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Trial record 30 of 112 for:    EPLERENONE

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. Identifier: NCT00147589
Recruitment Status : Completed
First Posted : September 7, 2005
Last Update Posted : January 25, 2008
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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

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

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 identifier (NCT number): NCT00147589

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Sponsors and Collaborators
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Study Director: Pfizer Call Center Pfizer

Additional Information:
Layout table for additonal information Identifier: NCT00147589     History of Changes
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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Vascular Diseases
Cardiovascular Diseases
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Natriuretic Agents
Antihypertensive Agents