Atacand Dose Range Finding Study in Pediatric Subjects 6 to <17 Years of Age
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|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|
- Trough sitting systolic blood pressure, the measure of effect is change from baseline to double-blind Week 4.
- The endpoint (outcome variable) is the slope by linear regression
- To further evaluate the antihypertensive effects and the safety of candesartan cilexetil in hypertensive pediatric subjects.
- Determine the slope of the change from baseline to double-blind treatment in:
- • trough sitting diastolic blood pressure,
- • trough standing diastolic blood pressure and standing systolic blood pressure,
- • trough sitting pulse pressure.
- - Mean change from baseline in SiSBP, SiDBP, pulse pressure, and standing SBP and DBP relative to placebo for each dose group and for all dose groups pooled
- - Safety as assessed by adverse events, adverse events that necessitate study drug discontinuation, SAEs, heart rate, electrocardiographic findings, physical exam findings, and laboratory tests.
|Study Start Date:||September 2003|
|Study Completion Date:||November 2005|
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|Study Director:||AstraZeneca Atacand Medical Science Director, MD||AstraZeneca|