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

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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

Trial contacts and locations

41

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Data sourced from clinicaltrials.gov

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