Status:
COMPLETED
The Long-term Study to Evaluate the Safety of Eplerenone in the Treatment of Hypertension in Children Aged 6 to 16 Years
Lead Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions:
Hypertension
Eligibility:
All Genders
6-16 years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- 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
- K/DOQI classification of stages of chronic kidney disease equal to 4 or 5
- Serum or whole blood potassium \> 5.5. mEq/L
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
End Date :
June 1 2006
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT00147615
Start Date
October 1 2004
End Date
June 1 2006
Last Update
December 22 2020
Active Locations (21)
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1
Pfizer Investigational Site
Los Angeles, California, United States, 90048
2
Pfizer Investigational Site
Park Ridge, Illinois, United States, 60068
3
Pfizer Investigational Site
Durham, North Carolina, United States, 27710
4
Pfizer Investigational Site
Columbus, Ohio, United States, 43205-2696