Atacand Dose Ranging in Hypertensive Pediatric Subjects 1 Year to Less Than 6 Years of Age
Status:
Completed
Trial end date:
2008-08-01
Target enrollment:
Participant gender:
Summary
This is a dose ranging study of candesartan cilexetil in hypertensive pediatric subjects ages
1 to less than 6 years of age. It employs a double blind, randomized, dose ranging design
intended for conduct as a multicenter trial. There are 3 study 'periods': a 1-week placebo
run-in, a 4-week double blind treatment, and a 52-week open-label, long-term treatment
period. 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 (0.05 mg/kg, or 0.20 mg /kg or 0.40 mg /kg), liquid formulation, in a 1:1:1 ratio
for 4-weeks. At the end of randomized dose allocation (Day 28), blood pressure assessment
will be performed and subjects may begin the 52-week, open-label treatment period of the
study.