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

This study has been completed.

First Received: September 2, 2005 Last Updated: January 23, 2008 History of Changes

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

Show 41 Study Locations

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 27, 2009