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

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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)

Trial contacts and locations

21

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Data sourced from clinicaltrials.gov

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