NCT00166634

Ambulatory Blood Pressure Monitoring in Hypertension

The Role of Ambulatory Blood Pressure Monitoring (ABPM) in Interventional Trials Conducted in Children With Hypertension

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 126 (estimated)
• Sponsor: Arkansas Children's Hospital Research Institute · Academic / Other
• Sex: All
• Age: 5 Years – 16 Years
• Healthy volunteers: Not accepted

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 methods can be developed, preliminary information must be collected to demonstrate that the device can be used for antihypertensive studies in children (i.e, to determine the dropout rate following the first ABP study, to determine the frequency of white coat hypertension in a selected population, to compare casual (office) blood pressures commonly used to diagnose hypertension in children with those obtained by ABPM, and to assess the placebo effect in children with borderline and mild hypertension). All participants will be asked to complete 24 hour ABPM on two occasions within one week. During the ABPM parents and children will be asked to keep a diary recording the times that the child slept. A crossover design will be used, where subjects are initially randomized to either drug or placebo and then will be crossed over to the other intervention at a set time during the study.

Conditions

• Hypertension

Interventions

Type	Name	Description
PROCEDURE	Ambulatory Blood Pressure Monitoring (ABPM)

Timeline

• Start date: 2003-07-01
• Primary completion: 2009-03-01
• Completion: 2009-03-01
• First posted: 2005-09-14
• Last updated: 2011-01-11

Locations

4 sites across 1 country: United States