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

Tracking Information

First Received Date ^ICMJE

September 2, 2005

Last Updated Date

January 23, 2008

Start Date ^ICMJE

September 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Efficacy of eplerenone in children

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00147589 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Safety and tolerability of eplerenone in hypertensive children

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Hypertension

Intervention ^ICMJE

Drug: Eplerenone

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

320

Completion Date

January 2007

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

6 Years to 16 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Dominican Republic, India, Russian Federation, South Africa

Administrative Information

NCT ID ^ICMJE

NCT00147589

Responsible Party

Study ID Numbers ^ICMJE

A6141001

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

March 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP