NCT00244634

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

Completed Phase 3 Last updated 17 December 2007

What this trial tests

Phase 3 trial testing candsartan cilexetil in Pediatric Hypertension in 238 participants. Completed in 1 November 2005.

Timeline

1 September 2003

1 November 2005

Quick facts

Lead sponsor	AstraZeneca
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	238
Start date	1 September 2003
Estimated completion	1 November 2005
Sites	44 locations across United States, Belgium, Hungary, Slovakia

Drugs / interventions tested

• candsartan cilexetil — full drug profile →

Conditions studied

• Pediatric Hypertension — all drugs for Pediatric Hypertension →

Sponsor

AstraZeneca — full company profile →

Who can join

Adults 6 to 17, any sex, with Pediatric Hypertension. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.