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

Completed · Phase 3

Conditions studied: Hypertension

In brief

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.

Key facts

Study ID

NCT00147615

Run by

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

People needed

140

Starts

2004-10-01

Expected to finish

2006-06-01

Last updated by the study team

2020-12-22

Who can join

Age: 6 and older, up to 16. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• K/DOQI classification of stages of chronic kidney disease equal to 4 or 5
• Serum or whole blood potassium > 5.5. mEq/L

Where it is running

• Pfizer Investigational Site — Los Angeles, California, United States
• Pfizer Investigational Site — Park Ridge, Illinois, United States
• Pfizer Investigational Site — Durham, North Carolina, United States
• Pfizer Investigational Site — Columbus, Ohio, United States
• Pfizer Investigational Site — Columbus, Ohio, United States
• Pfizer Investigational Site — Houston, Texas, United States
• Pfizer Investigational Site — Katy, Texas, United States
• Pfizer Investigational Site — Hyderabad, Andhra Pradesh, India
• Pfizer Investigational Site — Bangalore, Karnataka, India
• Pfizer Investigational Site — Chennai, Tamil Nadu, India
• Pfizer Investigational Site — Chennai, India
• Pfizer Investigational Site — Mumbai, India
• Pfizer Investigational Site — New Delhi, India
• Pfizer Investigational Site — Moscow, Russia
• Pfizer Investigational Site — Moscow, Russia
• Pfizer Investigational Site — Moscow, Russia
• Pfizer Investigational Site — Saint Petersburg, Russia
• Pfizer Investigational Site — Saint Petersburg, Russia
• Pfizer Investigational Site — Saint Petersburg, Russia
• Pfizer Investigational Site — Saint Petersburg, Russia
• Pfizer Investigational Site — Smolensk, Russia

Full record on ClinicalTrials.gov

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