NCT00244595

A Multicenter, Multinational, Open-Label Study of the Efficacy, Safety, and Pharmacokinetics of Candesartan Cilexetil in Hypertensive Paediatric Subjects 6 to < 17 Years of Age

Completed Phase 3 Last updated 8 December 2009

What this trial tests

Phase 3 trial testing candsartan cilexetil in Hypertension in 235 participants. Completed in 1 November 2006.

Timeline

1 September 2003

1 November 2006

Quick facts

Lead sponsor	AstraZeneca
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	235
Start date	1 September 2003
Estimated completion	1 November 2006
Sites	44 locations across United States, Belgium, Hungary, Slovakia

Drugs / interventions tested

• candsartan cilexetil — full drug profile →

Conditions studied

• Hypertension — all drugs for Hypertension →

Sponsor

AstraZeneca — full company profile →

Who can join

Adults 6 to 17, any sex, with 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.

• - Achieved sitting, trough, systolic blood pressure summarized over time and at Week 52 & the mean of the last two measures.
• - The measure of effect is the mean value and the corresponding descriptive statistics.
• - Additional measures include mean diastolic blood pressure, and the proportion of subjects meeting 'controlled' criteria.

Sponsor's own description

The objectives of this study are to describe candesartan cilexetil antihypertensive effects in terms of achieved blood pressure and hypertension control rates and the relationship between subject characteristics and antihypertensive efficacy, and between antihypertensive therapy (candesartan cilexetil dose and add-on treatments) and efficacy over a 1 year treatment period in hypertensive children ages 6 to \< 17 years; to describe growth in terms of height and weight in the study population; to describe change in neurocognition as assessed by the Full Scaled IQ score in a subset of study subjects; to determine the pharmacokinetics of candesartan in hypertensive paediatric subjects ages 6 to \< 17 years; and to describe safety including adverse events and adverse events necessitating study drug discontinuation including dose level and dose duration relationships and growth over a 1 year period in hypertensive children age 6 to \< 17 years.

Publications & conference data

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