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

Last updated on October 4, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Los Angeles, California, 90048 United States
Contact
1-800-718-1021
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

- 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
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 4 or 5

- Serum or whole blood potassium > 5.5. mEq/L

NCT00147615
Pfizer
Completed
The Long-Term Study to Evaluate the Safety of Eplerenone in the Treatment of Hypertension in Children Aged 6 to 16 Years

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The Long-Term Study to Evaluate the Safety of Eplerenone in the Treatment of Hypertension in Children Aged 6 to 16 Years
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
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.
Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
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
140
June 2006
Not Provided

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
Sexes Eligible for Study: All
6 Years to 16 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
India,   Russian Federation,   United States
 
 
NCT00147615
A6141077
Not Provided
Not Provided
Not Provided
Not Provided
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
June 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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1-800-718-1021

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