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

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NCT00147589

Last updated on May 12, 2018
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Study Location
Pfizer Investigational Site
Little Rock, Arkansas, United States
See other locations
Contact
1-800-718-1021
[email protected]
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Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Hypertension
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
6-16 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- K/DOQI classification of stages of chronic kidney disease equal to or greater than 3

- Serum or whole blood potassium > 5.5 mEq/L

NCT00147589
Pfizer
Completed
A Study to Evaluate the Efficacy and Safety of Eplerenone in the Treatment of Hypertension in Children.

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A Study to Evaluate the Efficacy and Safety of Eplerenone in the Treatment of Hypertension in Children.
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
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Hypertension
Drug: Eplerenone
Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
320
January 2007
Not Provided

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
Sexes Eligible for Study: All
6 Years to 16 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Dominican Republic,   India,   Russian Federation,   South Africa,   United States
 
 
NCT00147589
A6141001
Not Provided
Not Provided
Not Provided
Not Provided
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2007

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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[email protected]



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