NCT00244634

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 238 (planned)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 6 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pediatric Hypertension

Interventions

Type	Name	Description
DRUG	candsartan cilexetil

Timeline

• Start date: 2003-09-01
• Completion: 2005-11-01
• First posted: 2005-10-27
• Last updated: 2007-12-19

Locations

44 sites across 4 countries: United States, Belgium, Hungary, Slovakia