St. Petersburg, Russian Federation, 196191
Pfizer Investigational Site
St. Petersburg, Russian Federation, 194100
Pfizer Investigational Site
Smolensk, Russian Federation, 214019
Pfizer Investigational Site
St. Petersburg, Russian Federation
Pfizer Investigational Site
St. Petersburg, Russian Federation, 194291

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:	A6141077
Study First Received:	September 2, 2005
Last Updated:	June 4, 2007
ClinicalTrials.gov Identifier:	NCT00147615 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 27, 2009