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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00147589
Recruitment Status : Completed
First Posted : September 7, 2005
Last Update Posted : January 25, 2008
Sponsor:
Information provided by:
Pfizer

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.

Condition or disease Intervention/treatment Phase
Hypertension Drug: Eplerenone Phase 3

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Study Type : Interventional  (Clinical Trial)
Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: 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
Study Start Date : September 2004
Actual Study Completion Date : January 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Eplerenone




Primary Outcome Measures :
  1. Efficacy of eplerenone in children

Secondary Outcome Measures :
  1. Safety and tolerability of eplerenone in hypertensive children


Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   6 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00147589


Locations
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United States, Arkansas
Pfizer Investigational Site
Little Rock, Arkansas, United States
United States, California
Pfizer Investigational Site
Beverly Hills, California, United States
Pfizer Investigational Site
Inglewood, California, United States
Pfizer Investigational Site
Los Angeles, California, United States
United States, Florida
Pfizer Investigational Site
Jacksonville, Florida, United States
Pfizer Investigational Site
Miami, Florida, United States
United States, Georgia
Pfizer Investigational Site
Augusta, Georgia, United States
United States, Illinois
Pfizer Investigational Site
Park Ridge, Illinois, United States
United States, Kentucky
Pfizer Investigational Site
Louisville, Kentucky, United States
United States, Louisiana
Pfizer Investigational Site
Shreveport, Louisiana, United States
United States, Massachusetts
Pfizer Investigational Site
Boston, Massachusetts, United States
United States, Michigan
Pfizer Investigational Site
Ann Arbor, Michigan, United States
United States, Mississippi
Pfizer Investigational Site
Jackson, Mississippi, United States
Pfizer Investigational Site
Tupelo, Mississippi, United States
United States, New Jersey
Pfizer Investigational Site
Livingston, New Jersey, United States
United States, North Carolina
Pfizer Investigational Site
Carrboro, North Carolina, United States
Pfizer Investigational Site
Chapel Hill, North Carolina, United States
Pfizer Investigational Site
Pittsboro, North Carolina, United States
United States, Ohio
Pfizer Investigational Site
Cleveland, Ohio, United States
Pfizer Investigational Site
Columbus, Ohio, United States
Pfizer Investigational Site
Youngstown, Ohio, United States
United States, Oklahoma
Pfizer Investigational Site
Tulsa, Oklahoma, United States
United States, Oregon
Pfizer Investigational Site
Portland, Oregon, United States
United States, Pennsylvania
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States
United States, Tennessee
Pfizer Investigational Site
Memphis, Tennessee, United States
United States, Texas
Pfizer Investigational Site
Beaumont, Texas, United States
Pfizer Investigational Site
Houston, Texas, United States
Pfizer Investigational Site
Katy, Texas, United States
Dominican Republic
Pfizer Investigational Site
Santo Domingo, DN, Dominican Republic
India
Pfizer Investigational Site
Bangalore, Karnataka, India
Pfizer Investigational Site
Chennai, Tamil Nadu, India
Russian Federation
Pfizer Investigational Site
Moscow, Russian Federation
Pfizer Investigational Site
Smolensk, Russian Federation
Pfizer Investigational Site
St. Petersburg, Russian Federation
South Africa
Pfizer Investigational Site
Capital Park, Gauteng, South Africa
Pfizer Investigational Site
Johannesburg, Gauteng, South Africa
Pfizer Investigational Site
Pretoria, Gauteng, South Africa
Pfizer Investigational Site
Soweto, Gauteng, South Africa
Pfizer Investigational Site
Polokwane, Lipompo Province, South Africa
Pfizer Investigational Site
Parow, Western Cape, South Africa
Pfizer Investigational Site
Cape Town, South Africa
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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ClinicalTrials.gov Identifier: NCT00147589    
Other Study ID Numbers: A6141001
First Posted: September 7, 2005    Key Record Dates
Last Update Posted: January 25, 2008
Last Verified: March 2007
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
Eplerenone
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents
Antihypertensive Agents