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

Viatris

Status and phase: Completed; Phase 3

Conditions: Hypertension

Treatments: Drug: Eplerenone

Study type: Interventional

Funder types: Industry

Identifiers

NCT00147615

A6141077

Details and patient eligibility

About

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.

Sex: All

Ages: 6 to 16 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)