HypertensionNCT00166634
Ambulatory Blood Pressure Monitoring in Hypertension
A study testing Ambulatory Blood Pressure Monitoring (ABPM) in people with Hypertension, run by Arkansas Children's Hospital Research Institute at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 16 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Ambulatory Blood Pressure Monitoring (ABPM)
- Type of treatment
- Surgery or procedure
- How many people
- 126 participants
- Where
- 4 sitesUnited States
- Study dates
- Jul 2003to Mar 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Rainbow Babies and Children's Hospital
Cleveland, Ohio, 44106
Arkansas Children's Hospital
Little Rock, Arkansas, 72202
Kosair Children's Hospital
Louisville, Kentucky, 40202
University of Utah--Primary Children's Medical Center
Salt Lake City, Utah, 84132
About this study
Official title: The Role of Ambulatory Blood Pressure Monitoring (ABPM) in Interventional Trials Conducted in Children With Hypertension
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.
Read the 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
- Being tested
- Ambulatory Blood Pressure Monitoring (ABPM)
- Keywords
- Hypertension, ABPM, Ambulatory Blood Pressure Monitoring
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ambulatory Blood Pressure Monitoring (ABPM)Procedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startJul 2003
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arkansas Children's Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Pediatric Pharmacology Research Units Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00166634
- Sponsor's protocol ID
- PPRU 10668s
- Status last verified
- Jan 2011
- First submitted
- 9 Sep 2005
- Last updated
- 11 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Ambulatory Blood Pressure Monitoring (ABPM) in Interventional Trials Conducted in Children With Hypertension
- ClinicalTrials.gov ID
- NCT00166634
- Acronym / sponsor ID
- PPRU 10668s
- Conditions
- Hypertension
- Keywords
- Hypertension, ABPM, Ambulatory Blood Pressure Monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Arkansas Children's Hospital Research InstituteUniversity, hospital or other
- Collaborators
- Pediatric Pharmacology Research Units Network
- Study start
- Jul 2003
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 14 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
Who may qualify
- Ages
- 5 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ambulatory Blood Pressure Monitoring (ABPM) | Procedure or surgery | – |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ambulatory Blood Pressure Monitoring (ABPM) in people with Hypertension, run by Arkansas Children's Hospital Research Institute at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2011.