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Sponsors and Collaborators: |
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Pediatric Pharmacology Research Unit (PPRU) |
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Information provided by: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
ClinicalTrials.gov Identifier: | NCT00166634 |
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 | Intervention |
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Hypertension |
Procedure: Ambulatory Blood Pressure Monitoring (ABPM) |
Study Type: | Interventional |
Study Design: | Diagnostic, Randomized, Single Blind, Placebo Control, Crossover Assignment |
Official Title: | The Role of Ambulatory Blood Pressure Monitoring (ABPM) in Interventional Trials Conducted in Children With Hypertension |
Estimated Enrollment: | 126 |
Study Start Date: | February 2003 |
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.
Ages Eligible for Study: | 5 Years to 16 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Arkansas | |
Arkansas Children's Hospital | Recruiting |
Little Rock, Arkansas, United States, 72202 | |
Contact: Lee Howard, RN, CCRC 501-364-6990 | |
Principal Investigator: Thomas Wells, M.D. | |
United States, Kentucky | |
Kosair Children's Hospital | Active, not recruiting |
Louisville, Kentucky, United States, 40202 | |
United States, Ohio | |
Rainbow Babies and Children's Hospital | Active, not recruiting |
Cleveland, Ohio, United States, 44106 | |
United States, Utah | |
University of Utah--Primary Children's Medical Center | Active, not recruiting |
Salt Lake City, Utah, United States, 84132 |
Study ID Numbers: | PPRU 10668s |
Study First Received: | September 9, 2005 |
Last Updated: | June 19, 2007 |
ClinicalTrials.gov Identifier: | NCT00166634 |
Health Authority: | United States: Federal Government |
Hypertension ABPM Ambulatory Blood Pressure Monitoring |
Vascular Diseases Hypertension |
Cardiovascular Diseases |