The objectives of this study are to describe candesartan cilexetil antihypertensive effects
in terms of achieved blood pressure and hypertension control rates and the relationship
between subject characteristics and antihypertensive efficacy, and between antihypertensive
therapy (candesartan cilexetil dose and add-on treatments) and efficacy over a 1 year
treatment period in hypertensive children ages 6 to < 17 years; to describe growth in terms
of height and weight in the study population; to describe change in neurocognition as
assessed by the Full Scaled IQ score in a subset of study subjects; to determine the
pharmacokinetics of candesartan in hypertensive paediatric subjects ages 6 to < 17 years; and
to describe safety including adverse events and adverse events necessitating study drug
discontinuation including dose level and dose duration relationships and growth over a 1 year
period in hypertensive children age 6 to < 17 years.
Inclusion Criteria:
- The subjects must have fulfilled the eligibility criteria for and have participated in
Study 261A or did not participate in Study 261A but meet the following criteria:
- Diagnosed and untreated hypertension, or
- Diagnosed and treated, but off antihypertensive treatment for at least 2 days with a
mean sitting systolic blood pressure and/or sitting diastolic blood pressure ≥ 95th
percentile and ≤ 20 mm Hg (systolic) and/or 10 (diastolic) mm Hg above the 95th
percentile based on height-adjusted charts for age and gender.
- Females of childbearing potential (post-menarche), must have a negative urine
pregnancy test and adhere to a pregnancy prevention method (abstinence, a barrier
method plus a spermicidal foam or an 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
(except in Study 261A).
- Alcohol or drug abuse.
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, Trnava, Slovakia
Research Site, Phoenix, Arizona, United States
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
