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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00147615
First received: September 2, 2005
Last updated: June 4, 2007
Last verified: June 2007
  Purpose

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.


Condition Intervention Phase
Hypertension
Drug: Eplerenone
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Safety of eplerenone in hypertensive children

Secondary Outcome Measures:
  • Efficacy and pharmacokinetics of eplerenone in hypertensive children

Estimated Enrollment: 140
Study Start Date: October 2004
Estimated Study Completion Date: June 2006
  Eligibility

Ages Eligible for Study:   6 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00147615

Locations
United States, California
Pfizer Investigational Site
Los Angeles, California, United States, 90048
United States, Illinois
Pfizer Investigational Site
Park Ridge, Illinois, United States, 60068
United States, North Carolina
Pfizer Investigational Site
Durham, North Carolina, United States, 27710
United States, Ohio
Pfizer Investigational Site
Columbus, Ohio, United States, 43205
Pfizer Investigational Site
Columbus, Ohio, United States, 43205-2696
United States, Texas
Pfizer Investigational Site
Houston, Texas, United States, 77030
Pfizer Investigational Site
Katy, Texas, United States, 77094
India
Pfizer Investigational Site
Hyderabad, Andhra Pradesh, India, 500 033
Pfizer Investigational Site
Bangalore, Karnataka, India, 560034
Pfizer Investigational Site
Chennai, Tamil Nadu, India, 600 008
Pfizer Investigational Site
Chennai, India, 600 031
Pfizer Investigational Site
Mumbai, India, 400 012
Pfizer Investigational Site
New Delhi, India, 110029
Russian Federation
Pfizer Investigational Site
Moscow, Russian Federation, 119991
Pfizer Investigational Site
Moscow, Russian Federation, 117869
Pfizer Investigational Site
Moscow, Russian Federation, 127412
Pfizer Investigational Site
Smolensk, Russian Federation, 214019
Pfizer Investigational Site
St. Petersburg, Russian Federation, 194291
Pfizer Investigational Site
St. Petersburg, Russian Federation, 194100
Pfizer Investigational Site
St. Petersburg, Russian Federation
Pfizer Investigational Site
St. Petersburg, Russian Federation, 196191
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00147615     History of Changes
Other Study ID Numbers: A6141077
Study First Received: September 2, 2005
Last Updated: June 4, 2007
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Eplerenone
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 14, 2014