Ambulatory Blood Pressure Monitoring in Hypertension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00166634
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : January 11, 2011
Pediatric Pharmacology Research Units Network
Information provided by:
Arkansas Children's Hospital Research Institute

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.

Condition or disease Intervention/treatment Phase
Hypertension Procedure: Ambulatory Blood Pressure Monitoring (ABPM) Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single
Primary Purpose: Diagnostic
Official Title: The Role of Ambulatory Blood Pressure Monitoring (ABPM) in Interventional Trials Conducted in Children With Hypertension
Study Start Date : July 2003
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Primary Outcome Measures :
  1. The primary outcome measure is ABPM to examine borderline high blood pressure, mild or untreated blood pressure in children captured within a 24 hour period on two occasions within a week.

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Ages Eligible for Study:   5 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00166634

United States, Arkansas
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
United States, Kentucky
Kosair Children's Hospital
Louisville, Kentucky, United States, 40202
United States, Ohio
Rainbow Babies and Children's Hospital
Cleveland, Ohio, United States, 44106
United States, Utah
University of Utah--Primary Children's Medical Center
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
Arkansas Children's Hospital Research Institute
Pediatric Pharmacology Research Units Network

Additional Information:
Responsible Party: Leah Dawson, Arkansas Children's Hospital Research Institute Identifier: NCT00166634     History of Changes
Other Study ID Numbers: PPRU 10668s
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: January 11, 2011
Last Verified: January 2011

Keywords provided by Arkansas Children's Hospital Research Institute:
Ambulatory Blood Pressure Monitoring

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases