Pediatric Hypertension Clinical Trial
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 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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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