Clinical Trial: Atacand Dose Range Finding Study in Pediatric Subjects 6 to <17 Years of Age

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary:

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.


Detailed Summary:
Sponsor: AstraZeneca

Current Primary Outcome:

  • 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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.


Original Secondary Outcome: Same as current

Information By: AstraZeneca

Dates:
Date Received: October 25, 2005
Date Started: September 2003
Date Completion:
Last Updated: December 17, 2007
Last Verified: December 2007