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

Phase 3

Completed

• Conditions: Hypertension

• Registration Number: NCT00147615
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-10
• Study First Submitted: 2005-09-02
• Study First Submitted QC: 2005-09-02
• Study First Posted: 2005-09-07
• Study Completion: 2006-06
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-19
• Last Update Posted: 2020-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Safety of eplerenone in hypertensive children

Secondary Outcome Measures

Name	Time	Method
Efficacy and pharmacokinetics of eplerenone in hypertensive children

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇷🇺 St. Petersburg, Russian Federation