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

Viatris

Status and phase: Completed; Phase 3

Conditions: Hypertension

Treatments: Drug: Eplerenone

Study type: Interventional

Funder types: Industry

Identifiers

NCT00147589

A6141001

Details and patient eligibility

About

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.

Sex: All

Ages: 6 to 16 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind