Efficacy, Safety, & Pharmacokinetics of Candesartan Cilexetil in Hypertensive Paediatric Subjects 6 to < 17 Years of Age

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.