Efficacy, Safety, & Pharmacokinetics of Candesartan Cilexetil in Hypertensive Paediatric Subjects 6 to < 17 Years of Age
Status:
Completed
Trial end date:
2006-11-01
Target enrollment:
Participant gender:
Summary
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.