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

Peds I (Pediatric Eplerenone Development Study I): A Randomized, Double-Blind, Placebo Withdrawal, Parallel Group, Dose-Response Study To Evaluate The Efficacy And Safety Of Eplerenone In The Treatment Of Hypertension In Children

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00147589

Enrollment

320

Registered

2005-09-07

Start date

2004-09-30

Completion date

2007-01-31

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 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.

Interventions

DRUGEplerenone

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

6 Years to 16 Years

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

Design outcomes

Primary

Measure	Time frame
Efficacy of eplerenone in children	—

Secondary

Measure	Time frame
Safety and tolerability of eplerenone in hypertensive children	—

Countries

Dominican Republic, India, Russia, South Africa, United States

Outcome results

None listed

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