Atacand Dose Range Finding Study in Pediatric Subjects 6 to <17 Years of Age
Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pediatric Hypertension
Intervention: candsartan cilexetil (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s): AstraZeneca Atacand Medical Science Director, MD, Study Director, Affiliation: AstraZeneca
Summary
Study 261A is a dose-ranging and safety study of candesartan cilexetil. It is a
multinational, multicenter, randomized, double-blind, placebo-controlled, parallel-group
study with a 4 week treatment period in hypertensive pediatric subjects.
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.
Clinical Details
Official title: A Dose-Ranging and Safety Study of Candesartan Cilexetil in Hypertensive Pediatric Subjects 6 to <17 Years of Age: A 4-Week, Multinational, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Primary outcome: Trough sitting systolic blood pressure, the measure of effect is change from baseline to double-blind Week 4.The endpoint (outcome variable) is the slope by linear regression
Secondary outcome: To further evaluate the antihypertensive effects and the safety of candesartan cilexetil in hypertensive pediatric subjects.Determine the slope of the change from baseline to double-blind treatment in: • trough sitting diastolic blood pressure, • trough standing diastolic blood pressure and standing systolic blood pressure, • trough sitting pulse pressure. - Mean change from baseline in SiSBP, SiDBP, pulse pressure, and standing SBP and DBP relative to placebo for each dose group and for all dose groups pooled - Safety as assessed by adverse events, adverse events that necessitate study drug discontinuation, SAEs, heart rate, electrocardiographic findings, physical exam findings, and laboratory tests.
Eligibility
Minimum age: 6 Years.
Maximum age: 17 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Male or female ages 6 to < 17 years-of-age after parent or guardian's signing of
informed consent.
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:
- Any situation, clinical condition or laboratory abnormality that, in the opinion of
the investigator or sponsor, may interfere with the subject's participation in the
study or would pose a significant risk to the subject or interfere with the
assessment of safety and efficacy endpoints.
- 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.
Locations and Contacts
Research Site, Gent, Belgium
Research Site, Budapest, Hungary
Research Site, Miskolc, Hungary
Research Site, Szeged, Hungary
Research Site, Bratislava, Slovakia
Research Site, Martin, Slovakia
Research Site, Myjava, Slovakia
Research Site, Trnava, Slovakia
Research Site, Beverly Hills, California, United States
Research Site, Los Angeles, California, United States
Research Site, Madera, California, United States
Research Site, Yuba City, California, United States
Research Site, Newark, Delaware, United States
Research Site, Wilmington, Delaware, United States
Research Site, Miami, Florida, United States
Research Site, Athens, Georgia, United States
Research Site, Augusta, Georgia, United States
Research Site, Chicago, Illinois, United States
Research Site, Park Ridge, Illinois, United States
Research Site, Louisville, Kentucky, United States
Research Site, Ann Arbor, Michigan, United States
Research Site, Jackson, Mississippi, United States
Research Site, Port Gibson, Mississippi, United States
Research Site, St. Louis, Missouri, United States
Research Site, Las Vegas, Nevada, United States
Research Site, Paterson, New Jersey, United States
Research Site, Bronx, New York, United States
Research Site, Brooklyn, New York, United States
Research Site, New Hyde Park, New York, United States
Research Site, Charlotte, North Carolina, United States
Research Site, Winston-Salem, North Carolina, United States
Research Site, Cincinnati, Ohio, United States
Research Site, Cleveland, Ohio, United States
Research Site, Columbus, Ohio, United States
Research Site, Portland, Oregon, United States
Research Site, Philadelphia, Pennsylvania, United States
Research Site, Pittsburgh, Pennsylvania, United States
Research Site, Charleston, South Carolina, United States
Research Site, Beaumont, Texas, United States
Research Site, Houston, Texas, United States
Research Site, Salt Lake City, Utah, United States
Research Site, Charlottesville, Virginia, United States
Research Site, Norfolk, Virginia, United States
Research Site, Charleston, West Virginia, United States
Additional Information
Starting date: September 2003
Last updated: December 17, 2007
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