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

Peds II (Pediatric Eplerenone Development Study II)--An Open Label, Long-Term Study To Evaluate The Safety Of Eplerenone In The Treatment Of Hypertension In Children

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00147615

Enrollment

140

Registered

2005-09-07

Start date

2004-10-31

Completion date

2006-06-30

Last updated

2020-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Brief summary

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.

Interventions

DRUGEplerenone

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

6 Years to 16 Years

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

Design outcomes

Primary

Measure	Time frame
Safety of eplerenone in hypertensive children	—

Secondary

Measure	Time frame
Efficacy and pharmacokinetics of eplerenone in hypertensive children	—

Countries

India, Russia, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026