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

Phase 3

Completed

• Conditions: Hypertension

• Registration Number: NCT00147589
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-09
• Study First Submitted: 2005-09-02
• Study First Submitted QC: 2005-09-02
• Study First Posted: 2005-09-07
• Study Completion: 2007-01
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-19
• Last Update Posted: 2020-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 320

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Efficacy of eplerenone in children

Secondary Outcome Measures

Name	Time	Method
Safety and tolerability of eplerenone in hypertensive children

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇿🇦 Cape Town, South Africa