Status:
COMPLETED
Ambulatory Blood Pressure Monitoring in Hypertension
Lead Sponsor:
Arkansas Children's Hospital Research Institute
Collaborating Sponsors:
Pediatric Pharmacology Research Units Network
Conditions:
Hypertension
Eligibility:
All Genders
5-16 years
Phase:
NA
Brief Summary
The primary objective of this proposal is to demonstrate that ABPM can be used to improve study design for interventional trials in children with hypertension.
Detailed Description
ABPM is a standard technique in adult antihypertensive trials to study the magnitude and duration of effect of investigational drugs. These methods are needed for pediatric studies. Before such method...
Eligibility Criteria
Inclusion
- Male and female children 5-16 years of age.
- Borderline or mild systolic and or diastolic hypertension as defined by 1996 Task Force criteria.
- No current drug therapy for hypertension being taken.
- Must be ambulatory and willing to wear an ABP monitor for 24 hours
- Agree to refrain from swimming, showering and other activities that might result in damage to ABP monitor during the two 24 hour intervals that the monitor is worn.
- Standing height between 45 inches and 73 inches
- Informed parental consent and patient assent.
Exclusion
- Severe or life threatening hypertension.
- Any drug therapy that may raise or lower the blood pressure.
- Any severe bleeding disorder or concurrent treatment with anticoagulant medications
- Non-ambulatory
- Significant arrhythmia
- Previous history of significant non-compliance with prescribed medical care.
- Any other disease that, in the opinion of the investigator, might interfere with the accurate measurement of the blood pressure or place the subject at risk unnecessarily.
Key Trial Info
Start Date :
July 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2009
Estimated Enrollment :
126 Patients enrolled
Trial Details
Trial ID
NCT00166634
Start Date
July 1 2003
End Date
March 1 2009
Last Update
January 11 2011
Active Locations (4)
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1
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
2
Kosair Children's Hospital
Louisville, Kentucky, United States, 40202
3
Rainbow Babies and Children's Hospital
Cleveland, Ohio, United States, 44106
4
University of Utah--Primary Children's Medical Center
Salt Lake City, Utah, United States, 84132