Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-26 @ 12:55 AM
Study NCT ID:
NCT00166634
Status:
COMPLETED
Last Update Posted:
2011-01-11
First Post:
2005-09-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ambulatory Blood Pressure Monitoring in Hypertension
Sponsor:
Arkansas Children's Hospital Research Institute
Organization:
Study Overview
Official Title:
The Role of Ambulatory Blood Pressure Monitoring (ABPM) in Interventional Trials Conducted in Children With Hypertension
Status:
COMPLETED
Status Verified Date:
2011-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: