Atacand Dose Range Finding Study in Pediatric Subjects 6 to <17 Years of Age
NCT ID: NCT00244634
Last Updated: 2007-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
238 participants
INTERVENTIONAL
2003-09-30
2005-11-30
Brief Summary
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Subjects undergo a screening evaluation, then a 1-week, single-blind, placebo run-in after which eligible subjects are allocated to receive 1 of 3 dose levels of candesartan cilexetil or placebo. The study includes 2 panels based on subject weight.
The primary efficacy analysis is based on the intent-to-treat population and tests for slope = 0 in a linear regression model with change in sitting systolic blood pressure as the dependent and non-zero dose pooled across weight panels as the independent variable. For subjects without a Double-Blind Week 4 blood pressure determination, carrying the last value forward assigns the value.
Additional analyses will include data pooled from a similar dose ranging study conducted in children 1 to \< 6 years of age.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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candsartan cilexetil
Eligibility Criteria
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Inclusion Criteria
Subjects with hypertension that is either:
* Diagnosed and untreated with a mean sitting systolic and/or diastolic blood pressure ≥ 95th percentile and ≤ 20 mm Hg (systolic) and/or 10 mm Hg (diastolic) above the 95th percentile at randomisation based on height-adjusted charts for age and gender; or
* Previously diagnosed and currently treated with mean sitting systolic blood pressure and/or diastolic blood pressure ≥ 95th percentile and ≤ 20 mm Hg (systolic) and/or 10 mm Hg (diastolic) above the 95th percentile at randomisation (off treatment) based on height-adjusted charts for age and gender.
Females of childbearing potential (post-menarche) must have a negative urine pregnancy test prior to randomization and adhere to a pregnancy prevention method (abstinence, barrier method plus spermicidal foam, oral, or implanted contraceptive).
A signed informed consent by a parent or a legal guardian and an assent form signed by the subject (if applicable).
Exclusion Criteria
* Hypertension secondary to coarctation of the aorta, pheochromocytoma, hyperthyroidism, Cushing's syndrome, or medications (eg: corticosteroids).
* Known history of bilateral renal artery stenosis, unilateral renal artery stenosis or a renal transplant.
* Glomerular filtration rate \< 50 mL/min based on an estimated value using the Schwartz Formula.
* Nephrotic syndrome not in remission.
* Insulin dependent diabetes mellitus.
* Known bleeding, coagulation, or platelet disorder that could interfere with blood sampling.
* Clinically significant valvular heart disease.
* Clinical diagnosis of heart failure.
* Clinically significant arrhythmia (eg, any arrhythmia requiring medical therapy or that causes symptoms).
* Second or third degree AV block.
* Pregnant or breast-feeding an infant.
* Impaired liver function defined as either acute liver disease or chronic liver disease with persistent liver enzyme values greater than 1½ times the upper limit of the reference range for AST or ALT.
* Known hypersensitivity to ARBs.
* Unable to be off antihypertensive medication (diuretics, beta blockers, ACE Inhibitors, etc) for 6-weeks.
* Inability to discontinue medications which may contribute to elevated blood pressure e.g. systemic corticosteroids.
* Currently using, or used within 14 days prior to receiving double-blind medication, any concomitant medications which in the opinion of the investigator could negatively affect the subject.
* Unable or unwilling to comply with the study requirements including blood sampling and swallowing study drug tablets.
* Received an investigational agent within 30 days prior to receiving study medication.
* Alcohol or drug abuse.
6 Years
17 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Principal Investigators
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AstraZeneca Atacand Medical Science Director, MD
Role: STUDY_DIRECTOR
AstraZeneca
Locations
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Research Site
Beverly Hills, California, United States
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Los Angeles, California, United States
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Madera, California, United States
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Yuba City, California, United States
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Newark, Delaware, United States
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Wilmington, Delaware, United States
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Miami, Florida, United States
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Athens, Georgia, United States
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Augusta, Georgia, United States
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Chicago, Illinois, United States
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Park Ridge, Illinois, United States
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Louisville, Kentucky, United States
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Ann Arbor, Michigan, United States
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Jackson, Mississippi, United States
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Port Gibson, Mississippi, United States
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St Louis, Missouri, United States
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Las Vegas, Nevada, United States
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Paterson, New Jersey, United States
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Brooklyn, New York, United States
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New Hyde Park, New York, United States
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The Bronx, New York, United States
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Charlotte, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Columbus, Ohio, United States
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Portland, Oregon, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Charleston, South Carolina, United States
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Beaumont, Texas, United States
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Houston, Texas, United States
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Salt Lake City, Utah, United States
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Charlottesville, Virginia, United States
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Norfolk, Virginia, United States
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Charleston, West Virginia, United States
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Ghent, , Belgium
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Budapest, , Hungary
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Miskolc, , Hungary
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Szeged, , Hungary
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Bratislava, , Slovakia
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Martin, , Slovakia
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Myjava, , Slovakia
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Trnava, , Slovakia
Countries
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Other Identifiers
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261A
Identifier Type: -
Identifier Source: secondary_id
D2451C00261
Identifier Type: -
Identifier Source: org_study_id