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

• Status: Completed
• Trial end date: 2007-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer; Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• Treatments: Eplerenone; Spironolactone

Criteria

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