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NCT00147615 Clinical Trial

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

Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00147615
Other study ID # A6141077
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date October 2004
Est. completion date June 2006

Study information
Verified date December 2020
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 140
Est. completion date June 2006
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 6 Years to 16 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Eplerenone

Locations
Country Name City State
India Pfizer Investigational Site Bangalore Karnataka
India Pfizer Investigational Site Chennai Tamil Nadu
India Pfizer Investigational Site Chennai
India Pfizer Investigational Site Hyderabad Andhra Pradesh
India Pfizer Investigational Site Mumbai
India Pfizer Investigational Site New Delhi
Russian Federation Pfizer Investigational Site Moscow
Russian Federation Pfizer Investigational Site Moscow
Russian Federation Pfizer Investigational Site Moscow
Russian Federation Pfizer Investigational Site Smolensk
Russian Federation Pfizer Investigational Site St. Petersburg
Russian Federation Pfizer Investigational Site St. Petersburg
Russian Federation Pfizer Investigational Site St. Petersburg
Russian Federation Pfizer Investigational Site St. Petersburg
United States Pfizer Investigational Site Columbus Ohio
United States Pfizer Investigational Site Columbus Ohio
United States Pfizer Investigational Site Durham North Carolina
United States Pfizer Investigational Site Houston Texas
United States Pfizer Investigational Site Katy Texas
United States Pfizer Investigational Site Los Angeles California
United States Pfizer Investigational Site Park Ridge Illinois

Sponsors (1)
Lead Sponsor Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Countries where clinical trial is conducted

United States,  India,  Russian Federation, 

Outcome
Type Measure Description Time frame Safety issue
Primary Safety of eplerenone in hypertensive children
Secondary Efficacy and pharmacokinetics of eplerenone in hypertensive children
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