NCT00147589

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
320

participants targeted

Target at P50-P75 for phase_3 hypertension

Timeline
Completed

Started Sep 2004

Typical duration for phase_3 hypertension

Geographic Reach
5 countries

41 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 2, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 7, 2005

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
Last Updated

December 22, 2020

Status Verified

December 1, 2020

First QC Date

September 2, 2005

Last Update Submit

December 19, 2020

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

  • Efficacy of eplerenone in children

Secondary Outcomes (1)

  • Safety and tolerability of eplerenone in hypertensive children

Interventions

EplerenoneDRUG

Eligibility Criteria

Age6 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • K/DOQI classification of stages of chronic kidney disease equal to or greater than 3
  • Serum or whole blood potassium \> 5.5 mEq/L

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (41)

Pfizer Investigational Site

Little Rock, Arkansas, United States

Location

Pfizer Investigational Site

Beverly Hills, California, United States

Location

Pfizer Investigational Site

Inglewood, California, United States

Location

Pfizer Investigational Site

Los Angeles, California, United States

Location

Pfizer Investigational Site

Jacksonville, Florida, United States

Location

Pfizer Investigational Site

Miami, Florida, United States

Location

Pfizer Investigational Site

Augusta, Georgia, United States

Location

Pfizer Investigational Site

Park Ridge, Illinois, United States

Location

Pfizer Investigational Site

Louisville, Kentucky, United States

Location

Pfizer Investigational Site

Shreveport, Louisiana, United States

Location

Pfizer Investigational Site

Boston, Massachusetts, United States

Location

Pfizer Investigational Site

Ann Arbor, Michigan, United States

Location

Pfizer Investigational Site

Jackson, Mississippi, United States

Location

Pfizer Investigational Site

Tupelo, Mississippi, United States

Location

Pfizer Investigational Site

Livingston, New Jersey, United States

Location

Pfizer Investigational Site

Carrboro, North Carolina, United States

Location

Pfizer Investigational Site

Chapel Hill, North Carolina, United States

Location

Pfizer Investigational Site

Pittsboro, North Carolina, United States

Location

Pfizer Investigational Site

Cleveland, Ohio, United States

Location

Pfizer Investigational Site

Columbus, Ohio, United States

Location

Pfizer Investigational Site

Youngstown, Ohio, United States

Location

Pfizer Investigational Site

Tulsa, Oklahoma, United States

Location

Pfizer Investigational Site

Portland, Oregon, United States

Location

Pfizer Investigational Site

Philadelphia, Pennsylvania, United States

Location

Pfizer Investigational Site

Memphis, Tennessee, United States

Location

Pfizer Investigational Site

Beaumont, Texas, United States

Location

Pfizer Investigational Site

Houston, Texas, United States

Location

Pfizer Investigational Site

Katy, Texas, United States

Location

Pfizer Investigational Site

Santo Domingo, DN, Dominican Republic

Location

Pfizer Investigational Site

Bangalore, Karnataka, India

Location

Pfizer Investigational Site

Chennai, Tamil Nadu, India

Location

Pfizer Investigational Site

Moscow, Russia

Location

Pfizer Investigational Site

Saint Petersburg, Russia

Location

Pfizer Investigational Site

Smolensk, Russia

Location

Pfizer Investigational Site

Capital Park, Gauteng, South Africa

Location

Pfizer Investigational Site

Johannesburg, Gauteng, South Africa

Location

Pfizer Investigational Site

Pretoria, Gauteng, South Africa

Location

Pfizer Investigational Site

Soweto, Gauteng, South Africa

Location

Pfizer Investigational Site

Polokwane, Lipompo Province, South Africa

Location

Pfizer Investigational Site

Parow, Western Cape, South Africa

Location

Pfizer Investigational Site

Cape Town, South Africa

Location

Related Links

MeSH Terms

Conditions

Hypertension

Interventions

Eplerenone

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

LactonesOrganic ChemicalsPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2005

First Posted

September 7, 2005

Study Start

September 1, 2004

Study Completion

January 1, 2007

Last Updated

December 22, 2020

Record last verified: 2020-12

Locations

DO(1)IN(2)US(28)RU(3)ZA(7)