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

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.140 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

140

Conditions

Hypertension

Interventions

EplerenoneDRUG

Eligibility

Sex: ALLMin age: 6 YearsMax age: 16 Years

Medical Language ↔ Plain English

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

Locations (21)

Pfizer Investigational Site

Los Angeles, California, United States

Pfizer Investigational Site

Park Ridge, Illinois, United States

Outcomes

Primary Outcomes

Safety of eplerenone in hypertensive children

Secondary Outcomes

Efficacy and pharmacokinetics of eplerenone in hypertensive children

Data from ClinicalTrials.gov

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