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
1 other identifier
interventional
140
3 countries
21
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 hypertension
Started Oct 2004
Typical duration for phase_3 hypertension
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 2, 2005
CompletedFirst Posted
Study publicly available on registry
September 7, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2006
CompletedDecember 22, 2020
December 1, 2020
September 2, 2005
December 19, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Safety of eplerenone in hypertensive children
Secondary Outcomes (1)
Efficacy and pharmacokinetics of eplerenone in hypertensive children
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- K/DOQI classification of stages of chronic kidney disease equal to 4 or 5
- Serum or whole blood potassium \> 5.5. mEq/L
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
Pfizer Investigational Site
Los Angeles, California, 90048, United States
Pfizer Investigational Site
Park Ridge, Illinois, 60068, United States
Pfizer Investigational Site
Durham, North Carolina, 27710, United States
Pfizer Investigational Site
Columbus, Ohio, 43205-2696, United States
Pfizer Investigational Site
Columbus, Ohio, 43205, United States
Pfizer Investigational Site
Houston, Texas, 77030, United States
Pfizer Investigational Site
Katy, Texas, 77094, United States
Pfizer Investigational Site
Hyderabad, Andhra Pradesh, 500 033, India
Pfizer Investigational Site
Bangalore, Karnataka, 560034, India
Pfizer Investigational Site
Chennai, Tamil Nadu, 600 008, India
Pfizer Investigational Site
Chennai, 600 031, India
Pfizer Investigational Site
Mumbai, 400 012, India
Pfizer Investigational Site
New Delhi, 110029, India
Pfizer Investigational Site
Moscow, 117869, Russia
Pfizer Investigational Site
Moscow, 119991, Russia
Pfizer Investigational Site
Moscow, 127412, Russia
Pfizer Investigational Site
Saint Petersburg, 194100, Russia
Pfizer Investigational Site
Saint Petersburg, 194291, Russia
Pfizer Investigational Site
Saint Petersburg, 196191, Russia
Pfizer Investigational Site
Saint Petersburg, Russia
Pfizer Investigational Site
Smolensk, 214019, Russia
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 2, 2005
First Posted
September 7, 2005
Study Start
October 1, 2004
Study Completion
June 1, 2006
Last Updated
December 22, 2020
Record last verified: 2020-12