NCT00166634

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
126

participants targeted

Target at P50-P75 for not_applicable hypertension

Timeline
Completed

Started Jul 2003

Longer than P75 for not_applicable hypertension

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2003

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 14, 2005

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

January 11, 2011

Status Verified

January 1, 2011

Enrollment Period

5.7 years

First QC Date

September 9, 2005

Last Update Submit

January 10, 2011

Conditions

Hypertension

Keywords

HypertensionABPMAmbulatory Blood Pressure Monitoring

Outcome Measures

Primary Outcomes (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.

Interventions

Ambulatory Blood Pressure Monitoring (ABPM)PROCEDURE

Eligibility Criteria

Age5 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Arkansas Children's Hospital

Little Rock, Arkansas, 72202, United States

Location

Kosair Children's Hospital

Louisville, Kentucky, 40202, United States

Location

Rainbow Babies and Children's Hospital

Cleveland, Ohio, 44106, United States

Location

University of Utah--Primary Children's Medical Center

Salt Lake City, Utah, 84132, United States

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 14, 2005

Study Start

July 1, 2003

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

January 11, 2011

Record last verified: 2011-01

Locations

US(4)